Descriptor Brand Name. Alprostadil, Caverject, Edex, Prostin VR Pediatric. Calcimar, Miacalcin

Transcription

1 Self-Administered Drug Exclusion List R2 This article from Medicare A News, Issue 2106 dated January 23, 2013 and Medicare B News, Issue 283 dated January 23, 2013 is being revised to add Acthar ACTH gel (J3490), Kynamro (mipomersen sodium) (J3490), and Peginterferon alfa-2b (Sylatron ) (J3490) to the list of Self-Administered Drugs, effective June 26, All other information remains the same. This article provides notification of the Noridian self-administered drug (SAD) determinations. The following SAD list is current as of 05/07/2013. However, our Contractor Medical Directors (CMDs) review the list on an ongoing basis and may update and republish at their discretion. The SAD review process only applies to medications described by the CMS Internet Only Manual (IOM) Medicare Benefit Policy Manual, Publication , Chapter 15, Section 50.2 at Guidance/Guidance/Manuals/Downloads/bp102c15.pdf. Based on chronic, frequent injections, typically by the patient and with prolonged use, Noridian has determined that the following drugs are usually self-administered and therefore NOT COVERED by the Medicare program effective for dates of service on/after the date of service listed. (The article Self-Administered Drugs Process to Determine Which Drugs Are Usually Self-Administered by the Patient was published on our website. Code J0135 J0270 J0275 J0630 J1324 Descriptor Generic Name Injection, Adalimumab, 20 Injection, alprostadil per 1.25, mcg Alprostadil urethral suppository, Injection, calcitonin salmon, up to 400 units Injection, enfuvirtide, 1 Descriptor Brand Name Humira Alprostadil, Caverject, Edex, Prostin VR Pediatric Muse Calcimar, Miacalcin Fuzeon Exclusion Effective Date Exclusion End Date

2 J1438 Injection, etanercept, 25 Enbrel J1559 Injection, immune globulin, 100 Hizentra 02/15/2011 N/A J1562 Injection, immune globulin, 100 Vivaglobin J1595 Injection, glatiramer acetate, 20 Copaxone J1675 Injection, histrelin acetate, 10 mcg Supprelin LA 07/15/2006 N/A J1744 Injection, Icatibant, 1 Firazyr 07/31/2012 N/A J1815 J1817 J1830 J2170 J2354 J2440 Injection, insulin per 5 units Insulin for administration through DME per 50 units (i.e. insulin pump) Injection interferon beta- 1b, 0.25 Injection, mecasermin, 1 Injection, ocetreotide, non-depot form for sub-q or intravenous injection, 25 mcg Injection, papaverine HCL, up to 60 Humalog, Humulin, Iletin, Insulin Lispro, Lantus, Levemir, NPH, Pork Insulin, Regular Insulin, Ultralente, Velosulin, Humulin R, Iletin II Regular Pork, Insulin Purified Pork, Relion, Lente Iletin I, Novolin R, Humulin R U-500 Humalog, Humulin, Vesolin BR, Iletin II NPH Pork, Lispro- PFC, Novolin, Novolog, Novolog Flexpen, Novolog Mix, Relion Novolin Betaseron Iplex, Increlex Sandostatin

3 J2940 J2941 Injection, somatrem, 1 Injection somatropin, 1 Protropin Humatrope, Genotropin Nutropin, Biotropin, Genotropin, Genotropin Miniquick, Norditropin, Nutropin, Nutropin AQ, Omnitrope, Saizen, Saizen Somatropin RDNA Origin, Serostim, Serostim RDNA Origin, Zorbtive J3030 Injection sumatriptan succinate, 6 Imitrex J3110 Injection, teriparatide, 10 mcg Forteo J3140 Injection, testosterone suspension, up to 50 J3150 Injection, testosterone propionate, up to 100 J3355 Injection, urofollitropin, 75 Metrodin, Bravelle, IU Fertinex exanatide (Byetta ), 04/01/2006 N/A Acthar ACTH gel 06/26/2013 N/A Kynamro (mipomersen sodium) 06/26/2013 N/A Peginterferon alfa-2b (Sylatron ) 06/26/2013 N/A pramlintide acetate (Symlin ), 04/01/2006 N/A anakinra (Kineret ), efalizumab (Raptiva ),

4 J9212 J9213 J9216 J9218 Q0515 Q3025 Injection, interferon alfacon-1, recombinant, 1 mcg Injection, interferon, alfa- 2a, recombinant, 3 million units Injection, interferon gamma-1b, 3 million units Leuprolide acetate, per 1 Injection, sermorelin acetate, 1 mcg Injection, interferon beta- 1a, 11 mcg for IM use peginterferon, alfa-2a (Pegasys ), Peginterferon, alfa-2b (Peg-Intron ), pegvisomant (Somavert ), Infergen Roferon-A Actimmune Lupron Avonex, Rebif 05/01/2005 N/A 10/20/2010 N/A Providers are reminded that no form of insulin, regardless of route of administration including intravenous, intramuscular, subcutaneous, or inhalation, is reimbursable by Medicare. [This includes J8499-Insulin, inhaled (Exubera ), ] If a beneficiary's claim for a particular drug is denied because the drug is subject to the self-administered drug exclusion, the beneficiary may appeal the denial. Because it is a benefit category denial and not a denial based on medical necessity, an Advance Beneficiary Notice of Non-coverage (ABN) is not required. A benefit category denial (i.e., a denial based on the fact that there is no benefit category under which the drug may be covered) does not trigger the financial liability protection provisions of Limitation On Liability [under Section 1879 of the Act]. Therefore, physicians or providers may charge the beneficiary for such an excluded drug. Provider and Physician Appeals The hospital and a physician accepting assignment may appeal a denial under the provisions found in the IOM Medicare Claims Processing Manual, Publication , Chapter 29, Section 200 at Guidance/Guidance/Manuals/Downloads/clm104c29.pdf.

5 Reasonable and Necessary Noridian will make the determination of reasonable and necessary with respect to the medical appropriateness of the drug to treat the patient s condition and will continue to make the determination of whether the intravenous or injection form of a drug is appropriate, as opposed to the oral form. We will also continue to make the determination as to whether a physician s office visit was reasonable and necessary. However, while a physician s office visit may not be reasonable and necessary in a specific situation, the medical necessity of the injection will still be determined on its own merits based on this process for determining which drugs are usually selfadministered. Sources: IOM Medicare Benefit Policy Manual, Publication , Chapter 15, Covered Medical and Other Health Services, Section 50.2, Determining Self- Administration of Drug or Biological; Transmittal 123, CR 6950 dated April 30, 2010