Health care in the 21st century is moving toward consumerization of medicine, patient empowerment and increased price awareness resulting from higher out-of-pocket medical expenditures. The growth of … [Read more...]
FALSE CLAIMS
Case of the Month: Foundation Medicine Faces Lawsuits from Shareholders & a Business Rival
August 17, 2017
Astart-up diagnostics firm on the precipice of a lab product breakthrough becomes a Wall Street darling. But, alas, the product fails to meet its lofty expectations. The firm's stock tanks and the … [Read more...]
NEWS
Compliance Planning: OIG Switches from Semi-Annual to Monthly Work Plan Updates
August 17, 2017
When it comes to running a laboratory compliance plan, the semi-annual OIG Work Plan can be a big help to because it enables you to keep track of new enforcement initiatives and respond to emerging … [Read more...]
HEALTH CARE REFORM
Labs to CMS: Push Back PAMA & Add Hospital Labs to CLFS Mix
August 17, 2017
The lab industry continues to wait nervously for word from CMS regarding PAMA. Demand 1: Fix the Fee Schedule Methodology The industry's paramount concern remains the formula CMS proposes to use to … [Read more...]
DEAL TRENDS
Global Markets: Local Joint Ventures Represent New Path into China Market
August 7, 2017
While the strategy of targeting the China market is nothing new, the tactics have evolved. Recognizing the need for a strong local presence, western firms are increasingly teaming with operators on … [Read more...]
ENFORCEMENT TRENDS
New Fraud Takedown Shows that Coordinated Enforcement Remains Alive & Well under Trump
July 31, 2017
Last year at this time, the Justice Department announced the results of a nationwide takedown involving "the most defendants charged and largest alleged loss amount in Medicare Strike Force … [Read more...]
NEWS
FDA Approves First NGS Oncology Companion Dx for Multiple Therapies
July 26, 2017
In May, the U.S. Food and Drug Agency (FDA), the agency known for its stinginess in approving new products, broke new ground by approving Merck's Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor, a … [Read more...]
ENFORCEMENT
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
July 26, 2017
Lab Tech and Account Rep Face Jail for Test Fee and Commissions Scheme. Case: A pair of Texans face criminal charges for allegedly conspiring to cheat Medicare of nearly $837,000 over a 6-month … [Read more...]
MEDICARE REIMBURSEMENT
Proposed HOPPS Changes Would Allow Direct Billing of Molecular Pathology Tests & ADLTs
July 26, 2017
On July 13, the CMS proposed changes to Hospital Outpatient Prospective Payment System (HOPPS) rules for 2018. Here's a look at the three items that would affect laboratories that provide tests to … [Read more...]
NEWS
Case of the Month: Theranos Settles with Walgreens
July 26, 2017
On June 21, less than a week before the eye-popping announcement about Walmart and Quest teaming up on a new retail venture, a case exemplifying just how badly arrangements between big labs and retail … [Read more...]
