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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Nation’s Smaller Community Medical Laboratories Have Major Concerns about Financial Survival Once Medicare Officials Implement Deep Price Cuts to Lab Test Fees in 2018

In vitro diagnostic manufacturers and medical distributors share concerns, along with other types of medical labs in nation’s small cities and hinterlands that include rural hospital labs and physician office labs (POLs) because, along with financial erosion, there is the potential of reduced access by Medicare beneficiaries to clinical lab tests where they live

SAN ANTONIO, TEXAS—Owners and managers of community and regional independent lab companies and community laboratories gathered here last week at a lab conference to assess what many believe is a bleak future. That’s because, in less than 11 months, medical laboratories across the United States will be dealing with unprecedented price cuts to the Medicare Part B clinical laboratory fee schedule (CLFS) and how those price cuts erode the financial stability of these essential labs, often the only local medical laboratory serving smaller communities and rural areas throughout the nation.

The number one financial threat of concern to these community and regional lab owners is how the Protecting Access to Medicare Act (PAMA) rule for private-payer market-price reporting will be used by the Centers for Medicare and Medicaid Services (CMS) to make fee cuts—effective on January 1, 2018—that will be financially devastating to the nation’s small and mid-sized community and regional labs, rural hospitals, some individual and group physician practices, and community hospitals—while causing increased market concentration that benefits the nation’s two dominant publicly-traded lab companies. (more…)

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…)

Congress Passes Law Changing How Medicare Sets Prices for Clinical Laboratory Tests; Lab Industry Groups Differ on Which Labs Will Be Winners and Losers

Leaders from ACLA, AdvaMedDx, CAP, NILA will be at Executive War College on April 29-30 for first medical lab industry debate about the best and worst of the new law

Clinical laboratories will face new financial challenges following passage of a new federal law two weeks ago that makes deep changes in the way Medicare officials will establish prices for the Medicare Part B Clinical Laboratory Fee Schedule (CLFS). Many medical laboratory administrators, hospital lab managers, and pathologists remain unaware of the significant negative financial impact this law will have on their lab’s revenue and fiscal stability.

On April 1, President Barack Obama signed H.R. 4302: Protecting Access to Medicare Act of 2014. The law’s primary purpose is to extend the Sustainable Growth Rate (SGR) formula for 12 months. The House had passed the bill on the previous Thursday and the Senate passed the bill on the following Monday, March 31. (more…)

Changing Reimbursement for Clinical Pathology Laboratory Testing and Direct-to-Consumer Testing Discussed at California Clinical Laboratory Association Conference in San Diego

The end of fee-for-service payments has huge implications for U.S. medical laboratories and anatomic pathology practices

SAN DIEGO, CALIFORNIA—In the American healthcare system today, the era of fee-for-service medicine will soon end. This development has huge implications for every clinical laboratory and anatomic pathology practice in the United States because fee-for-service is their primary source of revenue.

This week at the 2013 Annual Conference of the California Clinical Laboratory Association (CCLA), no single topic got more attention than that of reimbursement for clinical laboratory tests and anatomic pathology services. (more…)

Community Clinical Lab Companies Hard Hit by Medicare Lab Test Fee Cuts and Owners Fear Negative Financial Consequences of Coming Price Cuts

Smaller community laboratories serve many of the nation’s nursing homes and long-term care facilities, and ongoing medical lab fee cuts are having major negative consequences

DATELINE: LAS VEGAS, NEVADA—Last week, the National Independent Laboratory Association (NILA), in conjunction with the Association of American Bioanalysts (AAB), conducted its annual conference here. It was a useful snapshot on the state of health for independent community lab companies, particularly given the different reimbursement environment for clinical laboratory testing.

NILA’s members are primarily community clinical laboratories. They generate revenue anywhere from $1 million per year to around $100 million per year. It is believed that there are between 150 and 200 of these types of lab companies across the United States. Further, within the towns and cities they serve, these are often the only medical laboratory organizations that fill important testing niches that were abandoned years ago by the national public lab companies. (more…)

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