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Health-Care Policy
Legislation

AACR Holds Congressional Briefing to Reiterate Moonshot Goals and Plans

“We are in an era of unprecedented scientific opportunities in cancer research,” said Margaret Foti, PhD, MD (hc), Executive Officer, American Association for Cancer Research (AACR), as she introduced the Congressional briefing, “Seizing Today’s Opportunities to Accelerate Cancer Research.” “Thanks ...

Issues in Oncology
Health-Care Policy

How the Oncology Center of Excellence Plans to Foster Collaboration Among Researchers to Advance Cancer Treatment

On June 29, 2016, Robert M. Califf, MD, MACC, the Commissioner of the U.S. Food and Drug Administration (FDA), announced the selection of Richard Pazdur, MD, FACP, as Acting Director of the FDA’s newly created Oncology Center of Excellence. The center was created in response to the overarching...

health-care policy

Study Finds United States Ranks First in Health-Care Spending, but Cancer Outcomes Do Not Reflect the Investment

The U.S. health-care system is characterized—on a global level—by its unsustainable spending, which does not necessarily correlate to better outcomes in patients with cancer. With $2.9 trillion spent in 2013, the United States ranks first in health-care spending among the world’s...

health-care policy
issues in oncology

New American Cancer Society Cancer Action Network Report Shows States Are Making Progress Implementing Policies to Reduce Toll of Cancer

Although a majority of states are still missing important opportunities to pass and implement legislative solutions proven to prevent and fight cancer, there is progress being made to move the nation closer to ending cancer as we know it, according to a report recently released by the American...

Health-Care Policy

Photonics and the Cancer Moonshot Initiative: Partnership Highlights Role of Technology and IT Infrastructure in Reaching Goals

Photonics—the science of light—may not be associated with cancer in most people’s minds. But photonic technologies are: CT (computed tomography) scans and digital x-rays, for instance, are in everyday use, and next-generation oncology applications are in development. As the White House’s National...

Issues in Oncology
Health-Care Policy

Moonshots and ‘Onco-nauts’

Where were you on July 20, 1969? I certainly remember where I was—sitting in a mess hall at summer camp watching a grainy black-and-white TV as Neil Armstrong took “one small step for man, one giant leap for mankind.” I recall the sense of jubilation and accomplishment that all American citizens...

Health-Care Policy

The National Cancer Moonshot Lifts Off

Just 6 months after President Barack Obama announced the establishment of a National Cancer Moonshot Initiative to accelerate the pace of research discoveries, improve patient access and care, and encourage data-sharing, dozens of new initiatives to accomplish those and other goals were rolled out...

Issues in Oncology
Health-Care Policy

Road to Successful Use of Real-World Evidence for Drug Development Is Long and Rocky

Friends of Cancer Research (Friends) has been a leader in the push for better and faster cancer drug development. Now it is tackling the use of real-world evidence in clinical trials. This is the report of a meeting on the subject that took place on June 16 in Washington, DC.1 Real-world evidence...

Health-Care Policy
Legislation

CMS Proposal for Part B Drug Payment: A Poorly Conceived Experiment

On March 11, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule in the Federal Register to test a change in reimbursement for Part B drugs.1 The first phase involves changing the 6% add-on to the average sales price (ASP) used to make drug payments under Part B to...

Health-Care Policy
Cost of Care
Issues in Oncology

Charting a New Course at the FDA

In February, after serving for a year as the U.S. Food and Drug Administration’s (FDA’s) Deputy Commissioner for Medical Products and Tobacco, Robert M. Califf, MD, MACC, was named the agency’s Commissioner of Food and Drugs. Prior to his appointment at the FDA, Dr. Califf was the Donald F....

health-care policy

FDA Advances Precision Medicine Initiative by Issuing Draft Guidances on Next-Generation Sequencing–Based Tests

In support of the President’s Precision Medicine Initiative, on July 6, the U.S. Food and Drug Administration (FDA) issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a...

health-care policy

At Cancer Moonshot Summit, Vice President Biden Announces New Actions to Accelerate Progress Against Cancer

Today, the Cancer Moonshot hosted a summit at Howard University, in Washington, DC, as part of a national day of action that also included more than 270 events in communities across the United States. Vice President Joe Biden joined over 350 researchers, oncologists, care providers, data and...

health-care policy

Richard Pazdur, MD, Named Acting Director of the FDA Oncology Center of Excellence

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement today regarding the appointment of the Acting Director of the FDA Oncology Center of Excellence. “The FDA is honored to be an integral part of the Vice President’s National Cancer...

health-care policy

ASCO Outlines Opposition to Medicare Part B Demo for Senate Finance Hearing

ASCO voiced its strong opposition to the proposed Medicare Part B demonstration project in comments submitted on June 28 for the U.S. Senate Finance Committee hearing, “Examining the Proposed Medicare Part B Drug Demonstration.” ASCO underscored the urgent need to advance a fairer...

Health-Care Policy
Issues in Oncology

Supporting Policy to Reduce Tobacco-Related Deaths

One billion lives. That is the estimated human death toll of tobacco use in the 21st century.1 Tobacco use is the leading cause of preventable death worldwide—20% of all deaths and 30% of cancer deaths in the United States are linked to tobacco use.2,3 Impacting this preventable public health...

Health-Care Policy

Statement From FDA Commissioner Robert Califf, MD, on the Release of the Final Individual Patient Expanded Access Form

On June 2, 2016, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement on the release of the final individual patient expanded access form.  “Today, the FDA finalized its efforts to streamline the process used by physicians to request expanded...

Health-Care Policy

Moving the Needle on HPV Vaccination

In 2012–2013, members of the President’s Cancer Panel (prescancerpanel.cancer.gov) focused their efforts on accelerating widespread acceptance of and use of approved human papillomavirus (HPV) vaccines to prevent cancer. The topic is important, because HPVs cause most cases of cervical cancer and...

Health-Care Policy

ASCO Statement on Human Papillomavirus Vaccination for Cancer Prevention

As reported in the Journal of Clinical Oncology by Howard H. Bailey, MD, of the University of Wisconsin Carbone Cancer Center, and colleagues, ASCO has released a statement on increasing human papillomavirus (HPV) vaccination to prevent HPV-related cancers in the United States.1  In the United...

Health-Care Policy

ASCO Urges Centers for Medicare & Medicaid Services to Withdraw Medicare Part B Demo in Formal Comments

ASCO President Julie M. Vose, MD, MBA, FASCO, issued this statement on May 10. “In comments1 submitted yesterday to the Centers for Medicare & Medicaid Services (CMS), ASCO underscored the urgent need to advance a more fair and responsible payment system for oncology than what is proposed in...

health-care policy

Statement from FDA Commissioner Robert Califf, MD, on the Release of the Final Individual Patient Expanded Access Form

“Today, the U.S. Food and Drug Administration (FDA) finalized its efforts to streamline the process used by physicians to request expanded access, often called ‘compassionate use,’ to investigational drugs and biologics for their patients. As a physician, I understand the...

health-care policy
legislation

Vulnerable Hospitals, Cancer Surgery Readmissions, and Penalizing Payment Programs

Readmission rates after complex cancer operations tend to be higher in hospitals that are considered to be vulnerable because they serve as safety nets in their communities or have a high number of Medicaid patients. Reasons for higher readmission rates are highly complex and involve socioeconomic...

health-care policy

ASCO Urges CMS to Withdraw Medicare Part B Demo in Formal Comments

ASCO President Julie M. Vose, MD, MBA, FASCO, issued this statement on May 10. “In comments submitted yesterday to the Centers for Medicare & Medicaid Services (CMS), ASCO underscored the urgent need to advance a more fair and responsible payment system for oncology than what is proposed ...

health-care policy

AACR 2016: Report Identifies Considerations for Alternative Payment Models for Cancer Care

A roundtable convened by the Turning the Tide Against Cancer initiative, composed of a multidisciplinary group of stakeholders, put forth five policy considerations that are critical to ensuring the delivery of high-quality oncology care while supporting innovation. The report was published by...

Health-Care Policy

Providing Perspective on Pressing Economic Issues Facing Cancer Care—Now and in the Future

CANCERSCAPE, the 2016 Annual Meeting of the Association of Community Cancer Centers (ACCC), provided a forum for about 300 attendees to gain insight into the complexities of oncology treatment, where “clinical advances, policy mandates, and value-based payment reform intersect.” Of particular...

health-care policy

NCI Announces Blue Ribbon Panel to Help Guide Vice President Biden’s National Cancer Moonshot Initiative

On April 4, 2016, The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), announced a Blue Ribbon Panel of scientific experts, cancer leaders, and patient advocates that will inform the scientific direction and goals at NCI of Vice President Joe Biden’s National...

health-care policy
palliative care

Joseph Simone, MD: Highlights of the 21st Annual NCCN Conference

Joseph V. Simone, MD, of the Simone Consulting Company, gives his expert perspective on the important messages of this year’s meeting.

Health-Care Policy

ASCO Issues Report on State of Cancer Care in America: 2016

The State of Cancer Care in America: 2016, published online in the Journal of Oncology Practice1 and presented earlier this month at a Congressional briefing in Washington, DC, is ASCO’s third annual assessment of national trends in cancer care delivery. The report highlights many promising cancer...

Health-Care Policy

340B Drug Pricing Program Revisited

I have to disagree with some of the conclusions drawn by Drs. Hagop Kantarjian and Robert Chapman in their editorial on the 340B Drug Pricing Program, which appeared in the January 25 issue of The ASCO Post. Although I’m sure I’m not the best person to provide an alternate view, I do feel strongly...

Health-Care Policy

Regulators Embrace Immunotherapy

The Cancer Drug Development Forum exists to provide, as the name implies, a meeting place to bring together academia, the pharmaceutical industry, and most important regulators for full and frank discussions to facilitate anticancer drug development. In the recent past, the Cancer Drug Development...

Legislation
Health-Care Policy

An Increase for the National Institutes of Health Budget

The National Institutes of Health (NIH) received a nearly $2 billion funding increase—the first large increase for the agency in more than 12 years—in the federal omnibus spending bill Congress passed on December 18, 2015. And President Barack Obama signed the bill into law a day later. The 6.6%...

Health-Care Policy

Pediatric Oncology Groups Endorse Ethical Framework for Rationing Scarce Drugs

The Children’s Oncology Group (COG) and the American Society of Pediatric Hematology/Oncology (ASPHO) have endorsed formal clinical recommendations for rationing chemotherapy and supportive care agents during times of shortage. The guidance is needed because persistent shortages of many standard...

health-care policy

Robert Miller, MD: CancerLinQ Update

Robert Miller, MD, ASCO’S Vice President of Quality and Guidelines, discusses CancerLinQ, the “big data” technology platform, and implementation of a rapid learning system for oncology based on Institute of Medicine principles.

Health-Care Policy

Oncology Drug Approvals: Year in Review

In 2015, the Office of Hematology and Oncology Products (OHOP) approved 16 new molecular entities. The most notable were drug approvals in disease areas such as non–small cell lung cancer, colorectal cancer, breast cancer, melanoma, renal cancer, and diseases that are particularly difficult to...

Health-Care Policy
Issues in Oncology

Evolving Tools for Clinical Decision-Making

Value in cancer care—and how to define it—is a hot topic. There is general agreement that it is some measure of benefit vs cost, but “should the focus be on providing value to patients at a population level or at an individual level?” asked Alan Balch, PhD, CEO of the Patient Advocate Foundation,...

health-care policy

Many Americans Favor a Tax Increase to Support the 'Moonshot' Cancer Initiative

Vice President Joe Biden's “moonshot” initiative to defeat cancer earned support for a tax increase to fund cancer research among half of respondents (50%) in a new national public opinion survey commissioned by Research!America. Thirty-eight percent disagree and an additional 12% are...

cost of care
health-care policy

Robert W. Carlson, MD, and Lee N. Newcomer, MD, MHA, on 20 Years of Improving Cancer Care Together: A Payer’s Perspective

Robert W. Carlson, MD, Chief Executive Officer of the National Comprehensive Cancer Network, and Lee N. Newcomer, MD, MHA, of UnitedHealthCare, discuss the value of NCCN Guidelines in determining coverage decisions, the future of affordable care, bundled payments, and the clear value approach.

global cancer care
health-care policy

Lawrence N. Shulman, MD, and Clifford A. Hudis, MD, on Cancer Care in Resource-Challenged Areas

Lawrence N. Shulman, MD, of Dana-Farber Cancer Institute, and Clifford A. Hudis, MD, of Memorial Sloan Kettering Cancer Center, discuss the delivery of cancer care in resource-constrained settings such as Rwanda and Haiti, and plans to conduct research in basic tumor biology of patients in these areas.

supportive care
health-care policy

Jeff Dunn, AO, PhD, GAICD, on Community-Based Response to Cancer

Jeff Dunn, AO, PhD, GAICD, of the Cancer Council Queensland, discusses reducing the burden of cancer on individuals and communities.

Health-Care Policy

ASCO Praises President’s Sharp Focus on Cancer

ASCO applauds President Obama for his bold vision to launch a national effort on cancer, which he described during his State of the Union address on January 12, 2016. We also join him in recognizing Vice President Biden’s leadership in calling for a “moonshot” that will reduce the cancer-related...

Health-Care Policy

ASCO Submits Comments to CMS on EHR Stage 3 of Meaningful Use and Modifications Final Rule

On December 15, ASCO submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the agency’s Electronic Health Record (EHR) Stage 3 of Meaningful Use and Modifications in 2015 through 2017. The Society’s comments provided recommendations to CMS regarding the implementation of...

health-care policy
issues in oncology

ASCO Calls for Improvements to Clinical Pathway Programs in Oncology

ASCO released a new policy statement with recommendations to ensure that clinical pathways in oncology promote—not hinder—the care of patients with cancer. Published by Zon et al in the Journal of Oncology Practice, the statement asserts that the way in which these treatment management...

Health-Care Policy

Opinion: The FDA–Pharmaceutical Industry Complex

On January 17, 1961, President Dwight D. Eisenhower, in his farewell address to the nation, coined the term “the military-industrial complex.” His purpose was to warn of the inefficiencies that could result from such a relationship, which would imperil the strength of our military and the safety of ...

Health-Care Policy

Conflicts of Interest in Health-care Reform?

Last year’s health-care reform legislation, the Patient Protection and Affordable Care Act, was designed to incrementally roll out major new bureaucratic entities, oversight, and mandates for the practice of medicine between its enactment and 2013, after the next presidential election. A new...

Health-Care Policy

Are Clinical Pathways Inevitable in Oncology’s Future?

Our health-care system is undergoing a gradual but inevitable sea change, shifting from traditional fee-for-service to fee-for-value. A session at this year’s Association of Community Cancer Centers meeting in Washington, DC, shed light on how this trend will reshape incentives and the clinical...

Cost of Care
Health-Care Policy

Rising Costs of Cancer Care: It's More Than Drugs

All parties—the government, payers, and consumers—agree that, left unchecked, rising health-care costs will eventually hamstring vital portions of our delivery system. For example, Medicare, which covers more than 50% of the nation’s patients with cancer, is marching headlong toward insolvency....

Global Cancer Care
Health-Care Policy

Cancer Care in the UK: A Conversation with Chris Parker, MD

In the contentious debate over rising health-care spending, the cancer care policies of the British National Health Service (NHS) are often cited by U.S. policymakers as an example of how health-care rationing denies patients life-prolonging treatments based on costs. The ASCO Post recently spoke...

Issues in Oncology
Health-Care Policy

Congressional Hearing Highlights Oncology Drug Shortages

Some oncology drugs are in such short supply that the situation is now critical, with almost 200 drugs affected—triple that of 2003. This was the background described by speakers at a July 2011 congressional briefing sponsored by the Association of Community Cancer Centers (ACCC), ASCO, and other...

Issues in Oncology
Health-Care Policy

Fixing the Drug Shortage: It’s About Time

I have spent the past 30 years trying to improve the results of treatment for advanced cancer. I had the privilege of working with Sir Michael Peckham when the late Professor Tim McElwain and he were evolving variants of the PVB (cisplatin, vinblastine, bleomycin) and PEB (cisplatin, etoposide,...

Cost of Care
Health-Care Policy

Increased Use of Hospital Services Boosts Oncology Spending

For our ongoing series on the rising costs of cancer care, The ASCO Post spoke with Lee N. Newcomer, MD, Senior Vice President of Oncology for UnitedHealthcare. Dr. Newcomer is responsible for improving cost-effective cancer care at the nation’s largest health insurer. He shed light on areas of...

Issues in Oncology
Health-Care Policy

Developing Targeted-agent Combinations: Business and Regulatory Issues, and Legal Obstacles

The Institute of Medicine’s National Cancer Policy Forum recently convened a public workshop, “Facilitating Collaborations to Develop Combination Investigational Cancer Therapies,” to address the promises and challenges involved in the development of combination oncologic drug therapies. In the...

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