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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Nearly One-Third of Traditional Medicare Payments Now Based on Value-Based Reimbursement and Alternative Payment Models

Faster than expected transition from fee-for-service healthcare should grab attention of clinical laboratories and anatomic pathology groups who face financial unknowns under new payment systems

Clinical laboratory executives should take note of a key financial fact. The transition from fee-for-service healthcare to value-based reimbursement is occurring at a faster clip than the Department of Health and Human Services (HHS) anticipated last year when federal officials announced a plan to tie 30% of traditional Medicare spending to alternative payments models by the end of 2016.

That means the transition away from fee-for-service payment for medical laboratory tests and other healthcare services is moving ahead of schedule. As evidence, HHS recently announced it reached the 30% target at the start of 2016, nearly a year ahead of the schedule laid out when the Obama Administration outlined a plan to reward healthcare providers based on quality of care rather than the volume of services they provide.

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Concierge Medicine Increases in Popularity as More Consumers Opt for This Care Model; Will Clinical Laboratories Exploit This Business Opportunity?

Patients using a concierge medicine practice expect to pay cash at the time of service, but few medical laboratories are equipped to collect from patients at time of service

One big challenge for clinical laboratories and anatomic pathology groups is how to adapt to the changing role of the consumer in healthcare. It a major goal of healthcare policymakers to have patients pay more out of pocket for clinical care so as to motivate them to select hospitals, physicians, and clinical labs based on a combination of cost and quality.

One sector of healthcare that is benefiting from this consumer-first dynamic is concierge medicine. Statistics show that recent increases in the number of people seeking concierge medicine is changing the way many individuals utilize the healthcare system in the United States. (more…)

Exact Sciences Sues Humana Over Cologuard Coverage in Spat over How Insurer Reimburses for This Clinical Laboratory Test

Filing a complaint with the Louisville division of the District Court for the Western District of Kentucky, Exact Sciences seeks payment from Humana for at least 4,664 Cologuard tests as well as coverage for the procedure in the commercial plans offered in mandate states

Citing more than $800,000 in unpaid service fees and damages, the Exact v Humana lawsuit is the latest example of the on-going struggle between health insurers and clinical laboratories offering proprietary and patent-protected lab procedures.

Exact Sciences Corp. (NASDAQ: EXAS), and Exact Sciences Laboratories, LLC (Exact) allege that Humana (NYSE: HUM) has denied 120 claims in Kentucky worth approximately $70,000 as well as 293 additional claims in other states with coverage mandates worth approximately $169,000.

Exact claims that attempts to appeal denied claims resulted in payment for some services but that more than half remain rejected. They also report roughly 350 claims in which Humana underpaid.

They are seeking full payment for all claims made since the start of 2014 in Kentucky, Georgia, Missouri, North Carolina, Texas, Illinois, Nevada, and Oklahoma. (more…)

CMS Notifies Theranos of CLIA Sanctions That Include Revoking Clinical Laboratory’s CLIA License and a Two-Year Ban on Holmes, Balwani, and Dhawan

Wall Street Journal obtained copy of letter sent by CMS to Theranos, dated March 18, 2016, that notified its executives of sanctions that include revocation of Theranos’ CLIA license and a process by which the medical lab company can appeal

Theranos, the high-profile clinical laboratory company, had a day of reckoning yesterday. That’s when The Wall Street Journal (WSJ) published a story revealing that Theranos was sent a letter by the federal Centers for Medicare & Medicaid Services (CMS) providing notice of sanctions.

In a letter to Theranos executives, CMS said it is prepared to:

• revoke the company’s CLIA certificate;

• impose a fine of $10,000 per day;

• suspend and cancel the lab’s approval to receive Medicare payments; and

• impose a two-year ban on the owner, operator, and laboratory director for owning or operating a clinical laboratory.

Dated March 18, the letter is addressed to Sunil Dhawan, MD, Director; Elizabeth Holmes, Owner; and Ramesh Balwani, Owner. (more…)

Steady Increase in the Number of Workers with ‘Critical Illness’ Coverage Presents Clinical Laboratories and Pathology Groups with a New Challenge

Medical laboratories will have to rethink billing practices when providing services to consumers receiving lump-sum payouts from their critical illness policy

Employers continue to look for ways to control the cost of health benefits for their employees. One emerging approach that will have financial consequences for clinical laboratories and anatomic pathology groups is a newer type of insurance that provides a lump-sum payout for some critical illnesses.

Policies with this lump-sum payment feature are sometimes referred to as critical illness coverage. Such policies typically pay a lump sum if someone is diagnosed with cancer, suffers a heart attack, stroke, kidney failure, or needs an organ transplant. Some plans also provide benefits for other major medical problems, such as loss of vision, paralysis, and Alzheimer’s disease. (more…)

Attention Pathologists! New Prostate Cancer Test Has CPT Code, NCCN Guideline Recommendation, and Potential Market of One Million Prostate Biopsies Annually

OPKO Health’s 4Kscore test predicts the rate of high-risk prostate cancer and may become a useful business case study for other labs developing proprietary diagnostic tests

Clinical laboratories and biotech companies with new medical laboratory tests are struggling to win coverage by Medicare and private payers. How big is this problem? There are currently tens of thousands of molecular diagnostic assays and genetic tests offered for clinical use.

Any lab company seeking to obtain an appropriate Current Procedural Terminology (CPT) code, favorable coverage guidelines, and adequate reimbursement from health insurers for its new lab test faces three big challenges, and they are related. First, payers are simply overwhelmed with requests to review new genetic tests. The flood of new test submissions exceeds the capability of payers to respond.

Most Payers May Not Have Right Scientific Expertise to Evaluate Genetic Tests

Second, most health insurance plans lack physicians and medical professionals who have the necessary experience in laboratory medicine, molecular diagnostics, and genetic medicine to evaluate these lab test submissions in a knowledgeable way. (more…)

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