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Medicare Part B
Medicare Part B medical insurance helps pay for some services and products not covered by Part A (hospital insurance) for Americans aged 65 and older who have worked and paid into the system. It also provides health insurance to younger people with disabilities.
Part B coverage begins once a patient meets his or her deductible ($147 in 2013), then typically Medicare covers 80% of approved services, while the remaining 20% is paid by the patient, either directly or indirectly by private Medigap insurance.
For clinical labs and pathology groups, Part B covers laboratory and diagnostic tests. Laboratory tests include certain blood tests, urinalysis, tests on tissue specimens, and some screening tests. They must be provided by a laboratory that meets Medicare requirements.
Complex rules are used to manage the benefit, and advisories are periodically issued which describe coverage criteria. On the national level these advisories are issued by CMS, and are known as National Coverage Determinations (NCD). Local Coverage Determinations (LCD) apply within the multi-state area managed by a specific regional Medicare Part B contractor, and Local Medical Review Policies (LMRP) were superseded by LCDs in 2003.
Medicare Part B payments make up about 15% of the revenue of the two biggest national lab companies. By contrast, it is common for community labs to have between 30% and 65% of their revenue come from Medicare Part B payments.
Part B coverage can also be provided by private insurers through Medicare Advantage Plans. Enrollment in private Medicare Advantage plans has more than doubled since 2006, according to the New York Times. As these plans gain popularity, clinical labs and pathology groups continue to find themselves without access to patients they once served. Medicare beneficiaries now enrolled in Advantage plans comprise nearly one-third of all Medicare beneficiaries.
Generally speaking, growth in Medicare Advantage enrollment favors the national labs, with private insurers providing them exclusive network contracts. This means less market access to these patients by community labs.
Reference Pricing’s New Lab Winners and Losers
By Robert Michel | From the Volume XXIII No. 12 – September 6, 2016 Issue
CEO SUMMARY: Expanded use of reference pricing by employers in coming years could trigger a cycle of cuts to lab test prices that would put the most pressure on the lab companies with the highest prices. Many hospital labs are viewed as having high prices. But because they run outreach sp…
Theranos Now Scrambling To Save What It Can
By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue
CEO SUMMARY: On July 7, CMS imposed severe sanctions on Theranos for CLIA violations. Included is a two-year ban on owning and operating a clinical laboratory for Theranos, CEO Elizabeth Holmes, the former COO, and the former medical director. Theranos appears to be pivoting away from a c…
ADLT Final Rule Creates Tough Questions for Labs
By Joseph Burns | From the Volume XXIII No. 10 – July 25, 2016 Issue
IT’S GOING TO BE A DIFFERENT AND TOUGHER WORLD for laboratory companies that market proprietary molecular and genetic tests. That’s the opinion of experts who have studied the final rule governing Advanced Diagnostic Laboratory Tests (ADLTs) that the federal Centers for Medicare & Med…
What will the future hold for Theranos?
By R. Lewis Dark | From the Volume XXIII No. 10 – July 25, 2016 Issue
This is an excerpt from a 1,900-word article in the July 25 issue of THE DARK REPORT. The complete article is available to paid members of the Dark Intelligence Group. …
PAMA Final Rule Issued, CMS Plans to Cut Rates by 5.6%
By Joseph Burns | From the Volume XXIII No. 9 – July 5, 2016 Issue
CEO SUMMARY: CMS issued its final rule for implementing the laboratory payment reform included in the Protecting Access to Medicare Act of 2014 (PAMA) on June 17. All labs will see significant reductions to the Medicare Part B Clinical Laboratory Fee Schedule that becomes effective on Jan…
PAMA Final Rule a Threat To Community Lab Survival
By Joseph Burns | From the Volume XXIII No. 9 – July 5, 2016 Issue
CEO SUMMARY: Will implementation of the final PAMA private payment rate reporting rule for labs put smaller, community labs at financial risk? Yes, says the National Independent Laboratory Association (NILA). By deliberately setting a standard to exclude private payer payment data from ho…
New Threat To Community Lab Survival: CMS Clinical Lab Fee Schedule Cuts
By Mary Van Doren | From the Volume XXIII No. 9 – July 5, 2016 Issue
This is an excerpt from a 2,000-word article in the July 5 issue of THE DARK REPORT. The original article is available to paid members of the Dark Intelligence Group. CEO SUMMARY: Everyone has read the basic facts, but THE DARK REPORT has gone further …
Attorney Cautions Laboratories Against Waiving Patient Fees
By Joseph Burns | From the Volume XXIII No. 6 – May 2, 2016 Issue
WHEN A CLINICAL LAB WAIVES patients’ fees in exchange for lab test referrals, competing labs face a legal dilemma. If the competing lab does not match the offer, it could lose volume to this aggressive sales technique. But if the lab does match the offer, it could run afoul of health plan requirem…
Just 66 of 742 Labs Submit Rate Data to California Department of Health Care Services
By Joseph Burns | From the Volume XXIII No. 5 – April 11, 2016 Issue
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State of Clinical Lab Industry Likely to Be Mixed in 2016
By Robert Michel | From the Volume XXII, Number 17 – December 7, 2015 Issue
CEO SUMMARY: Over the next 24 months, it will be essential for every clinical laboratory and anatomic pathology group to develop clinical and financial strategies that meet the changing needs of health insurers, hospitals and health systems, physicians, and patients. THE DARK REPORT provi…
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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