July 24, 2018
On July 23, the House of Representatives passed four Energy and Commerce Committee bills to authorize critical health workforce programs:
Posted 7/24/2018
July 23, 2018
On July 20, the Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym, Pfizer Inc.) for the treatment of chemotherapy-induced febrile neutropenia, acute myeloid leukemia (AML), patients with cancer receiving bone marrow transplant, peripheral blood progenitor cell collection and engraftment, and severe chronic neutropenia. This is the second approved biosimilar for filgrastim (Neupogen, Amgen) following the approval of filgrastim-sndz (Zarxio, Sandoz) in 2015. Read the Pfizer corporate press release here.
Posted 7/23/2018
July 20, 2018
The Centers for Medicare & Medicaid Services (CMS) will be hosting two "Office Hours" sessions over the next few weeks to provide a brief overview of the Merit-based Incentive Payment System (MIPS 2017) performance feedback and targeted review, answer frequently asked questions, and highlight available resources on performance feedback and targeted review. The two webinars will be held at the following times:
If you are interested in submitting a question to be considered, please email CMSQualityTeam@ketchum.com . This email address is only for office hours questions; do not use this to submit a targeted review request. Space for these sessions is limited; register now to reserve your spot. The audio portion of the sessions will be broadcast through the web. Questions? Contact the Quality Payment Payment program at qpp@cms.hhs.gov .
CMS is also hosting a series of webinars on the MIPS Performance Categories for Year 2 (2018) of the Quality Payment Program. The webinars will provide an overview on the Cost, Improvement Activities, and Quality performance categories for Year 2. CMS subject matter experts will cover topics including category requirements, scoring details, and data submission mechanisms. Below are details for these webinars:
MIPS Cost Performance Category for Year 2 (2018) Overview Webinar
MIPS Improvement Activities Performance Category for Year 2 (2018) Overview Webinar
MIPS Quality Performance Category for Year 2 (2018) Overview Webinar
The audio portion of these webinars will be broadcast through the web; you can listen to the presentation through your computer speakers. CMS will open the phone line for the Q&A portion, but if you are unable to hear audio through your computer speakers, please contact CMSQualityTeam@ketchum.com .
Posted 7/20/2018
July 20, 2018
On July 20, the Food and Drug Administration (FDA) approved ivosidenib (Tibsovo, Agios Pharmaceuticals, Inc.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA approved test. It is the first FDA-approved therapy for patients with R/R AML and an IDH1 mutation. Read the Agios corporate press release here.
Posted 7/20/18
July 18, 2018
On July 18, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corp.) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.
The FDA also approved ribociclib in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy. Read the full FDA press release here.
Posted 7/18/18
July 16, 2018
On July 16, the Association of Community Cancer Centers (ACCC) submitted comments to the Request for Information (RFI) included in the administration's Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs . The plan was released in May.
In its comments , ACCC expresses support for the overarching goal to "bend the cost curve by improving care, providing the right care at the right time, reducing over-treatment and under-treatment, and reducing hospital admissions and readmissions." However, ACCC cautions that "any policy solution to rein in drug costs must preserve patients' access to—and ability to afford—quality cancer care and, relatedly, mitigate any impact on already reduced payment rates for cancer providers."
In brief, ACCC comments on the following concerns:
Read the ACCC Comment letter for a full discussion of these issues.
Posted 7/16/2018
July 16, 2018
On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC).
This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC. Read FDA announcement .
Posted 7/16/2018
July 12, 2018
On July 12, 2018, the Centers for Medicare & Medicaid Services (CMS) released the CY 2019 Medicare Physician Fee Schedule (PFS) proposed rule . Included are proposals to update payment policies, payment rates, and quality provisions for services furnished under the Medicare PFS on or after January 1, 2019.
The agency's proposals for Year 3 of the Quality Payment Program (QPP) are incorporated under the CY2019 PFS proposed rule .
Comments on the proposed rule are due by September 10, 2018.
ACCC is currently analyzing the proposed rule and will provide an in-depth analysis for membership.
Read the CMS fact sheet on the 2019 PFS proposed rule .
Read the CMS fact sheet on proposed QPP changes .
On Tuesday, July 17 from 1:00 - 2:30 PM ET, CMS will host a webinar on the proposed rule for Year 3 (2019) of the Quality Payment Program. CMS subject matter experts will:
Register here .
Posted 7/12/2018
July 10, 2018
In an effort to refocus nationwide efforts in oncology care, the American Cancer Society (ACS) has begun to outline its vision for cancer control in the 21st century through a series of articles. The first article in this series , published July 1, addresses trends in cancer mortality and disparities in cancer outcomes. ACS found that one area of critical disparity in cancer outcomes was socioeconomic status, indicated by educational attainment. Future articles in the series will focus on areas such as prevention, screening and early detection, cancer care and treatment, and research. Read the full ACS press release here.
Posted 7/10/2018
July 10, 2018
On July 10, the National Cancer Institute (NCI) and the Department of Veterans Affairs (VA) announced the launch of the NCI and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE). NAVIGATE will be launching at 12 VA facilities across the country. As part of the agreement, NCI will provide infrastructure funding support needed for VA facilities to participate in NCI-sponsored clinical trials, and VA will manage organizational and operational activities within its national healthcare system to establish a network to focus on NCI trial goals. Read the full NIH press release here.
Posted 7/10/2018
July 3, 2018
In a report released on June 28, the Government Accountability Office (GAO) calls for improvement in federal oversight of compliance at 340B contract pharmacies. From 2010 to 2017, the number of pharmacies with which 340B covered entities have contracted increased from about 1,300 to almost 20,000. The 340B Drug Pricing Program is administered by the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS).
The GAO report describes:
1) financial arrangements selected covered entities have with contract pharmacies;
2) the extent that selected covered entities provide discounts on 340B drugs dispensed by contract pharmacies to low-income, uninsured patients; and
3) HRSA's efforts to ensure compliance with 340B Program requirements at contract pharmacies.
Among the report's seven recommendations for improving oversight are that HRSA audits assess for duplicate discounts in Medicaid managed care, and that HRSA require information on how entities determined the scope of noncompliance and evidence of corrective action before closing audits.
Read GAO recommendations .
Read full report .
Posted July 3, 2018
July 2, 2018
On July 2, 2018, CMS announced that participants in the Merit-based Incentive Payment System (MIPS) in 2017 could review their MIPS final score and performance feedback on the Quality Payment Program website . The payment adjustment received in 2019 is based on this final score. A positive, negative, or neutral payment adjustment will be applied to the Medicare paid amount for covered professional services furnished under the Medicare Physician Fee Schedule in 2019.
MIPS eligible clinicians or groups (along with their designated support staff or authorized third-party intermediary), including those who are subject to the APM scoring standard, may request for CMS to review their performance feedback and final score through a process called targeted review.
If you believe an error has been made in your MIPS payment adjustment calculation, you can request a targeted review until September 30, 2018 . The following are examples of circumstances in which you may wish to request a targeted review:
You can access your MIPS final score and performance feedback and request a targeted review by:
CMS has posted new resources on CMS.gov to help eligible clinicians and groups understand their Merit-based Incentive Payment System (MIPS) final score, performance feedback, and payment adjustment, as well as the targeted review process. The new resources include:
For more information, visit the Quality Payment Program Resource Library on CMS.gov to review new and existing Quality Payment Program resources, or contact the Quality Payment Program at QPP@cms.hhs.gov or 1-866-288-8292 (TTY: 1-877-715-6222).
Posted 7/2/2018
June 29, 2018
On June 29, the Centers for Medicare & Medicaid Services (CMS) announced that they would be advancing the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration, which would waive Merit-Based Incentive Payment System (MIPS) requirements for clinicians who participate sufficiently in certain Medicare Advantage plans that involve taking on risk. CMS seeks public comment on the information collection burdens associated with the demonstration, which is under consideration for formal approval. Read the full CMS press release here.
Posted 6/29/2018
June 27, 2018
On June 27, 2018, the U.S. Food and Drug Administration (FDA) approved encorafenib and binimetinib (Braftovi and Mektovi, Array BioPharma Inc.) in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Read FDA announcement .
Posted June 27, 2018
June 20, 2018
On June 15, 2018, the Association of Cancer Care Centers submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency's opening of a National Coverage Analysis (NCA) for CAR T therapies for cancer. Currently, two CAR T-cell therapies are approved the U.S. Food and Drug Administration, Kymriah® (tisagenlecleucel) and Yescarta® (axicabtagene ciloleucel). In comments its to the agency , ACCC urged that CMS:
Additionally, ACCC expressed concern that the outcome of the NCA process may be stifling to innovation of CAR T therapies in the pipeline. Read ACCC Comment Letter
Posted 6/20/2018
June 13, 2018
On June 13, 2018, the Food and Drug Administration approved bevacizumab (Avastin, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection.
Read the full FDA announcement here.
Posted 6/13/18
June 13, 2018
On June 12, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck and Co. Inc.) for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Read the full FDA press release here.
Posted 6/13/2018
June 13, 2018
At the 2018 ASCO Annual Meeting, we had the opportunity to connect with many ACCC members and engage a wide audience! Oncology Business Review, OncLive, and ASCO Post sat down with a number of ACCC advocates and leaders to discuss pressing issues in cancer care.
ACCC Treasurer Randall A. Oyer, MD , with an update on the ACCC Immuno-Oncology Institute:
ACCC Immuno-Oncology Institute Executive Committee Member Ivo Abraham, PhD, RN , speaks about value in cancer care:
ACCC Past President Jennie R. Crews, MD, MMM, FAC P , describes how care coordination in immunotherapy is engaging new providers with the cancer care team:
Dr. Abraham shares his perspective on hurdles to adoption of biosimilars in oncology:
Watch more from Dr. Abraham on:
Key features of a biosimilar- via OBR
Biosimilars approved and nearing approval for oncology- via OBR
Biosimilar pricing and reimbursement- via OBR
Dr. McBride Discusses financial toxicity in oncology with OncLive :
Lee S. Schwartzberg, MD, FACP, discusses how the ACCC Immuno-Oncology Institute is evolving to support integration of IO in the community through new working groups, resources for cross-specialty care coordination, and team education for this rapidly expanding field. - ASCO Post
Dr. Zibelman discusses managing immune-related adverse events with OncLive :
Posted 6/13/2018
June 11, 2018
On June 8, 2018, the Food and Drug Administration (FDA) granted regular approval to venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
Read the full FDA announcement here.
Posted 6/11/2018
May 30, 2018
In response to increasing incidence in young and middle-aged populations, the American Cancer Society (ACS) has updated its colorectal cancer (CRC) screening guideline. The revised guideline now recommends that CRC screening should begin at age 45 for people at average risk.
Read the ACS press release here , and the updated guideline here .
Posted 5/30/2018
May 24, 2018
On May 23, the FDA approved abiraterone acetate (Yonsa, Sun Pharmaceutical Industries Ltd.) in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Read the Sun Pharma press release here .
Posted 5/24/2018
May 22, 2018
On May 22, The National Institutes of Health (NIH) released its Annual Report to the Nation on the Status of Cancer , a collaborative effort with the Centers for Disease Control and Prevention, the American Cancer Society, and the North American Association of Central Cancer Registries.
The report finds that from 1999 to 2015, overall cancer death rates decreased by 1.8 percent per year among men and by 1.4 percent per year among women. From 2011 to 2015, death rates decreased for 11 of the 18 most common cancer types in men and for 14 of the 20 most common cancer types in women. Over the same period, death rates for cancers of the liver, pancreas, and brain and other nervous system increased in both men and women; death rates for cancer of the uterus increased in women; and death rates for cancers of the oral cavity and pharynx and soft tissue increased in men.
Read the full report here .
Posted 5/22/2018
May 21, 2018
On May 18, 2018, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals, oncology clinical investigators, and the public about decreased survival associated with the use of Keytruda (pembrolizumab) or Tecentriq (atezolizumab) as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1).
In two ongoing clinical trials (KEYNOTE-361 and IMVIGOR-130), the Data Monitoring Committees’ (DMC) early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy. There was no change in the adverse event profile of Keytruda or Tecentriq. Both Merck, manufacturer of Keytruda, and Genentech, manufacturer of Tecentriq, have stopped enrolling patients whose tumors have PD-L1 low status to the Keytruda or Tecentriq monotherapy arms per the DMCs’ recommendations.
The clinical trials compare platinum-based chemotherapy combined with Keytruda or Tecentriq to platinum-based chemotherapy alone. Both trials enrolled a third arm of monotherapy with Keytruda or Tecentriq to compare to platinum-based chemotherapy alone. The monotherapy arms remain open only to patients whose tumors have PD-L1 high status. The combination arms and the chemotherapy arms of both studies also remain open. The FDA is reviewing the findings of the ongoing clinical trials and will communicate new information as necessary.
Both Keytruda and Tecentriq are currently approved under accelerated approval for the treatment of locally advanced or metastatic urothelial carcinoma patients who are not eligible for cisplatin-containing chemotherapy, irrespective of PD-L1 status. Patients taking Keytruda or Tecentriq for other approved uses should continue to take their medication as directed by their healthcare professional.
Healthcare professionals should be aware that the populations enrolled in the ongoing clinical trials were eligible for platinum-containing chemotherapy, and therefore differ from those enrolled in the trials that led to the accelerated approvals of both Keytruda and Tecentriq in the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. FDA recommends providers select patients for the treatment of locally advanced or metastatic urothelial cancer using the criteria described in Section 14 of each label. These criteria supported the approvals for Keytruda and Tecentriq for initial monotherapy in cisplatin-ineligible patients. Keytruda and Tecentriq are also currently approved by the FDA for the treatment of multiple types of other cancers.
Patients should talk to their doctor if they have questions or concerns about either drug.
Health care professionals and patients are encouraged to report any adverse events or side effects related to the use of these products and other similar products to FDA’s MedWatch Adverse Event Reporting program .
Keytruda Prescribing InformationTecentriq Prescribing InformationAccess FDA announcement .
Posted 5/21/2018
May 21, 2018
On May 21, 2018, the Food and Drug Administration approved avatrombopag (Doptelet, AkaRx Inc.) for thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. Read the full FDA announcement here .
Posted 5/21/2018