September 16, 2020
Lilly announces their Thyroid Cancer Testing Program designed to provide access to molecular testing for appropriate advanced or metastatic medullary thyroid cancer (“MTC”) patients 12 years of age and older who require systemic therapy; and advanced or metastatic non-medullary thyroid cancer (“non-MTC”) patients 12 years of age and older who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Appropriate patients are eligible for one molecular test at no cost for the purpose of determining whether the patient has any actionable genetic alterations that may inform therapeutic decisions, without regard to purchase of any prescribed drug or any other product.*
No patient, healthcare program, payer, or beneficiary shall be billed for any test ordered pursuant to the Thyroid Cancer Testing Program.
Posted 9/16/2020
To request a test for your patient <and understand further requirements>, you may download the Thyroid Cancer Testing Program Test Request Form .
The Thyroid Cancer Testing Program is NOT available to New York State patients and facilities as the aforementioned NGS tests have not been approved by the New York State Department of Health.
Posted 9/16/2020
September 8, 2020
On September 4, 2020 Genentech announced that the U.S. Food and Drug Administration (FDA) approved Gavreto™ (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
Read the Genentech announcement .
Posted 9/8/2020
September 3, 2020
On September 2, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the fiscal year (FY) 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) final rule, which includes important provisions designed to ensure access to potentially life-saving diagnostics and therapies for hospitalized Medicare beneficiaries. The changes will affect approximately 3,200 acute care hospitals and approximately 360 Long-Term Care Hospitals. CMS estimates that total Medicare spending on acute care inpatient hospital services will increase by about $3.5 billion in FY 2021, or 2.7 percent.
CMS’ rule creates a new Medicare Severity Diagnostic Related Group (MS-DRG) that provides a predictable payment to help adequately compensate hospitals for administering Chimeric Antigen Receptor (CAR) T-cell therapies.
Also in the final rule, CMS approved a record number of 24 new technology add-on payments, which is an additional payment to hospitals for cases involving eligible new and relatively high cost technologies. This will provide additional Medicare payment for these technologies while real-world evidence is emerging, giving Medicare beneficiaries timely access to the latest innovations.
Read the fact sheet and final rule from the Federal Register.
Posted 9/2/2020
September 2, 2020
On September 1, 2020 the U.S. Food and Drug Administration (FDA) approved Onureg® (azacitidine) for the continued treatment of patients with acute myeloid leukemia (AML) who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.
Read the Bristol Myers Squibb announcement .
Read the FDA announcement .
Posted 9/2/2020
August 21, 2020
On August 20, 2020 the U.S. Food and Drug Administration (FDA) approved Darzalex® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received one to three previous lines of therapy.
Read Janssen's announcement .
Read the FDA announcement .
Posted 8/21/2020
August 19, 2020
On Monday August 10, 2020, the Centers for Medicare & Medicaid Services updated the Appropriate Use Criteria (AUC) Program website to announce that the Educational and Operations Testing Period, during which there are not payment penalties, has been extended through 2021. You can view this update at the top of the AUC web page in agreenboarder.
CMS does not have further information to share, but as new information becomes available it will be accessible via the outreach and education page of the AUC website .
Posted 8/19/20
August 19, 2020
On August 18, 2020, MorphoSys and Incyte announced that the National Comprehensive Cancer Network (NCCN) has included Monjuvi® (tafasitamab-cxix) in its latest Clinical Practice Guidelines update in oncology for B-cell Lymphomas. Specifically, the NCCN Guidelines in the United States now include Monjuvi in combination with lenalidomide with a Category 2A designation as an option for the treatment of previously-treated adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma who are ineligible for autologous stem cell transplant.
Read the corporate press release .
The U.S. Food and Drug Administration granted accelerated approved to Monjuvi in combination with lenalidomide in July 2020. Read the FDA approval announcement .
Posted 8/19/2020
August 13, 2020
The Centers for Medicare & Medicaid Services (CMS) will host a webinar on August 18, 2020 to provide an overview of the Community Health Access and Rural Transformation (CHART) Model.
The CHART Model will test whether upfront investments, predictable capitated payments, and operational and regulatory flexibilities will enable rural health care providers to improve access to high quality care while reducing health care costs.
During the session, the CHART Model team will present on key aspects of the Model, including its objectives, eligible participants and their roles, payment options, and timeline. The forum will also provide an opportunity for potential applicants to ask the CHART team questions regarding these topics. When: Tuesday, August 18, 2020, 1:00 pm to 2:30 pm ET. Click here to register .
To learn more about the model visit the CMS CHART Model web page . Following the event, presentation materials will also be available on its web page.
August 6, 2020
Registration is now open for the Centers for Medicare and Medicaid Services (CMS) Physician Fee Schedule (PFS) listening session. Please note that the PFS proposed rules include expanding telehealth and licensing flexibilities beyond the current public health emergency. Physician Fee Schedule Proposed Rule: Understanding 4 Key Topics Listening Session
Proposed changes to the CY 2021 Physician Fee Schedule are aimed at reducing burden, recognizing clinicians for the time they spend taking care of patients, removing unnecessary measures, and making it easier for clinicians to be on the path towards value-based care. During this listening session, CMS experts briefly cover provisions from the proposed rule and address your clarifying questions to help you formulate your written comments for formal submission:
When: Thursday, August 13, 2020, 1:30-3:00 pm ET. Who: Medicare Part B fee-for-service clinicians; office managers and administrators; state and national associations that represent health care providers; and other stakeholders.
Click here to register
CMS encourages you to review the following materials prior to the call:
Visit the CMS event page for more information.
Posted 8/6/2020
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