November 24, 2020
On Nov. 20, 2020, the Centers for Medicare & Medicaid Services (CMS) released the Most Favored Nation (MFN) Model Interim Final Rule with Comment Period (IFC) . The Model begins on Jan. 1, 2021, and will operate for seven years.
The Model is mandatory for all Medicare physicians, non-physician practitioners, supplier groups (such as group practices), hospital outpatient departments (including 340B-covered entities), ambulatory surgical centers, and other providers and suppliers that receive separate Medicare Part B fee-for-service payment for the Model’s included drugs.
Participants may be granted a financial hardship exemption from the Model; however, these exemptions will be granted at the sole discretion of the agency. Cancer hospitals, children’s hospitals, critical access hospitals, rural health clinics, federally qualified health centers and Indian Health Service facilities will not participate. CMS will also exclude from the Model hospitals participating in CMS Innovation Center models in which payment for outpatient services is made under a fully capitated or global budget basis, such as the Maryland Total Cost of Care Model. CMS will not exclude entities participating in the Oncology Care Model (OCM) but will adjust reconciliation calculations to avoid paying performance-based payments based on the MFN Model’s drug payment changes.
Included Drugs
The first year of the demonstration includes 50 Part B drugs that encompass a high percentage of Medicare Part B drug spending. Each year, CMS will re-assess the list and new Part B drugs may be added to include drugs that move into the top 50 drugs based on updated annual Part B spending, after applying certain exclusions. CMS will only remove drugs from the list under limited circumstances.
Certain categories of drugs are excluded from the MFN Model’s drug list, including:
Comment period on the Model ends 60 days after publication in the Federal Register .
More information is available on the Model's website here .
Posted 11/24/2020
November 23, 2020
On November 21, 2020, the U.S. Food and Drug Administration (FDA) announced its second emergency use authorization (EUA) for monoclonal antibodies to treat COVID-19. Under the EUA, casirivamab and imdevimab must be administered together by intravenous use for the treatment of mild to moderate COVID-19 in adults and pediatric patients who:
*This includes those who are 65 years of age or older or who have certain chronic medical conditions.
When administered together in patients with COVID-19 via clinical trial, casirivamab and imdevimab reduced COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. A benefit has not been shown in patients hospitalized due to COVID-19. The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.
Read the FDA announcement .
Posted 11/23/2020
November 20, 2020
On November 20, 2020, Pfizer and BioNTech announced that they have submitted a request to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for BNT162b2, the companies’ COVID-19 mRNA vaccine candidate. If approved, some Americans could receive the vaccine as early as mid-December.
Through an accelerated clinical trial process, the potential vaccine demonstrated a 95 percent efficacy rate with no serious safety concerns to date. The companies expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion by the end of 2021.
The companies have also initiated rolling submissions with regulatory agencies around the world. Upon authorization, the companies state that they will be ready to distribute the vaccine within hours.
Read Pfizer's announcement . Find out more about Pfizer and BioNTech’s COVID-19 vaccine candidate from AP News , New York Times , and Washington Post .
Posted 11/20/2020
November 16, 2020
The Centers for Medicare & Medicaid Services (CMS) recognizes that not all practices have been impacted by COVID-19 to the same extent. For the 2020 performance year, CMS will be using its extreme and uncontrollable circumstances policy to allow merit-based incentive payment system (MIPS) eligible clinicians, groups, and virtual groups to submit an application requesting reweighting of one or more of their MIPS performance categories to zero percent due to the COVID-19 public health emergency.
If you have any concerns about the effect of the COVID-19 pandemic on your practice's 2020 performance data, including cost measures, submit an Extreme and Uncontrollable Circumstances application and be sure to cite COVID-19 as the reason for your application. Applications are dueDecember 31, 2020 .
If an application is approved, you can still receive scores for the quality, improvement activities and Promoting Interoperability performance categories if you submit data. If the cost performance category is included in your approved application, you will not be scored on cost measures even if other data are submitted. Once an application has been submitted, you will be notified by email if your request is approved or denied. If approved, the exception will be added to your eligibility profile on the QPP Participation Status Tool but may not appear until the submission window opens in 2021.
Read the 2020 Exceptions Applications fact sheet . For more information, visit the promoting interoperability hardship exception and extreme and uncontrollable circumstances exception webpages.
For Alternate Payment Model (APM) Entities: CMS has proposed to allow APM entities to submit an application to reweight MIPS performance categories as a result of extreme and uncontrollable circumstances, such as the public health emergency resulting from the COVID-19 pandemic. Applications are due December 31, 2020 . Learn more in the 2021 Quality Payment Program Proposed Rule Overview Fact Sheet .
Posted 11/16/2020
November 16, 2020
On November 13, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Keytruda® (pembrolizumab) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.
Read the FDA announcement .
Read the Merck press release .
Posted 11/16/2020
November 11, 2020
The Centers for Medicare & Medicaid Services (CMS) Quality Payment Program website includes 2020 Alternative Payment Model (APM) incentive payment details. To access information on the incentive amount and organization paid, clinicians and surrogates can log in to the QPP website using their HARP credentials. In order to receive payments, certain clinicians will need to verify their Medicare billing information by November 13, 2020 .
Eligible clinicians who were qualifying APM participants have already begun receiving their 2020 APM incentive payments last month based on their 2018 performance. If you are a clinician and have already received your payment, you do not need to update anything.
CMS also posted a new 2020 APM Incentive Payment Fact Sheet to explain:
For any questions, contact the CMS Quality Payment Program at QPP@cms.hhs.gov or 1.866.288.8292. To receive assistance more quickly, consider calling during non-peak hours—before 10 a.m. and after 2 p.m. ET.
Posted 11/11/20
November 2, 2020
The Centers for Medicare & Medicaid Services (CMS) announced that the open enrollment period for the federal health insurance exchange will officially begin on Sunday, November 1 and run through Tuesday, December 15, 2020. Coverage will begin as soon as January 1, 2021.
Consumers can log in to HealthCare.gov and CuidadodeSalud.gov , or they can call 1-800-318-2596 to fill out an application and enroll in a 2021 exchange health plan.
Please note: Current enrollees who don’t update their application and enroll in a plan by the deadline on December 15, 2020 will be automatically enrolled in the same plan, or another plan with the same insurance company intended to be as similar as possible. If that’s not available, they will generally be enrolled in another plan with a different insurance company.
Consumers who miss the deadline to re-enroll in a plan of their choice during open enrollment will also not be able to make any plan changes until the next coverage year, unless they qualify for certain special enrollment periods.
Read the CMS fact sheet for more information.
Posted 11/02/2020
October 22, 2020
The Centers for Medicare & Medicaid Services (CMS) has received feedback from a number of stakeholders about the challenges of preparing to implement the Radiation Oncology (RO) Model by January 1, 2021. Based on this feedback, it intends to delay the RO Model start date to July 1, 2021, and is pursuing rulemaking to make this change.
Read the CMS announcement .
Posted 10/22/2020
October 19, 2020
On October 16, 2020, the U.S. Food and Drug Administration (FDA) granted regular approval to Venclexta® (venetoclax) in combination with azacitidine, decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities precluding intensive induction chemotherapy.
Venetoclax was initially granted accelerated approval for this indication in November 2018.
Read Roche's announcement and the FDA announcement .
Posted 10/19/2020
October 15, 2020
Immunomedics announced the new C-Code (C-9066) for Trodelvy™ (sacituzumab govitecan-hziy), effective October 2020. Trodelvy is indicated for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.
C-codes are used primarily to report services under the Outpatient Prospective Payment System (OPPS), but may also be recognized by other private and public payer types. Please check with each payer for specific requirements.
Find out more on billing and coding for Trodelvy on its website .
Posted 10/15/2020
October 15, 2020
On October 15, 2020, the U.S. Food and Drug Administration (FDA) approved an expanded label for Keytruda® (pembrolizumab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) classical Hodgkin lymphoma (cHL). Keytruda is the first anti-PD-1 therapy approved for adult patients with relapsed or refractory cHL after frontline therapy.
Read Merck's press release and the FDA announcement .
Posted 10/15/2020
October 5, 2020
On October 2, 2020 the U.S. Food and Drug Administration (FDA) approved the combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) as a first-line treatment for adult patients with unresectable malignant pleural mesothelioma.
Read the FDA Announcement .
Read the Bristol Myers Squibb Announcement .
Posted 10/5/2020
September 25, 2020
The Community Oncology Alliance (COA) has released a position statement on the continued use of telehealth in cancer care beyond the COVID-19 public health emergency . COA board of directors support telehealth visits "as a valuable supplement to in-person visits during the COVID-19 (novel coronavirus) pandemic and continued usage when appropriate after the pandemic has subsided."
Though telehealth has been widely adopted by oncology providers and patients, COA states that as an effective substitute for some patients, it cannot be applied to all. It further states that in-person visits for cancer care should continue beyond the COVID-19 public health emergency.
“ Prior to the COVID-19 pandemic, telehealth regulations were extremely cumbersome and limiting at the state and federal levels, with poor reimbursement," COA Medical Director Mark Thompson, MD, said in a statement. "The rapid response of Federal policymakers to loosen telehealth restrictions and raise reimbursement rates were a true lifesaver for patients and practices. Community oncology practices are resilient and quickly integrated telehealth into their workflow thanks to these changes ."
COA states that telehealth should not replace in-person care. It supports the "continued use of telehealth as a care tool" and will act as a voice when "the time comes to integrate telehealth into the normal regulation structure."
Read COA's news release and position statement .
Posted 9/25/2020
September 24, 2020
On August 7, the U.S. Food and Drug Administration (FDA) approved FoundationOne ® Liquid CDx and Guardant360 ® CDx as next generation sequencing based liquid biopsy companion diagnostics for osimertinib (Tagrisso ® ) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test; and for patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
See full prescribing information . About FoundationOne ® Liquid CDx . About Guardant360 ® CDx .
Posted 9/24/2020
September 18, 2020
On Friday, September 18, 2020 the Centers for Medicare & Medicaid Services (CMS) released the final rule for the Radiation Oncology (RO) Model. The RO Model seeks to improve the quality of care for cancer patients receiving radiotherapy (RT) and move toward a simplified and predictable payment system. The RO Model tests whether bundled, prospective, site neutral, modality agnostic, episode-based payments to physician group practices, hospital outpatient departments, and freestanding radiation therapy centers for RT episodes of care reduces Medicare expenditures while preserving or enhancing the quality of care for Medicare beneficiaries. The RO Model has a five-year Model performance period that begins on January 1, 2021 and runs through December 31, 2025.
For additional information on the final rule and the model, please visit the radiation oncology website . The following resource documents about RO may also be helpful: Press Release , Fact Sheet , and Final Rule . For questions regarding the RO Model, please reach out to the RO Model Helpdesk by phone: 1.844.711.2664, option 5; or email: RadiationTherapy@cms.hhs.gov .
Posted 9/18/2020
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