On September 28, 2018, the U.S. Food and Drug Administration announced that the agency is permitting marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow.
MRD is a general measure of the amount of cancer in the body (tumor burden), specifically the number of cancer cells that remain in a person’s bone marrow, either during or after treatment. Measuring MRD provides a tool to detect very low levels of tumor burden. MRD is useful to evaluate in patients who have responded to therapy when their tumor burden is below what can be detected with standard methods. The detection of MRD is associated with recurrence of the disease in those patients.
Read details in the FDA announcement.
On Tuesday, September 25, 2018, the U.S. House passed by voice vote two Senate bills that ban so-called "gag clauses" which prevent pharmacists from informing consumers when it would cost less to pay out-of-pocket for prescriptions drugs instead of using their health insurance.
On Monday, the U.S. Senate passed two pieces of legislation that would prohibit such "gag clauses." The Patient Right to Know Drug Prices Act, S. 2554, impacts private health plans including those in the ACA marketplace, and the Know the Lowest Price Act of 2018, S. 2553, covers Medicare Advantage and Part D plans.
On September 24, 2018, the Association of Community Cancer Centers (ACCC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's proposed CY 2019 Outpatient Prospective Payment System (OPPS) rule.
In its comments, ACCC recommends that CMS:
Pfizer Oncology has announced emergency relief protocols to ensure that patients who receive their Pfizer Oncology medicines through the Pfizer Patient Assistance Program and are impacted by Hurricane Florence have continued access to their medications.
On September 17, the Centers for Medicare & Medicaid Services (CMS) released the Medicare & Medicaid; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction proposed rule for calendar year 2019. This proposed rule was released to build upon the administration’s ‘Patients Over Paperwork’ and ‘Cut the Red Tape’ initiatives. The deadline for submitting comments on the proposed rule is 60 days from the rule's release into the US Federal Register.
ACCC is currently analyzing the rule and will provide an update to members soon.
View the proposed CY 2019 rule.