January 2024 Advocacy Update on Seniors' Access to Critical Medications

Problem/Issue:
In September 2021, the Centers for Medicare & Medicaid Services (CMS) published a Frequently Asked Questions document (FAQ) prohibiting physicians from delivering oral cancer drugs and other medications to their patients by mail, FedEx, UPS, courier, or other means. CMS’ FAQ also prohibits a spouse, family member, or caregiver from picking up medication on a patient’s behalf.

According to CMS, the delivery of a drug or having a caregiver pick it up is a violation of Stark Law (Stark), a regulation that prevents physicians from making a referral to an individual or entity with whom the physician has a financial relationship. To justify its position, CMS points to a 2001 rule issued two years before Medicare Part D was created and five years before it was implemented.

At no time between the 2001 rule and the 2021 FAQ has CMS clarified it was a Stark violation to deliver drugs or allow pickup by someone other than the patient. In fact, hospitals can deliver drugs, yet independent physician practices cannot. How this would be a violation of Stark was not explained, as physicians are not financially compensated for the delivery of drugs.

During the COVID-19 public health emergency (PHE), CMS had Stark waivers in place allowing delivery or pick up of drugs. When the PHE ended in May 2023, CMS issued another FAQ stating that the Stark waivers had expired and delivery of drugs to patients was a violation.

CMS’ Interpretation Harms Patients and Impedes Cancer Treatment
The impact of this faulty CMS interpretation compromises the well-being of patients with cancer and others with serious diseases. These patients are often too sick to pick up medications in person, are in rural areas distant from their physicians, or simply do not have reliable transportation.

A recent study found that CMS’ interpretation “imposes a substantial burden” on patients, particularly those living in socioeconomically disadvantaged neighborhoods, forcing many to undertake long journeys to obtain essential cancer medications.

Solution: Seniors’ Access to Critical Medications Act (H.R. 5526 & S. 3458)
These identical bipartisan, bicameral bills very simply amend section 1877 of the Social Security Act to clarify that delivering medicines by mail or allowing a family member or caregiver to pick up medicines on behalf of a patient does not violate Stark. Additionally, the legislation would require CMS to rescind
the two FAQs.

H.R. 5526 was introduced by Representatives Harshbarger & Wasserman Schultz and has 51members signed on. S. 3458 was just recently introduced by Senators Sinema and Blackburn. This is bipartisan legislation.