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Now, for the first time, there's a publication that allows you to review all the key legislative changes,
latest developments, mergers and acquisitions (and more!) that affect the daily management of your lab,
diagnostic testing and compliance programs.
This is the product that lab executives have been asking for. It's the end of time-consuming, fruitless
internet searches to gather the all the details you need to successfully run your business. In just minutes,
you can learn about all the recent significant developments that affect your lab and how they unfolded.
This groundbreaking quarterly publication covers:
- Government Policy for Diagnostic Testing and Related Services
- policy actions
- bills and advisories
- analysis of current policy issues
- and more
- Compliance
- agency recommendations
- policy changes and guidance
- perspectives on current issues
- settlements and legal actions
- Lab Strategy and Diagnostic Testing
- mergers, acquisitions & strategy
- analysis of lab and test trends and markets
- new tests and test markets
- patents, approvals and reimbursement
- and much more
The subscription's quarterly issues, published with gold-embossed, leatherette soft covers, are conveniently
organized by broad subject area and arranged chronologically. So, you can easily review what led up to the latest
policy action, advisory, or new regulation—and understand how they may affect you and your next business decision.
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 | DGPC Spring 2007 (Full-Issue PDF) |
| I. Government Policy For Diagnostic Testing & Related Medical Services
a. Policy Actions, Bills & Advisories 9
b. Analysis of Current Policy Issues 29
II. Compliance Developments
a. Agency Recommendations, Guidance & Policy Changes 53
b. Perspectives on Current Compliance Issues 67
c. Settlements & Legal Actions 79
III. Lab Strategy Developments
a. Mergers, Acquisitions and Strategy 91
b. Analysis of Lab Trends and Markets 105
c. New Tests and Test Markets 117
IV. Diagnostic Test Developments
a. Mergers, Acquisitions and Strategy 125
b. Analysis of Test Trends and Markets 135
c. New Tests, Patents, Approvals andReimbursement 145
Full Article |
| Diagnostics: Genzyme Introduces Pharmacogenomic Test For Lung Cancer |
| Reported by Washington G-2, January 2007
Genzyme (Cambridge, MA) has launched a test to help identify non-small cell lung cancer (NSCLC) patients who may not respond to targeted therapies. The company’s KRAS Mutation Analysis can help identify NSCLC patients who test positive for specific mutations in the KRAS gene that have been associated with resistance to certain chemotherapeutic drugs known as tyrosine kinase inhibitors (TKIs), including erlotinib (Tarceva) and gefitinib (Iressa).
Full Article |
| Lab Strategy: Spotlight on Pap Testing: Monolayer Testing To Take 100% Of Market In ’07? |
| Reported by Washington G-2, January 2007
Washington G-2 Reports estimates that laboratory service revenue from Pap testing topped $1.5 billion last year and will continue to grow. Meanwhile, more than 80% of the Pap test market is dominated by two companies: Cytyc (Marlborough, MA) and TriPath Imaging (Burlington, NC), which is now owned by Becton, Dickinson (see pg. 9). Both companies market a mono-layer Pap test (versus traditional smears). The Cytyc product, ThinPrep, was approved by the FDA in May 1996. The TriPath Imaging system, SurePath, was approved by the FDA in June 1999.
Full Article |
| Compliance: Miami Hospital Pays $15 Million In Fraud Settlement |
| Reported by Washington G-2, January 2007
Larkin Community Hospital in Miami and its current and former owners, Dr. Jack Michel, Dr. James Desnick, Morris Esformes, and Philip Esformes, have paid $15.4 million to settle federal and Florida civil healthcare fraud claims against them, according to the U.S. Department of Justice.
Full Article |
| Diagnostics: Pap Testing Growing, Gaps In Knowledge Of Screening |
| Reported by Washington G-2, January 2007
Since 2003, the cytology market in the United States has grown 60% and is now valued at $2 billion. While Pap test volumes have increased steadily, a recent survey by the National Cancer Institute (NCI) shows that most American women are unaware in the change in guidelines recommending a Pap test every three years for healthy adult women.
Full Article |
| Diagnostics: Magellan Biosciences Buys Trek Diagnostic Systems, Gets $50M |
| Reported by Washington G-2, January 2007
Magellan Biosciences (Chelmsford, MA) has acquired Trek Diagnostic Systems (Cleveland, OH), a microbiology company that specializes in clinical diagnostic products for infectious diseases. Financial terms of the deal were not disclosed.
Full Article |
| Lab Strategy: Competitive Bidding Demo In Holding Pattern Awaiting OMB’s OK |
| Reported by Washington G-2, January 2007
After years of discussion about competitive bidding for laboratory services, CMS is expected to make 2007 the year in which it will fulfill the directive of the Medicare Modernization Act of 2003 and implement a demonstration project for lab competitive bidding. The demo project is currently in a holding pattern awaiting United States Office of Management and Budget (OMB) approval on its structure and budget, but industry leaders expect it to begin by June of this year.
Full Article |
| Lab Strategy: Sonic To Acquire American Esoteric Laboratories For $180M |
| Reported by Washington G-2, January 2007
Sonic Healthcare (Sonic; Sydney, Australia) finished 2006 with a bang. The Australian lab giant, which made its second United States acquisition last October with the purchase of Cognoscenti Health Institute (Orlando, FL), has signed an agreement to acquire all of American Esoteric Laboratories (AEL) from two private equity firms, ABS Capital Partners and Oak Investment Partners, and the company’s management. Sonic will pay about $180 million in a cash transaction that is expected to close by the middle of this month.
Full Article |
| Compliance: What Is The FDA Doing With Lab-Developed Tests? |
| Reported by Washington G-2, January 2007
Concern is growing among laboratories over the Food and Drug Administration’s (FDA) recent move to begin treating laboratories developing and marketing some laboratory-developed tests (LDTs—also called “home brew” tests) as medical device manufacturers and requiring these labs to obtain FDA clearance or approval for these tests. What is going on? Will LDTs be subject to FDA regulation as medical devices in the future? First, some background on LDTs and regulation of these tests.
Full Article |
| Compliance: Congress Provides Relief To Pathologists |
| Reported by Washington G-2, January 2007
Pathologists got a last-minute reprieve from Congress in December when lawmakers approved a bill that includes a provision to reverse a 5% reduction in Medicare physician payment, as well as a provision to allow independent laboratories to continue billing Medicare directly for the technical component of surgical pathology services provided to hospital patients through 2007.
Full Article |
| Government Policy: Medicare Fee Fix Tops Physicians’ Legislative Agenda |
| Reported by Washington G-2, January 2007
Pathologists and other physicians escaped a 5% cut in their Medicare fees this year and got a zero update instead from the lame-duck session of the GOP-run 109th Congress. Now, they face an even steeper cut in 2008 unless the Democratic-run 110th Congress intervenes.
Full Article |
| Government Policy: Claims Will Be Paid At Correct ’07 Rates, CMS Assures Doctors |
| Reported by Washington G-2, January 2007
Pathologists and other physicians can rest assured that their Part B claims for services on and after January 1, 2007, will be paid at the new rates mandated by Congress, the Centers for Medicare & Medicaid Services says. In enacting the Tax Relief & Health Care Act (P.L. 109-432) last month, Congress approved a zero update to physician fees, averting the 5% cut scheduled to take effect under the statutory update formula.
Full Article |
| DGPC Spring 2007 (Full-Issue PDF) |
| I. Government Policy For Diagnostic Testing & Related Medical Services
a. Policy Actions, Bills & Advisories 9
b. Analysis of Current Policy Issues 29
II. Compliance Developments
a. Agency Recommendations, Guidance & Policy Changes 53
b. Perspectives on Current Compliance Issues 67
c. Settlements & Legal Actions 79
III. Lab Strategy Developments
a. Mergers, Acquisitions and Strategy 91
b. Analysis of Lab Trends and Markets 105
c. New Tests and Test Markets 117
IV. Diagnostic Test Developments
a. Mergers, Acquisitions and Strategy 125
b. Analysis of Test Trends and Markets 135
c. New Tests, Patents, Approvals andReimbursement 145
Full Article |
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