Department of Health & Human Services (DHHS) Centers for Medicare & Medicaid Services (CMS) Transmittal 2235 Date: June 3, 2011

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anual ystem Pub 100-04 edicare laims Processing Department of ealth & uman ervices (D) enters for edicare & edicaid ervices () Transmittal 2235 Date: June 3, 2011 hange equest 7445 UBJET: July 2011 Update of the mbulatory urgical enter () Payment ystem. UY O NGE: This ecurring Update Notification describes changes to and billing instructions for payment policies implemented in the July 2011 payment system update per hapter 14, section 10. s appropriate, this notification also includes updates to the ealthcare ommon Procedure oding ystem (P). EETVE DTE: July 1, 2011 PLEENTTON DTE: July 5, 2011 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.. NGE N NUL NTUTON: (N/ if manual is not updated) =EVED, N=NEW, D=DELETED-Only One Per ow. /N/D N/ PTE / ETON / UBETON / TTLE. UNDNG: or iscal ntermediaries (s), egional ome ealth ntermediaries (s) and/or arriers: No additional funding will be provided by ; contractor activities are to be carried out within their operating budgets. 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 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 e-mail, and request formal directions regarding continued performance requirements. V. TTENT: ecurring Update Notification *Unless otherwise specified, the effective date is the date of service.

ttachment ecurring Update Notification Pub. 100-04 Transmittal: 2235 Date: June 3, 2011 hange equest: 7445 UBJET: July 2011 Update of the mbulatory urgical enter () Payment ystem Effective Date: July 1, 2011 mplementation Date: July 5, 2011. GENEL NOTON. Background: This ecurring Update Notification describes changes to, and billing instructions for, payment policies implemented in the July 2011 payment system update per hapter 14, section 10. inal policy under the revised payment system, as set forth in edicare Program; evised Payment ystem Policies for ervices urnished in mbulatory urgical enters (s), beginning in Y 2008 (72 42470), requires that payment rates for covered separately payable drugs and biologicals be consistent with the payment rates under the edicare hospital outpatient prospective payment system (OPP). Those rates are updated quarterly. Therefore, beginning with Transmittal 1488P, hange equest () 5994, issued pril 9, 2008, has issued quarterly updates to payment rates for separately paid drugs and biologicals. also updates the lists of covered surgical procedures and covered ancillary services to include newly created P codes, as appropriate. This instruction provides information on six newly created P codes that will be added to the list of covered surgical procedures and nine newly created P codes that will be added to the list of covered ancillary services effective July 1, 2011. n this, is issuing instructions to contractors to modify their systems to accept the July 2011 ee chedule (), the July 2011 Payment ndicator (P) file, the July 2011 DUG file, and the updated pril 2010, July 2010, October 2010, and January 2011 DUG files and to ensure that the updated files properly interface with all other module programming. The July 2011 is an updated file only. The July 2011 P file is a full replacement file. ll of the DUG files are full replacement files that include payment rates for all separately payable drugs and biologicals applicable to the calendar quarter. B. Policy: 1. New ategory PT odes that are eparately Payable under the Payment ystem Effective July 1, 2011 ix new ategory PT codes have been created for payable surgical procedures that are payable for dates of service on and after July 1, 2011. The new P codes, the long descriptors, the short descriptors, and payment indicators are identified in Table 1 below. The new separately payable codes and their payment rates are included in the July 2011 file.

Table 1 -- ategory PT odes mplemented as of July 1, 2011 P ode 0263T 0264T 0265T 0269T Long Descriptor ntramuscular autologous bone marrow cell therapy, with preparation of harvested cells, multiple injections, one leg, including ultrasound guidance, if performed; complete procedure including unilateral or bilateral bone marrow harvest ntramuscular autologous bone marrow cell therapy, with preparation of harvested cells, multiple injections, one leg, including ultrasound guidance, if performed; complete procedure excluding bone marrow harvest ntramuscular autologous bone marrow cell therapy, with preparation of harvested cells, multiple injections, one leg, including ultrasound guidance, if performed; unilateral or bilateral bone marrow harvest only for intramuscular autologous bone marrow cell therapy evision or removal of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed) hort Descriptor m b1 mrw cel ther cmpl m b1 mrw cel ther xcl hrvst m b1 mrw cel ther hrvst onl ev/remvl crtd sns dev total 0270T evision or removal of ev/remvl crtd sns dev G2 Payment ndicator Effective 7/1/2011 G2 G2 G2 G2

0271T carotid sinus baroreflex activation device; lead only, unilateral (includes intra-operative interrogation, programming, and repositioning, when performed) evision or removal of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed) lead ev/remvl crtd sns dev gen G2 2. Billing for Drugs, Biologicals, and adiopharmaceuticals s are strongly encouraged to report charges for all separately payable drugs and biologicals, using the correct P codes for the items used. s billing for these products must make certain that the reported units of service for the reported P codes are consistent with the quantity of the drug or biological that was used in the care of the patient. s should not report P codes and separate charges for drugs and biologicals that receive packaged payment through the payment for the associated covered surgical procedure. reminds s that under the payment system if two or more drugs or biologicals are mixed together to facilitate administration, the correct P codes should be reported separately for each product used in the care of the patient. The mixing together of two or more products does not constitute a "new" drug as regulated by the ood and Drug dministration (D) under the New Drug pplication (ND) process. n these situations, s are reminded that it is not appropriate to bill P code 9399. P code 9399, Unclassified drug or biological, is for new drugs and biologicals that are approved by the D on or after January 1, 2004, for which a P code has not been assigned. Unless otherwise specified in the long description, P descriptions refer to the non-compounded, Dapproved final product. f a product is compounded and a specific P code does not exist for the compounded product, the should include the charge for the compounded product in the charge for the surgical procedure performed. nstructions for downloading the DUG file updates are included in the business requirements section below. P payment updates are posted to the web site quarterly at: http://www.cms.gov/payment/11_ddenda_updates.asp#topofpage a. orrect eporting of Drugs and Biologicals When Used s mplantable Devices When billing for a biological for which the P code describes a product that is solely surgically implanted or inserted, and that is separately payable under the payment system, the should report the P code for the product. f the implanted biological is packaged, that is, not eligible for separate payment under the payment system, the should not report the biological product P code. Units should be reported in multiples of the units included in the P descriptor. s should not bill the units based on the way the implantable biological is packaged, stored, or stocked. The P short descriptors are limited to 28 characters, including spaces, so short descriptors do not always capture the complete description of the implantable biological. Therefore, before submitting edicare claims for biologicals that are used as

implantable devices, it is extremely important to review the complete long descriptors for the applicable P codes. When billing for a biological for which the P code describes a product that may be either surgically implanted or inserted or otherwise applied in the care of a patient, s should not report the P code for the product when the biological is used as an implantable device (including as a scaffold or an alternative to human or nonhuman connective tissue or mesh used in a graft) during surgical procedures. Under the payment system, s are provided a packaged payment for surgical procedures that includes the cost of supportive items. When using biologicals during surgical procedures as implantable devices, s may include the charges for these items in their charge for the procedure. b. orrect eporting of Units for Drugs s are reminded to ensure that units of drugs administered to patients are accurately reported in terms of the dosage specified in the P long code descriptor. That is, units should be reported in multiples of the units included in the P descriptor. or example, if the description for the drug code is 6 mg, and 6 mg of the drug was administered to the patient, the units billed should be 1. s another example, if the description for the drug code is 50 mg, but 200 mg of the drug was administered to the patient, the units billed should be 4. s should not bill the units based on the way the drug is packaged, stored, or stocked. That is, if the P descriptor for the drug code specifies 1 mg and a 10 mg vial of the drug was administered to the patient, bill 10 units, even though only 1 vial was administered. The P short descriptors are limited to 28 characters, including spaces, so short descriptors do not always capture the complete description of the drug. Therefore, before submitting edicare claims for drugs and biologicals, it is extremely important to review the complete long descriptors for the applicable P codes. s discussed in Pub.100-04, edicare laims Processing anual, hapter 17, ection 40, encourages s to use drugs efficiently and in a clinically appropriate manner. owever, also recognizes that s may discard some drug and biological product when administering from a single use vial or package. n that circumstance, edicare pays for the amount of drug or biological discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label. ulti-use vials are not subject to payment for discarded amounts of drug or biological. 3. New P odes for Drugs and Biologicals eparately Payable under the Payment ystem Effective July 1, 2011 a. New P odes for Drugs and Biologicals eparately Payable under the Payment ystem Effective July 1, 2011 Nine drugs and biologicals have been granted payment status effective July 1, 2011. These items, along with their long and short descriptors, and payment indicators are identified in Table 2 below.

Table 2: New Drugs and Biologicals eparately Payable under the Payment ystem Effective July 1, 2011 P ode 9283 9284 9285 9365 9406 Q2041* Q2042 Q2043* Q2044 Long Descriptor njection, acetaminophen, 10 mg njection, ipilimumab, 1 mg Lidocaine 70 mg/tetracaine 70 mg, per patch Oasis Ultra Tri-Layer atrix, per square centimeter odine -123 ioflupane, diagnostic, per study dose, up to 5 millicuries njection, von willebrand factor complex (human), Wilate, 1 i.u. vwf:rco njection, hydroxyprogesterone caproate, 1 mg ipuleucel-t, minimum of 50 million autologous cd54+ cells activated with pap-gm-csf, including leukapheresis and all other preparatory procedures, per infusion njection, belimumab, 10 mg hort Descriptor njection, acetaminophen njection, ipilimumab Patch, lidocaine/tetracaine Oasis Ultra Tri-Layer atrix Dx -123 ioflupane, per dose Wilate injection ydroxyprogesterone caproate ipuleucel-t auto D54+ Belimumab injection P NOTE: The P codes above are new codes effective July 1, 2011. The P codes identified with an asterisk * are replacement codes. P code Q2041 is replacing P code J7184 beginning on July 1, 2011. The payment status of J7184 beginning July 1, 2011 will change from ( Drugs and biologicals paid separately when provided integral to a surgical procedure on list; payment based on OPP rate) to Y5 ( non-surgical procedure/item not valid for edicare purposes because of coverage, regulation and/or statute; no payment made) P code Q2043 is replacing P code 9273 beginning on July 1, 2011. 9273 will be deleted for dates of service July 1, 2011 and forward. The July 2011 P file will reflect the changes P=Y5 for J7184 and P=D5 for 9273 effective 7/1/2011. b. Updated Payment ate for P ode J2505 Effective pril 1, 2010 through June 30, 2010 The payment rate for J2505 was incorrect in the pril 2010 DUG file. The corrected payment rate is listed in Table 3 below and has been included in the revised pril 2010 DUG file effective for services furnished on pril 1, 2010 through implementation of the July 2010 update. uppliers who think they may have

received an incorrect payment between pril 1, 2010 and June 30, 2010 may request contractor adjustment of the previously processed claims. Table 3 -- Updated Payment ate for P ode J2505 Effective pril 1, 2010 through June 31, 2010 P ode hort Descriptor Payment P J2505 njection, pegfilgrastim 6mg $2,386.39 c. Updated Payment ates for ertain P odes Effective July 1, 2010 through eptember 30, 2010 The payment rates for twelve P codes were incorrect in the July 2010 DUG file. The corrected payment rates are listed in Table 4 below and have been included in the revised July 2010 DUG file effective for services furnished on July 1, 2010 through implementation of the October 2010 update. uppliers who think they may have received an incorrect payment between July 1, 2010 and eptember 30, 2010 may request contractor adjustment of the previously processed claims. Table 4 -- Updated Payment ates for ertain P odes Effective July 1, 2010 through eptember 30, 2010 P ode J0150 J2430 J2505 J9065 J9178 J9200 J9206 J9208 J9209 J9211 hort Descriptor Payment P njection adenosine 6 G $11.47 Pamidronate disodium /30 G $15.12 njection, pegfilgrastim 6mg $2,423.91 nj cladribine per 1 G $25.61 nj, epirubicin hcl, 2 mg $2.19 loxuridine injection $34.99 rinotecan injection $3.36 fosfomide injection $29.83 esna injection $4.15 darubicin hcl injection $41.14

J9263 Oxaliplatin $4.35 J9293 itoxantrone hydrochl / 5 G $44.38 d. Updated Payment ates for ertain P odes Effective October 1, 2010 through December 31, 2010 The payment rates for thirteen P codes were incorrect in the October 2010 DUG file. The corrected payment rates are listed in Table 5 below and have been included in the revised October 2010 DUG file effective for services furnished on October 1, 2010 through implementation of the January 2011 update. uppliers who think they may have received an incorrect payment between October 1, 2010 and December 31, 2010 may request contractor adjustment of the previously processed claims. Table 5 -- Updated Payment ates for ertain P odes Effective October 1, 2010 through December 31, 2010 P ode J0150 J2430 J9065 hort Descriptor Payment njection adenosine 6 G $9.59 Pamidronate disodium /30 G $11.81 nj cladribine per 1 G $24.97 nj, epirubicin hcl, 2 mg $9.17 ludarabine phosphate inj $158.16 loxuridine injection $32.17 rinotecan injection $4.68 fosfomide injection $31.54 esna injection $4.62 darubicin hcl injection $84.06 P J9178 J9185 J9200 J9206 J9208 J9209 J9211 J9263 Oxaliplatin $4.60 Pegaspargase J9266 injection $2,675.40 itoxantrone hydrochl / 5 J9293 G $33.48

e. Updated Payment ates for ertain P odes Effective January 1, 2011 through arch 31, 2011 The payment rates for nine P codes were incorrect in the January 2011 DUG file. The corrected payment rates are listed in Table 6 below and have been included in the revised January 2011 DUG file effective for services furnished on January 1, 2011 through implementation of the pril 2011 update. uppliers who think they may have received an incorrect payment between January 1, 2011 and arch 31, 2011 may request contractor adjustment of the previously processed claims. Table 6 -- Updated Payment ates for ertain P odes Effective January 1, 2011 through arch 31, 2011 P ode J9065 J9178 J9200 J9206 J9208 J9211 J9265 J9266 J9293 hort Descriptor Payment nj cladribine per 1 G $24.93 nj, epirubicin hcl, 2 mg $1.90 loxuridine injection $37.92 rinotecan injection $5.31 fosfomide injection $33.40 darubicin hcl injection $118.41 Paclitaxel injection $6.95 Pegaspargase injection $2,701.13 itoxantrone hydrochl / 5 G $33.36 P. BUNE EQUEENT TBLE Use hall" to denote a mandatory requirement Number equirement esponsibility (place an in each applicable column) / D hared- ystem OTE B E aintainers E

7445.1 edicare contractors shall download and install the July 2011 file LENE: U00.@B12390..Y11..JUL.P.V0603 onfirmation and date of retrieval will be provided in a separate email communication from. 7445.2 edicare contractors shall download and install the July 2011 P file LENE: U00.@B12390..Y11.P.JUL.P.V0610 onfirmation and date of retrieval will be provided in a separate email communication from. 7445.3 edicare contractors shall download and install the July 2011 DUG file. LENE: U00.@B12390..Y11.DUG.JUL.P.V0622 Date of retrieval will be provided in a separate email communication from. 7445.4 edicare contractors shall download and install the revised pril 2010 DUG file. LENE: U00.@B12390..Y10.DUG.P.P.V0622 Date of retrieval will be provided in a separate email communication from. 7445.4.1 edicare contractors shall adjust as appropriate claims brought to their attention that: 1) ave dates of service on or after pril 1, 2010 through June 30, 2010 and ; 2) Were originally processed prior to the installation of the revised pril 2010 DUG ile. 7445.5 edicare contractors shall download and install the revised July 2010 DUG file. LENE: U00.@B12390..Y10.DUG.JUL.P.V0622 Date of retrieval will be provided in a separate email communication from. 7445.5.1 edicare contractors shall adjust as appropriate claims brought to their attention that: 1) ave dates of service on or after July 1, 2010 through eptember 31, 2010 and ; 2) Were originally processed prior to the installation V W OB ll EDs OB ll EDs OB ll EDs OB ll EDs OB ll EDs OB ll EDs OB ll EDs

Number equirement esponsibility (place an in each applicable column) / D hared- ystem OTE B E aintainers E of the revised July 2010 DUG ile. V W 7445.6 edicare contractors shall download and install the revised October 2010 DUG file. LENE: U00.@B12390..Y10.DUG.OT.P.V0622 Date of retrieval will be provided in a separate email communication from. 7445.6.1 edicare contractors shall adjust as appropriate claims brought to their attention that: 1) ave dates of service on or after October 1, 2010 through December 31, 2010 and ; 2) Were originally processed prior to the installation of the revised October 2010 DUG ile. 7445.7 edicare contractors shall download and install the revised January 2011 DUG file. LENE: U00.@B12390..Y11.DUG.JN.P.V0622 Date of retrieval will be provided in a separate email communication from. 7445.7.1 edicare contractors shall adjust as appropriate claims brought to their attention that: 1) ave dates of service on or after January 1, 2011 through arch 31, 2011 and ; 2) Were originally processed prior to the installation of the revised January 2011 DUG ile. OB ll EDs OB ll EDs OB ll EDs OB ll EDs 7445.8 W shall assign Type of ervice (TO) for 9283-9285, 9365, 9406, Q2044, Q2041-Q2043, and 0263T-0271T for dates of service beginning July 1, 2011. 7445.9 ontractors shall modify the procedure code file and TO tables for P code 9283-9285, 9365, 9406, Q2044, Q2041-Q2043, 0263T-0271T.

Number equirement esponsibility (place an in each applicable column) / D hared- ystem OTE B E aintainers E 7445.10 ontractors shall accept 9283-9285, 9365, 9406, Q2044, Q2041-Q2043, and 0263T-0271T for claims with a DO beginning July 1, 2011. 7445.11 ontractors shall deny J7184 in their systems effective July 1, 2011 based on the July 2011 P file communicated in this instruction. 7445.11.1 ontractors shall return as unprocessable 9273 in their systems effective July 1, 2011 based on the July 2011 P file communicated in this instruction. 7445.12 ontractors shall make July 2011 fee data for their payment localities available on their Web sites. V W. POVDE EDUTON TBLE Number equirement esponsibility (place an in each applicable column) / D hared- ystem OTE B E aintainers 7445.13 provider education article related to this instruction will be available at http://www.cms.hhs.gov/lnattersrticles/ 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 E V W

Number equirement esponsibility (place an in each applicable column) / D hared- ystem OTE B E aintainers LN atters articles with localized information that would benefit their provider community in billing and administering the edicare program correctly. E V W V. UPPOTNG NOTON ection : or any recommendations and supporting information associated with listed requirements, use the box below: N/ -ef equirement Number ecommendations or other supporting information: ection B: or all other recommendations and supporting information, use this space: N/ V. ONTT Pre-mplementation ontact(s): Payment Policy: huck Braver at chuck.braver@cms.hhs.gov or 410-786-6719;. arrier/ B laims Processing ssues: Yvette ousar at yvette.cousar@cms.hhs.gov or 410-786-2160. Post-mplementation ontact(s): ontact your ontracting Officer s Technical epresentative (OT) or ontractor anager, as applicable. V. UNDNG ection : or iscal ntermediaries (s), egional ome ealth ntermediaries (s), and/or arriers: 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): 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 e-mail, and request formal directions regarding continued performance requirements.