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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Decisions in Prometheus, Myriad, and Classen Cases Help Clarify Patent Eligibility Requirements for Genetic Lab Tests and Molecular Diagnostics

Court rulings in several controversial patenting cases are largely consistent

Recent decisions from the U.S. Court of Appeals for the Federal Circuit (CAFC) offer some much-needed clarity in the controversial issues surrounding the legality of life sciences patents.

This will be of interest to pathologists and medical laboratory managers, because many clinical laboratories and pathology groups must pay royalties to patent-holders for rights to use the technologies. There are multiple legal cases winding their way through the federal court system, so legal decisions in these cases have the potential to change in status quo in patent law.

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AMA Survey Reveals That Physician Interest Lags In ACO Participation

Many physicians say they lack specific details about the care model and how it will reimburse providers

In its own news service, the American Medical Association (AMA) reports lagging interest by physicians when they are asked about their participation in accountable care organizations (ACO). This survey of AMA members was conducted last fall.

According to an article at amednews.com (AMN), this survey found that—although many physicians are familiar with the concept—a significant number of them indicate they will either opt out of an ACO or unsure whether they will participate in an ACO.

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Many Clinical Laboratories, Other Providers Struggle to Transition to 5010; Likely To See Payment Shortfall

Payors also are straining to handle new payment requirements under Form 5010, say intermediaries

Across the nation, providers, including clinical laboratories and pathology groups, are holding their collective breath as they wait to see whether implementation of the electronic claim Form 5010 goes smoothly, becomes a disaster, or ends up somewhere between.

Just two weeks into this national transition, experts are predicting that most providers—including medical labs and pathology groups—are likely to see a drop in revenue collections. Worse yet, it is not until the first claim denial forms are received from payors that clinical labs and pathology groups can learn the reasons why different payors rejected these claims.

UNEXPECTED PROBLEMS

“We expected, with a transition of this magnitude, that the industry would encounter challenges,” said Jackie Griffin, Director, Client Services, Gateway EDI, a bill-paying clearinghouse in St. Louis, Missouri. “But in addition to the problems we expected, we’ve seen a lot of unexpected problems too.”

Gateway EDI serves both small and large practices, but has seen that its clients that are small labs and physician practices of 1 to 5 doctors are experiencing more problems than larger provider organizations because the smaller entities lacked the resources to prepare for 5010, Griffin explained. Providers are likely to see less reimbursement in the coming weeks because many claims are being rejected and going unpaid, she said. (more…)

Australia’s ‘Hospital in the Home’ Care Model Demonstrates Major Cost Savings and Comparable Patient Outcomes

New report determines in-home patient care can save an average of 22% over inpatient care for six different health conditions

Momentum continues to build in favor of the “Hospital in the Home”, known by the acronym HITH. For certain health conditions, this care model allows the patient to remain in his or her home, instead of staying in a hospital. Caregivers, including specialist physicians, come to the residence with almost the same frequency as occurs for hospital inpatients.

Wider adoption of this model of patient care would directly affect pathologists and clinical laboratory managers who work in hospital laboratories. Over time, it could mean fewer inpatient admissions and thus, less medical laboratory test volumes for inpatient services. On the other hand, more HITH patients would increase the need to collect specimens in patient’s homes and get them to a local clinical laboratory for testing. Hospital-based medical laboratories—because they are central to the communities they serve—would be well-positioned to provide this diagnostic testing.

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Palmetto GBA Execs Explain MolDx, Its New “Molecular Diagnostic Services” Program for Clinical Pathology Laboratories

Registry for genetic tests and molecular diagnostic assays is one step in process to assess the science and clinical utility

Clinical laboratory and pathologists have dozens of questions about the proposed draft local coverage determinations (LCDs) that Medicare carrier Palmetto GBA issued on September 28. The draft LCDs represent Palmetto GBA’s efforts to identify the growing number of laboratory-developed molecular diagnostic assays and genetic tests.

In an exclusive interview with Dark Daily, Palmetto Medical Director Elaine Jeter, M.D., and Palmetto Vice President Mike Barlow explained the need for the new LCDs and offered insight into the process Palmetto GBA is developing to create a molecular test registry and a coverage determination and reimbursement process. This is an important development for the clinical laboratory industry. (more…)

Medicare Officials Announce Bundled Reimbursement Initiative and Clinical Pathology Laboratory Tests Are to Be Included

“Bundled Payments for Care Improvement Initiative” will be voluntary for hospitals, physicians, and other providers, including medical laboratories

Yesterday, Medicare officials took the first steps to implement a program for bundled Medicare payments by issuing documents which describe how this program would work. At least two of the four models for bundled reimbursement will include clinical pathology laboratory tests as part of the bundled care arrangement.

Clinical laboratory managers and pathologists will want to pay close attention to this development. The Centers for Medicare and Medicaid Services (CMS) titled this new effort the “Bundled Payments for Care Improvement Initiative.” It is a voluntary program. Only those providers who submit proposals and bids which are accepted will be paid through this program. The goal is to encourage different providers to collaborate on the care of a patient. Each of the four models for bundled healthcare has a slightly different payment arrangement.

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