Drug & Device News

Fed. Court Says Medicare Must Cover Off-Label
Prescriptions

In Layzer v. Leavitt, 07 Civ. 11339 (HB), NYLJ 1202485563289, at *1 (SDNY, Decided March 7, 2011), the U.S. Court of Appeals for the Southern District of New York recently concluded that the Department of Health and Human Services must cover the costs of prescription medications prescribed “off label.” The case involved two patients, one prescribed Cetrotide to treat a rare form of ovarian cancer and the other prescribed Increlex to treat a rare and degenerative form of muscular dystrophy. Their Medicare Part D plan sponsors denied coverage for the drugs because they had not been approved by the Food and Drug Administration (FDA) for treatment of the two patients' conditions. On appeal, a Medicare Part D Independent Review Entity affirmed the denials, concluding that the plan sponsors were not required to provide coverage because the drugs were not being used for a medically accepted indication. The appeals authority explained that “a medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in ' drug compendia.” (The compendia are: 1) the American Hospital Formulary Service Drug Information; 2) the United States Pharmacopeia-Drug Information; and 3) the DRUGDEX Information System. 42 U.S.C. ' 1396r-8(g)(1)(B)(i).) When the plaintiffs sought final review of the Health and Human Services secretary's denial of reimbursement under 42 USC ' 405(g), the federal court reversed and ordered coverage. It found that the definition of a “covered part D drug” in the Social Security Act, 42 USC ' 1395 et seq., did not impose the so-called compendia requirement.

IV-Administered Nutrition Kills Several Hospital
Patients in AL

The Alabama Department of Public Health announced in March that nine patients in six hospitals had died as a result of being fed through contaminated bags of total parenteral nutrition (TPN), a liquid intravenous nutrition administered through an IV using a catheter. Ten others were also injured by bacterial infections brought on by use of the adulterated products. All of the contaminated products were traced to a single pharmacy, which, following notification of the outbreak voluntarily recalled all of its IV compounded products. The source of the bacteria has been traced to a water faucet in the pharmacy.

Monthly Liver Enzyme Testing No Longer Required for Letairis Users

The FDA has approved a modification to the boxed warning for Letairis that removes the recommendation that monthly liver enzyme tests be performed on users. Letairis tablets (ambrisentan) are used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH). The FDA authorized the change after reviewing data from clinical trials and postmarket reports that showed the risk of liver injury with use of Letairis is very low. For further information, see www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245848.htm.

Fed. Court Says Medicare Must Cover Off-Label
Prescriptions

In Layzer v. Leavitt, 07 Civ. 11339 (HB), NYLJ 1202485563289, at *1 (SDNY, Decided March 7, 2011), the U.S. Court of Appeals for the Southern District of New York recently concluded that the Department of Health and Human Services must cover the costs of prescription medications prescribed “off label.” The case involved two patients, one prescribed Cetrotide to treat a rare form of ovarian cancer and the other prescribed Increlex to treat a rare and degenerative form of muscular dystrophy. Their Medicare Part D plan sponsors denied coverage for the drugs because they had not been approved by the Food and Drug Administration (FDA) for treatment of the two patients' conditions. On appeal, a Medicare Part D Independent Review Entity affirmed the denials, concluding that the plan sponsors were not required to provide coverage because the drugs were not being used for a medically accepted indication. The appeals authority explained that “a medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in ' drug compendia.” (The compendia are: 1) the American Hospital Formulary Service Drug Information; 2) the United States Pharmacopeia-Drug Information; and 3) the DRUGDEX Information System. 42 U.S.C. ' 1396r-8(g)(1)(B)(i).) When the plaintiffs sought final review of the Health and Human Services secretary's denial of reimbursement under 42 USC ' 405(g), the federal court reversed and ordered coverage. It found that the definition of a “covered part D drug” in the Social Security Act, 42 USC ' 1395 et seq., did not impose the so-called compendia requirement.

IV-Administered Nutrition Kills Several Hospital
Patients in AL

The Alabama Department of Public Health announced in March that nine patients in six hospitals had died as a result of being fed through contaminated bags of total parenteral nutrition (TPN), a liquid intravenous nutrition administered through an IV using a catheter. Ten others were also injured by bacterial infections brought on by use of the adulterated products. All of the contaminated products were traced to a single pharmacy, which, following notification of the outbreak voluntarily recalled all of its IV compounded products. The source of the bacteria has been traced to a water faucet in the pharmacy.

Monthly Liver Enzyme Testing No Longer Required for Letairis Users

The FDA has approved a modification to the boxed warning for Letairis that removes the recommendation that monthly liver enzyme tests be performed on users. Letairis tablets (ambrisentan) are used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH). The FDA authorized the change after reviewing data from clinical trials and postmarket reports that showed the risk of liver injury with use of Letairis is very low. For further information, see www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm245848.htm.