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
March 7, 2018
Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma has announced the administration's new MyHealthEData, an initiative that aims to give Americans more complete access to their healthcare data. She made the announcement in an address on March 6, 2018, at the Healthcare Information and Management Systems Society (HIMSS) Annual Conference in Las Vegas. The government-wide initiative is being led by the White House Office of American Innovation with participation from the Department of Health and Human Services, including CMS; Office of the National Coordinator for Health Information Technology (ONC); the National Institutes of Health; and the Department of Veterans Affairs.
As part of MyHealthEData announcement, CMS also announced that the agency intends to "overhaul" the EHR Incentive Programs to "refocus the programs on interoperability and to reduce the time and cost required" for providers to meet requirements.
In her remarks, Administrator Verma also described Medicare's Blue Button 2.0 - a tool that would allow Medicare beneficiaries to access and their personal health data in a "universal digital format."
As part of this initiative, the administration is also calling on healthcare insurers to follow suit and give patients access to their claims data in a digital format.
The administration is still developing a timeline for the initiative, Verma said in an interview with Bloomberg BNA . Read the CMS press release . Read the CMS fact sheet .
Posted 3/7/18
March 6, 2018
On March 6, 2018, the U.S. Food and Drug Administration (FDA) authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It is the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population.
The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The test only detects three out of more than 1,000 known BRCA mutations. This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.
The FDA press release states:
"Consumers and healthcare professionals should not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries. Such decisions require confirmatory testing and genetic counseling. The test also does not provide information on a person’s overall risk of developing any type of cancer. The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor." Read the FDA announcement .
Posted 3/6/2018
February 27, 2018
On February 26, 2018, the U.S. Food and Drug Administration FDA) approved abemaciclib (Verzenio™, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Read FDA announcement .
Posted 2/27/2018
February 20, 2018
On September 16, 2018, the U.S. Food and Drug Administration (FDA) approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).
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February 14, 2018
On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.
Erleada works by blocking the effect of androgens, a type of hormone, on the tumor. These androgens, such as testosterone, can promote tumor growth.
The sponsor for Erleada is the first participant in the FDA’s recently-announced Clinical Data Summary Pilot Program , an effort to provide stakeholders with more usable information on the clinical evidence supporting drug product approvals and more transparency into the FDA’s decision-making process. Soon after approval, certain information from the clinical summary report will post with the Erleada entry on Drugs@FDA and on the new pilot program landing page . Read FDA press release .
Posted 2/14/2018
February 14, 2018
On February 14, 2018, the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) jointly announced release of guidance on managing side effects of immunotherapy with immune checkpoint inhibitors. The organizations note that these guidelines pertain only to immune checkpoint inhibitors, not to other types of immunotherapy.
To date, several checkpoint inhibitor immunotherapies have been approved by the U.S. Food and Drug Administration (FDA) for treatment of a number of cancer types, including melanoma, Hodgkin lymphoma, and lung, liver, kidney, and bladder cancer. In the rapidly evolving cancer immunotherapy landscape, the number of agents, new indications, and combination therapies continues to grow.
In a joint news release, ASCO and NCCN briefly outline the guideline development process, which included convening multidisciplinary panels with representation from medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, neurology, hematology, emergency medicine, and nursing, as well as patient advocacy experts. The clinical recommendations were based on a systematic literature review and an informal consensus process.
"The Management of Immune-related Adverse Events in Patients Treated with Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline," was published online February 14, 2018, in the Journal of Clinical Oncology. Read the article .
NCCN Guidelines® for Management of Immunotherapy-Related Toxicities were published online at NCCN.org on February 14, 2018.
ASCO and NCCN welcome feedback on their guidelines from oncologists, practitioners, and patients through the ASCO Guidelines Wiki or via the NCCN submission form at NCCN.org .