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A federal judge has ruled against the Health Resources and Services Administration over provider access to 340B Drug Pricing Program discounts for orphan drugs.

Judge Rudolph Contreras of the U.S. District Court for the District of Columbia vacated a HRSA “interpretive rule,” in which HRSA sought to make drug companies provide discounts on some uses of orphan drugs.

Contreras determined that Congress specifically excluded all uses of orphan drugs from the 340B program.

	340B Guidance to Scale Back Discounts; Hospitals Will Need to Show Patient Benefit The 340B Drug Discount Program—designed to help hospitals that serve needy patients—is on the brink of a major revamp. The Health Resources and Services Administration issued a sweeping guidance that would provide stricter definitions for which patients and entities should be covered (The Cancer Letter, Sept. 11). The draft guidance, called the 340B Program Omnibus Guidance, was issued Aug. 28. Its public comment period ends Oct. 27. Previous Coverage of 340B
	NCCN Unveils Evidence Blocks as Part of Oncology Guidelines The National Comprehensive Cancer Network unveiled a new initiative—NCCN Evidence Blocks—in the new versions of the NCCN Clinical Practice Guidelines in Oncology for Chronic Myelogenous Leukemia and Multiple Myeloma.
	Funding Opportunity Stand Up To Cancer Offering $7.5 Million in Funding For Early-Career Investigators Stand Up To Cancer is making $7.5 million in research funding available to early-career scientists who are pursuing innovative approaches to cancer. Proposals may focus on any discipline within basic, translational, or clinical research.
	In Brief Manuel Hidalgo Named Director of BIDMC Clinical Cancer Programs Alec Kimmelman named chair of radiation oncology at NYU Langone Maciej Lesniak named chair of neurological surgery at Northwestern University Ann Nattinger appointed senior associate dean for research at Medical College of Wisconsin Edward Schaeffer joins Northwestern as chair of urology Peter Kanetsky elected president of American Society of Preventive Oncology IBM acquires Merge Healthcare Inc. American College of Gastroenterology holds first annual SCOPY awards Eli Lilly and Co. to expand its NYC research center
	Drugs and Targets FDA approves Opdivo in non-squamous NSCLC FDA Orphan Designation granted to Blueprint’s BLU-554 European Orphan Designations granted to CF102 and ENMD-2076 Genentech and Arvinas enter into license agreement Ontario Institute for Cancer Research, Novera, and Janssen to collaborate on small molecule drugs for hematological cancers Eli Lilly and Innovent expand their anti-PD-1 collaboration Sequenom to collaborate with University Medical Center Hamburg-Eppendorf MedImmune joins Human Vaccine Project

20151009 - Oct 9, 2015

ISSUE 37 – OCT. 9, 2015

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CT Colonography and Stool DNA

Fail to Make USPSTF A-List

CT colonography and stool DNA failed to get on the list of preferred tools for screening for colorectal cancer.

A draft guideline from the U.S. Preventive Services Task Force released Oct. 6 calls for using one of three strategies:

• Fecal immunochemical test or high-sensitivity guaiac-based fecal occult blood test every year;

• Flexible sigmoidoscopy every ten years, plus FIT every year; or

• Colonoscopy every ten years.

	Capitol Hill Collins to Congress: A Flat, Year-long CR Would Be “Devastating” to NIH Research If Congress passes another year-long, flat-funding resolution, the effect on NIH “would be simply devastating,” Director Francis Collins told a Senate appropriations subcommittee during a hearing Oct. 7. “I can’t emphasize enough how much we are worried about this,” Collins said, sitting alongside NCI Acting Director Douglas Lowy and other institute directors.
	CMS Issues Updated Pricing For Clinical Lab Fee Schedule Centers for Medicare and Medicaid Services issued updated pricing determinations for the Clinical Laboratory Fee Schedule, which reversed a payment cut for the Oncotype DX breast cancer test.
	Letter to the Editor from the Coalition for 21st Century Medicine Dear Editor, We are writing to clarify a few points in your Oct. 2 article, “CMS to Trim Spending on Diagnostic Lab Tests,” as it mistakenly intertwines two issues.
	In Brief Tomas Lindahl, Paul Modrich, and Aziz Sancar win the Nobel Prize Alexander Eggermont’s directorship of Institut Gustave Roussy extended by 5 years Victoria Seewaldt joins City of Hope NYU Langone names Shohei Koide to lead new biologics research program Memorial Sloan Kettering and Cornell University to launch nanomedicine center Oncology Nursing Society launches clinical resource platform SWOG to fund Veterans Affairs Department medical centers
	Drugs and Targets FDA grants breakthrough therapy designation to abemaciclib in breast cancer Merck and Bionomics Ltd. extend collaboration Immunovia and OHSU form pancreatic cancer collaboration MD Anderson and Theraclone Sciences launch OncoResponse company

20151002 - Oct 2, 2015

ISSUE 36 – OCT. 2, 2015

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CMS to Trim Spending on Diagnostic Lab Tests

The Centers for Medicare and Medicaid Services appear to be executing a two-step strategy to shrink the $8 billion annual price tag of clinical diagnostic laboratory tests.

On Sept. 25, CMS released a final payment determination for the Clinical Laboratory Fee Schedule that cuts payment by over 90 percent for some tests.

One of the industry leaders, Genomic Health, saw payments for Oncotype DX breast cancer tests drop by 15 percent, and a 79 percent drop for its colon cancer test. The determination involves a set of nine codes for advanced diagnostic laboratory tests.

Related Coverage of Lab Developed Tests

	Guest Editorial Local Medicare Contractors Bring Chaos to CMS Coverage of Next Generation Tests By Dane Dickson Yesterday, two Medicare administrative contractors—National Government Services and Cahaba Government Benefit Administrators—released draft local coverage determinations for next generation sequencing in advanced lung cancer. The NGS LCD covers the initial diagnosis of lung cancer and Cahaba’s LCD covers patients who have been re-biopsied to test for additional mutations that may have been missed on testing of the initial biopsy by older technology.
	BMS Combination Approved in Melanoma; Dana-Farber Challenges BMS Patent Rights A combination of two Bristol-Myers Squibb immuno-oncology agents—Opdivo (nivolumab) and Yervoy (ipilimumab)—received an accelerated approval for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. The Oct. 1 announcement marks the first time FDA has approved a combination regimen of two immuno-oncology agents in cancer—both drugs had previously been approved as monotherapies for the same indication.
	Capitol Hill Congress Averts Shutdown, Funds NIH Through December Congress passed a continuing resolution Sept. 30—averting a shutdown—that will fund the federal government at current levels through Dec. 11. Funding for both NIH and NCI dipped slightly as part of a 0.21 percent cut to all non-defense discretionary agencies.
	USPSTF Speaks on its Role In the Affordable Care Act The U.S. Preventive Services Task Force published a viewpoint in the Journal of the American Medical Association to clarify how their recommendations are linked to the Affordable Care Act coverage mandate—and how they believe clinicians, payers, and the public should interpret their recommendations. The viewpoint, titled “Evidence-Based Clinical Prevention in the Era of the Patient Protection and Affordable Care Act: The Role of the US Preventive Services Task Force,” describes how some have misinterpreted task force grades of C or I as recommendations against screening or even against coverage.
	Funding Opportunity Pershing Square Sohn Cancer Research Alliance Prize For Young Investigators The Pershing Square Sohn Cancer Research Alliance is taking applications for its Prize for Young Investigators in Cancer Research.
	In Brief Richard O’Reilly to step down as chair of pediatrics at MSKCC James Wade named deputy director at Inova cancer institute MSKCC’s Lorenz Studer named MacArthur Fellow Three investigators named winners of the Paul Marks Prize Kesari joins Providence Saint John’s Health Center Turaga named endowed professor in sarcoma research at Medical College of Wisconsin Jan Schluchter named CCO at Myriad Genetics GmbH Stand Up to Cancer Canada Dream Team members announced Center to Advance Palliative Care publishes state-by-state report card
	Drugs and Targets FDA grants accelerated approval to Keytruda in NSCLC EMA CHMP grants two positive opinions to Kyprolis and Blincyto FDA grants priority review to defibrotide for hepatic VOD Aspen Park acquires Ohio State’s APP-111 UbiVac and Janssen form collaboration City of Hope and Sorrento Therapeutics form LA Cell Inc.

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