ASCO in Action

ASCO in Action provides the latest news and analysis related to critical policy issues affecting the cancer community, updates on the Association for Clinical Oncology’s ongoing advocacy efforts, and opportunities for members and others in the cancer care community to take action.

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August 9, 2022

UPDATE: On August 7, 2022, the Senate passed the Inflation Reduction Act (IRA), a broad climate, tax, and healthcare reconciliation bill, 51 to 50. Healthcare provisions in IRA will extend Affordable Care Act (ACA) premium tax credits, allow Medicare to negotiate prescription drug prices, place inflationary caps on Medicare Part B and Part D drugs, and cap out-of-pocket spending on prescription drugs for Medicare beneficiaries. The House of Representatives will reconvene on August 12 to consider and vote on the legislation--which is expected to pass--after which President Biden will sign the bill into law.

August 2, 2022

On August 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2023 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long‑Term Care Hospital (LTCH) Prospective Payment System (PPS) final rule. In addition to updating Medicare payment rates and policies for inpatient hospital services in FY 2023, the final rule aims to improve beneficiary access, improve the quality of maternity care, and advance health equity.

July 15, 2022

On July 15, 2022, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2023 Medicare Hospital Outpatient Prospective Payment System (OPPS). The Association for Clinical Oncology (ASCO) is assessing the full proposal, but ASCO’s initial analysis is included here.

July 14, 2022

On July 14, 2022, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT). 

June 27, 2022

On June 24, 2022, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. It is not indicated for the treatment of patients with primary central nervous system lymphoma.

June 23, 2022

On June 22, 2022, the Food and Drug Administration granted accelerated approval to dabrafenib (Tafinlar, Novartis) in combination with trametinib (Mekinist, Novartis) for the treatment of adult and pediatric patients ≥ 6 years of age with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Dabrafenib in combination with trametinib is not indicated for patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition. Dabrafenib is not indicated for patients with wild-type BRAF solid tumors. 

June 21, 2022

The Association for Clinical Oncology (ASCO) submitted comments to the Centers for Medicare & Medicaid Services (CMS) in response to the fiscal year (FY) 2023 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long‑Term Care Hospital (LTCH) Prospective Payment System (PPS) proposed rule. ASCO’s Comments address CAR-T reimbursement and respond to several Requests for Information (RFI) on social determinants of health data collection, measuring healthcare disparities across CMS’s quality programs, climate change, and advancing digital quality.

June 21, 2022

The Supreme Court released a unanimous decision in American Hospital Association et al. v. Becerra, Secretary of Health and Human Services, et al. in favor of the American Hospital Association (AHA) and its objection to reduced reimbursement rates for Medicare Part B drugs purchased through the 340B drug pricing program. 

June 21, 2022

The U.S. House of Representatives passed its comprehensive legislation to reauthorize the Food and Drug Administration (FDA) user fee agreements, including the Prescription Drug User Fee Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the Biosimilar User Fee Act (BsUFA), and the Medical Device User Fee Act (MDUFA). ASCO is pleased that several of the Association’s priorities were included in the final House-passed bill.

May 31, 2022

On May 27, 2022, the Food and Drug Administration approved the following for the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC): 

May 31, 2022

On May 27, 2022, the Food and Drug Administration granted accelerated approval to tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

May 25, 2022

On May 25, 2022, the Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) in combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

May 20, 2022

On May 20, 2022, the Food and Drug Administration approved azacitidine (Vidaza, Celgene Corp.) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).

May 10, 2022

Proposals to reauthorize the Food and Drug Administration (FDA) user fee agreements include several ASCO priorities, including those that would increase diversity of clinical trials and strengthen the accelerated approval process.

May 9, 2022

The Centers for Medicare & Medicaid Services (CMS) released the Contract Year 2023 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit Programs final rule. The rule finalizes the administration’s efforts to improve consumer protections, reduce disparities, and improve equity in the MA and Medicare Part D programs in 2023 and beyond.

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