FLASCO News

FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection

Posted September 12, 2024

On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS)....

Prescription for Change: Doctors Cast Their Votes for a Healthier Future

Posted August 28, 2024

As oncologists, you are at the forefront of our community’s well-being. This election season, your vote can make a significant impact on the future of cancer care. Your daily encounters with patients provide you with a unique perspective on the healthcare system’s strengths and weaknesses. Voting is not just a civic duty; by exercising your...

Centers for Medicare & Medicaid Services (CMS) Releases the First Ten Drug Prices Negotiated in IRA Process for Part D

Posted August 28, 2024

The Biden-Harris Administration announced that it has reached agreements for new, lower prices for all 10 drugs selected for negotiations. According to CMS, these negotiated drugs are some of the most expensive and most frequently dispensed drugs in the Medicare program and are used to treat conditions such as heart disease, diabetes, and cancer. The...

Merit-based Incentive Payment System (MIPS) Automatic Extreme and Uncontrollable Circumstances (EUC) Policy Applied to MIPS Eligible Clinicians in Florida

Posted August 28, 2024

In response to Hurricane Debby, as identified by both the Health and Human Services (HHS) Public Health Emergency (PHE) declaration (Florida) and Federal Emergency Management Agency (FEMA) disaster declaration (DR-4806-FL), the Centers for Medicare & Medicaid Services (CMS) has determined that the MIPS automatic EUC policy will apply to MIPS eligible clinicians in designated affected...

2025 Hospital Inpatient Payment Rule Addresses Drug Shortages, Social Determinants of Health, Graduate Medical Education; Finalizes New Payment Model

Posted August 28, 2024

CMS issued the fiscal year (FY) 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS) final rule. The rule finalizes updates to Medicare fee-for-service payment rates and policies for inpatient hospitals and LTCHs for FY 2025. Key highlights of the final rule include: Standardized Amount, Drug Shortages,...

ASCO Research Statement Details Recommendations To Improve Accessibility Of Cancer Clinical Trials Through Decentralization

Posted August 19, 2024

Strategies to bring clinical trials closer to patients gained momentum during the COVID-19 pandemic, enabling more participants to receive treatment and/or testing in their local communities. Incorporation of decentralized trial elements presents both opportunities and challenges, spanning regulatory, technical, and operational aspects. This ASCO research statement includes timely consensus-driven recommendations and a call for engagement...

Health Information Exchange Proposal Focuses on Real-Time Benefit Tools, Information Blocking, Interoperability

Posted July 22, 2024

The Department of Health and Human Service, through the Office of the National Coordinator for Health Information Technology (ONC), released the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule. The HTI-2 proposal includes new and revised standards and certification criteria for the ONC Health IT Certification Program...

Governor Signs Legislation Taking First Step to Improving Access to Biomarker Testing for Floridians

Posted June 27, 2024

Gov. Ron DeSantis signed HB885 into law on June 18th, which expands patient access to biomarker testing, a key tool used by physicians to identify the most effective treatment of cancer and other diseases. In the case of a cancer diagnosis, biomarker testing allows doctors to develop a personalized treatment plan. It opens the door...

CMS Opens Registration for Second Oncology Payment Model Cohort on July 1

Posted June 24, 2024

The Centers for Medicare & Medicaid Services Innovation Center (CMMI) announced it is reopening the Enhancing Oncology Model for a second cohort of participants and payers. The second cohort will begin on July 1, 2025, and end on June 30, 2030, for a 5-year model performance period. For more details and eligibility criteria, please read...

Bipartisan, ASCO-Endorsed Prior Authorization Bill Reintroduced in Congress

Posted June 24, 2024

Bipartisan members of the Unites States House of Representatives and Senate have reintroduced the Association for Clinical Oncology (ASCO)-endorsed Improving Seniors’ Timely Access to Care Act (H.R.8702/S.4532) to streamline prior authorization within Medicare Advantage (MA) plans. The bill currently has 175 combined cosponsors (45 senators and 130 representatives). Last Congress, this legislation unanimously passed in...

Nationwide Recall of Docetaxel Issued Over Particulate Concerns

Posted June 7, 2024

On May 28, Sagent Pharmaceuticals announced a voluntary nationwide recall of two lots of docetaxel injection (80 mg per 8 mL multidose vials and 160 mg per 16 mL multidose vials). The move was prompted by a customer complaint regarding possible particulate matter. Although no adverse events have been reported thus far, injection of particulate...

New Cervical Cancer Guidelines Released

Posted March 26, 2024

The American Society for Colposcopy and Cervical Pathology (ASCCP) is proud to announce a major milestone by the groundbreaking Enduring Guidelines initiative, aimed at revolutionizing the fight against cervical cancer. In a bid to ensure the most current and effective clinical management strategies, the Enduring Guidelines process seeks to integrate emerging technologies and the latest...