December 9, 2021
On December 3, 2021, the Centers for Medicare and Medicaid Services (CMS) released a new data snapshot , featuring telemedicine utilization data that make the case for expanded and permanent telehealth coverage for Medicare beneficiaries.
These data are about people with Medicare who used telemedicine services between March 1, 2020, and February 8, 2021, and they come from Medicare Fee-for-Service data, Medicare Advantage encounter data, and Medicare enrollment information.
CMS states that the agency has seen large increases in telemedicine use during the defined time frame with variations across geographic and demographic groups. This increase is credited to the agency's expansion of telemedicine services during the COVID-19 public health emergency.
The snapshot shows that telemedicine utilization (e.g., telehealth, e-visits, and virtual check-ins) increased from 910,490 unique users pre-pandemic to 28,255,180 unique users during the pandemic. And the majority (53%) of the pandemic's telemedicine users were Medicare beneficiaries. To see a detailed breakdown of these data, read the full snapshot report .
For more information on Medicare's telemedicine expansions, visit its dedicated telehealth website .
Posted 12/9/2021
December 8, 2021
On December 8, 2021, the U.S. Food and Drug Administration (FDA) approved FoundationOne ® CDx to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, which includes BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations.
Read the Foundation Medicine announcement .
Posted 12/8/2021
December 6, 2021
LeanTaaS will be hosting its Transform Hospital Operations Virtual Summit, which will feature a keynote address from Dr. Scott Gottlieb, from December 7 to 8. This event is hosted in partnership with Becker's Healthcare .
Health system executives, technology leaders, and industry experts will be brought together to discuss solutions for current pressing issues for health systems, such as backlog challenges, staffing shortages and burnout, as increased patient wait times.
Registration is free for all attendees. Go online to view the event's agenda and to register.
Posted 12/6/2021
December 6, 2021
On December 2, 2021, the U.S. Food and Drug Administration approved rituximab in combination with chemotherapy for pediatric patients (greater than or equal to 6 months to less than 18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.
Read the FDA announcement .
Posted 12/6/2021
December 6, 2021
On December 3, 2021, the U.S. Food and Drug Administration approved Keytruda ® (pembrolizumab) for the adjuvant treatment of adult and pediatric (greater than or equal to 12 years of age) patients with stage IIB or IIC melanoma following complete resection.
Read the FDA announcement .
Read Merck's announcement .
Posted 12/6/2021
December 2, 2021
On November 30, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received one to three prior lines of therapy.
Read the FDA announcement .
Read Janssen, Inc.'s announcement .
Posted 12/2/2021
November 30, 2021
The Center for Medicare & Medicaid Innovation (CMS Innovation Center) announced an update to its special roundtable discussion. This roundtable will discuss how the CMS Innovation Center can execute its strategic objective to advance health equity.
The roundtable is scheduled for Wednesday, December 8, 2021, from 1:30 to 3:00 PM EST. To participate, register online .
Learn more about this roundtable and the CMS Innovation Center's objective in advancing health equity by reading its recently published white paper and visiting its website.
Posted 11/30/2021
November 30, 2021
On November 29, 2021, the U.S. Food and Drug Administration (FDA) approved pafolacianine, an imaging drug intended to assist surgeons in identifying ovarian cancer lesions. The drug is designed to improve the ability to locate additional ovarian cancerous tissue that is normally difficult to detect during surgery.
Read the FDA announcement .
Read On Target Laboratories, Inc.'s announcement .
Posted 11/20/2021
November 23, 2021
On Novemeber 23, 2021, the U.S. Food and Drug Administration (FDA) approved sirolimus protein-bound particles for injectable suspension (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Read Aadi Bioscience, Inc.'s announcement .
Posted 11/23/2021
November 18, 2021
On November 17, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.
Read the FDA announcement .
Read Merck's announcement .
Posted 11/18/2021
November 16, 2021
On Monday, November 15, 2021, the United States Multi-Society Task Force (MSTF) on Colorectal Cancer released updated screening recommendations. The Task Force now suggests that colorectal cancer screening starts in average-risk individuals age 45 to 49. This update is aligned with multiple other professional societies, including the United States Preventative Services Task Force, National Comprehensive Cancer Network, and American Cancer Society.
Unchanged recommendations from their 2017 update include:
The Multi-Society Task Force on Colorectal Cancer is represented by the American College of Gastroenterology , American Gastroenterological Association , and American Society for Gastrointestinal Endoscopy .
Full recommendations were published online via Gastrointestinal Endoscopy , Gastroenterology , and TheAmerican Journal of Gastroenterology . All articles will be available in January 2022 print issues.
Posted 11/16/2021
November 15, 2021
On November 12, 2021, the U.S. Food and Drug Administration (FDA) approved ropeginterferon alfa-2b-njft for the treatment of adults with polycythemia vera.
Read the FDA announcement .
Read PharmaEssentia's announcement for more information.
Posted 11/15/2021
November 3, 2021
On November 2, 2021, the Centers for Medicare & Medicaid Services (CMS) released the CY 2022 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems final rule (CMS-1753-F) . This announcement includes the finalized modifications to the Radiation Oncology (RO) Model.
The RO Model is set to begin January 1, 2022, and end December 31, 2026. The proposed rule includes the summarized modifications below:
For additional information on the RO Model and CMS' final rules, visit the RO Model website or read more on the final rule . For questions on the model or for participants needing their model ID, contact RadiationTherapy@cms.hhs.gov .
Posted 11/3/2021
November 1, 2021
On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors, and approved asciminib for adult patients with Ph+ CML in chronic phase with the T315I mutation.
Read the FDA announcement .
Read Novartis' announcement .
Posted 11/1/2021
October 20, 2021
Adaptive Biotechnologies launched an enhanced version of its clonoSEQ ® B-cell Clonality report. It will now feature the immunoglobulin heavy chain variable gene mutation status for patients with chronic lymphocytic leukemia (CLL).
The clonoSEQ assay was approved by the U.S. Food and Drug Administration to detect and monitor minimal residual disease in the blood or bone marrow of patients with CLL.
For more information on the clonoSEQ assay and its enhancements, read the Adaptive Biotechnologies announcement .
Posted 10/19/2021
October 18, 2021
On October 15, 2021, U.S. the Food and Drug Administration (FDA) approved atezolizumab for adjuvant treatment following resection and platinum-based chemotherapy in patients with Stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.
Read the FDA announcement .
Read Roche's announcement .
Posted 10/18/2021
October 14, 2021
On October 13, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test.
Read the FDA announcement .
Read Merck's announcement .
Posted 10/14/2021
October 14, 2021
On October 12, 2021, the U.S. Food and Drug Administration (FDA) approved abemaciclib with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score greater than or equal to 20 percent, as determined by an FDA approved test.
Read the FDA announcement .
Read Eli Lilly and Company's announcement .
Posted 10/14/21
October 4, 2021
On October 1, 2021, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel for adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).
Read the FDA announcement .
Read Kite Pharma's announcement .
Posted 10/4/2021
October 1, 2021
G1 Therapeutics announced the new permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Cosela™ (trilaciclib) issued by the Centers for Medicare & Medicaid Services (CMS). The code J1448 is effective October 1, 2021, for trilaciclib injection of 1mg for provider billing at all sites of care.
Read more on the Cosela website or G1 Therapeutics announcement .
Posted 10/1/2021
September 29, 2021
On September 28, 2021, the U.S. Food and Drug Administration (FDA) granted approval of a new indication for cetuximab in combination with encorafenib for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Read Eli Lilly's announcement .
Posted 9/29/2021
September 21, 2021
On September 16, 2021, Bayer Healthcare released data from three subset analyses and one matching-adjusted indirect comparison model for Vitrakvi ® (larotrectinib). These reports showcase the product's clinical profile and add to its safety data for patients with solid tumors harboring an NTRK gene fusion, which is also known as TRK fusion cancer.
Key elements of Bayer's news includes:
"These analyses add to the body of evidence for the compound, which has the largest dataset and longest follow-up of any TRK inhibitor," says Bayer.
Read more at Bayer Healthcare's website .
Posted 9/21/2021
September 21, 2021
On September 20, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Read the FDA announcement .
Read Seagen and Genmab's announcement .
Posted 9/21/2021
September 16, 2021
On September 15, 2021, the U.S. Food and Drug Administration (FDA) approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Read the FDA announcement .
Read Takeda's announcement .
Posted 9/16/2021