May 7, 2018
On May 4, 2018, the Food and Drug Administration approved dabrafenib (Tafinlar, Novartis Pharmaceuticals Corp.) and trametinib (Mekinist, Novartis Pharmaceuticals Corp.), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body (metastatic), and has a type of abnormal gene, BRAF V600E (BRAF V600E mutation-positive).
Read the full FDA announcement here.
Posted 5/1/2018
May 1, 2018
On May 1, 2018, Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication - the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
Kymriah is not indicated for the treatment of patients with primary central nervous system lymphoma. Read the company press release . Read FDA announcement .
Posted 5/1/2018
May 1, 2018
The Centers for Medicare & Medicaid Services (CMS) is hosting a webinar on Wednesday, May 9at 1:00 PM ET to provide an overview of participation criteria used to determine inclusion in the Merit-based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs).
Attendees will learn about:
CMS will address questions from participants at the end of the webinar, as time allows.
Webinar DetailsTitle: Participation Criteria for Year 2 of the Quality Payment Program Date: Wednesday, May 9, 2018 Time: 1:00-2:15 p.m. ET Registration Link:https://engage.vevent.com/rt/cms/index.jsp?seid=1091
Posted 5/1/2018
May 1, 2018
The National Academies of Sciences, Engineering, and Medicine (NASEM) has published the proceedings of several new workshops , including a workshop held by the National Cancer Policy Forum on long-term cancer survivorship care.
Long-Term Survivorship Care After Cancer Treatment summarizes the proceedings of a July 2017 workshop held in Washington, D.C., to examine progress made in cancer survivorship care since the publication of the 2006 consensus study report From Cancer Patient to Cancer Survivor: Lost in Transition . Workshop participants highlighted potential opportunities to improve the planning, management, and delivery of cancer survivorship care.
The Global Forum on Innovation in Health Professional Education also published the proceedings of their Improving Health Professional Education and Practice Through Technology workshop held in November 2017. Participants explored effective use of technologies as tools for bridging identified gaps within and between health professions education and practice in order to optimize learning, performance and access in high-, middle-, and low-income areas while ensuring the well-being of the formal and informal health workforce.
Posted 5/1/2018
May 1, 2018
On April 30, 2018, the Food and Drug Administration granted regular approval to dabrafenib (Tafinlar, Novartis Pharmaceuticals Corp.) and trametinib (Mekinist, Novartis Pharmaceuticals Corp.) in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. Read the full FDA announcement here.
Posted 5/1/2018
April 25, 2018
On April 24, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System.
Among the proposed changes, CMS seeks to overhaul the Medicare and Medicaid EHR Incentive Programs to “focus on interoperability, improve flexibility, relieve burden and place emphasis on measures that require the electronic exchange of health information between providers and patients,” according to the agency’s fact sheet. To reflect this new focus, CMS proposes to change the EHR incentive program name from the “Meaningful Use” program to “Promoting Interoperability.”
In addition to payment and policy proposals, CMS is releasing a Request for Information (RFI) to gain stakeholder input on the possibility of revising Conditions of Participation related to interoperability as a way to increase electronic sharing of data by hospitals.
The deadline for submitting comments on the proposed rule and the RFI is June 25, 2018.
Read the full rule here , and access the CMS fact sheet here .
Posted 4/25/2018
April 24, 2018
Earlier this week, the Centers for Medicare & Medicaid Services (CMS) announced the release of the more than 1,000 comments the agency received in response to its “New Direction” RFI for the Innovation Center. In a statement, the agency said that it is sharing the feedback “to promote transparency and facilitate further discussion” on ways to move the Innovation Center in a new direction. Learn more .
CMS also opened a new RFI for a “potential model in the area of direct provider contracting” as a next step. The agency is seeking input on a possible direct provider contracting care model between payers and primary care or multispecialty groups.The model might be tested within the Medicare fee-for-service (FFS) program (Medicare Parts A and B), Medicare Advantage program (Medicare Part C), and Medicaid. Read more on the RFI .
Posted 4/24/2018
April 23, 2018
On April 22, the White House stated that President Donald Trump's planned speech on lowering drug costs has been postponed. Originally planned for April 26, the speech has been postponed to an undetermined date in the "near future," according to Hogan Gidley, deputy White House press secretary.
Source: Bloomberg BNA
Posted 4/23/2018
April 18, 2018
On April 17, 2018, the U.S. Food and Drug Administration (FDA) approved fostamatinib disodium hexahydrate tablets (Tavalisse, Rigel Pharmaceuticals, Inc.) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Read FDA announcement . 4/18/18
April 16, 2018
On April 16, 2018, the Food and Drug Administration granted approval to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk previously untreated advanced renal cell carcinoma.
Read the full press release here.
Posted 4/16/2018
April 13, 2018
On April 6, Secretary of Health and Human Services (HHS) Alex Azar announced that Adam Boehler would assume leadership of the Center for Medicare & Medicaid Innovation (CMMI) on the week of April 9. Boehler, the founder and chief executive officer of Landmark Health, replaced acting leader Amy Bassano as the head of CMMI, the office responsible for testing Medicare and Medicaid payment innovations. Read more here.
Posted 4/13/2018
April 11, 2018
The American Cancer Society Cancer Action Network (ACS CAN) has released a report detailing the barriers to patient enrollment in therapeutic clinical trials for cancer. In its report, ACS CAN compiles all relevant evidence for clinical trial barriers in one place and discusses them in relation to each other, addressing each component’s contribution to the problem as a whole. ACS CAN also provides a complementary set of 23 recommendations for overcoming clinical trial barriers in numerous areas, including provider and institutional barriers, patient barriers, trial-design barriers, and disparities.
Posted 4/11/2018
April 6, 2018
On April 6, 2018, the Food and Drug Administration approved rucaparib (Rubraca, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
April 4, 2018
The Centers for Medicare & Medicaid Services (CMS) has begun mailing its newly-designed Medicare cards with new Medicare Beneficiary Identifiers to newly eligible and current Medicare beneficiaries. Cards will be sent out on a rolling basis throughout 2018 to fulfill the CMS requirement to remove Social Security Numbers from all Medicare cards by April 2019.
CMS will host a special Open Door Forum on April 5, 12:30 – 1:30 PM EST, to share updates about the new Medicare card mailing, information on how people with Medicare can look up their new Medicare card number or print a replacement card, and updates on resources for partners. To participate, visit https://webinar.cms.hhs.gov/r51uia09fgq/ and use the following information:
Check cms.gov/newcard often for the most up-to-date information.
Posted 4/4/2018
April 4, 2018
On April 4, the American Society for Radiation Oncology (ASTRO) issued an update to its clinical guideline for the use of palliative-intent radiation therapy for patients with incurable non-small cell lung cancer (NSCLC). The updated guideline now recommends the addition of concurrent chemotherapy to radiation therapy for certain patients with incurable stage III NSCLC that are able to tolerate chemotherapy and have a longer life expectancy than three months, reflecting new evidence gathered from randomized clinical trials.
Read the press release from ASTRO here.
Posted 4/4/2018
April 3, 2018
On April 2, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to update Medicare Advantage (MA) and the Part D prescription drug benefit program. Included in the final rule, among additional changes, are:
Read a CMS fact sheet that provides details on the major provisions of the final rule.
Posted 4/3/2018
March 29, 2018
On March 29, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Read FDA announcement .
Posted 3/29/2018
March 29, 2018
The Centers for Medicare & Medicaid Services has announced that eligible clinicians participating in the Quality Payment Program (QPP) now have until Tuesday,April 3, 2018, at 8 PM EDT to submit their 2017 MIPS performance data. Eligible clinicans can submit their performance data using the new feature on the Quality Payment Program website .
Note: For groups that missed the March 16 CMS Web Interface data submission deadline, it’s not too late to submit your data through another mechanism. How to Get Started
Go to qpp.cms.gov and click on “sign in” on the top right side of the web page.
For questions or help using the data submission feature, contact the Quality Payment Program by email at qpp@cms.hhs.gov or toll free at 1-866-288-8292.
View the data submission fact sheet and this video to learn more about the Quality Payment Program data submission feature.
Posted 3/29/18
March 23, 2018
On March 22, 2018, the U.S. Food and Drug Administration (FDA) approved nilotinib (Tasigna, Novartis Pharmaceuticals Corporation) for pediatric patients 1 year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (CML) in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy. Read FDA announcement .
Posted 3/23/2018
March 21, 2018
The United States Preventive Services Task Force (USPSTF) released its final recommendation statement on behavioral counseling to prevent skin cancer. The task force recommends counseling young adults, adolescents, children, and parents of young children about minimizing exposure to ultraviolet (UV) radiation for persons aged 6 months to 24 years with fair skin types to reduce their risk of skin cancer. The USPSTF recommendation comes with B grade.
Read the recommendation here .
Read the full article published March 20, 2018, in the Journal of the American Medical Association .
Posted 3/21/18
March 20, 2018
The Centers for Medicare & Medicaid Services (CMS) has announced that the Oncology Care Model team will host a public forum for stakeholders on Thursday, May 3 from 1:00 PM – 4:00 PM EDT. All interested OCM stakeholders are invited to attend this public meeting, with the goal of hearing feedback about OCM. The meeting will include a brief introduction from the OCM team followed by discussion.
Registrants will be sent an agenda one week prior to the meeting that will include compiled topics submitted via the text field in the registration form.
Attendees may attend virtually or in-person at the Centers for Medicare & Medicaid Services Central Office located at 7500 Security Boulevard, Baltimore, Maryland 21244.
Registration for in-person attendance will close at 5:00 PM EDT on April 26, 2018 . Virtual registration will remain open until 1:00 PM EDT on Thursday May 3 . Virtual attendees will receive call-in information in the registration confirmation email.
Additional information, including access to the registration link, is available on the Oncology Care Model - Stakeholder Feedback Public Forum web page .
Posted 3/20/2018
March 20, 2018
On March 20, 2018, the U.S. Food and Drug Administration (FDA) approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. Read the FDA announcement .
Posted 3/20/2018
March 13, 2018
A report from the President's Cancer Panel released March 13 calls on stakeholders from all segments of oncology to join together to "maximize the value and affordability of cancer drug treatment" while continuing to support investment in research to propel future innovations.
"Cancer patients should not have to choose between paying for their medications or paying their mortgages. For so many, it is truly a matter of life and death," said Barbara K. Rimer, DrPH, chair of the President's Cancer Panel, in a statement. "This is a national imperative that will not be solved by any one sector working alone."
The report, Promoting Value, Affordability, and Innovation in Cancer Drug Treatment , urges action informed by three guiding principles:
The President's Cancer Panel, established by the National Cancer Act of 1971, is an independent entity charged with monitoring the National Cancer Program and reporting to the President on any barriers to its execution. Learn more about the Panel's role and members .
Read the Executive Summary .
Read the Recommendations at a Glance .
Posted 3/13/18
March 13, 2018
The American Society for Radiation Oncology (ASTRO) today issued a new clinical guideline for the use of whole breast radiation therapy (WBRT) for breast cancer that expands the population of patients recommended to receive accelerated treatment known as hypofractionated therapy.
Reflecting current evidence from clinical trials and large cohort studies, the new guideline recommends hypofractionated WBI for breast cancer patients regardless of age, tumor stage, and whether they have received chemotherapy.
The guideline provides clinical guidance for dosing, planning and delivering whole breast irradiation (WBI) with or without an additional "boost" of radiation therapy to the tumor bed. Full recommendations and supporting evidence are provided in the guideline . Read the ASTRO press release .
Posted 3/13/18