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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Tough Times Ahead for Anatomic Pathology as Group Revenue Declines and Pathologists’ Incomes Drop Due to Payer Price Cuts, Narrow Networks, and Claims Denials

Many pathology groups report shrinking revenue, yet some innovative pathology groups continue to grow through savvy pricing and by adding value to payers and physicians

Times are tough for anatomic pathologists in private practice. Medicare programs and private payers regularly slash prices for both technical component and professional component services. In addition, the growing number of narrow networks means that pathology groups find themselves excluded from access to an ever-larger proportion of patients.

This is not news for the typical anatomic pathologist working in a private practice setting, who today may be making substantially less personal income than just a few years ago. Over the past decade, pathologists have seen multiple assaults to their revenue by client physicians, health insurers, and consumers. (more…)

Payers Hit Medical Laboratories with More and Tougher Audits: Why Even Highly-Compliant Clinical Labs and Pathology Groups Are at Risk of Unexpected Recoupment Demands

A related issue is the growing use of contract sales representatives to sell clinical laboratory and pathology testing services and whether such arrangements violate federal compliance requirements

More and tougher payer audits are hitting an expanding number of clinical laboratories and anatomic pathology groups in recent months. Across the nation, experts in medical laboratory billing and collections are reporting that health insurers are auditing for a host of issues, several of them unexpected and without precedent.

Three types of clinical lab companies seem to be the highest-profile targets for these intense payer audits. Reports identify lab companies offering toxicology and pain management testing as undergoing rigorous audits. Medical lab companies with proprietary molecular diagnostic assays and genetic tests are known to have been audited in this manner. Some anatomic pathology groups are believed to have also experienced such audits. (more…)

FDA Pushes Forward with Plans to Regulate Laboratory-Developed Tests, in a Move that Will Impact Many Clinical Laboratory Companies and Pathology Groups

It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs

After sitting in a state of suspended animation for several years, the Food & Drug Administration’s (FDA) plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of LDTs.

If the federal agency wanted to get the full attention of the clinical laboratory industry, it certainly succeeded. In the four weeks since the FDA alerted Congress of its plans for LDT regulation, there has been a flood of national news stories about this development. (more…)

Pathology Groups and Clinical Laboratories Should Prepare for Medicare RAC Auditors

2011 is the year that Medicare expands its Recovery Audit Program to include providers such as medical laboratories and pathology groups

During the next 12 months, many pathology groups and clinical laboratories will undergo their first audit as part of Medicare’s recently-expanded RAC (Recovery Audit Contractor) program. This is a big-dollar audit program. When Congress passed the enabling legislation, it was estimated that RAC would generate $10 billion in recoveries from hospitals, physicians, medical laboratories and other providers.
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CLIA Inspections of Clinical Pathology Laboratories Appear to Be Tougher on Loosely-Managed Labs

Pathologists and medical laboratory managers should be alert to compliance changes


CLIA inspections of medical laboratories may be getting more rigorous in certain areas of laboratory operations, according to anecdotal information emerging from the field. Clinical laboratory management consulting firms report that they are experiencing an increased number requests for help from hospitals following a recent CLIA inspection of their laboratories.

Laboratory management consultants tell Dark Daily that, for the most part, well-run medical laboratories are having few problems when CLIA inspectors show up on site. Because these laboratories are diligent about compliance with legal requirements, the CLIA inspection seldom turns up a serious deficiency nor identifies a major compliance failure within the laboratory.

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