RSSCategory: Government

Understanding Reimbursement Changes in the U.S. and What They Mean to Your Anatomic Pathology (AP) Laboratory

| January 24, 2017 | 0 Comments

Save your spot to learn more about the effects of reimbursement changes in the US on the anatomic pathology market and in your laboratory You are invited to our next complimentary webinar – January 24, 2017 Understanding Reimbursement Changes in the U.S. and What They Mean to Your Anatomic Pathology (AP) Laboratory The United States […]

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Register Now for Upcoming Digital Pathology Association Webinar

| January 22, 2017 | 0 Comments

What to Expect for the Future of Regulatory Thursday, January 26, 2017 | 1 – 2 PM EST Presenter: Esther Abels Director Quality & Regulatory and Medical Affairs Philips Presentation Overview: Digital pathology is seen as bringing flexibility in the workflow and facilitating the pathologist to easier share information. DP has the potential to enhance cancer […]

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Patients Protest at Medical Conference

| December 11, 2016 | 0 Comments

It has been said there are only two certainties in life – death and taxes. Actually, there are a few more. The annual ASCO meeting always takes place during the first week of June, the annual RSNA meeting happens the week after Thanksgiving. The annual ASH meeting and the San Antonio Breast Cancer Symposium (SABCS) […]

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House Passes 21st Century Cures Act

| December 1, 2016 | 0 Comments

USA Today (11/30, Shesgreen, 5.28M) reports that the House on Wednesday approved the 21st Century Cures Act, a “sweeping health policy bill…aimed at sparking medical innovation, strengthening mental health services, and curbing the nation’s deadly opioid epidemic.” The legislation “cleared the House with broad bipartisan support, 392-to-26.” The New York Times (11/30, Steinhauer, Tavernise, Subscription Publication, 13.9M) says Senate passage […]

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FDA Delays Final Guidance on Regulating LDTs

| November 25, 2016 | 0 Comments

medpagetoday.com posted a brief but concise article earlier this week on the issue of FDA regulating laboratory developed tests (LDTs). While the FDA has had the ability to regulate these tests since 1976, largely once regarded as “simple and scarce” as the article mentions, not before a draft guidance issued in 2014 has the FDA […]

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Multi-Center Clinical Validation Study by Philips to be Submitted to FDA in Support of Expanded Indications for Use for Philips IntelliSite Digital Pathology Solution in the U.S.

| October 24, 2016 | 0 Comments

Great news from Philips who announced on October 21st their completion of a glass versus digital concordance study to be submitted to FDA.  The press release mentions 2,000 cases with approximately 16,000 reads. The press release goes on to say that the final discordance rate was 1%. Philips will submit the results of the study along […]

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Crowdsourcing Effort Takes Aim at Metastatic Breast Cancer

| October 4, 2016 | 0 Comments

The AP (10/3, Tanner) reports breast cancer patients are getting involved in a “big new project that aims to gather enormous troves of information about their diseases in hopes of finding new and better ways of treating patients like them – women whose cancer has spread, or metastasized, and left them nearly out of options.” […]

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Young Survival Coalition Expresses Concern About Overlooked Moonshot Recommedations

| September 30, 2016 | 0 Comments

I haven’t written much about the President’s Cancer Moonshot initiative recently and as much as I would like – perhaps because following some Blue Ribbon Panel recommendations and a large number of organizations and individuals expressing, in general, positive feedback among the cancer community, there hasn’t been a lot of news about next steps.  I […]

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Dismissiveness of “Pinktober” Starting Early

| September 9, 2016 | 0 Comments

Last Fall I wrote a couple of posts about the growing disenchantment with ‘Pinkification’ and ‘Pinktober’ referencing the all-out blitz during October to go “Pink” for breast bancer awareness and prevention.  In one of the pieces I mentioned by disenchantment with what happened a number of years ago I saw in clinical practice and last […]

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Pathology 2.0 Comes of Age: Recommendations for Protecting Privacy While Motivating Education

| August 10, 2016 | 0 Comments

There is an interesting article in this month’s AMA Journal of Ethics by Drs. Crane and Gardner on the use of pathology images in social media. The authors introduce the article in their abstract as “There is a rising interest in the use of social media by pathologists. However, the use of pathology images on […]

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Beauty Queen Fakes Cancer Diagnosis

| August 9, 2016 | 0 Comments

Courtesy of The Washington Post: Brandi Lee Weaver-Gates does not have cancer. The 24-year-old former beauty queen never has, nor has she ever undergone the agonizing trials of chemotherapy. She has never shivered in a hospital room, awaiting her prognosis. She has never been forced to wonder if she would live another year. With that in mind, […]

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Proposed Medicare 2017 Reimbursement Schedule Whacks Biopsy Payments; Digital Pathology Payments Up

| July 20, 2016 | 3 Comments

The bread and butter of every surgical pathologist, the 88305 biopsy code, among others for larger specimens, face a significant reduction for technical cost reimbursement.  The professional reimbursements are expected to change very little. The proposed reimbursement for an 88305 of under $3o I believe is getting close to what it may cost many labs […]

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Vice President Biden Addresses Attendees at ASCO 2016

| June 7, 2016 | 0 Comments

“This is good news in the fight against cancer. With the launch of this new national resource, anyone can freely access raw genomic and clinical data for 12,000 patients – with more records to follow. Increasing the pool of researchers who can access data and decreasing the time it takes for them to review and […]

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FDA Approves First Liquid Biopsy Test for Use in Non-Small Cell Lung Cancer

| June 1, 2016 | 0 Comments

Exciting news today from FDA with news of approval of first liquid biopsy test for use in non-small cell lung cancer.  The cobas EGFR test is already approved for use in formalin-fixed paraffin-embedded (FFPE) tissue. This new use is intended for detection of these specific mutations in circulating-free tumor DNA (cfDNA) from plasma for first […]

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