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Oncology Newsfeed

FDA Issues Rule Expanding Oversight to All Tobacco Products, Including e-Cigarettes

On May 5, 2016, the U.S. Food and Drug Administration (FDA) finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This sweeping rule allows the FDA to improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide.

Before today, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. Today’s rule changes that with provisions aimed at restricting youth access, which go into effect in 90 days, including:

  • Not allowing products to be sold to persons under the age of 18 years (both in person and online);
  • Requiring age verification by photo ID;
  • Not allowing the selling of covered tobacco products in vending machines(unless in an adult-only facility); and
  • Not allowing the distribution of free samples.

Read the FDA press release here.

Posted 5/5/16

CMS Finalizes Quality Measure Development Plan

On May 2, 2016, the Centers for Medicare & Medicaid Services (CMS) posted its final Quality Measure Development Plan on the CMS website. The plan is a strategic framework for clinician quality measurement development to support the new Merit-based Incentive Payment System (MIPS) and advanced alternative payment models (APMs) mandated under MACRA. The agency recently released the proposed regulation to implement these payment incentives.

The plan “will provide the foundation for building and implementing a measure portfolio to support the quality payment programs under MACRA,” writes Kate Goodrich, MD, MHS, Director, Center for Clinical Standards & Quality, CMS, in a CMS blog post.

Posted 5/2/16

CMS Webinars & MLN National Provider Call on the MACRA Proposed Rule

The Centers for Medicare & Medicaid Services (CMS) invites the public to three opportunities on the recently released Notice of Proposed Rulemaking (NPRM), which implements key provisions of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) through the unified framework of the Quality Payment Program (QPP). CMS encourages participants to review the proposed rule (CMS-5517-P) prior to the listening sessions.

Webinars

Title: Overview of the Quality Payment Program Proposed Rule
Date: Tuesday, May 3, 2016
Time: 12:00 pm - 1:00 pm EDT
Register: To participate, visit the registration webpage.


Title: The Merit-Based Incentive Payment System (MIPS) in the Quality Payment Program
Date: Wednesday, May 4, 2016
Time: 12:00 pm - 1:00 pm EDT
Register: To participate, visit the registration webpage.

Space for these webinars is limited. Register now to secure your spot. After your registration is completed, you will receive a follow-up email with step-by-step instructions on how to log-in to the webinar.

MLN Connects®National Provider Call

Title: MACRA Listening Session: Quality Payment Program Proposed Rule – Register Now
Date: Tuesday, May 10, 2016
Time: 2:00 pm - 3:00 pm EDT
To Register: Visit MLN Connects Event Registration.

Space may be limited, register early.


Please note: There will not be a Q&A period during these webinars and National Provider Call because CMS must protect the rulemaking process and comply with the Administrative Procedure Act. Participants are encouraged to submit comments through the formal process outlined in the Federal Register. CMS will not consider feedback during the call as formal comments on the rule. See the proposed rule for information on submitting these comments by the close of the 60-day comment period on June 27, 2016.

For More Information
For more information on the NPRM and MIPS, visit the website, review the press release and fact sheet.

Posted 4/29/16

FDA Approves Gilotrif for Patients with Squamous Cell Carcinoma of the Lung

Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

The U.S. approval follows the recent marketing authorization of Gilotrif in this patientpopulation by the European Commission. Gilotrif, an oral, once-daily EGFR-directed therapy, is currently approved in the U.S. for the first-line treatment of specific types of EGFR mutation-positive NSCLC.

Read the corporate press release here.

Posted 4/29/16

CMS Issues Proposed Rule on Two-Track Physician Payment System

On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed regulation that would move ahead the two-track physician payment system required under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA repealed the sustainable growth rate (SGR) formula—the approach previously used for updating physician reimbursement under Medicare—and mandated the phase in of a new payment system.
The proposed Quality Payment Program (QPP) offers providers two options:

  • aligning with an advanced alternative payment model (APM) and receiving a 5 percent annual bonus, or
  • being subject to a quality performance score that could result in either increases or decreases in their Medicare reimbursement (Merit-Based Incentive Payment System, or MIPS).

Over time, providers will be able to move from one track to the other, CMS Acting Administrator Andy Slavitt stated in a press briefing.

Comments on the proposed rule are due June 27, 2016. The final rule is slated to be released in fall 2016. ACCC is currently analyzing the proposal and will update members shortly.

Read CMS press release here.

CMS fact sheet on the Quality Payment Program.

CMS fact sheet on the MIPS.

View MACRA QPP timeline.

Posted 4/28/16

FDA Approves Cabometyx for Advanced Renal Cell Carcinoma Patients

On April 25, 2016, the U. S. Food and Drug Administration (FDA) approved cabozantinib (cabometyx, Exelixis, Inc.) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.

Read the FDA announcement here.

Posted 4/25/16

Next Generation ACO Model Letter of Intent Deadline Extended

The Centers for Medicare & Medicaid Services (CMS) announced that the deadline for submission of a Next Generation ACO Model Letter of Intent (LOI) has been extended to May 20, 2016.

Learn more here. The application deadline remains May 25, 2016 for the narrative portion and June 3, 2016 for the 2017 Participant List.

Posted 4/21/16

CMS Hosting April 26 Virtual Office Hour on PQRS Reporting Measures

The Centers for Medicare & Medicaid Services (CMS) will host the second session of a three-part Virtual Office Hours series regarding 2016 Physician Quality Reporting System (PQRS) quality measures.

The second session, “2016 PQRS Reporting: Introduction to Quality Measures Reporting (session 2 of 3),” will take place on Tuesday, April 26, 2016 from 1:00–2:00 pm ET. Topics to be discussed in this session include an overview of the 2016 PQRS measures, a live walkthrough of the 2016 PQRS Measures List, the 2016 PQRS Individual Claims/Registry Measure Specification Supporting Documents, and the new web-based measure search tool, which are all available on the Measures Codes page of the CMS PQRS website. This PQRS Virtual Office Hours session will allow stakeholders an opportunity to ask a CMS representative questions about 2016 PQRS quality measures.

Click here to register.

Posted 4/14/16

FDA Approves Venclexta Tablets for CLL Patients

On April 11, 2016, the U. S. Food and Drug Administration (FDA) approved venetoclax (Venclexta tablets, marketed by AbbVie, Inc. and Genentech USA, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.

Read the FDA announcement here.

Posted 4/12/16

CMS Issues Oncology Care Model Notices Of Acceptance

On March 29, 2016, the Centers for Medicare & Medicaid Services (CMS) issued Oncology Care Model notices to practices accepted to that demonstration.


Source: InsideHealthPolicy

Posted 4/1/16

FDA Approves Defitelio for Hepatic Veno-Occlusive Disease

On March 30, 2016, the U. S. Food and Drug Administration (FDA) approved Defitelio (defibrotide sodium, Jazz Pharmaceuticals, Inc.) for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). 

Read the FDA announcement here.

Posted 3/30/16

New C-Code Issued for Onivyde Injection

Merrimack Pharmaceuticals has announced that the Centers for Medicare & Medicaid Services (CMS) issued a C-code for Onivyde™ (irinotecan liposome injection), effective April 1, 2016:
C9474, Injection, irinotecan liposome, 1 mg.

Onivyde (irinotecan liposome injection) is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

Learn more here.

Posted 3/24/16

CMS Hosting March 29 Virtual Office Hour on PQRS Reporting Measures

The Centers for Medicare & Medicaid Services (CMS) will host the first session of a three-part Virtual Office Hours series regarding 2016 Physician Quality Reporting System (PQRS) quality measures.

The first session, “2016 PQRS Reporting: Introduction to Quality Measures Reporting (session 1 of 3)”, will take place on Tuesday, March 29, 2016 from 1:00–2:00 pm ET. Topics in this session include How to Get Started with PQRS and what are claims/qualified registry clinical quality measures. Participants will have an opportunity to ask a CMS representative questions about how to get started with quality measures for 2016 PQRS reporting.

Click here to register.

Posted 3/21/16

MedPAC Releases 2016 Report to Congress

On March 15, 2016, the Medicare Payment Advisory Commission (MedPAC) released its March 2016 Report to Congress: Medicare Payment Policy. The report includes MedPAC’s analyses of payment adequacy in fee-for-service Medicare and reviews Medicare Advantage and Part D, the Medicare prescription drug benefit. In 2016, more drugs under Part D Medicare drug plans are subject to some form of utilization management, the report finds. Read the report. The MedPAC report fact sheet is available here.

Source: Bloomberg BNA.

Posted 3/16/16

ASCO Issues Annual State of Cancer Care in America Report

On March 15, 2016, the American Society for Clinical Oncology (ASCO) released its The State of Cancer Care in America: 2016 report on national trends in cancer care delivery.  While highlighting promising advances in cancer care, the report also calls attention to significant challenges including “uneven health insurance coverage, rapidly rising costs, and other barriers to accessing new treatments.”

Read ASCO press release here. Access the report here.

Posted 3/16/16

FDA Approves Xalkori for Metastatic NSCLC

On March 11, 2016, the U.S. Food and Drug Administration (FDA) approved crizotinib capsules (Xalkori, Pfizer, Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients whose tumors are anaplastic lymphoma kinase (ALK)-positive. 

Read the FDA announcement here.

Posted 3/11/16

ACCC Expresses Strong Opposition to CMS Proposed Medicare Part B Payment Model Rule

On March 8, 2016, the Centers for Medicare & Medicaid Services (CMS) issued the anticipated proposed rule to test new models for how Medicare Part B pays for prescription drugs. According to a CMS fact sheet, the proposal “is designed to test different physician and patient incentives to do two things: drive the prescribing of the most effective drugs, and test new payment approaches to reward positive patient outcomes.”

Under the proposal, CMS will choose a group of Part B providers based on Primary Care Service Areas (PCSAs), and instead of paying physicians and hospital outpatient departments for drugs at the current ASP +6 percent, the model would drop the add-on payment to 2.5 percent plus a flat fee payment of $16.80 per drug per day to test whether this “changes prescribing incentives and leads to improved quality and value.”

CMS proposes to update the flat fee at the beginning of each year by the percentage increase in the consumer price index for medical care for the most recent 12-month period. The agency plans to begin the test in fall 2016 (no earlier than 60 days after the rule is finalized). In January 2017, CMS will require providers to use value-based purchasing tools such as indication-based pricing, reference pricing, and clinical decision support tools to receive Part B payments.

Last week, the Association of Community Cancer Centers (ACCC) joined with the American Society of Clinical Oncology (ASCO), the Community Oncology Alliance (COA), and approximately 100 other organizations in a letter to HHS Secretary Sylvia Burwell and Acting CMS Administrator Andy Slavitt expressing “strong concern” about the agency’s plans to put forward a proposed rule for the Medicare Part B Drug Payment Model and asking the agency not to proceed with the initiative.

The rule is scheduled to be published in the March 11 Federal Register. Comments on the proposed rule are due by May 9.

Read letter here. Read the ACCC press release here.

Read the CMS proposed rule here. Read CMS fact sheet here.

Posted 3/9/16

FDA Approves Imbruvica for the First-line Treatment of Chronic Lymphocytic Leukemia

On March 4, 2016, the U.S. Food and Drug Administration (FDA) approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL).

Learn more here.

Posted 3/7/16

CMS Extends Meaningful Use Hardship Exception Deadline for Hospitals

The Centers for Medicare & Medicaid Services (CMS) announced that the application deadline for hospitals seeking hardship exceptions from the Medicare meaningful use program for electronic health records has been extended until July 1.

CMS extended the deadline so healthcare providers could have sufficient time to submit their applications and avoid a Medicare reimbursement penalty for failing to meet the requirements of the meaningful use program.

Click here to access the applications.

Source: Bloomberg BNA

Posted 2/26/16

FDA Approves New Indication for Afinitor for Progressive, Nonfunctional GI and Lung NET

On Feb. 26, 2016, the U. S. Food and Drug Administration (FDA) approved everolimus (Afinitor, Novartis) for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. 

Read the FDA announcement here.

Posted 2/26/16

FDA Approves Gazyva Injection for Previously Treated Follicular Lymphoma

On Feb. 26, 2016, the U. S. Food and Drug Administration (FDA) approved obinutuzumab (Gazyva Injection, Genentech, Inc.) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Obinutuzumab was previously approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia.

Read the FDA announcement here.

Posted 2/26/16

Pfizer Receives Expanded FDA Approval For Ibrance (Palbociclib)

On Feb. 19, 2016, the U. S. Food and Drug Administration (FDA) approved palbociclib (Ibrance Capsules, Pfizer, Inc.) in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

Read the FDA announcement here.

Read the corporate press release here.

Posted 2/22/16

CMS Announces First Set of Core Clinical Quality Measures

On Feb. 16, 2016, the Centers for Medicare & Medicaid Services (CMS) released seven sets of clinical quality measures developed by the Core Quality Measure Collaborative. The Collaborative includes the America’s Health Insurance Plans (AHIP) and its member plans’ chief medical officers, leaders from CMS, and the National Quality Forum (NQF), as well as national physician organizations, employers, and consumers. The Collaborative promotes alignment and harmonization of measure use and collection across payers in both the public and private sectors.

The guiding principles used by the Collaborative in developing the core measure sets are that they be meaningful to patients, consumers, and physicians, while reducing variability in measure selection, collection burden, and cost. Payers have committed to using these core sets of quality measures for reporting as soon as feasible.

The core measures are in the following seven sets:

  • Accountable Care Organizations (ACOs), Patient Centered Medical Homes (PCMH), and Primary Care
  • Cardiology
  • Gastroenterology
  • HIV and Hepatitis C
  • Medical Oncology
  • Obstetrics and Gynecology
  • Orthopedics

CMS will go through a public notice and comment rule-making for implementation of the new measures across applicable Medicare quality programs, and commercial health plans will roll out the new core measures as part of their contract cycle. Learn more here.  Access the Medical Oncology core measures here. Access CMS fact sheet here.

Posted 2/16/16

FDA Approves Merck’s Single-Dose Emend® for Injection for Prevention of Delayed Nausea

On Feb. 4, 2016, Merck announced that the FDA has approved a supplemental new drug application (sNDA) for single-dose Emend® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines, for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). Emend has not been studied for the treatment of established nausea and vomiting.

Click here to read the corporate press release.

Posted 2/12/16

Medicare Reporting and Returning of Self-Identified Overpayments Final Rule

The Centers for Medicare & Medicaid Services (CMS) has published a final rule that requires Medicare Parts A and B healthcare providers and suppliers to report and return overpayments by the later of the date that is 60 days after the date an overpayment was identified, or the due date of any corresponding cost report, if applicable. 

Under this final rule, overpayments must be reported and returned only if a person identifies the overpayment within six years of the date the overpayment was received. 

Click here to read the final rule. This rule was published in the Feb. 12 edition of the Federal Register.

Posted 2/12/16

Administration Proposes a $4.1 Trillion Spending Blueprint for FY2017

This week President Obama unveiled his final budget proposal to Congress, calling for billions to support clean energy, education and healthcare. The President’s budget serves as a suggested policy roadmap; it’s unlikely many of these proposals in their current form will be passed by Congress.

The President’s proposal was subsequently met with strong opposition on Capitol Hill, all but solidifying a tough road to a budget compromise before the fiscal year ends September 30.  

The proposed FY2017 budget includes proposals that would:

  • Significantly invest in cancer research, including a dedicated $1 billion to the Administration’s new “Moonshot” Initiative, $195 million to NIH to support new cancer initiatives in FY16, and $755 million in mandatory funding for FDA and NIH in FY2017. The Administration also proposes to create a new virtual Oncology Center of Excellence at the FDA that will leverage agency knowledge of drugs, biologics and devices to speed development of new combination products.
  • Reduce reimbursement for Medicare Part B drugs from 106% to 103% of ASP starting in 2017 (a proposal we’ve seen in years past).
  • Provide 100% federal matching funds to states for Medicaid expansions for three years regardless of when the state expands (under current policy, all states must start to contribute to the cost of Medicaid expansion in 2017).

The document contains additional proposals aimed at reducing federal spending on prescription drugs, limited revisions to ACA provisions, and additional value-based payment reforms. ACCC continues to analyze the proposal. For additional detail, please see the Department of Health and Human Services Budget in Brief.

Posted 2/11/16

ACCC Joins in Letter in Support of Administration’s Budget Proposals for Moonshot Initiative

The Association of Community Cancer Centers (ACCC) joined in a February 9 letter initiated by the American Society of Clinical Oncology (ASCO) thanking Vice President Biden and President Obama for the Administration’s FY 2017 Budget Proposal that calls for $1 billion in funding for the National Cancer Institute (NCI) Moonshot initiative starting with an immediate investment of $195 million for the National Institutes of Health (NIH) for FY 2016 and the inclusion of $755 million in new mandatory funds for the NIH and the Food and Drug Administration (FDA) in the FY 2017 Budget Proposal.

We have heard your call for a greater degree of collaboration and interaction, and we are writing to express our collective ambition and enthusiasm to work with you to carry this mission forward,” the letter states.

Joining ASCO and ACCC in this letter of support are 45 state societies and nearly 200 other organizations and cancer centers.

Posted 2/11/16

Major Companies Join Together to Form Healthcare Alliance

Twenty of the largest companies in the U.S. (including Macy's, IBM, and Coca-Cola) announced Feb. 5 the formation of an alliance to improve the way they pay for healthcare. Together these companies spend more than $14 billion annually on healthcare benefits, and the first focus of their new alliance will be on the cost of prescription drugs.

The overall goal of the Health Transformation Alliance (HTA) is "to break with existing marketplace practices that are costly, wasteful, and ineffecient," and create better healthcare outcomes, according to a press release.

Source: Bloomberg BNA

Posted 2/9/16

ASCO Issues New Guideline on Use of Biomarkers to Guide Early Breast Cancer Therapy Decisions

On Feb. 8, 2016, the American Society of Clinical Oncology (ASCO) issued a new clinical practice guideline for women with early-stage invasive breast cancer and known HER2 receptor status. The guideline includes evidence-based recommendations on the appropriate use of breast tumor biomarker tests to guide decisions on adjuvant systemic therapy. 

Key guideline recommendations include:

  • The following biomarker tests may be used to guide decisions on adjuvant systemic therapy for certain patients with breast cancer: estrogen receptor, progesterone receptor, HER2 receptor, Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1.
  • No biomarker test, except for estrogen receptor, progesterone receptor, and HER2 receptor should be used to guide choices of specific drugs or treatment regimens. 
  • Treatment decisions should also consider disease stage, comorbidities, and patient preferences.

Read the full press release here.

Posted 2/9/16

CMS Announces Proposed Changes to Medicare Shared Savings Program

On Jan. 28, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would update the methodology used to calculate the benchmarks of Accountable Care Organizations (ACOs) that continue their participation in the Medicare Shared Savings Program after an initial three-year agreement period. This expands upon issues discussed in the June 2015 Shared Savings Program final rule, in which CMS committed to engaging in additional rulemaking around modifications to the Program’s methodology for resetting benchmarks.

Read the CMS fact sheet here.

There will be a 60-day public comment period on this proposed rule. The comment period closes on March 28, 2016. Comments can be submitted at: http://www.regulations.gov/.

Posted 1/29/16

White House Cancer Moonshot Task Force

President Barack Obama issued a memorandum appointing key federal agency heads to the White House Cancer Moonshot Task Force. The Task Force "will focus on making the most of Federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement initiatives, and other mechanisms to support cancer research and enable progress in treatment and care."

Vice President Joe Biden will serve as Chair of the Task Force. Read the entire White House memorandum here.

Posted 1/28/16

FDA Approves Eribulin for Treatment of Liposarcoma

On Jan. 28, 2016, the U. S. Food and Drug Administration (FDA) approved eribulin (Halaven injection, Eisai Co., Ltd.) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. 

Read the FDA announcement here.

Posted 1/28/16

CMS Releases Guide to Preventing Readmissions Among Racially and Ethnically Diverse Medicare Beneficiaries

The Centers for Medicare & Medicaid Services Office of Minority Health (CMS OMH), released a new Guide to Preventing Readmissions Among Racially and Ethnically Diverse Medicare Beneficiaries.

Developed in collaboration with the Disparities Solutions Center at Massachusetts General Hospital and the National Opinion Research Center (NORC) at the University of Chicago as part of the CMS Equity Plan for Improving Quality in Medicare, the Guide is designed to assist hospital leaders and stakeholders focused on quality, safety, and care redesign in identifying root causes and solutions for preventing avoidable readmissions among racially and ethnically diverse Medicare beneficiaries. Download the Guide here.

Posted 1/27/16

FDA Approves Expanded Use for Opdivo in Melanoma

On Jan. 23, 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma.

This approval is based on progression-free survival (PFS) and expands the original indication for the Opdivo + Yervoy Regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial.

Read the corporate press release here.

Posted 1/27/16

CMS Broadens Meaningful Use Hardship Exceptions

On Jan. 22, 2016, the Centers for Medicare & Medicaid Services (CMS) released details of the agency's new system for providers and hospitals applying for a hardship exception from Meaningful Use (MU) penalties. Read the revised applications and instructions for applying for the hardship exception from MU penalties for failing to meet program requirements in 2015 here.

With the new application, providers can apply for an exception under certain categories, rather than the agency considering each application on its own merits. Providers have until March 15 to apply. Hospitals and critical access hospital have until April 1 to apply.

Posted 1/27/16

CMS Releases Medicaid Covered Outpatient Drugs Final Rule

The Centers for Medicare & Medicaid Services (CMS) released final rulemaking changes to how the government pays for outpatient prescription drugs in the Medicaid program.

The rule (released Jan. 21, 2016) assists states and the federal government in managing drug costs, establishes the long-term framework for implementation of the Medicaid drug rebate program, and creates a fairer reimbursement system for Medicaid programs and pharmacies. Read the CMS fact sheet here.

The rule is set for publication Feb. 1 in the Federal Register. CMS is accepting comments for 60 days.

Posted 1/22/16

FDA Approves Ofatumumab (Arzerra Injection) for Patients with Recurrent or Progressive CLL

On Jan. 19, 2016, the U.S. Food and Drug Administration (FDA) approved ofatumumab (Arzerra Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab.

Read the FDA announcement here.

Posted 1/19/16

MedPAC Recommends Medicare Cuts to 340B Hospitals

On Jan. 14, 2016, the Medicare Payment Advisory Commission (MedPAC) voted in favor of a draft recommendation to reduce Medicare payments to 340B hospitals. Program savings would be redistributed to the Medicare-funded uncompensated care fund.

MedPAC, an advisory board to Congress, included the 340B proposal in its recommendation on updating inpatient and outpatient Medicare payments. The recommendations will be included in MedPAC's March report to Congress.

View additional information from MedPage Today here.

Posted 1/15/16

President Obama Announces “Moonshot” Initiative to Cure Cancer

In his final State of the Union address on Jan. 12, 2016, President Barack Obama announced a “Cancer Moonshot Initiative” to cure cancer, a new national effort that would ramp up public and private resources, break down barriers to data sharing, employ innovations in technology, and improve access to clinical trials. The President named Vice President Joe Biden to lead the initiative.

Read Vice President Biden’s Medium channel post, “Inspiring a New Generation to Defy the Bounds of Innovation: A Moonshot to Cure Cancer,” here.

Posted 1/13/16

USPSTF Issues Final Recommendation Statement on Breast Cancer Screening

On Jan. 12, 2016, the U.S. Preventive Services Task Force (USPSTF) published its final recommendation statement on mammography screening for breast cancer upholding its 2015 draft recommendation.

Final USPSTF Recommendations by Age:

  • Age 40-49: Recommends informed, individualized decision making based on a woman’s values, preferences, and health history. (C recommendation)
  • Age 50-74: Recommends mammography every two years. (B recommendation)
  • Age 75 and older: More research needed. Current science inadequate to recommend for or against.

View additional information on the USPSTF breast cancer screening website.

Posted 1/12/16

CMS Announces 121 New Participants in ACOs

On Jan. 11, 2016, the Centers for Medicare & Medicaid Services (CMS) announced 121 new participants in Medicare Accountable Care Organization (ACO) initiatives aimed at improving patient care while lowering health system costs. ACOs now represent 49 states and the District of Columbia, the agency said in a press release.

CMS also announced that providers and hospitals are joining new types of ACOs, including 21 ACOs that have signed up for the Next Generation ACO Model, which allows participants to assume higher levels of financial risk than current initiatives.

As of Jan. 1, 2016, the Medicare Shared Savings Program (MSSP) has added 100 new ACOs along with close to 150 renewing ACOs, the agency said. Of these, 39 MSSP ACOs will participate in the ACO Investment Model (AIM), which provides pre-paid shared savings to encourage formation of new ACOs in rural and underserved areas and to encourage current program participants to transition to a performance-based risk arrangement.

More information on the Next Generation ACO Model available here (includes list of participants).

More information on the Medicare Shared Savings Program available here.

More information on the ACO Investment Model available here.

Posted 1/11/16

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