The Centers for Medicare & Medicaid Services (CMS) released a Request for Information seeking public comment on various aspects of the Medicare Advantage (MA) program as CMS works toward establishing more equitable, high-quality care in MA. The Association for Clinical Oncology (ASCO) submitted a response to the agency on a variety of issues including health equity, expanding access to coverage and care, promoting person-centered care, and supporting sustainability and affordability. Some of the issues addressed in ASCO’s comments are summarized here.
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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On August 26, 2022, the Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.
On August 25, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a final rule indefinitely delaying the start of the Radiation Oncology Model. CMS will establish new start and end dates for the model through future rulemaking, which may also modify the model’s design. CMS will propose a new start date for the model at least six months prior to the proposed date.
On August 24, 2022, the Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for pediatric patients ≥ 1 year of age with chronic graft versus host disease (cGVHD) after failure of 1 or more lines of systemic therapy. Formulations include capsules, tablets, and oral suspension.
In July 2022, ASCO and the African Organisation for Research and Training in Cancer (AORTIC) signed a memorandum of understanding committing the two organizations to collaborate to advance cancer research in Africa.
The Inflation Reduction Act extends Affordable Care Act (ACA) tax credit subsidies, allows Medicare to negotiate prescription drug prices, places inflationary caps on price increases for Medicare Part B and Part D drugs, and limits Medicare beneficiaries’ out-of-pocket spending on Part D prescription drugs.
In response to the recent Supreme Court decision, ASCO has developed and compiled resources related to reproductive health in patients with cancer to help members navigate changes and ensure patient access to high-quality cancer care.
The American Medical Association (AMA) recently released new guidelines for reporting Evaluation and Management (E/M) services, which are to go into effect on January 1, 2023.
On August 11, 2022, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This is the first drug approved for HER2-mutant NSCLC.
On August 10, 2022, the Food and Drug Administration granted regular approval to capmatinib (Tabrecta, Novartis Pharmaceuticals Corp.) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.
The American Society of Clinical Oncology (ASCO) applauds President Biden for his decision to appoint ASCO-Past President Monica M. Bertagnolli, MD, FACS, FASCO, as the new Director of the National Cancer Institute (NCI). An accomplished cancer surgeon and researcher with deep expertise in community-based cancer research, Dr. Bertagnolli has the knowledge, passion, and skillset to successfully lead the nation’s top federal cancer research agency and the wider U.S. cancer research enterprise. We enthusiastically endorse her selection, recognizing Dr. Bertagnolli’s distinguished leadership and experience in advancing evidence-based cancer care and research.
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.
On August 5, 2022, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH‑) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
On August 5, 2022, the Food and Drug Administration approved darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).
As of August 1, applications for ASCO’s 2023-2024 Leadership Development Program Asia Pacific (LDP-AP) are open through October 31.