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Oncology Newsfeed

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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