Department of Health & CMS Manual System Human Services (DHHS) Pub 100-04 Medicare Claims Center for Medicare & Processing Medicaid Services (CMS) Transmittal 756 Date: NOVEMBER 10, 2005 Change Request 4142 SUBJECT: Temporary Hook and Hold of OPPS Claims that Include Certain HCPCS with Status Indicator of G or K

I. SUMMARY OF CHANGES: A standard system program must be created to “hook” and hold claims with bill types 12x, 13x,14x, or 76x or 13x with condition code 41, with dates of service on or after January 1, 2006, where one or more of the HCPCS codes with status indicator G or K, from the attached list, is included.

NEW/REVISED MATERIAL EFFECTIVE DATE: January 01, 2006 IMPLEMENTATION DATE: January 03, 2006

Disclaimer for manual changes only: The revision date and transmittal number apply only to red italicized material. Any other material was previously published and remains unchanged. However, if this revision contains a table of contents, you will receive the new/revised information only, and not the entire table of contents.

II. CHANGES IN MANUAL INSTRUCTIONS: (N/A if manual is not updated) R = REVISED, N = NEW, D = DELETED – Only One Per Row. R/N/D Chapter / Section / SubSection / Title

III. FUNDING: No additional funding will be provided by CMS; Contractor activities are to be carried out within their FY 2006 operating budgets.

IV. ATTACHMENTS: One-Time Notification *Unless otherwise specified, the effective date is the date of service.

Attachment – One-Time Notification

Pub. 100-04 Transmittal: 756 Date: November 10, 2005 Change Request 4142

SUBJECT: Temporary Hook and Hold of OPPS Claims that Include Certain HCPCS with Status Indicator of G or K

I. GENERAL INFORMATION

A. Background: CMS has proposed to pay for all outpatient drugs using ASP pricing. The schedule for submission of all ASP pricing is statutory per Section 621(a) of the MMA. Drug manufacturers are required to submit drug ASPs within 30 days of the close of their fiscal quarter. Given the complexity, volume of data, and the number of drugs effected, approximately 6 weeks are required to process, validate, and issue final ASPs for a given quarter. The ASP rates for drugs furnished on or after January 1, 2006, won’t be available until mid-December, 2005.

The 2006 OPPS Pricer is ready for implementation on January 1, 2006. However, the drug HCPCS, which are included in the attached list, won’t have the new drug prices included, for the reasons explained above. All submitted claims after January 1, 2006, should be processed and paid except for those claims that include one or more listed HCPCS codes (with status indicator G or K) on the attached list of drugs. These claims will need to be held until a revised Pricer, that includes the new drug payment information, can be finalized, validated and tested. We expect to have the revised Pricer available as soon as possible after January 1, 2006.

B. Policy: A standard system program must be created to “hook” and hold claims with bill types 12x, 13x, 14x, or 76x or 13x with condition code 41, with dates of service on or after January 1, 2006, where one or more of the HCPCS codes with status indicator G or K, from the attached list, is included. Those claims can be processed to payment when the revised OPPS Pricer software has become effective in production.

II. BUSINESS REQUIREMENTS

“Shall" denotes a mandatory requirement "Should" denotes an optional requirement

Requirement Requirements Responsibility (“X” indicates the Number columns that apply) F R C D Shared System Other I H a M Maintainers H r E F M V C I r R I C M W i C S S S F e S r Requirement Requirements Responsibility (“X” indicates the Number columns that apply) F R C D Shared System Other I H a M Maintainers H r E F M V C I r R I C M W i C S S S F e S r 4142.1 The standards system maintainer shall create a X program to form a “hook” to hold claims with bill types 12x, 13x, 14x, or 76 x or 13x with condition code 41, with dates of services on or after 1/1/2006, that include HCPCS codes from the attached list with status indicator G or K. 4142.2 The fiscal intermediary shall process “hooked” X claims to payment after the revised Pricer software has become effective in production

III. PROVIDER EDUCATION

Requirement Requirements Responsibility (“X” indicates the Number columns that apply) F R C D Shared System Other I H a M Maintainers H r E F M V C I r R I C M W i C S S S F e S r 4142.3 No provider education is required for this X instruction.

IV. SUPPORTING INFORMATION AND POSSIBLE DESIGN CONSIDERATIONS

A. Other Instructions: N\A

X-Ref Requirement # Instructions

B. Design Considerations: N\A

X-Ref Requirement # Recommendation for Medicare System Requirements

C. Interfaces: N\A

D. Contractor Financial Reporting/Workload Impact: N\A

E. Dependencies: N\A

F. Testing Considerations: N\A

V. SCHEDULE, CONTACTS, AND FUNDING

Effective Date*: January 1, 2006 No additional funding will be provided by CMS; contractor Implementation Date: January 3, 2006 activities are to be carried out within their FY 2006 operating Pre-Implementation Contact(s): Chuck Braver, budgets. (410) 786-6719

Post-Implementation Contact(s): Appropriate Regional Office

*Unless otherwise specified, the effective date is the date of service.

Attachment List of Hook and Hold Specific HCPCS Codes 1

2006 2006 HCPCS Description 2006 SI APC C9220 Sodium hyaluronate G 9220 C9221 Graftjacket Reg Matrix G 9221 C9222 Graftjacket SftTis G 9222 C9225 Fluocinolone acetonide G 9225 J0128 Abarelix, Inject Suspension G 9216 J0878 Injection, daptomycin G 9124 J2278 Ziconotide injection G 1694 J2357 Injection, Omalizumab G 9300 J2503 Pegaptanib sodium injection G 1697 J2783 Rasburicase G 0738 J2794 Injection, risperidone G 9125 J7518 Mycophenolic Acid, Oral G 9219 J8501 Oral aprepitant G 0868 J9027 Clofarabine injection G 1710 J9035 Injection, Bevacizumab G 9214 J9055 Injection, Cetuximab G 9215 J9264 Paclitaxel injection G 1712 J9305 Injection, Pemetrexed G 9213 Q4079 Injection, natalizumab G 9126 C1178 BUSULFAN IV, 6 Mg K 1178 C9003 Palivizumab, per 50 mg K 9003 C9121 Injection, argatroban K 9121 J0130 Abciximab injection K 1605 J0135 Adalimumab injection K 1083 J0150 Injection adenosine 6 MG K 0379 J0152 Adenosine injection K 0917 J0180 Injection, agalsidase beta K 9208 J0205 Alglucerase injection K 0900 J0207 Amifostine K 7000 J0210 Methyldopate hcl injection K 2210 J0256 Alpha 1 proteinase inhibitor K 0901 J0285 Amphotericin B K 9030 J0287 Amphotericin b lipid complex K 9024 J0288 Ampho b cholesteryl sulfate K 0735 J0289 Amphotericin b liposome inj K 0736 J0395 Arbutamine HCl injection K 9031 J0475 Baclofen 10 MG injection K 9032 J0475 Baclofen 10 MG injection K 9032 J0585 Botulinum toxin a per unit K 0902 J0587 Botulinum toxin type B K 9018 J0600 Edetate calcium disodium inj K 0892 J0630 Calcitonin salmon injection K 0893 J0637 Caspofungin acetate K 9019 J0706 Caffeine citrate injection K 0876 J0735 Clonidine hydrochloride K 0935 J0740 Cidofovir injection K 9033 J0800 Corticotropin injection K 1280 J0835 Inj cosyntropin per 0.25 MG K 0835 J0850 Cytomegalovirus imm IV /vial K 0903 J0895 Deferoxamine mesylate inj K 0895 List of Hook and Hold Specific HCPCS Codes 2

2006 2006 HCPCS Description 2006 SI APC J1110 Inj dihydroergotamine mesylt K 1210 J1190 Dexrazoxane HCl injection K 0726 J1260 Dolasetron mesylate K 0750 J1327 Eptifibatide injection K 1607 J1330 Ergonovine maleate injection K 1330 J1410 Inj estrogen conjugate 25 MG K 9038 J1436 Etidronate disodium inj K 1436 J1438 Etanercept injection K 1608 J1440 Filgrastim 300 mcg injection K 0728 J1441 Filgrastim 480 mcg injection K 7049 J1452 Intraocular Fomivirsen na K 9040 J1457 Gallium nitrate injection K 1085 J1565 RSV-ivig K 0906 J1566 Immune globulin, powder K 2731 J1567 Immune globulin, liquid K 2732 J1610 Glucagon hydrochloride/1 MG K 9042 J1620 Gonadorelin hydroch/ 100 mcg K 7005 J1626 Granisetron HCl injection K 0764 J1655 Tinzaparin sodium injection K 1655 J1670 Tetanus immune globulin inj K 1670 J1730 Diazoxide injection K 1740 J1742 Ibutilide fumarate injection K 9044 J1745 Infliximab injection K 7043 J1756 Iron sucrose injection K 9046 J1785 Injection imiglucerase /unit K 0916 J1830 Interferon beta-1b / .25 MG K 0910 J1835 Itraconazole injection K 9047 J1931 Injection, laronidase K 9209 J1950 Leuprolide acetate /3.75 MG K 0800 J2020 Linezolid injection K 9001 J2353 Octreotide injection, depot K 1207 J2355 Oprelvekin injection K 7011 J2405 Ondansetron hcl injection K 0768 J2425 Palifermin injection K 1696 J2430 Pamidronate disodium /30 MG K 0730 J2469 Injection, palonosetron HCL K 9210 J2505 Injection, pegfilgrastim 6mg K 9119 J2700 Oxacillin sodium injeciton K 1635 J2730 Pralidoxime chloride inj K 2730 J2770 Quinupristin/dalfopristin K 2770 J2788 Rho d immune globulin 50 mcg K 9023 J2790 Rho d immune globulin inj K 0884 J2792 Rho(D) immune globulin h, sd K 1609 J2820 Sargramostim injection K 0731 J2940 Somatrem injection K 2940 J2941 Somatropin injection K 7034 J2993 Reteplase injection K 9005 J2995 Inj streptokinase /250000 IU K 0911 J2997 Alteplase recombinant K 7048 J3030 Sumatriptan succinate / 6 MG K 3030 List of Hook and Hold Specific HCPCS Codes 3

2006 2006 HCPCS Description 2006 SI APC J3100 Tenecteplase injection K 9002 J3240 Thyrotropin injection K 9108 J3246 Tirofiban hydrochloride K 7041 J3305 Inj trimetrexate glucoronate K 7045 J3315 Triptorelin pamoate K 9122 J3350 Urea injection K 9051 J3365 Urokinase 250,000 IU inj K 7036 J3396 Verteporfin injection K 1203 J3465 Injection, voriconazole K 1052 J3487 Zoledronic acid K 9115 J7190 Factor viii K 0925 J7191 Factor VIII (porcine) K 0926 J7192 Factor viii recombinant K 0927 J7193 Factor IX non-recombinant K 0931 J7194 Factor ix complex K 0928 J7195 Factor IX recombinant K 0932 J7198 Anti-inhibitor K 0929 J7308 Aminolevulinic acid hcl top K 7308 J7310 Ganciclovir long act implant K 0913 J7342 Metabolically active tissue K 9054 J7344 Nonmetabolic active tissue K 9156 J7350 Injectable human tissue K 9055 J7501 Azathioprine parenteral K 0887 J7502 Cyclosporine oral 100 mg K 0888 J7504 Lymphocyte immune globulin K 0890 J7505 Monoclonal antibodies K 7038 J7507 Tacrolimus oral per 1 MG K 0891 J7511 Antithymocyte globuln rabbit K 9104 J7513 Daclizumab, parenteral K 1612 J7515 Cyclosporine oral 25 mg K 7515 J7517 Mycophenolate mofetil oral K 9015 J7520 Sirolimus, oral K 9020 J7525 Tacrolimus injection K 9006 J8510 Oral busulfan K 7015 J8520 Capecitabine, oral, 150 mg K 7042 J8560 Etoposide oral 50 MG K 0802 J8700 Temozolomide K 1086 J9001 Doxorubicin hcl liposome inj K 7046 J9010 Alemtuzumab injection K 9110 J9015 Aldesleukin/single use vial K 0807 J9017 Arsenic trioxide K 9012 J9020 Asparaginase injection K 0814 J9031 Bcg live intravesical vac K 0809 J9040 Bleomycin sulfate injection K 0857 J9041 Injection, bortezomib K 9207 J9045 Carboplatin injection K 0811 J9050 Carmus bischl nitro inj K 0812 J9065 Inj cladribine per 1 MG K 0858 J9098 Cytarabine liposome K 1166 J9130 Dacarbazine 100 mg inj K 0819 List of Hook and Hold Specific HCPCS Codes 4

2006 2006 HCPCS Description 2006 SI APC J9150 Daunorubicin K 0820 J9151 Daunorubicin citrate liposom K 0821 J9160 Denileukin diftitox, 300 mcg K 1084 J9170 Docetaxel K 0823 J9178 Inj, epirubicin hcl, 2 mg K 1167 J9185 Fludarabine phosphate inj K 0842 J9200 Floxuridine injection K 0827 J9201 Gemcitabine HCl K 0828 J9202 Goserelin acetate implant K 0810 J9206 Irinotecan injection K 0830 J9208 Ifosfomide injection K 0831 J9209 Mesna injection K 0732 J9211 Idarubicin hcl injection K 0832 J9212 Interferon alfacon-1 K 0912 J9213 Interferon alfa-2a inj K 0834 J9214 Interferon alfa-2b inj K 0836 J9215 Interferon alfa-n3 inj K 0865 J9216 Interferon gamma 1-b inj K 0838 J9217 Leuprolide acetate suspnsion K 9217 J9218 Leuprolide acetate injeciton K 0861 J9219 Leuprolide acetate implant K 7051 J9245 Inj melphalan hydrochl 50 MG K 0840 J9265 Paclitaxel injection K 0863 J9266 Pegaspargase/singl dose vial K 0843 J9268 Pentostatin injection K 0844 J9270 Plicamycin (mithramycin) inj K 0860 J9280 Mitomycin 5 MG inj K 0862 J9293 Mitoxantrone hydrochl / 5 MG K 0864 J9300 Gemtuzumab ozogamicin K 9004 J9310 Rituximab cancer treatment K 0849 J9320 Streptozocin injection K 0850 J9340 Thiotepa injection K 0851 J9350 Topotecan K 0852 J9355 Trastuzumab K 1613 J9390 Vinorelbine tartrate/10 mg K 0855 J9395 Injection, Fulvestrant K 9120 J9600 Porfimer sodium K 0856 P9041 Albumin (human),5%, 50ml K 0961 P9045 Albumin (human), 5%, 250 ml K 0963 P9046 Albumin (human), 25%, 20 ml K 0964 P9047 Albumin (human), 25%, 50ml K 0965 Q0166 Granisetron HCl 1 mg oral K 0765 Q0179 Ondansetron HCl 8mg oral K 0769 Q0180 Dolasetron mesylate oral K 0763 Q2009 Fosphenytoin, 50 mg K 7028 Q2017 Teniposide, 50 mg K 7035 Q3025 IM inj interferon beta 1-a K 9022

Q9945 LOCM <=149 mg/ml iodine, 1ml K 9157 List of Hook and Hold Specific HCPCS Codes 5

2006 2006 HCPCS Description 2006 SI APC

Q9946 LOCM 150-199mg/ml iodine,1ml K 9158

Q9947 LOCM 200-249mg/ml iodine,1ml K 9159

Q9948 LOCM 250-299mg/ml iodine,1ml K 9160

Q9949 LOCM 300-349mg/ml iodine,1ml K 9161

Q9950 LOCM 350-399mg/ml iodine,1ml K 9162

Q9951 LOCM >= 400 mg/ml iodine,1ml K 9163

Q9952 Inj Gad-base MR contrast, ml K 9164

Q9954 Oral MR contrast, 100 ml K 9165 Q9955 Perflexane lipid micro K 9203 Q9956 Octafluoropropane K 9202 Q9957 Perflutren lipid micro, 2ml K 9112 90371 Hep b ig, im K 1630 90375 Rabies ig, im/sc K 9133 90376 Rabies ig, heat treated K 9134 90396 Varicella-zoster ig, im K 9135 90476 Adenovirus vaccine, type 4 K 9136 90581 Anthrax vaccine, sc K 9169 90585 Bcg vaccine, percut K 9137 90636 Hep a/hep b vacc, adult im K 9138 90665 Lyme disease vaccine, im K 9170 90675 Rabies vaccine, im K 9139 90676 Rabies vaccine, id K 9140 90708 Measles-rubella vaccine, sc K 9141 90714 Td vaccine no prsrv >/= 7 im K 1634 90716 Chicken pox vaccine, sc K 9142 90717 Yellow fever vaccine, sc K 1636 90733 Meningococcal vaccine, sc K 9143 90734 Meningococcal vaccine, im K 9145 90735 Encephalitis vaccine, sc K 9144 A9535 Injection, methylene blue K 1640 C9224 Injection, galsulfase K 9224 J0132 Acetylcysteine injection K 1680 J0215 Alefacept K 1633 J0215 Alefacept K 1633 J0278 Amikacin sulfate injection K 1681 J0350 Injection anistreplase 30 u K 1606 J0365 Aprotonin, 10,000 kiu K 1682 J0470 Dimecaprol injection K 1638 J0476 Baclofen intrathecal trial K 1631 J0480 Basiliximab K 1683 J0795 Corticorelin ovine triflutal K 1684 J0881 Darbepoetin alfa, non-esrd K 1685 List of Hook and Hold Specific HCPCS Codes 6

2006 2006 HCPCS Description 2006 SI APC J0885 Epoetin alfa, non-esrd K 1686 J1162 Digoxin immune fab (ovine) K 1687 J1180 Dyphylline injection K 9166 J1430 Ethanolamine oleate K 1688 J1451 Fomepizole K 1689 J1640 Hemin K 1690 J1751 Iron dextran 165 injection K 1691 J1752 Iron dextran 267 injection K 1692 J1945 Lepiridin K 1693 J2325 Nesiritide injection K 1695 J2504 Pegademase bovine, 25 iu K 1739 J2513 Pentastarch 10% solution K 1698 J2805 Sincalide injection K 1699 J2850 Inj secretin synthetic human K 1700 J2910 Aurothioglucose injeciton K 1639 J3285 Treprostinil injection K 1701 J3355 Urofollitropin, 75 iu K 1741 J3470 Hyaluronidase injection K 1637 J3471 Ovine, up to 999 USP units K 1702 J3472 Ovine, 1000 USP units K 1703 J7188 Inj Vonwillebrand factor iu K 1704 J7189 Factor viia K 1705 J7197 Antithrombin iii injection K 0930 J7318 Hyaluron/deriv intra-art inj K 1706 J7340 Metabolic active D/E tissue K 1632 J7340 Metabolic active D/E tissue K 1632 J7341 Non-human, metabolic tissue K 1707 J7343 Nonmetabolic act d/e tissue K 1629 J8540 Oral dexamethasone K 1708 J9025 Azacitidine injection K 1709 J9225 Histrelin implant K 1711 J9263 Oxaliplatin K 1738 J9357 Valrubicin, 200 mg K 9167

Q9953 Inj Fe-based MR contrast, ml K 1713 Q9958 HOCM <=149 mg/ml iodine K 1714 Q9960 HOCM 200-249mg/ml iodine K 1715 Q9961 HOCM 250-299mg/ml iodine K 1734 Q9962 HOCM 300-349mg/ml iodine K 1735 Q9963 HOCM 350-399mg/ml iodine K 1736 Q9964 HOCM >= 400 mg/ml iodine K 1737