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

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...

Issues in Oncology
Health-Care Policy

Oncology Drug Shortage: An Unintended Consequence of the Medicare Modernization Act and Free-market Forces?

Oncology has a drug shortage problem, and the FDA says that it is getting worse. Drug shortages are not a new phenomenon, but over the past few years we have seen a rapidly growing number of shortfalls that are limiting providers’ ability to care for their patients. In 2004, the FDA reported 58...

Health-Care Policy

A Conversation with Monica Morrow, MD, FACS

Over the past 15 years, practice guidelines have become an accepted tool to help physicians optimize patient care by offering informed assessment of the benefits and potential harms associated with various care options. However, a plethora of new guidelines have entered the market, many of which...

Cost of Care
Palliative Care
Health-Care Policy

Palliative Care, Quality of Life, and Cost

More than half of our nation’s patients with cancer are Medicare beneficiaries, making the entitlement program ground zero in the heated debate on health-care spending. Total Medicare expenditures attributable to beneficiaries in their last year of life runs upward of 30%; this statistic serves as...

Health-Care Policy

Oncology Community Faces Complex Challenges in Evolving Policy Arena

As the political environment heats up in advance of the upcoming presidential campaign season, many issues crucial to the oncology community are being placed on the political chopping block as policymakers seek ways to reduce the mounting debt and soaring health-care spending. To help clarify some...

Health-Care Policy

ASCO Issues Policy Statement to Reduce Cancer Care Disparities

Last August, ASCO issued the policy statement, “Opportunities in the Patient Protection and Affordable Care Act to Reduce Cancer Care Disparities” in the Journal of Clinical Oncology.1 The statement builds on ASCO’s policy on disparities in cancer care released in 2009. It calls on both the...

Health-Care Policy

Can Bayesian Design Streamline Our Sluggish Clinical Trial System?

The randomized controlled clinical trial has long been the gold standard for new cancer drugs to demonstrate worthiness of FDA approval; however, many experts contend that that our method of bringing drugs to the market is plagued by undue costs, long delays, and overregulation. According to Donald ...

Health-Care Policy

Health-care Policy: A Three-act Play

The health of Americans, the economy, the debt crisis, and the action or inaction in Washington are all seriously interrelated. Decades ago, the bank robber Willie Sutton was asked why he robs banks. His famous answer, “Because that’s where the money is,” succinctly describes the approach that...

Global Cancer Care
Health-Care Policy

Tobacco Remains the Dominant Global Risk Factor Underlying Cancer

Despite clear evidence that tobacco causes at least 18 types of cancer, as well as many other diseases, many people all over the world smoke or chew tobacco, or are exposed to secondhand smoke. Although smoking among Americans has declined slowly but steadily over the past 40 years, it remains the...

Health-Care Policy

AACR Issues Landmark Report on Cancer Progress

At a recent press conference in Washington, DC, the American Association for Cancer Research (AACR) assembled luminaries from the cancer research and care communities to discuss the salient points of the association’s newly released progress report on the current and future state of cancer research ...

Health-Care Policy

ASCO Supports the United Nations Political Declaration on Noncommunicable Diseases

In September, government leaders from around the world as well as representatives from civil society, the private sector and academia gathered at the United Nations in New York for the first-ever summit on the growing economic and human crisis posed by noncommunicable diseases (NCDs), especially in ...

Health-Care Policy

Medicare Reimbursement to Physicians: Déjà Vu All Over Again

In February 2011, The ASCO Post published an opinion piece (“Congress and the ‘Doctor Fix’: Looking Back, Looking Ahead”) about the ping-pong of legislative continuing resolutions to avert a 21.3% cut in physician reimbursement. These continuing resolutions were necessary because the Affordable...

Issues in Oncology
Health-Care Policy

A Conversation with Ezekiel J. Emanuel, MD, PhD

Last September, Ezekiel J. Emanuel, MD, PhD, a leading scholar in bioethics and health-care policy, was named the Diane v.S. Levy and Robert M. Levy University Professor and Vice Provost for Global Initiatives at the University of Pennsylvania in Philadelphia. His appointment will be shared between ...

Health-Care Policy

FDA Completes Work on Three Drug User Fee Programs

The FDA recently completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biologic products to patients, according to FDA Commissioner Margaret A. Hamburg, MD. The programs include the fifth authorization of...

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