All labs must have this credential -- certification comes in low, moderate and high.
What is CLIA?
100
This determination would limit Medicare coverage for routine non-specific or comprehensive orders for drug qualitative screening, and/or confirmatory/ quantitation testing.
What is the Noridian [DRAFT] Local Coverage Determination (LCD)?
100
In 2011 the State of California settled claims with Quest for $241 million and claims with LabCorp for $49.5 million for this pricing practice.
What is discounting below Medi-Cal pricing?
100
In this publication, OIG gave guidance to labs about: (i) in-office phlebotomists, (ii) write-offs of managed care billing, and (iii) free items, supplies, services, waste pick up, computers/fax machines.
What is the 1994 Special Fraud Alert?
100
According to OIG, a lab may loan this to a physician/client as long as it is “integral to, and exclusively used for, performance of the outside laboratory’s work.”
What is lab-related equipment?
200
This law imposes security and privacy obligations on Business Associates and Covered Entities.
What is HIPAA?
200
According to OIG guidelines, if a client wants to order any of these, the lab should have the client sign a written acknowledgement.
What are custom panels?
200
Ameritox paid $16.3 million to settle government allegations it violated the Anti-Kickback Statute and Stark Law by engaging in this practice.
What is placement of processors? (and payments to physicians for collecting patient urine specimens)
200
In a 1999 Advisory Opinion, OIG warned labs against "swapping" these on account billing business for profitable full-price Federal health care program business.
What are discounts?
200
OIG says there is “no statutory exception or ‘safe harbor’ to [this] practice because the Federal programs do not realize the [same] benefit.”
What is Professional Courtesy? (or Free Testing to Doctors)
300
This law can be violated if even "one purpose" of the arrangement is to give the doctor something of value in exchange for referring lab testing.
What is the Anti-Kickback Statute?
300
Both federal and California laws recognize that when a lab (or other provider) has reasonable cause to believe a patient is unable to obtain insurance coverage for services provided, the lab may offer these.
What are patient discounts?
300
Bundling and unbundling these was the basis for the government’s “Operation LabScam” during the 1990’s against the nation’s largest labs -- National Health Laboratories, SmithKline Beecham Clinical Laboratories, LabCorp, Damon Clinical Laboratories, MetPath -- and others, resulting in $823 million in settlements, and prison terms for at least 3 individuals.
What are clinical laboratory test panels?
300
In this recent publication, OIG reported that over 20% of all claims for clinical laboratory services submitted to Medicare Part B in 2010 were tied to "questionable billing patterns."
What is the OIG July 2014 Report on Questionable Billing for Medicare Part B Clinical Laboratory Services?
300
The Stark Law permits these to be provided to physicians in appropriate quantities as long as they “are used solely to (I) collect, transport, process, or store specimens for the [Lab] providing the item, device or supply, or (II) order or communicate the results of tests or procedures for [the Lab].”
What are lab-related supplies?
400
This law is a strict liability statute -- labs and physicians can be held responsible even for unintentional and/or technical violations.
What is the Stark Law?
400
Under Federal law a clinical lab may not perform testing on a patient sample without first receiving this authorization.
What is an order from an “authorized person”?
400
In 2012 Calloway Labs agreed to pay a $20 million penalty and 2 of its top executives pled guilty to charges involving these practices with addiction rehab group homes.
What are kickbacks and bribes?
400
In this recent (6/25/14) Special Fraud Alert, OIG warned of these two “suspect” arrangements between labs and doctors.
What are Specimen Processing Arrangements and Patient Registry Arrangements?
400
This is the amount set by the government in 2014 as the per-year cap on nonmonetary compensation that may be given by a lab to any physician referral source.
What is $385?
500
This law, which has been the basis for nearly all of the big dollar settlements in healthcare (totaling approximately $30 billion since mid- 1980's), has been around since Abe Lincoln's time.
What is the False Claims Act?
500
Medicare requires labs to get this information from the ordering practitioner before billing Medicare for lab testing.
What are diagnosis codes? (or ICD-9/ICD-10 codes)?
500
A federal jury in Florida found that Millennium Laboratories' provision of these items to physicians at no charge violates federal Stark and Anti-Kickback laws, and awarded $14.775 million damages to Ameritox.
What are point-of-care testing cups?
500
According to the 1998 OIG Program Guidance for Clinical Laboratories, clinical laboratories should not contract with physicians (or other ordering providers) on this list.
What is the OIG Exclusions Database?
500
Although CMS, at the end of last year, discontinued the Stark and Anti-Kickback exception permitting labs to donate to doctors 85% of the cost of EHR software, CMS made clear that it is still OK for labs to donate the following item to physician customers.