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Oncology Newsfeed

FDA Approves Pembrolizumab for Certain Previously Treated Patients with Advanced or Metastatic Gastric or GEJ Cancer

On Sept. 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.

Read company press release.

Posted 9/22/2017

CMS to Host PQRS Provider Call

On Tuesday, Sept. 26, the Centers for Medicare & Medicaid Services will host a Physician Quality Reporting System (PQRS) National Provider Call. Participants will learn about the PQRS downward payment adjustments, the PQRS feedback reports, and the informal review process for Program Year (PY) 2016 and 2018 payment adjustment determinations.

Sept. 26, 2017
1:30 to 3:00 pm ET

Register here.

Note: Program Year 2016 was the last year for the PQRS program. The final data submission timeframe for 2016 PQRS quality data, to avoid the 2018 PQRS downward payment adjustment, was January through March 2017. The Merit-based Incentive Payment System (MIPS) under the new Quality Payment Program combines the PQRS, the Value-based Modifier, and the Medicare EHR Incentive Program for Eligible Professionals into one program. The first MIPS performance period year is January through December 2017. For more information, visit the Quality Payment Program website.

Posted 9/22/2017

CMS Issues RFI Seeking Feedback on New Direction for CMMI

On Sept. 20, 2017, the Centers for Medicare & Medicaid Services (CMS) announced an informal Request for Information (RFI) seeking stakeholder feedback on a “new direction to promote patient-centered care and test market-driven reforms that empower beneficiaries as consumers, provide price transparency, increase choices and competition to drive quality, reduce costs, and improve outcomes” for the Center for Medicare and Medicaid Innovation (CMMI).

Additional details on the RFI are provided on the CMMI website here. The agency states that:

While existing partnerships with healthcare providers, clinicians, states, payers and stakeholders have generated important value and lessons, CMS is setting a new direction for the Innovation Center. We will carefully evaluate how models developed consistent with the new directions can complement what we are learning from the existing initiatives. In particular, the Innovation Center is interested in testing models in the following eight focus areas:

  1. Increased participation in Advanced Alternative Payment Models (APMs);
  2. Consumer-Directed Care & Market-Based Innovation Models;
  3. Physician Specialty Models;
  4. Prescription Drug Models;
  5. Medicare Advantage (MA) Innovation Models;
  6. State-Based and Local Innovation, including Medicaid-focused Models;
  7. Mental and Behavioral Health Models; and
  8. Program Integrity.
Comments may be submitted online or by email to CMMI_NewDirection@cms.hhs.gov through 11:59 pm, EST, Nov. 20, 2017.

Posted 9/20/2017

QPP Exception Decisions Due to Hurricanes

The Centers for Medicare & Medicaid Services (CMS) has announced that the agency is currently reviewing reporting requirements for the Quality Payment Program (QPP) and will be making exception decisions regarding the impact of Hurricanes Harvey and Irma. Read the latest information from CMS in response to Hurricanes Harvey and Irma here, and sign up for Quality Payment Program updates to stay informed.

Posted 9/19/2017

NCCN Clinical Practice Guidelines to Include “Categories of Preference”

The National Comprehensive Cancer Network (NCCN) announced Sept. 15, that it has instituted Categories of Preference for recommendations within the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). The NCCN Guidelines for Multiple Myeloma will be the first to include Categories of Preference for drugs and biologics recommended within the Guidelines. Additional cancer types are to follow.

As explained in an NCCN press release, the NCCN categories of preference will provide guidance on which recommendations within Guidelines are optimal, while providing a range of recommendations to accommodate a variety of clinical circumstances.

The press release states that “all recommendations in the NCCN Guidelines are considered appropriate.” The Categories of Preference are:

  • Preferred intervention: Interventions that are based on superior efficacy, safety, and evidence; and, when appropriate, affordability
  • Other recommended intervention: Other interventions that may be somewhat less efficacious, more toxic, or based on less mature data; or significantly less affordable for similar outcomes
  • Useful in certain circumstances: Other interventions that may be used for selected patient populations (defined with recommendation)

Learn more.

NCCN Categories of Preference FAQs.

Posted 9/19/2017

FDA Approves Copanlisib for Adults with Relapsed Follicular Lymphoma

On Sept. 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma, a cancer of the lymph system.

Aliqopa is a kinase inhibitor that works by blocking several enzymes that promote cell growth.

Read FDA announcement.

Posted 9/18/2017

FDA Approves First Biosimilar for Treatment of Cancer

On Sept. 14, 2017, the U.S. Food and Drug Administration (FDA) approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers. Specifically, the approved indications include:

  • Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrmidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
  • Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.
  • Metastatic renal cell carcinoma, in combination with interferon alfa.
  • Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

Read FDA announcement.

Posted 9/18/2017

NQF Proposes Measurement Guidance for Telehealth and Interoperability

The National Quality Forum (NQF) released two new reports that provide national guidance to advance health information technology. "Creating a Framework to Support Measure Development for Telehealth," identifies critical areas where measurement can effectively assess the quality and impact of telehealth services. A second document, "Interoperability 2016-2017 Final Report, assesses the current state of interoperability and its impact on quality processes and outcomes.

Read NQF press release.

Posted 9/13/2017

AACR Issues 2017 Cancer Progress Report

On Sept. 13, the American Association for Cancer Research (AACR) released its 2017 Cancer Progress Report: Harnessing Research Discoveries to Save Lives. The report cites immunotherapy and precision medicine as being on the leading edge of progress.

Learn more.

Posted 9/13/2017

Sept. 8 CMS Webinar on MIPS for Small, Rural, & Underserved Practices

Join the Centers for Medicare & Medicaid Services (CMS) and the National Rural Health Association for a September 8 webinar on the Merit-based Incentive Payment System (MIPS) track of the Quality Payment Program. Dr. Ashby Wolfe, Chief Medical Officer for Region IX, and Adam Richards, Health Insurance Specialist at CMS, will present:

  • A brief overview of the Quality Payment Program
  • An overview of MIPS
  • Flexibilities and resources for small practices

There will be a Q&A session at the end of the presentation.

What: Overview of MIPS for Small, Rural, and Underserved Practices
Date: Sept. 8, 2017
Time: 1:00 - 2:30 PM EST

Register here.

Posted 9/06/2017

FDA Approves Mylotarg for Acute Myeloid Leukemia

On September 1, 2017, the U.S. Food and Drug Administration (FDA) approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML). The FDA also approved Mylotarg for the treatment of patients aged 2 years and older with CD33-positive AML who have experienced a relapse or who have not responded to initial treatment (refractory).

Read FDA press release.

Posted 9/01/2017

CMS Grants Disaster Exceptions/Exemptions for Medicare-Certified Providers Affected by Hurricane Harvey

The Centers for Medicare & Medicaid Services (CMS) is granting exceptions under certain Medicare quality reporting and value-based purchasing programs without having to submit an extraordinary circumstances exception request if they are located in one of the Texas counties or Louisiana parishes, all of which have been designated by the Federal Emergency Management Agency (FEMA) as a major disaster county.

The scope and duration of the exception under each Medicare quality reporting program is described in the memo posted on 8-31-17, however, all of the exceptions are being granted to assist these providers while they direct their resources toward caring for their patients and repairing structural damages to facilities.

If FEMA expands the current disaster declaration for Hurricane Harvey to include additional counties or parishes, CMS will update this memo to expand the list of providers eligible to receive an exception without submitting a request to include the hospitals, PPS-exempt cancer hospitals, inpatient psychiatric facilities, skilled nursing facilities, home health agencies, hospices, inpatient rehabilitation facilities, long-term care hospitals, and ambulatory surgical centers located in the additional counties and parishes.

In addition, CMS will continue to monitor the situation and adjust exempted reporting periods and submission deadlines accordingly.

Emergency information for people with Medicare can be found here.

Additional details and materials are available on the CMS emergency Hurricanes webpage

Posted 9/01/2017

FDA Approval of Kymriah Brings First Gene Therapy to U.S.

In a historic action, the U.S. Food and Drug Administration (FDA) today approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). Kymriah, a CAR T-cell therapy, is approved in the U.S. for the treatment of patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse.

Kymriah is a genetically-modified autologous T-cell immunotherapy. Each dose of Kymriah is a customized treatment created using an individual patient’s own T-cells, a type of white blood cell known as a lymphocyte. The patient’s T-cells are collected and sent to a manufacturing center where they are genetically modified to include a new gene that contains a specific protein (a chimeric antigen receptor or CAR) that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. Once the cells are modified, they are infused back into the patient to kill the cancer cells.

Read the FDA announcement.

Posted 8/30/2017

FDA Approves Expanded Use of Fulvestrant as First-Line Hormonal Breast Cancer Therapy

On Aug. 28, 2017, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved fulvestrant (Faslodex) 500mg as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy.

The approval is based on data from the Phase 3 FALCON trial, published in the November 2016 issue of The Lancet.

Read the company press release.

Posted 8/30/2017

CDC Report Shows Uninsured Rate Below 9 Percent

Data released by the Centers for Disease Control & Prevention (CDC) Aug. 29 shows the U.S. uninsured rate falling below 9 percent. The CDC report provides health insurance estimates from the first quarter of the 2017 National Health Interview Survey.

According to the "Health Insurance Coverage: Early Release of Estimates From the National Health Interview Survey, January – March 2017," in the first 3 months of 2017, the percentage of persons of all ages who were uninsured at the time of interview was 8.8% (28.1 million). A total of 20.5 million fewer persons lacked health insurance coverage in the first 3 months of 2017 compared with 2010 (48.6 million or 16.0%).

Read report highlights.

Posted 8/30/2017

It's Official: CMS Withdraws Medicare Part B Drug Demo

The Centers for Medicare & Medicaid Services (CMS) has officially withdrawn its Part B Drug Demo proposed rule from the Office of Management and Budget (OMB), effective Aug. 1, 2017. ACCC along with other oncology stakeholders had advocated strongly against the ill-conceived mandatory demonstration project.

The notice is slated to appear in an upcoming issue of the Federal Register.

The proposed Part B Drug Payment Model was initially released by CMS in March 2016.

Posted 8/30/2017

USPSTF Issues Final Research Plan: Screening for Pancreatic Cancer

On Aug. 17, 2017, the U.S. Preventive Services Task Force (USPSTF) posted a final research plan on screening for pancreatic cancer.

The USPSTF draft research plan for this topic was posted for public comment from April 27 to May 24, 2017. The Task Force reviewed all comments that were submitted and took these into consideration as it finalized the research plan.

View the final research plan.

Posted 8/28/2017

USPSTF Issues Final Research Plan for BRCA-Related Cancer: Risk Assessment and Genetic Counseling & Testing

On Aug. 24, the U.S. Preventive Services Task Force (USPSTF) posted a final research plan on risk assessment, genetic counseling, and genetic testing for BRCA-related cancer.

The USPSTF draft research plan on this topic was open for public comment from March 16 to April 12, 2017. The Task Force reviewed all comments received and took these into consideration as it finalized the research plan.

The final research plan is used to guide a systematic review of the evidence by researchers at an Evidence-based Practice Center. The resulting Evidence Review will form the basis of the USPSTF Recommendation Statement on this topic.

Learn more.

Posted 8/24/2017

HOP Panel Recommends CMS Drop Proposed Cuts to 340B Program

In a meeting on Monday, Aug. 21, 2017, the Hospital Outpatient Payment (HOP) advisory panel to the Centers for Medicare & Medicaid Services (CMS), voted to recommend that the agency not finalize its proposal to cut reimbursement for drugs purchased under the 340B Drug Pricing Program. Under the proposed CY 2018 Outpatient Prospective Payment System (OPPS) rule, CMS has proposed reducing payment for drugs purchased under the 340B program from average sale price (ASP) plus 6% to ASP minus 22.5%.

The HOP panel also voted to recommend that CMS not go forward with its proposal to package Level 1 and Level 2 drug administration services.

The Association of Community Cancer Centers (ACCC) joined with other stakeholders in testifying against the proposed cuts to 340B reimbursement. ACCC also testified against the agency’s proposed packaging of Level 1 and 2 drug administration services.

Posted 8/23/2017

President Trump Signs FDA Reauthorization Act into Law

On Aug. 18, 2017, President Trump signed the FDA Reauthorization Act of 2017 (FDARA) into law. FDARA reauthorizes user fees paid to the U.S. Food and Drug Administration (FDA) to support regulatory review of innovator drugs and biologics, medical devices, generic drugs, and biosimilar biologics. Together with congressional appropriations, the fees help fund FDA operations. 

This FDA Voice blog post provides highlights on the critical support the new law will provide for important FDA activities related to medical product regulation, including:

  • Enhancing the FDA's ability to capture the patient voice in drug development.
  • Advancing and facilitating the development and timely approval of drugs and biologics for rare diseases, including diseases of children. In particular, FDARA provides the FDA with new authority to require a pediatric investigation into an adult cancer drug if that drug is directed at a molecular target that is relevant to a pediatric cancer.

Learn more here.

Posted 8/21/2017

FDA Approves Besponsa for Relapsed or Refractory B-cell Precursor ALL

On Aug. 17, 2017, the U.S. Food and Drug Administration (FDA) approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

B-cell precursor ALL is a rapidly progressing type of cancer in which the bone marrow makes too many B-cell lymphocytes, an immature type of white blood cell. The National Cancer Institute estimates that approximately 5,970 people in the United States will be diagnosed with ALL this year.

Besponsa is a targeted therapy that is thought to work by binding to B-cell ALL cancer cells that express the CD22 antigen, blocking the growth of cancerous cells.

Read FDA press release.

Posted 8/21/2017

FDA Approves Olaparib Tablets for Maintenance Treatment in Ovarian Cancer

On Aug. 17, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib tablets (Lynparza, AstraZeneca) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.

With the addition of the new indication, a tablet formulation of olaparib is introduced. The FDA approved olaparib capsules in 2014 for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. On Aug. 17, 2017, the FDA also approved olaparib tablets for this indication.

Olaparib tablets and capsules are not interchangeable. Olaparib capsules are being phased out of the U.S. market and will be available only through the Lynparza Specialty Pharmacy Network.

Read the FDA announcement here.

Posted 8/18/2017

NIH Awards $18.9 Million for Research to Accelerate Use of Genomics in Clinical Care

The National Institutes of Health (NIH) is awarding $18.9 million in support of research that aims to accelerate the use of genome sequencing in clinical care. The NIH announcement states that these new awards will generate innovative approaches and best practices to ensure that the effectiveness of genomic medicine can be applied to all individuals and groups, and in healthcare settings beyond academic medical centers.

The research is being funded as part of the Clinical Sequencing Evidence-Generating Research (CSER2) Consortium.

Read NIH press release.

Posted 8/11/2017

Senate Passes FDA User Fee Bill

On August 3, 2017, by a vote of 94-1 the U.S. Senate voted to approve H.R. 2430, which reauthorizes the Prescription Drug User Fee Act (PDUFA) that allows the FDA to collect industry-paid fees. The fees, together with congressional appropriations, fund the FDA.

The bill is now headed to the President's desk.

Source: Bloomberg BNA

Posted 8/3/2017

CMS to Host Aug. 16 Office Hours on QPP Proposed Rule

The Centers for Medicare & Medicaid Services (CMS) will host an office hours session on Wednesday, August 16 from 12 noon to 1 pm ET on the draft provisions included in the Quality Payment Program (QPP) Year 2 proposed rule. During the webinar CMS will provide a brief overview of the QPP and respond to questions on the Year 2 notice of proposed rule making (NPRM).

Register here.

Posted 8/3/2017

FDA Approves Vyxeos for Certain Types of High-Risk AML

On August 3, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos, Jazz Pharmaceuticals, Inc.) for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis.

This is the first FDA-approved treatment specifically for patients with t-AML or AML-MRC.

Read the FDA announcement.

Read the FDA press release.

Posted 8/3/2017

CMS Opens QPP Hardship Exception Application for 2017 Transition Year

The Centers for Medicare & Medicaid Services (CMS) has announced that the Quality Payment Program (QPP) Hardship Exception Application for the 2017 transition year is now available on the Quality Payment Program website.

The agency’s announcement states that Merit-Based Incentive Payment System (MIPS) eligible clinicians and groups may qualify for a reweighting of their Advancing Care Information performance category score to 0% of the final score, and can submit a hardship exception application, for one of the following specified reasons:

  • Insufficient internet connectivity
  • Extreme and uncontrollable circumstances
  • Lack of control over the availability of Certified EHR Technology (CEHRT)

CMS notes that there are some MIPS eligible clinicians who are considered Special Status, who will be automatically reweighted (or, exempted in the case of MIPS eligible clinicians participating in a MIPS APM) and do not need to submit a Quality Payment Program Hardship Exception Application. 

CMS also offers an option for clinicians to verbally submit an application by contacting the QPP Service Center and working with a representative.

For more information

Posted 8/3/2017

FDA Expands Ibrutinib Indications to Chronic GVHD

On August 2, 2017, the U.S. Food and Drug Administration approved ibrutinib (Imbruvica, Pharmacyclics LLC) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. This is the first FDA-approved therapy for the treatment of cGVHD.

FDA previously approved ibrutinib for the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma with 17p deletion, Waldenström’s macroglobulinemia, marginal zone lymphoma, and mantle cell lymphoma.

Read the FDA announcement.

Posted 8/2/2017

FDA Grants Regular Approval to Enasidenib for Relapsed or Refractory AML

On August 1, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to enasidenib (Idhifa, Celgene Corp.) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.

This is the first FDA approval for relapsed or refractory AML specifically with an IDH2 mutation. The FDA concurrently approved a companion diagnostic, the RealTime IDH2 Assay, used to detect the IDH2 mutation.

Read the FDA announcement.

Read the FDA press release.

Posted 8/1/2017

FDA Grants Nivolumab Accelerated Approval for MSI-H or dMMR Colorectal Cancer

On July 31, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb Company) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Read the FDA announcement.

Posted 8/1/2017

Senate Votes to Proceed to Debate on ACA Repeal

On Tuesday, July 25, U.S. Senate voted on the motion to proceed to the consideration of H.R. 1628, the Budget Reconciliation Act, which is the most recent effort to repeal the Affordable Care Act (ACA).  While this vote will not produce a final bill, this motion to proceed sets up a process that will allow for open debate and amendments to the AHCA, the House version of ACA repeal, on the Senate floor. Vice President Mike Pence broke the 50-50 tie with the goal of both the Senate and the House of Representatives ultimately retiring to conference and striking a compromise between the Senate (BCRA) and House (AHCA) versions of ACA repeal.

The Association of Community Cancer Centers (ACCC) plans to review the new legislation that is produced from this motion to proceed and will measure it against ACCC’s health reform principles.

Posted 7/25/2017

ASCO Issues Position Statement Addressing Affordability of Cancer Drugs

On July 19, 2017, the American Society of Clinical Oncology (ASCO) issued a position statement that seeks to contribute to the national conversation on the increasing cost of cancer drugs. The statement emphasizes the importance of ensuring patients' access to care and supporting innovation, and makes several recommendations for a way forward.

Read ASCO's statement.

Posted 7/19/2017

USPSTF Seeks Comments on Draft Recommendation on Screening for Ovarian Cancer

The U.S. Preventive Services Task Force (USPSTF) is seeking public comment on a draft recommendation statement and draft evidence review on screening for ovarian cancer. After reviewing the evidence, the Task Force recommends against screening for ovarian cancer in asymptomatic women. The draft recommendation statement and draft evidence review are available for review and public comment from July 18, 2017 through August 14, 2017 

Posted 7/18/2017

FDA Approves Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-positive Breast Cancer

On July 17, 2017, the U.S. Food and Drug Administration (FDA) approved neratinib (Nerlynx, Puma Biotechnology, Inc.) for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

Read the FDA announcement.

Posted 7/18/2017

CMS Releases Proposed 2018 Physician Fee Schedule Rule

On July 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that includes proposals to update payment policies, payment rates, and quality provisions for services furnished under the Medicare Physician Fee Schedule (PFS) on or after January 1, 2018.

The proposed rule is scheduled for publication in the July 21, Federal Register.

CMS will accept comments on the proposed rule until September 11, 2017. 

Read CMS fact sheet.

The Association of Community Cancer Centers (ACCC) is currently analyzing the proposed rule and will provide an in-depth analysis for its membership.

Posted 7/13/2017

CMS Releases Proposed 2018 OPPS Rule

On July 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System proposed rule (CMS-1678-P) that includes updates to the 2018 rates and quality provisions, and proposes other policy changes.

The proposed rule is scheduled for publication in the July 20, Federal Register.

CMS will accept comments on the proposed rule until September 11, 2017, and will respond to comments in a final rule on or about November 1, 2017. 

Read CMS fact sheet.

The Association of Community Cancer Centers (ACCC) is currently analyzing the proposed rule and will provide an in-depth analysis for its membership.

Posted 7/13/2017

Senate Releases Revised Version of BCRA

On Thursday, July 13, U.S. Senate Republicans released their revised draft of the Better Care Reconciliation Act of 2017 (BCRA). The updated bill is the latest effort to repeal and replace the Affordable Care Act (ACA). The new version of the BCRA includes some concessions to both moderates and conservatives.

Kaiser Health News provides a side by side comparison of the two versions of the bill.

The Association of Community Cancer Centers (ACCC) is currently reviewing the new legislation and measuring against ACCC's health reform principles

Posted 7/13/2017

FDA Clears Expanded Use of Cooling Cap to Reduce Alopecia During Chemotherapy

On July 3, the U.S. Food and Drug Administration (FDA) cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors.

The DigniCap Cooling System is indicated to reduce the frequency and severity of hair loss during chemotherapy in solid tumor cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used. It is a computer-controlled system used during treatment. A cap is worn on the head and circulates liquid to a cap to cool the scalp during chemotherapy treatment. The cap is covered by a second cap made from neoprene, a type of rubber that holds the cooling cap in place and acts as an insulation cover to prevent loss of cooling.

The device is contraindicated for pediatric patients, patients with certain cancers and patients undergoing specific chemotherapy treatments. Additionally, DigniCap may not be appropriate for patients with cold sensitivity or susceptibility to cold-related injuries.

Read FDA announcement.

Posted 7/05/2017

FDA Grants Regular Approval to Dabrafenib and Trametinib Combo for Metastatic NSCLC with BRAF V600E Mutation

On June 22, 2017, the U.S. Food and Drug Administration (FDA) granted regular approvals to dabrafenib and trametinib (Tafinlar® and Mekinist®, Novartis Pharmaceuticals Inc.) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.

These are the first FDA approvals specifically for treatment of patients with BRAF V600E mutation-positive metastatic NSCLC.

The FDA today also approved the Oncomine™ Dx Target Test (Thermo Fisher Scientific), a next generation sequencing (NGS) test to detect multiple gene mutations for lung cancer in a single test from a single tissue specimen. This test detects the presence of BRAF, ROS1, and EGFR gene mutations or alterations in tumor tissue of patients with NSCLC. This test can be used to select patients with NSCLC with the BRAF V600E mutation for treatment with the combination of dabrafenib and trametinib. This is the first NGS oncology panel test approved by the FDA for multiple companion diagnostic indications.

Read FDA announcement.

Posted 6/23/2017

Senate Republican Leaders Release Draft of ACA Repeal & Replace Bill

On Thursday, June 22, Senate Majority Leader Mitch McConnell (R-KY) released a "discussion draft" of the Better Care Reconciliation Act of 2017, a Senate version of ACA repeal and replace legislation.

Read the Bill.

Posted 6/22/2017

FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of FL, DLBCL, and CLL

On June 22, 2017, the U.S. Food and Drug Administration (FDA) approved the combination of rituximab and hyaluronidase human (Rituxan Hycela, Genentech Inc.) for adult patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).

The approval provides patients a subcutaneous route of rituximab administration that shortens the administration time to 5 to 7 minutes as compared to intravenous infusion that can take several hours. This new product also provides for flat dosing.

Rituxan Hycela is not indicated for the treatment of non-malignant conditions.

Read FDA announcement.

Posted 6/22/2017

CMS to Host Webinar on QPP Year 2 Proposed Rule

On Monday, June 26 at 1:00 PM ET, the Centers for Medicare & Medicaid Services (CMS) will host an overview webinar on the Medicare Quality Payment Program (QPP) Year 2 proposed rule.
Join the webinar to hear CMS policy experts provide an overview of proposed participation requirements for the second year of the Quality Payment Program.

  • Webinar: Medicare Quality Payment Program Year 2 Proposed Rule Overview
  • Date: Monday, June 26
  • Time: 1:00 – 2:30 p.m. ET

Register here.

The agency notes that space is limited. There will a Q&A session if time allows.

The 60-day comment period for the proposed rule ends on Monday, August 21.

Posted 6/21/2017

CMS Issues Proposed Rule for CY 2018 Updates to Quality Payment Program

On June 20, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would make changes in the second year of the Quality Payment Program (QPP) as required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). CMS’s proposed rule “. . .aims to simplify the program, especially for small, independent, and rural practices. . ." the agency said in a statement.

Read CMS fact sheet on the proposed rule here.

Read the proposed rule (CMS-5522-P) here.

Information on the Quality Payment Program is available here.

Posted 6/20/2017

Insurers’ Obamacare Rate Deadline Nears

Health insurance companies that plan to participate in the federal Obamacare marketplace next year are expected to send their proposed rates to the U.S. government this week. The Trump administration had extended the deadline until Wednesday, June 21 to give insurance companies more time, as uncertainty around the fate of the Affordable Care Act has made it challenging for insurers to determine rate plans.

While insurers have already filed rates in a number of states, major insurers (Aetna Inc. and Humana Inc.) have pulled out of certain markets for 2018. Further, the wide variation across states and companies reflects the uncertainty of the market, Bloomberg BNA reports.

Source: Bloomberg BNA

Posted 6/19/2017

FDA Approves Darzalex Combination for Certain Multiple Myeloma Patients

On June 16, 2017, Janssen Biotech, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the immunotherapy Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (an immunomodulatory agent) and a proteasome inhibitor.

Read the corporate press release here.

Posted 6/19/2017

MedPAC Releases June Report to Congress, Including Recommended Part B Changes

On June 15, 2017, the Medicare Payment Advisory Commission (MedPAC) issued its June 2017 Report to Congress. Chapter 2 of the report focuses on the Commission’s recommendations pertaining to Medicare payment for Part B drugs. In broad terms, MedPAC is recommending that Congress make the following changes to Medicare’s payment for Part B drugs and biologicals:

  • Make specific modifications to the average sales price (ASP) system in 2018.
  • No later than 2022, create and phase in a voluntary Drug Value Program (DVP); MedPAC outlines required elements for the DVP.
  • On implementation of DVP or no later than 2022, reduce the ASP add-on under the ASP system.

MedPAC is a nonpartisan legislative branch agency that provides the U.S. Congress with analysis and policy advice on the Medicare program.

ACCC has joined with 269 organizations in June 8 letter to HHS Secretary Thomas Price urging protection of Medicare Part B. Read the letter.

Access the full MedPAC June 2017 Report here.

Posted 6/16/2017

ACCC Congratulates Dr. Barbara McAneny, AMA President-Elect

On June 13, 2017, delegates of the American Medical Association (AMA) voted Barbara L. McAneny, MD, FASCO, AMA president-elect. Dr. McAneny is a practicing medical oncologist and CEO of New Mexico Oncology Hematology Consultants, Ltd., in Albuquerque, NM. The first oncologist elected to lead the AMA, Dr. McAneny will serve a one-year term as president-elect, and assume the AMA presidency in June 2018.

“It is a deep honor and privilege to be elected a leader of an organization that is committed to serving as a strong physician voice and a dedicated patient advocate,” said Dr. McAneny in a statement. “The AMA will play a pivotal role in the changing health care environment as our nation confronts pressing health care issues. With vision and perseverance, I look forward to creating a brighter future for patients and the medical profession.”

A long-standing ACCC member, Dr. McAneny has served in a number of leadership roles at both the national and state level, including as an AMA board member since 2010, and prior to that, as a board member of the American Society of Clinical Oncology (ASCO) and as the delegate to the AMA from ASCO.

In 2012, Dr. McAneny was awarded a federal grant to develop the Community Oncology Medical Home Model that demonstrated improved outcomes and patient satisfaction, while reducing hospitalizations and costs. In 2014, ACCC-member New Mexico Oncology Hematology Consultants received an ACCC Innovator Award for its COME HOME—A Model Oncology Medical Home initiative.

Read AMA press release here.

Posted 6/14/2017

HHS OIG Report Finds $729M in Improper Medicare EHR Incentive Payments

An estimated $729 million in Medicare Electronic Health Records (EHR) Incentive program payments went to recipients who failed to meet requirements, according to a report released June 12 by the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG). Between 2011 and 2014, the EHR incentive program, which was designed to incentivize adoption of electronic health records (EHRs), made payments to hospitals and physicians who never demonstrated meaningful use of their EHR systems, the report finds

The OIG’s $729 million estimate was derived by extrapolating from a smaller sample, Bloomberg BNA reports. OIG auditors looked at 100 EPs out of 250,470, and found 14 payments, which totaled $291,222, that did not meet meaningful use requirements, Bloomberg BNA said.

The OIG report calls for CMS to try to recover improper payments and to increase education for providers on satisfying meaningful use requirements. Under MACRA, the EHR Incentive program has been replaced by the Merit-Based Incentive Program System (MIPS) but some meaningful use criteria remain that providers will have to meet.

Read the report here.

Source: Bloomberg BNA

Posted 6/13/2017

CMS Releases PQRS Reporting Experience

Nearly two-thirds (63%) of eligible professionals (EPs) participating in Medicare’s Physician Quality Reporting System (PQRS) program avoided a 2 percent reduction in their 2017 Medicare PFS services, based on 2015 reporting; however, 501,933 providers that did not report quality measures satisfactorily will see a 2 percent cut, according to a Centers for Medicare & Medicaid Services (CMS) report released June 9. Of those physicians seeing a pay reduction, nearly 16 percent were in primary care.

Although PQRS participation increased by 14 percent from 2014 to 2015, CMS said that 31 percent of 1.36 million EPs did not participate. PQRS ends in 2018 with payments based on 2016 reporting. Components of PQRS were rolled into the Merit-Based Incentive Payment Systems (MIPS), created under MACRA, that will affect payments starting in 2019.

Read the report here.

Source: Bloomberg BNA

Posted 6/13/2017

ACCC Joins in Coalition Letter Urging Protection of Medicare Part B

In a June 8, 2017, letter to U.S. Health & Human Services Secretary Thomas Price, the Association of Community Cancer Centers (ACCC) joined with 269 organizations in urging protection of the Medicare Part B reimbursement program for drugs and biologicals administered by physicians.

The letter asks that MedPAC’s “Drug Value Program” be rejected, stating that “[the program] would create a middleman between doctors and their patients by placing new restrictions on treatment decisions that currently do not exist within Part B. We urge you to reject the use of the MedPAC proposals and any such proposals that over-bureaucratize Part B.”

Read the letter here.

Posted 6/8/2017

FDA Grants Accelerated Approval for Imfinzi to Treat mUC

On May 1, 2017, AstraZeneca UK Limited announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to durvalumab (Imfinzi) for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Read the FDA announcement here.

Posted 6/8/2017

Keytruda Receives Accelerated Approval for First Tissue/Site Agnostic Indication, and Receives FDA Approval for Advanced Urothelial Carcinoma

On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Keytruda (pembrolizumab) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

This is the FDA's first tissue/site-agnostic approval.

Click here to read the FDA announcement. Listen to the FDA podcast about this approval here.

On May 18, 2017, the FDA granted regular approval for Keytruda for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The FDA also granted accelerated approval to Keytruda for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplain-containing chemotherapy.

Click here to read the FDA announcement.

Posted 6/2/2017

Alunbrig (brigatinib) Receives FDA Approval for ALK+ NSCLC

Takeda Oncology has announced U.S. Food and Drug Administration (FDA) approval of Alunbrig (brigatinib), a kinase inhibitor, for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Click here to read the corporate press release.
Prescribing information can be found here.

Posted 6/1/2017

FDA Approves Keytruda as a Combination in Metastatic Nonsquamous NSCLC

On May 10, 2017, Merck announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed (brand name Alimta®) and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for the first-line treatment of metastatic nonsquamous NSCLC, irrespective of PD-L1 expression.

Read the corporate press release here.

Posted 5/11/2017

USPSTF Final Recommendation Statement on Screening for Thyroid Cancer

On May 9, 2017, the U.S. Preventive Services Task Force (USPSTF) released a final recommendation statement on screening for thyroid cancer. The Task Force found that clinicians should not screen for thyroid cancer in adults who have no signs or symptoms of the disease.

Learn more here.

Posted 5/11/2017

FDA Approves Bavencio Injection for mUC Patients

On May 9, 2017, EMD Serono and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) had approved Bavencio® (avelumab) Injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Read the corporate press release here.

Posted 5/11/2017

New CMS Tool Helps Clinicians Determine MIPS Participation Status

The Centers for Medicare & Medicaid Services (CMS) released a new tool to aid clinicians unsure of their participation status in the Merit-based Incentive Payment System (MIPS). Clinicians can now use an interactive tool found on the CMS Quality Payment Program website to determine if they should participate in 2017.

To determine your status, enter your national provider identifier (NPI) into the entry field on the tool. Information will then be provided on whether or not you should participate in MIPS this year and where to find additional resources. 

Posted 5/10/2017

American Health Care Act Passes House

On May 4, 2017, the U.S. House of Representatives passed the GOP bill to repeal and replace the Affordable Care Act. After a 217-213 vote, the American Health Care Act now moves to the Senate where legislators will determine the bill's fate.

This vote represents the start of serious changes to current healthcare law and will significantly impact the care received by millions of Americans. Read more here.

Posted 5/4/2017

NCCN Adds Nine New Disease Sites to Radiation Therapy Compendium

The National Comprehensive Cancer Network® (NCCN®) added nine more NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) to its NCCN Radiation Therapy Compendium™. The new disease sites added to the published radiation therapy (RT) recommendations include:

  • Acute Lymphoblastic Leukemia, Version 2.2016
  • Basal Cell Skin Cancer, Version 1.2017
  • Dermatofibrosarcoma Protuberans, Version 1.2017
  • Gastric Cancer, Version 1.2017
  • Hodgkin Lymphoma, Version 1.2017
  • Merkel Cell Carcinoma, Version 1.2017
  • Ovarian Cancer, Version 1.2017
  • Squamous Cell Skin Cancer, Version 1.2017
  • Thymomas and Thymic Carcinomas, Version 1.2017.
Additional cancer types will be published on a rolling basis over the coming months.

Posted 4/20/2017

FDA Grants Accelerated Approval for Tecentriq to Treat mUC

On April 17, 2017, Genentech announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Tecentriq® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy.

Tecentriq was previously approved for people with locally advanced or mUC who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).

Read the corporate press release here.

Posted 4/19/2017

Two New Reports Released on Costs of Cancer Care

On April 11, 2017, Milliman released a research report, "A Multi-Year Look at the Cost Burden of Cancer Care." The report characterized costs to breast, lung, and colorectal cancer patients and their health plans from 2011-2014. One major finding from the report: patients often incur large out-of-pocket costs in the first year of diagnosis as well as in following years. "For patients who survived and maintained their insurance coverage, the growth of cumulative total healthcare spending slowed after the second year, but spending and cost sharing never returned to their pre-diagnosis levels." Download the full report here.

The American Cancer Society Cancer Action Network (ACSCAN) also released a report examining the out-of-pocket cost burden on cancer patients. The report found that U.S. cancer patients paid nearly $4 billion in out-of-pocket costs in 2014 and the disease cost the country $87.8 billion in cancer-related healthcare spending. Read the full report here.

Posted 4/12/2017

USPSTF Seeks Comments on Draft Recommendation Statement on Screening for Prostate Cancer

On April 11, 2017, the U.S. Preventive Services Task Force (USPSTF) posted for public comment a draft recommendation statement and three draft evidence reviews on screening for prostate cancer. The Task Force's draft recommendation statement and draft evidence reviews have been posted for public comment on the Task Force website from April 11 to May 8.

Through its systematic review of the evidence, the Task Force determined that the potential benefits and harms of prostate-specific antigen (PSA)-based screening are closely balanced in men ages 55 to 69, and that the decision about whether to be screened should be an individual one. The draft recommendation applies to adult men who have not been previously diagnosed with prostate cancer and have no signs or symptoms of the disease.

Posted 4/12/2017

FDA Approves Tagrisso for NSCLC Patients

On March 30, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to osimertinib (Tagrisso, AstraZeneca Pharmaceuticals, LP) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. 

Read the FDA announcement here.

Posted 4/3/2017

OncLive CANCERSCAPE coverage

Read the latest OncLive coverage of the ACCC 43rd Annual meeting, CANCERSCAPE.

Posted 3/30/2017

FDA Approves Niraparib for Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

On March 27, 2017, the U.S. Food and Drug Administration (FDA) approved niraparib (ZEJULA, Tesaro, Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

Read the FDA announcement here.

Posted 3/27/2017

FDA Approves Avelumab for Rare Skin Cancer

On March 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer.

Read the FDA announcement here.

Posted 3/23/2017

FDA Approves Keytruda® For Classical Hodgkin Lymphoma

The U.S. Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab, Merck), an anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy.

Read the corporate press release here.

Posted 3/15/2017

FDA Approves Kisqali® For Metastatic Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved Kisqali® (ribociclib, formerly known as LEE011, Novartis) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

Read the corporate press release here.

Posted 3/15/2017

Republicans Reveal Plans for Repeal and Replace of ACA

On Feb. 6, 2017, both the House Ways and Means Committee and the House Energy and Commerce Committee released legislation to repeal and replace the Affordable Care Act (ACA).

The budget resolution passed by the House in January outlined specific instructions for the Ways and Means and Energy and Commerce Committees—the primary Committees with jurisdiction over healthcare—to draft legislative recommendations that the Budget Committee could compile into one reconciliation package, the American Health Care Act.

To read the entire bill, including legislative recommendations from the Energy and Commerce and Ways and Means Committees, click here.

Posted 3/7/2017

Walgreens Designates Specialty Pharmacies as Cancer-Specialized Locations

Walgreens announced that the company has designated more than 50 of its local specialty pharmacies as cancer-specialized locations. These cancer-specialized locations are to be led by pharmacists and pharmacy technicians who have advanced cancer training to assist patients.

The pharmacy staff at these locations have completed a cancer-focused curriculum of advanced education courses, focused on colorectal, lung, prostate and breast cancer, as well as various blood cancers such as leukemia, lymphomas, multiple myeloma, myeloproliferative neoplasms, and myelodysplatic syndrome.

Read the press release here.

Posted 3/6/2017

FDA Approves Lenalidomide for Multiple Myeloma Following Autologous Stem Cell Transplant

On Feb. 22, 2017, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.

In 2006, lenalidomide, an orally administered thalidomide analogue, received FDA approval for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy. In 2015, the indication was expanded for use in combination with dexamethasone for the treatment of patients with multiple myeloma, to include newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplant. Lenalidomide is also approved in myelodysplastic syndromes and mantle cell lymphoma. 

Read the FDA announcement here.

Posted 2/24/2017

CMS Awards Approximately $100 Million to Small Practices in Quality Payment Program

The Centers for Medicare & Medicaid Services (CMS) awarded approximately $20 million to 11 organizations for the first year of a five-year program to provide training and education about the Quality Payment Program for clinicians in individual or small group practices of 15 clinicians or fewer.

Over the remaining four years, CMS intends to invest up to an additional $80 million. These community-based organizations will provide hands-on training to help small practices, especially those in historically under-resourced areas. The training and education resources will be available immediately, nationwide, and provided at no cost to eligible clinicians and practices.

Posted 2/21/2017

FDA Approval for Opdivo in Previously Treated Urothelial Carcinomas

The U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb Company) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.

Read the FDA announcement here.

Posted 2/6/2017

HHS Withdraws 340B "Mega-Guidance”

On Jan. 30, 2017, the White House Office of Management and Budget (OMB) marked the final 340B guidance document as withdrawn and sent it back to the Department of Health and Human Services (HHS).

The proposed guidance defined who is considered a patient for purposes of the 340B drug program and also covers drug company responsibilities, such as procedures for issuing credits and refunds. The 340B program helps safety-net providers such as hospitals obtain discounted drugs. In order to advance, the guidance would now need to be resubmitted to the OMB.

However, it could be more difficult to implement the guidance due to the recent Executive Order declaring that for every new regulation or guidance introduced, two must be eliminated.

Source: BNA Healthcare

Posted 2/1/2017

FDA Approves Imbruvica for Marginal Zone Lymphoma Patients

The U.S. Food and Drug Administration (FDA) has approved Imbruvica® (ibrutinib) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Read the full press release here.

Posted 1/19/2017

ACCC Advocates for Community Oncology at the White House and on Capitol Hill

On Jan. 11, 2017, the Association of Community Cancer Centers (ACCC) joined with leading cancer organizations in discussions at the White House and on Capitol Hill that focused on issues and challenges facing community oncology and to advocate for access to care for patients in the communities where they live.

At the White House Making Health Care Better: Community Oncology event on Wednesday morning, ACCC President Jennie R. Crews, MD, MMM, FACP, and ACCC Governmental Affairs Committee member William Holden, MBA, RT(T)(R), FACHE, participated in a panel on Addressing Disparities. On behalf of the Cancer Moonshot initiative, the event explored critical aspects of community oncology including cancer disparities, survivorship and support services, advancing clinical trials, and innovative models of care delivery in the community setting.

On Capitol Hill, ACCC co-sponsored an afternoon briefing on Innovation and Access in Quality Cancer Care. Advocates heard a panel discussion and comments from patients, providers, the Centers for Medicare & Medicaid Services, and the Cancer Moonshot Task Force. Co-sponsoring the briefing along with ACCC were the Cancer Support Community, the American Cancer Society Cancer Action Network, the Community Oncology Alliance, McKesson Specialty Health, Sarah Cannon, and The US Oncology Network.

Posted 1/12/2017

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