¶¶Òô´ó¹Ï has signed a letter to the Centers for Medicare and Medicaid Services (CMS) requesting a change in policy to ensure Part B coverage of physician-administered drug formulations when self-administration is not clinically appropriate or feasible.
Under current Medicare law and regulations, Medicare Administrative Contractors (MACs) use CMS criteria to determine which drugs should be included on the when drugs are available in both self-administered and physician-administered forms. Drugs placed on the SAD Exclusion List are excluded from Part B coverage. As a result, beneficiaries who require the physician-administered formulation, because they cannot self-administer a drug, must pay out-of-pocket.
As an example, ustekinumab (Stelara) is available in self-administered and physician-administered forms; however, using CMS criteria, the MACs moved it to the SAD Exclusion List. As a result, this drug is no longer covered under Part B, compromising many beneficiaries’ access to this medication.
The letter highlights a report from the that found “Medicare expenditures for Stelara have increased almost tenfold, from $300 million in 2016 to almost $3 billion in 2023,” as a result of being put on the SAD Exclusion List.
Among the changes being sought by ¶¶Òô´ó¹Ï and other groups are changes to the criteria by which CMS interprets “not usually self-administered by the patient.”