OBR Daily Commentary

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Almost One-Third of Chemotherapy Used "Off-Label"

(Reuters) Feb 19, 2013 - About one-third of chemotherapies are used to fight cancers that drug regulators never approved them to treat, says a new study.

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William McGivney, PhD (Posted: February 20, 2013)

quotesI am responding to the article as written and presented not to the scientific publication. The presentation is very confusing and seems to result from a less than complete understanding of the off-label use issue for drugs and biologics in cancer care. There is confusion in the article as to whether off-label is defined simply as off-indication or as off-indication and/or off-approved dose. In some analyses, nonapproved combinations are considered off-label as well. As written, it is hard to figure out how we have 30% off-label use with 14% supported by the NCCN and 10% supported neither by the NCCN nor approved by the FDA. That leaves an important 6% that is off-label and thus must be not FDA approved and not recommended by the NCCN Compendium. Finally, if 10% of the prescribing of drugs and biologics is supported neither by the NCCN nor by the FDA that is surprising given that medical oncologists would be risking denial of payment for one out of every 10 of their patients. quotes

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Shedding Light on the Sunshine Act Final Rule

(ACCCBuzz) Feb 6, 2013 - The Centers for Medicare & Medicaid Services (CMS) just released the much-anticipated final rule on the Sunshine Act, which is designed to illuminate the relationship between providers and drug and device manufacturers.

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William McGivney, PhD (Posted: February 11, 2013)

quotes Enlightened Interpretation of the Sunshine Act by CMS Transparency in activities that ultimately impact clinical decisions about individual patient care is critical and indisputable. Also critical is collaborative interaction between innovator companies and the provider community in order to achieve the effective transfer of the fruits of basic and translational research into therapeutics available to patients in need; hence, the term, Technology Transfer. Pharmaceutical, biotech and medical device companies pay for a substantial majority of the clinical research in the United States (JAMA, 2010. 303: 137-143). Recent years have seen criticism of industry and provider relationships and the imposition of barriers between innovator companies and the provider community. Clearly, some of this distancing was brought on by activities that needed to be corrected. However, a negative consequence has been the significant diminution of the funding made available for continuing medical education (CME). The technology transfer process cannot help but be hurt when the flow of scientific information from the largest supporters and conductors of clinical research is impeded. The February 1 ruling by CMS regarding CME activities and reporting of support and payment to physicians by industry showed recognition of the need for presentation and open discussion in an area, CME, where there is already substantial oversight by independent bodies. In CME activities run by an independent third party where the speaker/presenter is not selected by the innovator company, payment to speakers is considered “indirect” and hence not reportable. Hopefully, the enlightened CMS ruling on this one focused area of technology transfer signals the first step into an Age of Reason in the monitoring of the relationships among all needed constituents of the Technology Transfer process in Medicine. quotes

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Less Than Two Percent of Hospitals Are Paperless As Medicare Penalties Loom

(Forbes) Jan 16, 2013 - With less than two years to go before penalties kick in from the government for hospitals that are not using electronic health records, new data shows less than 2% have operational systems.

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William McGivney, PhD (Posted: January 21, 2013)

quotesThe present article illustrates how the full implementation and realization of utility of electronic health record systems is difficult to achieve. There remain standardization issues that diminish the ability to communicate even within hospital systems and networks, the need for sophisticated staffing to apply and benefit from system functionalities, and the substantial cost of start-up and maintenance. In community oncology, these issues are only magnified. EHRs have been shown to improve practice workflow, effectiveness, and safety under study conditions. Progress is being made. However, clinicians can feel overwhelmed by the input and data requirements of installed systems. As one doctor wrote in an oped piece (10/23/12) in the Wall Street Journal, “Who’s got time to listen to patients when the government demands ‘meaningful’ data entry?” Clearly in this Era of Accountability in Medicine, with millions of patients, millions of patient encounters, and trillions of health care dollars expended, electronic systems are essential. The road to implementation will be challenging as new systems are implemented and change (e.g., ICD-10 coding) continues. quotes

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Meet the Editorial Board

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
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H. Jack West, MD

Medical Director, Thoracic Oncology Program, Swedish Ca...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics
Pr...

Community Oncology
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Jeff Patton, M.D.

CEO Tennessee Oncology...

Precision Medicine Section Editor
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Jennifer Levin Carter, MD, MPH

Chief Medical Officer and Founder, N-of-One...

Financial Sector
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Michael G. King Jr.

Managing Director and Senior Biotechnology Analyst...

Gastrointestinal Cancers
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Richard Goldberg, MD

Director WVU Cancer Institute Director of Cancer Signa...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Professor and Director, Division of Hematology Oncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Community Oncology
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William Harwin MD

Florida Cancer Specialists President and Managing Part...

Health Policy
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William McGivney, PhD

National Health Policy Expert...

Payer
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Winston Wong, PharmD

President, W-Squared Group...