CMS Expected To Issue Clarification on Medicare Coverage of Self-Injected Medications

In the next few weeks, CMS officials and HHS Secretary Tommy Thompson are expected to issue a clarification on Medicare's policy for covering injectable drugs administered by patients -- an announcement that could have a big impact on patients and drugmakers, the Wall Street Journal reports. In general, Medicare only pays for injectable drugs that are administered in a doctor's office as part of medical treatment and does not pay for injectable drugs patients give themselves, such as insulin. Over a year ago, however, Congress said that Medicare should cover self-injected drugs that are "not usually self-administered by the patients" without defining exactly what "not usually" means. CMS, which was left to interpret the meaning, has not yet done so, and throughout the country, private insurance companies that contract with Medicare have been making different reimbursement decisions on the same drugs. The Journal reports that it is unclear how the government and private contractors should decide whether a drug is usually self-administered or not. One way is to use drug company customer data to see whether a drug is usually administered by a doctor or a patient. Another way is to rely on FDA labeling, which often says whether self-administration is safe. Coverage could also be determined by whether the shot goes into muscle, which is a difficult procedure, or skin, which is easier. As CMS mulls its decision, the "stakes are high" for certain drug companies, such as Amgen and Biogen, which make injectable drugs that treat multiple sclerosis, anemia and side effects of chemotherapy, the Journal reports. Companies and patient-advocacy groups have been "furious[ly] lobbying," as winning Medicare coverage can affect the likelihood that a drug is prescribed and sold (Lueck, Wall Street Journal, 4/11).