The Social Security Act permits Medicare Part B to pay for drugs and biologicals that are not usually self-administered by the patient and furnished as “incident to” a physician’s service. As a result, drugs that are “usually self-administered” are statutorily excluded from coverage and payment under Part B.
In Chapter 15, Section 50.2 of the Medicare Benefit Policy Manual, CMS instructs its Medicare Administrative Contractors (MACs) regarding determinations on drugs that are “not usually self-administered by the patient”. This guidance describes the evidentiary criteria MACs should use in determining whether a drug is usually self-administered, directs MACs to publish a description of the process they use to make that determination, and instructs them to issue a list of these “self-administered drugs” (SADs) that are subject to exclusion from Part B coverage on their website. Each MAC keeps their own version of the SAD list, which is applicable to that MAC’s area of jurisdiction. While the SAD lists are often similar between MAC jurisdictions, they are not identical. Any drugs, including those previously covered by Part B, that are placed on a SAD list are excluded from Part B coverage in that MAC’s jurisdiction.
In response to concerns and objections to the process by which the SAD lists are determined and promulgated, CMS has requested comments on the existing SAD list policy and the process used to determine if a drug is usually self-administered by the patient. Specifically, CMS is requesting comments on the definitions in the SAD list process (e.g., “self-administered” and “usually”) as well as comments on the process for issuing decisions on changes to drug classifications on the SAD list.
In requesting these comments, CMS seems primarily concerned with how newly approved drugs are treated in the current SAD list process. However, through our comments to CMS, submitted this week, the Center for Medicare Advocacy calls attention to the risk of beneficiary liability and the inherent violation of due process baked into the SAD list determination process. Importantly, neither MACs nor providers are required to provide notice to beneficiaries when drugs are added to the SAD list. As a result, some of the Center’s clients and contacts have unwittingly continued to receive their drugs in an outpatient setting, reasonably believing that the administration of these drugs would be covered by Part B, and subsequently received notice that their provider can bill them hundreds of thousands of dollars for expensive, suddenly uncovered drugs that are now “usually self-administered” and excluded from coverage.
Although notice to Medicare beneficiaries is required in many situations before they receive a non-covered service, this type of coverage exclusion for SAD-list drugs has no such protection. Thus, this aspect of the SAD-list process strips beneficiaries of their Medicare benefits without notice and due process of law. Additionally, the Center takes note of beneficiaries who, due to disability, are physically unable to self-administer drugs despite their classification as “usually self-administered.” The Center is concerned that their needs are not being taken into account.
In light of these circumstances, the Center urges CMS to amend its SAD list guidance to protect beneficiaries from unjust liability incurred due to a lack of notice or disability discrimination.
The Center for Medicare Advocacy encourages all stakeholders with knowledge of beneficiary harm caused by the current SAD determination procedure to offer their comments to CMS by the September 11, 2023 deadline, as well as to us at the Center. This is an invaluable opportunity to inform CMS about these issues and any other potential problems for beneficiaries in the SAD-list process.
You can view the full text of the RFI and post a comment publicly to CMS via this link and clicking the green button that says, “Submit a Formal Comment.”
August 17, 2023 – J. Lalor