FDA Authorizes 23andMe to Report Results of Direct-to-Consumer Pharmacogenetics Test to Customers without a Prescription, Bypassing Doctors and Clinical Laboratories

FDA cautions patients to not use data gained from the DTC test to make healthcare decisions on their own Clinical laboratories continue to be impacted by the growing direct-to-consumer (DTC) testing market, as more walk-in lab customers order at-home tests. Now, the US Food and Drug Administration (FDA) has authorized a DTC test company to provide results of a pharmacogenetic (PGx) test to customers without needing a doctor’s order. This is the first genetic test of its kind to receive such...

Balance Billing Under Increased Scrutiny at Both State and Federal Levels; Clinical Laboratory Tests Top List of Surprise Bills Received by Patients

Experts blame insurance regulators for not ensuring the adequacy of healthcare networks that include hospital-based physicians, such as pathologists and radiologists According to a recent study, clinical laboratories, anatomic pathologists, radiologists, and anesthesiologists top the list of providers who bill patients for the difference between what they charge for their services and a hospital’s contracted reimbursement rates. This so-called “balance-billing” not only causes hardship for...

Double-Digit Increase in Medicare Advantage Plan Growth May Be Good News for Seniors but Bad News for Local Clinical Laboratories and Pathology Groups in 2019

Popularity of Medicare Advantage Plans fuels influx of new companies into the marketplace with anticipated enrollment of more than 22.6 million beneficiaries, or more than one-third of Medicare-eligible consumers Continuing enrollment growth in Medicare Advantage plans is expected in 2019 and beyond. The projections are for double-digit percentage increases in Medicare Advantage enrollees. This is not auspicious for clinical laboratories and anatomic pathology groups because it means a...

Excessive $48,329 Charge for California Patient’s Outpatient Clinical Laboratory Testing Calls Attention to Chargemaster Rates and New CMS Price Transparency Rule

Studies show medical laboratories may be particularly hit by adjustments to hospital chargemasters as hospitals prepare to comply with Medicare’s New Transparency Rule Recently, Kaiser Health News (KHN) published a story about a $48,329 bill for allergy testing that cast a spotlight on hospital chargemaster rates just as healthcare providers are preparing to publish their prices online to comply with a new Centers for Medicare and Medicaid Services (CMS) rule aimed at increasing pricing...

Milliman Medical Index Predicts Families Will Spend More for Healthcare in 2018 Than Previous Years; Growth Trend Could Impact Clinical Laboratories Unprepared to Collect Fees at Time of Service

Employers and consumers continue to pay more for health benefits from one year to the next, continuing a trend that is not auspicious for clinical laboratories and anatomic pathology groups Most clinical laboratories don’t have the capability to collect payments from patients at time of service the same way patients pay doctors during office visits. Thus, Milliman’s annual report which details the increasing amounts patients are expected to pay out of their own pockets should be of interest to...

CMS Finalizes Rule Rebranding ‘Meaningful Use’ Program to ‘Promoting Interoperability’

Ongoing federal regulatory push for EHR interoperability requires medical laboratories and anatomic pathology groups to have strategies for ensuring seamless interfaces with providers and hospitals What difference does a name make? Clinical laboratories and anatomic pathology groups soon may know the answer to that question following the renaming of the Centers for Medicare and Medicaid Services (CMS) “Meaningful Use” program to “Promoting Interoperability” (PI). CMS first announced the...