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 and 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:
- Absent evidence to the contrary, drugs delivered intravenously should be presumed to be not usually self-administered by the patient.
- Absent evidence to the contrary, drugs delivered by intramuscular injection should be presumed to be not usually self-administered by the patient.
- 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 |
| J1562 | Immune Globulin Subcutaneous (Vivaglobin) | 01/01/07 | 02/15/07 |
| J2170 | Mecasermin rinfabate | 01/01/07 | 02/15/07 |
| J3590 | Efalizumab | 04/01/06 | 05/16/06 |
| J3590 | Anakinra | 04/01/06 | 05/16/06 |
| J1324 | Enfuvirtide | 04/01/06 | 05/16/06 |
| J1595 | Glatiramer | 04/01/06 | 05/16/06 |
| J1675 | Histrelin acetate 10mg | 02/01/06 | 03/18/06 |
| Q0515 | Sermorelin acetate, 1 microgram | 01/01/06 | 02/15/06 |
| J3590 | Peginterferon alfa-2a | 07/01/05 | 08/15/05 |
| J3490 | Pramlintide acetate | 07/01/05 | 08/15/05 |
| J3590 | Exenatide | 07/01/05 | 08/15/05 |
| J3110 | Teriparatide*** | 11/01/03 | 12/15/03 |
| J3590 | Peginterferon Alfa-2B | 11/01/03 | 12/15/03 |
| J0135 | Adalimumab*** | 07/03/03 | 08/17/03 |
| J3490 | Nitroglycerin lingual spray | 04/01/03 | 05/16/03 |
| J1438 | Etanercept | 03/01/03 | 04/15/03 |
| J9212 | Interferon alfacon-1, recombinant | 03/01/03 | 04/15/03 |
| J9216 | Interferon, gamma 1-B | 03/01/03 | 04/15/03 |
| Q3026 | Interferon beta-1a* | 03/01/03 | 04/15/03 |
| J0275 | Alprostadil urethral suppository | 12/01/02 | 01/15/03 |
| J2760 | Phentolamine mesylate injection, up to 5mg | 12/01/02 | 01/15/03 |
| J2440 | Papaverine HCL injection (up to 60 mg) | 12/01/02 | 01/15/03 |
| J1820 | Insulin | 10/15/02 | 11/29/02 |
| J1815 | Insulin** | 01/01/03 | |
| J0270 | Alprostadil injection | 10/15/02 | 11/29/02 |
| J2940 | Somatrem | 10/15/02 | 11/29/02 |
| J2941 | Somatropin | 10/15/02 | 11/29/02 |
| J0630 | Calcitonin-salmon | 10/15/02 | 11/29/02 |
| J2354 | Octreotide acetate* | 10/15/02 | 11/29/02 |
| J1830 | Interferon beta 1b | 10/15/02 | 11/29/02 |
| J9218 | Leuprolide acetate, 1mg | 10/15/02 | 11/29/02 |
| J3030 | Sumatriptan succinate | 10/15/02 | 11/29/02 |
|
***True Code effective 01/01/05 *For subcutaneous injection **Dosage change; new code 01/01/03 |
|||
Page Last Updated: Monday, 09-Jun-2008 13:20:32 CDT
