 | 06/24/09 - CDC Seeks Industry Input in Establishing Laboratory Best Practices |
| Goal of initiative is to develop evidence-based methods that evaluate practice effectiveness for improving the quality of health care
Full Article |
| 06/23/09 - House Bill Makes Pathology TC Billing Protection Permanent |
| Independent clinical laboratories could continue to bill Medicare Part B in 2010 and beyond for the technical component (TC) of pathology services to hospital inpatients and outpatients, under legislation pending in the House. The bill would make permanent the “grandfather” protection for such billings that expires Dec. 31 of this year.
Full Article |
| 06/23/09 - Compliance Officer Sentenced to Prison for Fraudulent Contracts |
| A federal district court in Hawaii has sentenced a former compliance officer to 40 months in prison and ordered her to pay $639,430 in restitution after she pleaded guilty to fraud by entering into contracts with a hospital for consulting services she actually performed as an employee (United States v. Syling).
Full Article |
| 06/23/09 - LabCorp to Acquire Monogram Biosciences |
| Deal valued at $155 million would boost LabCorp's presence in companion diagnostics, cancer testing.
Full Article |
| 06/17/09 - Quest Launches New HIV Tropism Test |
| New laboratory-developed pharmacogenomic test will compete with Monogram Biosciences' market-leading Trofile assay.
Full Article |
| 06/10/09 - Laboratory’s Role Can Determine Billing Requirements |
| Rules vary depending on whether the lab is acting as a hospital lab or as an outreach lab.
Full Article |
| 06/10/09 - At G-2’s Outreach Conference, an Emphasis on ‘Knowing Your Numbers’ to Succeed in a Growing Market |
| Power of data is key topic at the eighth annual laboratory outreach conference, presented by Washington G-2 Reports and Chi Solutions on June 8-10 in San Diego, Calif.
Full Article |
| 06/10/09 - Senate Bill Would Revise ‘Date of Service’ Policy in Labs’ Favor |
| Under Senate legislation introduced June 9, independent laboratories offering complex, advanced diagnostic tests would be allowed to bill Medicare directly for the tests when ordered less than 14 days after a patient’s discharge from the hospital.
Full Article |
| 06/10/09 - Washington G-2 Reports/Chi Solutions’ Latest Survey Finds Outreach Lab Profitability over 20% and Annual Revenue Growth Over 3% |
| Survey also reveals some interest in M&A
Full Article |
| 06/10/09 - Appeals Court Upholds Revocation of Lab’s CLIA Certificate |
| A federal appeals court has upheld the government’s one-year revocation of a laboratory’s CLIA certificate for referring proficiency testing samples to another lab for analysis before submitting its own results.
Full Article |
| 05/27/09 - Bill Would Make Pathology ‘Grandfather’ Protection Permanent |
| Bipartisan legislation has been introduced in the Senate to make permanent the “grandfather” provision that allows independent clinical laboratories to bill Medicare Part B separately for the technical component (TC) of anatomic pathology services to hospital inpatients and outpatients. This protection is set to expire at the end of this year.
Full Article |
| 05/27/09 - Groups Can Help Fund Testing Services, Says OIG |
| A nonprofit charitable group can help financially needy Medicare and Medicaid patients pay their cost-sharing amounts for advanced diagnostic testing used in treating HIV and colon cancer without risking federal civil penalties, the Department of Health and Human Services Office of Inspector General (OIG) said in a new advisory opinion.
Full Article |
| 05/27/09 - Agendia Opens CLIA Lab |
| Cancer testing company boosts U.S. presence with California laboratory, new hires.
Full Article |
| 05/27/09 - Medicare Part B Lab Spending Up 3.3% to $7.3 Billion in 2008 |
| Total Medicare spending reached almost $470 billion in 2008
Full Article |
| 05/15/09 - Nanogen Files for Chapter 11, Agrees to Sell Assets |
| Bankrupt molecular diagnostics and point-of-care diagnostics company in deal to sell assets to France's Elitech Group for $25.7 million
Full Article |
| 05/13/09 - Quest Diagnostics Develops H1N1 Flu Identification Test |
| Company's Focus Diagnostics infectious disease reference lab touts 24-hour turn around time.
Full Article |
| 05/13/09 - ACLU Sues Over Breast Cancer Gene Patents |
| Association for Molecular Pathology, American Society for Clinical Pathology, College of American Pathologists among plaintiffs in suit against Myriad Genetics, charging that BRCA1 and BRCA2 patents stifle research.
Full Article |
| 05/13/09 - PLUS Diagnostics Opens West Coast Lab; Plans to Offer Hem/Onc Services This Year |
| East Coast expansion will triple overall lab capacity
Full Article |
| 05/12/09 - CMS Proposes Specific Clinical Trial Coverage for Warfirin Response Testing |
| The Centers for Medicare & Medicaid Services (CMS) May 4 proposed that pharmacogenomic testing to predict how a beneficiary responds to an anticoagulant drug will not be covered by Medicare, unless the beneficiary is enrolled in a clinical trial that meets specific guidelines.
Full Article |
| 05/11/09 - Major Medicare Cuts Proposed in President’s Budget |
| While physicians would see their Medicare fees rise, a host of other providers, including hospitals, managed care plans, and home health agencies would see payment reductions under the president’s budget request for fiscal 2010, released May 7.
The budget proposes $309 billion in Medicare and Medicaid spending cuts over 10 years to help finance the $634 billion reserve fund for health care reform.
Full Article |
| 04/29/09 - FDA Okays Test Panel for H1N1 Diagnosis |
| The Food and Drug Administration has given the green light to public health and other qualified laboratories to make emergency use of the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) for the presumptive diagnosis of the new H1N1 strain.
The panel is authorized for use in “individuals who have been diagnosed with influenza A caused by a virus not subtypeable by currently available FDA-cleared devices.” There is no adequate, approved, and available alternative to emergency use of the panel, the FDA noted.
Full Article |
| 04/28/09 - OIG Finds Improper Medicaid Spending on Lab Services |
| Medicaid programs in eight of 11 states examined by the Department of Health and Human Services Office of Inspector General spent $1.3 million in fiscal years 2005 and 2006 on potentially improper payment for outpatient clinical diagnostic laboratory services for Medicare beneficiaries who also are entitled to some Medicaid benefits, the OIG says in a new report.
Full Article |
| 04/28/09 - Thermo Fisher to Acquire Alesco's Biolab Division for $120 Million |
| Purchase of instruments and consumables business will allow Thermo Fisher to expand into Australia, New Zealand, and South Pacific.
Full Article |
| 04/27/09 - CDC Issues Swine Flu Biosafety Guidelines for Lab Workers |
| The Centers for Disease Control and Prevention (CDC) on April 24 issued biosafety guidelines for laboratory personnel who may be processing or performing diagnostic testing on clinical specimens from patients with suspected swine influenza A (H1N1) virus infection or who are performing viral isolation.
Full Article |
| 04/24/09 - Solid Volume Growth Drives LabCorp’s First Quarter Revenues Up 4.8% to $1.16 Billion |
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Full Article |
| 04/24/09 - Test Volume Growth Slowdown Continues in 1st Quarter; Labs Still Predict 2.5% Full-Year Increase |
| Labs also report cutting travel, training costs
Full Article |
| 04/20/09 - Combination Test Can Predict End-Stage Renal Disease |
| New study finds that measuring glomerular filtration rate and urinary albumin levels can help determine prognosis of chronic kidney disease patients.
Full Article |
| 04/16/09 - Quest Agrees to $302 Million Settlement in Marketing Case |
| Lab resolves criminal and civil claims concerning test kits manufactured, marketed, and sold through its now defunct Nichols Institute subsidiary.
Full Article |
| 04/15/09 - Lawmakers Face Decision on Fix of Physician Payment System |
| House and Senate lawmakers will return from their Easter recess next week facing several crucial decisions as they attempt to meld their differing fiscal 2010 budget resolutions.
Full Article |
| 04/15/09 - Clinical Data Sells Genomics Services Business to Focus on Pharma |
| Beckman Coulter has purchased Clinical Data's Cogenics division for $17 million.
Full Article |
| 04/14/09 - Gov. Schwarzenegger Commits $32 Million to Combat California’s Allied Health Worker Shortage |
| Initiative aims to add lab and radiology technician and technologists to health care facilities over next three years
Full Article |
| 04/01/09 - Inverness Launches New Rapid Test for C. difficile Infection |
| FDA-cleared test will be marketed and distributed as an in vitro diagnostic aid for Clostridium difficile-associated disease.
Full Article |
| 04/01/09 - Lab Testing Market to Grow Over 90% through 2017 |
| Washington G-2 Reports releases 2009 laboratory market projections.
Full Article |
| 04/01/09 - G-2’s 2009 AP Market Survey Indicates Reimbursement, New Client Development as Key Growth Challenges |
| Technology development also a challenge during recession
Full Article |
| 03/31/09 - CBO Warns of Effects of Physician Payment Cuts |
| The effect of a 21 percent reduction in Medicare physician payment rates in January 2010 and a cumulative cut of 40 percent by 2014 would likely result in reduced physician participation in Medicare, the Congressional Budget Office (CBO) said March 27.
Full Article |
| 03/31/09 - AdvaMed Proposal to FDA Reignites Controversy Over Lab-Developed Tests |
| All tests developed in-house by clinical laboratories, including genetic testing increasingly used in personalized medicine, should be brought under regulation by the Food and Drug Administration, according to a proposal submitted to the agency by a leading medical device industry group.
Full Article |
| 03/25/09 - OIG Refines Self-Disclosure Protocol |
| The Department of Heatlh and Human Services Office of Inspector General (OIG) said March 24 it is refining its self-disclosure protocol (SDP) for the health care industry by focusing on kickbacks intended to induce or reward a physician's referral.
Full Article |
| 03/23/09 - Bill Introduced to Modernize Lab Fee Schedule |
| Legislation has been introduced in the House to devise a payment alternative to the Medicare Part B fee schedule and to increase the Medicare fee for collecting lab test specimens.
Full Article |
| 03/23/09 - CombiMatrix Focuses on Increasing Test Utilization, Developing Cancer Screening Test |
| The biotechnology company is devoting 2009 to increasing usage of its microarray-based diagnostic tests as it continues developing a Comprehensive Cancer Array test.
Full Article |
| 03/20/09 - CAP Urges CMS to Take Different Tack on Cytology PT |
| The College of American Pathologists has asked the Centers for Medicare and Medicaid Services to withdraw its proposed revisions to CLIA requirements for the proficiency testing (PT) of pathologists and cytotechnologists who do Pap testing and to consider a continuing medical education alternative.
Full Article |
| 03/20/09 - California Sues Labs Over Alleged Fraud |
| California Attorney General Jerry Brown has joined a legal action against seven clinical laboratories, alleging the labs defrauded the state of hundreds of millions of dollars by charging the Medi-Cal program substantially more than it charged other clients.
Full Article |
| 03/18/09 - CMS Requires New Disclosure of Hospital, Physician Ties |
| Medicare administrative contractors (MACs) must notify hospitals by June 8 of updated requirements for disclosing to patients whether referring physicians have an ownership stake in the hospital, the Centers for Medicare and Medicaid Services has announced.
Full Article |
| 03/17/09 - Lab IT Leaders Sound Off on Industry’s Challenges and Opportunities for Growth |
| Industry must tackle interface and interoperability obstacles
Full Article |
| 03/17/09 - CMS To Suspend MUEs for Labs |
| The Centers for Medicare and Medicaid Services (CMS) will suspend implementation of Phase VIII of the agency's medically unlikely edits (MUEs) for laboratories temporarily while problems are being resolved, acccording to the American Clinical Laboratory Association (ACLA).
Full Article |
| 03/13/09 - FDA Approves Hologic’s HPV Tests |
| Hologic's Cervista HPV HR (high risk) and the Cervista HPV 16/18 will compete directly with the Qiagen-owned Digene HPV tests.
Full Article |
| 03/12/09 - SACGHS Issues Draft Report on Gene Patents |
| The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) has issued a draft report on gene patents and licensing practices and their impact on patient access to genetic tests.
Full Article |
| 03/12/09 - Roche Reaches Deal to Acquire Genentech |
| After raising the offer price to $95 a share, Roche has agreed to buy the 44% of Genentech that it doesn't already own in a deal worth approximately $46.8 billion.
Full Article |
| 03/04/09 - MedPAC Would Link Payment Increase to Quality |
| Medicare Payment Advisory Commission recommendations would provide hospitals with a full payment update in 2010 for inpatient and outpatient services as a reward for better performance on quality measures, according to MedPAC's annual report to Congress.
Full Article |
| 03/03/09 - Survey Finds Over Half of Labs Struggle to Hire Personnel; Medical Technologist Vacancy Rate Highest at Over 10% |
| Increased competition for qualified staff and low compensation cited as the primary challenges to filling vacancies
Full Article |
| 02/27/09 - Olympus to Exit Clinical Diagnostics; In Deal to Sell Dx Systems Division to Beckman Coulter |
| The $800 million deal includes R&D, production, and marketing functions of the diagnostics systems business of Olympus.
Full Article |
| 02/25/09 - Quest Acquires Rights to Biomarker for Prostate Cancer Test Development |
| Nation's largest commerical laboratory acquires non-exclusive rights to Epigenomics' DNA methylation biomarker.
Full Article |
| 02/25/09 - Sonic’s Acquisition Strategy Drives Revenue up 28% to $938M for First Half 2009; U.S. Organic Rev Up 6% |
| Australian lab giant forecasting 15%+ revenue growth in 2009
Full Article |
| 02/18/09 - Dx Lab Market to Grow Nearly 70% by 2017 to $98 Billion |
| G-2 Reports estimates annual growth of 6.7% in the lab industry over the next ten years
Full Article |
| 02/18/09 - Court Refuses to Certify Class in Claims Against Quest |
| A federal court on February 11 refused to certify a class in a billing complaint against Quest Diagnostics (Agostino v. Quest Diagnostics Inc).
Full Article |
| 02/18/09 - Big Boost for Health IT, Medicaid in Economic Recovery Act |
| The economic stimulus bill that President Obama signed into law Feb. 17 includes nearly $20 billion in Medicare and Medicaid spending to help hospitals, physicians, and clinics adopt health information technology (HIT), saving an estimated $12 billion over 10 years.
Full Article |
| 02/18/09 - Pathwork Diagnostics Expands Tissue of Origin Test |
| The test that analyzes gene expression to help identify tumor source is now available for use with formalin-fixed paraffin-embedded tissue samples.
Full Article |
| 02/17/09 - Bostwick Laboratories Launches Hematopath Division, Names Medical Director |
| Hematocor will be headed up by Guy Nichols, M.D., Ph.D., formerly of Bon Secours Richmond Regional Laboratory System
Full Article |
| 02/12/09 - Esoteric Testing Continues to Fuel LabCorp Growth; Rev up 11.3% to $1.1 Billion, Organic Volumes up 3% for Q408 |
| Recession-related decline in drugs-of-abuse testing continues to drag down core volume growth
Full Article |
| 02/04/09 - Medicare Panel to Examine Genetic Testing Coverage |
| A key committee advising Medicare on coverage policy will hold the first of two public forums this month on the benefits of genetic testing for program beneficiaries.
Full Article |
| 02/03/09 - Building a Better Molecular Test Menu Involves Number of Variables |
| Deciding which tests to add to a clinical laboratory's molecular test menu involves a number of variables, from patient/provider needs to the capability of the lab to return on investment. Speaking at Washington G-2 Report's Molecular Diagnostics Conference on February 2, Lynette Savaloja, cytopathology technical supervisor at Regions Hospital in Saint Paul, Minn., suggests using a decision matrix to evaluate and prioritize options.
Full Article |
| 01/26/09 - Quest Diagnostics’ Revenue up 8% to $7.2B for 2008; Q4 Revenues up 1.7% |
| Lab testing leader grappling with industry-wide slowing in volume growth
Full Article |
