May 18, 2018
On May 17, 2018, the American Urological Association (AUA) announced updates to its castration-resistant prostate cancer (CRPC) guideline. The guideline was updated to incorporate new published research related to the treatment of patients with asymptomatic non-metastatic CRPC. Read the newly amended guideline here .
Posted 5/18/2018
May 15, 2018
On May 15, 2018, the Food and Drug Administration approved epoetin alfa-epbx (Retacrit, Hospira Inc.) as a biosimilar to epoetin alfa (Epogen/Procrit, Amgen Inc.) for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis, use of zidovudine in patients with HIV infection, and the effects of concomitant myelosuppressive chemotherapy. It is also approved for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
Read the FDA announcement here.
Posted 5/15/2018
May 14, 2018
On May 14, the Department of Health and Human Services (HHS) issued a formal request for information (RFI) regarding the Trump Administration’s proposed drug pricing blueprint . HHS seeks “all suggestions to improve the affordability and accessibility of prescription drugs, including reflections and answers to questions not specifically asked.” Questions specifically posed by HHS are:
ACCC will be submitting comments, but we also encourage our member programs to weigh in on this important document. Comments must be submitted on or before July 15, 2018. To submit electronically, go to http://www.regulations.gov .
Posted 5/14/2018
May 11, 2018
On Friday, May 11, President Trump and U.S. Department of Health and Human Services Secretary Alex M. Azar II announced the administration's plan to lower drug prices.
Access " American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs ."
ACCC is continuing to look at the policies' implications for our members and their patients. Stay tuned for updates.
Posted 5/11/2018
May 8, 2018
On May 8, 2018, the U.S. Preventive Services Task Force (USPSTF) released a final recommendation statement and evidence summaries on screening for prostate cancer. The USPSTF final recommendation provides clinicians and patients with important new information about the benefits and harms of prostate-specific antigen (PSA)-based screening.
For men 55 - 69 years of age, the USPSTF final recommendation calls for informed individual decision-making based on the individual's values and specific clinical circumstances. This is a C recommendation.
The USPSTF recommends against PSA-based screening for prostate cancer in men age 70 and older.
Read the USPSTF Recommendation Statement and access the evidence summary and FAQs .
Posted May 8, 2018
May 8, 2018
On May 7, 2018, the Food and Drug Administration approved daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant (ASCT).
Read the Johnson & Johnson press release here.
Posted 5/8/2018
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