J5 MAC Part B Providers serving beneficiaries in Iowa, Kansas, Missouri and Nebraska

Usually Self-Administered Drugs

The Medicare program provides limited benefits for outpatient prescription drugs. The program covers drugs that are furnished "incident to" a physician's service provided the drugs are not usually self-administered by the patients who take them. On May 15, 2002, the Centers for Medicare & Medicaid Services (CMS) issued Program Memorandum AB- 02-072/Change Request 2200, which contains guidelines to be used by contractors to determine whether a drug or biological is usually self-administered and excluded from payment. For the purposes of applying this exclusion, the term "usually" means more than 50 percent of the time for all Medicare beneficiaries who use the drug. Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage.

The following guidelines are to be used for the process of determining whether a drug is usually self-administered:

Evidentiary Criteria

Only evidence of the following types will be considered: peer reviewed medical literature, standards of medical practice, evidence based practice guidelines, FDA approved labeling information and package inserts.

Presumptions

Because reliable statistical information on the extent of self-administration by the patient may not always be available, the following considerations will be used:

  1. Absent evidence to the contrary, drugs delivered intravenously should be presumed to be not usually self-administered by the patient.
  2. Absent evidence to the contrary, drugs delivered by intramuscular injection should be presumed to be not usually self-administered by the patient.
  3. Absent evidence to the contrary, drugs delivered by subcutaneous injection should be presumed to be usually self-administered by the patient.
Additional consideration will be given to whether the condition being treated by the drug is acute or chronic and the frequency of administration.

Apparent on its Face

For certain injectable drugs, it will be apparent due to the nature of the condition(s) for which they are administered or the usual course of treatment for those conditions, they are, or are not, usually self-administered. For example, an injectable drug used to treat migraine headaches is usually self-administered. On the other hand, an injectable drug, administered at the same time as chemotherapy, used to treat anemia secondary to chemotherapy is not usually self-administered.

The list of drugs identified below have been determined, following the above guidelines, to be usually self-administered by the patients who use them and are excluded from payment. Publication on this list begins a 45 day notice period whereby existing medical review and payment procedures will remain in effect. After the 45-day notice period ends, payment will be denied. The list will be reviewed periodically and updated as further determinations are made. Therefore, the absence of any particular drug on the exclusion list does not mean, at some later date, the drug might be deemed excluded based on the guidelines listed above.

HCPCS Descriptor Notice Date Effective Date of Exclusion Exclusion End Date Comments
J0135 Adalimumab, 20 mg 12/17/2007 02/01/2008    
J0270 Alprostadil injection, 1.25 mcg 12/17/2007 02/01/2008    
J0275 Alprostadil urethral suppository 12/17/2007 02/01/2008    
J3590 Anakinra, 1mg 12/17/2007 02/01/2008    
J0630 Calcitonin-Salmon, up to 400 units 12/17/2007 02/01/2008    
J3590 Efalizumab, 150 mg 12/17/2007 02/01/2008    
J1324 Enfuvirtide, 1 mg 12/17/2007 02/01/2008    
J1438 Etanercept, 25 mg 12/17/2007 02/01/2008    
J3590 Exenatide, 5 mcg 09/01/2008 10/16/2008    
J1595 Glatiramer, 20 mg 12/17/2007 02/01/2008    
J1675 Histrelin, 10 mcg 12/17/2007 02/01/2008    
J1562 Immune globulin subcutaneous, 100 mg(Vivaglobin) 12/17/2007 02/01/2008    
J1815 Insulin, per 5 units 12/17/2007 02/01/2008    
J1817 Insulin for administration through DME, per 50 units 12/17/2007 02/01/2008    
J9212 Interferon alfacon-1, 1 mcg 12/17/2007 02/01/2008    
J1830 Interferon beta- 1b, 0.25 mg 12/17/2007 02/01/2008    
J9216 Interferon gamma-1b, 3 million units 12/17/2007 02/01/2008    
J9218 Leuprolide, 1 mg 12/17/2007 02/01/2008    
J2170 Mecasermin, 1 mg 12/17/2007 02/01/2008    
J2354 Octreotide, nondepot form, 25 mcg 12/17/2007 02/01/2008    
J2440 Papaverine, up to 60 mg 12/17/2007 02/01/2008    
J3590 Peginterferon alfa-2a 12/17/2007 02/01/2008    
J3590 Peginterferon alfa-2b 12/17/2007 02/01/2008    
J3590 Pegvisomant 10 mg 12/17/2007 02/01/2008    
J3490 Pramlintide 3 mg 12/17/2007 02/01/2008    
Q0515 Semorelin 1 mcg 09/01/2008 10/16/2008    
J2941 Somatropin 1 mcg 12/17/2007 02/01/2008    
J2940 Somatrem 1 mg 12/17/2007 02/01/2008    
J3030 Sumatriptan 6 mg 12/17/2007 02/01/2008    
J1350 Testosterone propionate up to 100 mg 12/17/2007 02/01/2008    
J3140 Testosterone suspension up to 50 mg 12/17/2007 02/01/2008    
J3110 Teriparatide 10 mcg 12/17/2007 02/01/2008    
J3355 Urofollitropin 75 IU 12/17/2007 02/01/2008    

 

 

Page Last Updated: Friday, 06-Nov-2009 14:07:32 CST