August 6, 2020
On August 6, 2020, GlaxoSmithKline announced the U.S. Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.
Read the corporate press release .
Read the FDA announcement .
Posted 8/6/2020
August 4, 2020
On August 4, 2020, the Centers for Medicare & Medicaid Reimbursement (CMS) issued the calendar year (CY) 2021 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment Proposed Rule (CMS-1736-P). ACCC and counsel are reviewing these proposed rules and will be providing comments.
Until this analysis is complete, read the proposed rule . Then register for ACCC’s August 14 webcast on The 2021 Proposed PFS and OPPS Rules: Practical Implications and Considerations to gain insight into how these proposed rules will affect your cancer program.
Posted 8/4/2020
August 4, 2020
On August 4, 2020, the Centers for Medicare & Medicaid Reimbursement (CMS) issued the calendar year (CY) 2021 Physician Fee Schedule (PFS) Proposed Rule. ACCC and counsel are reviewing these proposed rules and will be providing comments.
Until this analysis is complete, read the proposed rule . Then register for ACCC’s August 14 webcast on The 2021 Proposed PFS and OPPS Rules: Practical Implications and Considerations to gain insight into how these proposed rules will affect your practice.
Posted 8/4/2020
August 3, 2020
On July 31, 2020 MorphoSys and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Monjuvi® (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
Read corporate press release . Read FDA announcement .
Posted 8/3/20
July 31, 2020
The American Society of Clinical Oncology (ASCO) has released a position statement on Home Infusion of Anticancer Therapy that raises safety and oversight concerns related to home infusion of anticancer therapy and the Centers for Medicare & Medicaid Services (CMS) regulations regarding the practice.
In response to the COVID-19 public health emergency, CMS has enabled temporary flexibility related to home infusion for Part B cancer drugs. “We understand that COVID-19 has resulted in treatment challenges in some cases, and that home infusion services have been utilized as an alternative to treatment in outpatient facilities, but it is still unclear if the benefits outweigh the risks of this approach,”ASCO President Lori J. Pierce, MD, FASTRO, FASCO, said in a statement. “During and beyond this pandemic, patient safety must continue to be the first priority, and the decision to administer anticancer therapy in a home setting should be made only if both the treating physician and patient agree it’s in the patient’s best interest.”
ASCO states that the decision to administer anticancer therapy in a home setting should be made by the treating physician in consultation with the patient, and only after consideration of the availability of necessary precautions to protect medical staff, patients, and caregivers during infusion and disposal. The position statement makes the following six recommendations:
Read ASCO's news release and position statement .
Posted 7/31/2020
July 31, 2020
On July 31, 2020, Roche announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq ® (atezolizumab) plus Cotellic ® (cobimetinib) and Zelboraf ® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.
Read corporate press release .
Read FDA announcement .
Posted 7/31/2020
July 31, 2020
The U.S. Department of Health and Human Services (HHS) this week released a report showing that traditional Medicare saw a dramatic increase in telehealth usage due to the COVID-19 pandemic, particularly in larger urban areas. While its use has leveled off, the report finds physicians still expect visits to be held via telehealth post-pandemic.
The report by the HHS Assistant Secretary for Planning and Evaluation (APSE), which looked at telehealth visits from January through June 2020, found that virtual services made up 43.5 percent of Medicare primary care visits in April, a significant jump from February when telehealth accounted for less than 1 percent of visits. Usage dipped by May as in-person visits resumed but continued to remain significant compared to pre-pandemic.
The report also finds that providers in both rural and urban counties saw increases in telehealth adoption and utilization; however, providers in rural counties saw a smaller growth in telehealth visits as a proportion of all primary care visits in March and April, with a decrease again in May.
A recent survey of practitioners suggests continued interest in telehealth among healthcare providers. In the IQVIA survey of about 300 practitioners (oncologists, specialists, and primary care) between April 17 and 22, 2020, only 9 percent of respondents reported that their patient interaction was via telehealth prior to the pandemic; however, during the pandemic period usage increased to 51 percent, and respondents expected it to remain at 21 percent after the pandemic ends. Read the full HHS report here .
Source: InsideHealthPolicy
Posted 7/31/2020
July 29, 2020
The Centers for Medicare & Medicaid Services (CMS) continues to host regularly scheduled COVID-19 stakeholder engagement calls. These include office hours calls, weekly site-specific calls for COVID-19 care, and lessons from the front lines. Calls are open to members of the healthcare community and are intended to provide updates, share best practices among peers, and offer attendees an opportunity to ask questions of CMS and other subject matter experts. CMS COVID-19 Office Hours Call (Tuesdays at 5:00-6:00 pm ET)Tuesday, August 4, 2020
Toll Free Attendee Dial In: 833-614-0820; Access Code: 3296947 Audio Webcast LinkTuesday, August 11, 2020
Toll Free Attendee Dial In: 833-614-0820; Access Code: 3498643 Audio Webcast LinkLessons from the Front Lines: COVID-19 (twice a month on Fridays at 12:30 - 2:00 pm ET)Friday, August 7, 2020
Toll Free Attendee Dial In: 833-614-0820; Access Code: 4695240 Audio Webcast Link
See the CMS Coronavirus (COVID-19) Partner Toolkit for a full list of sessions and times. Audio webcast links and dial-in information is also available on this page. All previous session recordings and transcripts are posted to the CMS podcast page.
Posted 7/29/2020
July 29, 2020
On July 28, 2020, the Centers for Medicare & Medicaid Services (CMS) released its first monthly update of data that provides a snapshot of the impact of COVID-19 on the Medicare population.
The updated data on COVID-19 cases and hospitalizations of Medicare beneficiaries covers the period from January 1 to June 20, 2020. It is based on Medicare claims and encounter data CMS received by July 17, 2020.
For the first time, the snapshot includes data for American Indian/Alaskan Native Medicare beneficiaries. The new data indicate that American Indian/Alaskan Native beneficiaries have the second highest rate of hospitalization for COVID-19 among racial/ethnic groups after Blacks.
The updated data confirm that the COVID-19 public health emergency is disproportionately affecting vulnerable populations, particularly racial and ethnic minorities. This is due, in part, to the higher rates of chronic health conditions in these populations and issues related to the social determinants of health.
Other key data points:
Access CMS' Medicare COVID-19 Data Snapshot and additional information here.
Posted 7/29/2020
July 24, 2020
On July 24, 2020, Kite, a Gilead Company, announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel, formerly KTE-X19), the first and only approved chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). Read FDA announcement .
Read corporate press release .
Posted 7/24/2020
July 24, 2020
On Thursday, July 23, U.S. Department of Health and Human Services (HHS) Secretary Alex Azar signed an extension of the COVID-19 public health emergency (PHE) designation for another 90 days. The PHE would have expired on July 25. Read Secretary Azar's tweet .
Posted 7/24/2020
July 21, 2020
To support wide adoption of telemedicine, the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Preparedness and Response is partnering with the ECHO Institute at the University of New Mexico and the Public Health Foundation’s TRAIN Learning Network to deliver a 10-week, virtual peer-to-peer learning community for ambulatory providers called Telemedicine Hack.
What: HHS Telemedicine Hack is a 10-week virtual, peer-to-peer learning community to accelerate telemedicine implementation for ambulatory providers. Components include: five teleECHO sessions; five virtual “office hour” discussion panels; and inter-session peer-to-peer learning facilitated via virtual discussion boards. CME/CEU credits are available at no cost to participants.
When: Telemedicine Hack sessions will take place on Wednesdays, from July 22–September 23, 2020, Noon–1 PM ET
How to sign up: Click here to register .
See the HHS Telemedicine Hack Flyer for more information.
Posted 7/21/20
July 7, 2020
The U.S. Preventive Services Task Force (USPSTF) released a draft recommendation on July 7 that could nearly double the population of those eligible for annual lung cancer screening with low-dose CT. The proposed changes revise the USPSTF high-risk category to include:
The Task Force issued the recommendation with a "B" grade.
When finalized, this recommendation will replace the 2014 USPSTF recommendation on annual screening for lung cancer with LDCT in adults ages 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years.
The updated recommendation is open for public comment until 8:00 PM on August 3, 2020 .
The USPSTF is an independent, non-federal, volunteer group of national experts in prevention and evidence-based medicine. The Task Force works to improve the health of all Americans by making evidence-based recommendations about clinical preventive services, such as screenings, counseling services, and preventive medicines. The recommendations apply to people with no signs or symptoms of the disease being discussed.
Posted 7/7/2020
July 7, 2020
On July 7, 2020, the U.S. Food and Drug Administration (FDA) approved an oral combination of decitabine and cedazuridine (Inqovi, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS) including the following:
Read the FDA announcement .
Posted 7/7/2020
July 1, 2020
On June 30, 2020, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. Read FDA announcement .
Posted 7/1/2020
June 30, 2020
On June 29, 2020, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. Read FDA announcement .
Posted 6/30/2020
June 29, 2020
On June 29, 2020, the U.S. Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (Phesgo, Genentech, Inc.) for subcutaneous injection for the following indications:
Read the FDA announcement .
Posted 6/29/2020
June 23, 2020
On June 23, the Centers for Medicare & Medicaid Services (CMS) released a preliminary snapshot of the COVID-19 pandemic's impact on the Medicare population, based on Medicare claims data.
The data released today includes the total number of reported COVID-19 cases and hospitalizations among Medicare beneficiaries between January 1 and May 16, 2020. The snapshot breaks down COVID-19 cases and hospitalizations for Medicare beneficiaries by state, race/ethnicity, age, gender, dual eligibility for Medicare and Medicaid, and urban/rural locations.
CMS data shows that more than 325,000 Medicare beneficiaries received a diagnosis of COVID-19 between January 1 and May 16, 2020. During this same time period, nearly 110,000 Medicare beneficiaries were hospitalized for COVID-19-related treatment. According to the CMS snapshot released today, Black Medicare beneficiaries were hospitalized with COVID-19 at a rate nearly four times higher than whites.
CMS data shows that:
Access CMS' Preliminary Medicare COVID-19 Data Snapshot and additional information here .
Posted 6/23/2020
June 23, 2020
On June 23, the Centers for Medicare & Medicaid Services (CMS) announced creation of the Office of Burden Reduction and Health Informatics. The new office is intended to consolidate CMS' efforts to reduce regulatory and administrative burden, according to the agency's announcement. The unveiling of the new office, "permanently embeds a culture of burden reduction" across all platforms of CMS operations, the agency said. Read the CMS announcement .
Posted 6/23/2020
June 22, 2020
On June 22, 2020, Karyopharm Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has approved oral Xpovio ® (selinexor), the company’s first-in-class, selective inhibitor of nuclear export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication was approved based on response rate under the FDA’s Accelerated Approval Program. Read the corporate press release .
Posted 6/22/2020
June 18, 2020
On June 18, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options.
On the same day, the FDA also approved the cobas EZH2 Mutation Test (Roche Molecular Systems, Inc.) as a companion diagnostic for tazemetostat. Read FDA announcement .
Posted 6/18/2020
June 17, 2020
On June 17, the Centers for Medicare & Medicaid Services (CMS) released the " Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements (CMS 2482-P) ."
The agency states that the proposals put forward support state flexibility to enter innovative value-based purchasing arrangements (VBPs) with drug manufacturers for new expensive therapies, and to provide manufacturers with regulatory flexibility to enter into VBPs with commercial payers, which will benefit Medicaid programs. The proposed rule also creates minimum standards in state Medicaid Drug Utilization Review (DUR) programs designed to reduce opioid-related fraud, misuse and abuse. Read the CMS fact sheet on the proposed rule . Access the proposed rule .
Read HealthAffairsblog by CMS Administrator Seema Verma .
Posted 6/17/2020
June 17, 2020
On June 16, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
On the same day, the FDA also approved the FoundationOneCDx assay as a companion diagnostic for pembrolizumab. Read the FDA announcement .
Posted 6/17/2020
June 16, 2020
On June 15, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to lurbinectedin (Zepzelca, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Read the FDA announcement .
Posted 6/16/2020