October 6, 2022 The Honorable Lina Khan Chairwoman Federal Trade Commissioner 600 Pennsylvania Avenue, N.W. Washington, D.C. 20580 Dear Chair Khan, We support the Federal Trade Commission’s (FTC) issuance of a Section 6(b) order and conducting a study of pharmacy benefits managers’ (PBM) business practices. In your recent participation before the Subcommittee on Competition
To assess how changes in OPPS payment for reimbursement of drugs under the 340B program would affect hospital reimbursement and Medicare Part B beneficiary cost sharing, Avalere estimated the impact of increasing reimbursement for 340B drugs in Medicare Part B to ASP + 6%. The analysis finds that most hospitals would see overall payment decreases, while payments would be subject to higher cost sharing.
On behalf of the Community Oncology Alliance (“COA”), we are submitting our concerns regarding the Enhancing Oncology Model (“EOM”) to the leadership at the Centers for Medicare & Medicaid Services (“CMS”) and Center for Medicare and Medicaid Innovation (“CMMI”).
We are writing to express our concerns with your instituted step-edit policy for antiemetic drugs used to combat chemotherapy-induced nausea and vomiting, or CINV. We have been consistently hearing about aggressive step therapy schemes that are putting our constituents suffering from cancer at an increased risk of experiencing horrific side effects, by first requiring oncologists to prescribe CINV drugs that they do not deem to be appropriate for certain treatment regimens.
On behalf of the Board of Directors of the Community Oncology Alliance (COA), we are submitting this comment letter regarding the CY 2023 Medicare Physician Fee Schedule (“MPFS”), CMS-1770-P, Proposed Rule (“Proposed Rule”). As you know, COA is an organization dedicated to advocating for the complex care and access needs of patients with cancer and the community oncology practices that serve them. COA is the only nonprofit organization in the United States dedicated solely to independent community oncology practices, which serve the majority of Americans receiving treatment for cancer. Since its grassroots founding close to 20 years ago, COA’s mission has been to ensure that patients with cancer receive quality, affordable, and accessible cancer care in their own communities where they live and work, regardless of their racial, ethnic, demographic, or socioeconomic status.
Hospital spending has continued to grow rapidly (by more than six percent annually), both before and during the pandemic, and most recently represented $1.3T, equivalent to 31 percent of total national health care spending and almost seven percent of the U.S. Gross Domestic product.1 The steady growth and consolidation of the hospital sector has led a range of stakeholders to demand more transparency and accurate price reporting to better inform decision-making.2 It has also raised serious questions about the degree to which deep 340B Drug Pricing Program discounts may have fueled this s growth and consolidation.3
Biological products, or biologic drugs, have transformed the way patients with many diseases, including cancer, are treated. Some examples of biologics include hormones, blood products, cytokines, growth factors, vaccines, gene and cellular products, fusion proteins, insulin, interferon, and monoclonal antibody products. Biologics are expensive, ranging in cost from tens of thousands of dollars to hundreds of thousands of dollars each year per patient. As biologic drugs lose their patent protection, there exists an opportunity for the introduction of “biosimilar” drugs. A biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine. It may be used in patients who have been previously treated with the reference product, as well as patients who have not previously received the reference product.
On behalf of the Board of Directors of the Community Oncology Alliance (COA), we are submitting this comment letter regarding the CY 2023 Medicare Physician Fee Schedule (“MPFS”), CMS-1770-P, Proposed Rule (“Proposed Rule”). As you know, COA is an organization dedicated to advocating for the complex care and access needs of patients with cancer and the community oncology practices that serve them. COA is the only nonprofit organization in the United States dedicated solely to independent community oncology practices, which serve the majority of Americans receiving treatment for cancer. Since its grassroots founding close to 20 years ago, COA’s mission has been to ensure that patients with cancer receive quality, affordable, and accessible cancer care in their own communities where they live and work, regardless of their racial, ethnic, demographic, or socioeconomic status.
PHARMACY BENEFIT MANAGERS use measures like the medication possession ratio (MPR) as a performance/quality metric to evaluate specialty pharmacies and assess direct and indirect remuneration clawback fees. Abundant evidence shows that measuring MPR does not correlate with patients’ experiences while on oral cancer oncolytics and does not accurately reflect their clinical outcomes. The authors demonstrate that as an alternative to MPR, the Florida Cancer Specialists & Research Institute’s Rx To Go in-house pharmacy offers value; it uses a multifaceted approach to comprehensively evaluate the services that specialty oncology pharmacies provide to patients with cancer who are being treated with oral oncolytics.
Continuing efforts to raise awareness and fight the takeover of the 340B Drug Pricing Program by for-profit pharmacy benefit manager (PBM) contract pharmacies, the Community Oncology Alliance (COA) filed an amicus curiae brief with the United States Court of Appeals for the Third Circuit. The out-of-control growth of 340B contract pharmacy arrangements by mail
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