Recently, the United States House of Representatives Energy and Commerce Committee unanimously passed the bipartisan H.R. 5526, the Seniors’ Access to Critical Medications Act of 2024. This legislation, if passed, would amend the Social Security Act to clarify the application of the in-office ancillary services exception to the Stark Law prohibition for drugs provided under the Medicare program.
The legislation would make permanent a waiver issued by the Centers for Medicare and Medicaid Services (CMS) that allowed for Medicare patients to receive critical medications by mail, or allow for caregivers and family members to obtain medications for them. The waiver got its start during the COVID-19 public health emergency, at which time CMS allowed independent physicians to mail medications directly to their patients or have them delivered by a family member or caregiver, if a Medicare patient was unable to be present in the office.
However, upon the ending of the COVID-19 public health emergency, CMS ruled that the waiver also ended. This means that some patients are unable to receive their prescriptions in a timely manner from their healthcare provider, as physicians and their practices face a Stark violation if they continue to deliver drugs to their patients or allow someone other than a patient to pickup drugs from the medical practice — as they had been doing throughout the pandemic with no issues.
This legislation has bipartisan support, being co-introduced by Reps. Debbie Wasserman Schultz (D-FL), Chuck Fleischmann (R-TN), Donald Davis (D-NC), Mariannette Miller-Meeks (R-IA), and Troy Balderson (R-OH).
“Increasing access to care is vital, and few places is it more important than for cancer survivors. As a breast cancer survivor, I know the difficult realities that patients, their families, and caregivers face along their journey of survivorship – and my goal is to remove as many as possible,” said Congresswoman Wasserman Schultz. “The Seniors’ Access to Critical Medications Act, which I am proud to co-lead with Rep. Harshbarger, will pull down another obstacle for survivors to access the drugs they need. Our legislation would make it clear that physicians can deliver medicines to their patients by mail without fear of violating federal law, ensuring Medicare beneficiaries have timely access to them. Seniors, cancer survivors, and many others should not have to face additional hurdles to receiving the care and treatment they need, when they need it.”
The Community Oncology Alliance (COA) is urging Congress to pass this legislation to allow patients to have “unfettered access to the medications they critically need.” “Thanks to the bipartisan leadership of the House Committee on Energy and Commerce, we are one step closer to ensuring that no patient is left behind due to this misinterpreted regulation,” said Ted Okon, executive director of COA. “This is a huge victory for seniors across America who face daily challenges in accessing their medications. We are grateful to the committee’s leaders and its members for their commitment to this cause. Now the Senate and full Congress must act as soon as possible to make this legislation a reality for patients.”