News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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CMS Issues PAMA Final Rule That Aims to Cut Medicare’s Clinical Laboratory Test Price Schedule Sharply Beginning in 2018

Analysis shows new rule requires data gathering effort that favors larger medical laboratories and thus threatens community labs that serve smaller towns and rural areas

When The Centers for Medicare and Medicaid Services (CMS) issued their Final Rule for lab test market price reporting under the Protecting Access to Medicare Act of 2014 (PAMA) last month, it put the clinical laboratory industry on a path that will have significant financial consequences for all labs, whether large or small. Some experts believe this will be the most disruptive event to the medical laboratory industry in the past 30 years.

By now, the story is well known among pathologists and clinical laboratory directors. That story comes from CMS, which issued the Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule—AKA the Clinical Laboratory Fee Schedule (CLFS)—that directly affects clinical labs. Under this Final Rule, published in the Federal Register, June 17, 2016, “laboratories and physician offices are required to report private payer rate and volume data if they have more than $12,500 in Medicare revenues from laboratory services on the CLFS and they receive more than 50% of their Medicare revenues from laboratory and physician services during a data collection period. Laboratories will collect private payer data from January 1, 2016 through June 30, 2016 and report it to CMS by March 31, 2017.

“The first data reporting period (that is, the period during which data from the collection period will be submitted to CMS) will be from January 1, 2017, through March 31, 2017. All subsequent data collection and reporting periods for CDLTs [Clinical Diagnostic Laboratory Tests], except for ADLTs [Advanced Diagnostic Laboratory Tests], will follow this same data collection and reporting schedule, every three years. Reporting of private payer rates for ADLTs will occur on the same schedule except it will be on an annual basis,” states the Final Rule. (more…)

Bio-Reference Laboratories Acquires Hunter Laboratories as a Way to Enter California’s Competitive Clinical Laboratory Marketplace

Acquisition gives BRLI a core laboratory facility in Northern California, along with Hunter Laboratories’ Medi-Cal license, 29 patient service centers, and its courier network

Yesterday’s announcement that BioReference Laboratories, Inc. (Nasdaq:BRLI), of Elmwood Park, New Jersey, had acquired a majority interest in Hunter Laboratories—a clinical laboratory company in Campbell, California—caught many medical laboratory executives by surprise.

It is a strategic move that gives Bio-Reference Laboratories an important beachhead for developing its laboratory testing business in the large and growing California market. This is the first time that BRLI will own and operate a licensed clinical-laboratory facility west of the Mississippi River. (more…)

Supreme Court Strikes down Myriad Gene Patents in Unanimous Vote; Decision Is Expected to Benefit Clinical Pathology Laboratories

Pathologists and clinical laboratory managers can expect to see an expansion of genetic testing in the wake of the Supreme Court’s decision in the Myriad case

Pathologists and clinical laboratory professionals got a major victory on June 13. That’s when the United States Supreme Court (SCOTUS) ruled 9-0 to end the 30-year-old practice of awarding patents on human genes. The unanimous decision invalidates certain hotly contested patents held by Myriad Genetics, Inc., (NASDAQ: MYGN) on the BRCA1 and BRCA2 genes.

Moreover, this Supreme Court decision also opens the doors to other medical laboratories  to develop their own diagnostics around the BRCA genes and compete for breast-cancer testing market share. (more…)

Some Clinical Laboratories Report Drop in Average Number of Tests-Per-Patient

Medical laboratories and pathology groups can participate in national survey about changes in average revenue-per-requisition and average number of tests-per-requisition

Across the country, a number of clinical laboratory organizations have privately told The Dark Report editorial team that they have experienced a decline in the average number of lab tests-per-requisition over the past 18 months. Since the sample size is so small, it would be inappropriate to conclude that the experience of these labs reflects a national trend.

At the same time, even though this data is anecdotal and from a handful of lab organizations, it could be an early sign of an important shift in lab test utilization by clinicians. In recent years, employers, private payers, and the Medicare/Medicaid programs have initiated a variety of initiatives that have the common goal of encouraging physicians to more wisely utilize medical laboratory tests.


Survey Set to Measure Impact of Trend by Urologists and GIs to Create Their Own In-Office Anatomic Pathology Laboratories

Medical laboratories and pathology groups lose access to tissue specimens when office-based physicians operate their own in-clinic pathology laboratory

One trend reshaping the profession of anatomic pathology with surprising speed is the growth of in-clinic pathology laboratories by specialist physicians. As each office-based physician group builds its own in-clinic pathology laboratory, local pathology groups and medical laboratories lose access to the tissue specimens these doctors now process in their own pathology lab.

This trend has significant consequences for the nation’s 3,300 pathology group practices, as well as those national pathology and clinical laboratory companies that compete for the biopsy tissue referrals of office-based physicians. Losing access to the tissue referrals of local physicians makes it tougher for local pathologists to develop a broad range of experience and skills.