what is compliance - apollomdx labs › training › compliance_training.pdf · what is compliance...
TRANSCRIPT
What is COMPLIANCE
Conducting business and oneself in an ethical, moral, and legal manner
3
BY FEDERAL AND STATE AGENCIES
AGGRESSIVE STEPS
Enforcement budgets – increasing each year by millions of dollars
The HEAT is on! (Health Care Fraud Prevention and Enforcement Action Team)
• Strike force teams = OIG, DOJ, FBI, state law agencies• Use complex data analytics to uncover fraud• Relators = big source for non-compliance
WHAT THEY’RE LOOKING FOR
Billing for services not rendered
Medically unnecessary services
Solicitation and receipt of kickbacks
Includes illegal payments to physicians and patients
Medically Necessary - Definition
Health-care services or supplies needed to
prevent, diagnose, or treat an illness, injury,
condition, disease, or its symptoms and that
meet accepted standards of medicine.
FALSE CLAIMS ACT
ANTI-KICKBACK STATUTE
STARK LAW INDIVIDUAL STATE LAWS
KEY
LAWS
The False Claim Act is a federal law that makes
it a crime for any person or organization to
make a false record or file a false claim
regarding any federal health care program.
FAL
SE C
LA
IMS
AC
T DEFINITION
FAL
SE C
LA
IMS
AC
TBilling for services not rendered
Altering provider claims to obtain a higher reimbursement
Submitting false information
Sales rep persuades provider to change test ordering pattern – perform unnecessary tests
Lab routinely waives co-payment, deductible or balance obligation
EXAMPLES
FAL
SE C
LA
IMS
AC
T
Forged doctor’s signatures
Coded “medical review” as “pathology services”
Calloway’s president sentenced to 18 months in jail
CASES
CALLOWAY
FAL
SE C
LA
IMS
AC
T
Unnecessary testing: $183 appropriate testing out of a bill for $3,118
CASES
HEALTH DIAGNOSTICS LAB
MILLENNIUM HEALTHSettled $260 million for allegations of unnecessary urine drug testing through use of custom profiles/standing orders and for allegations relating to genetic testing being routinely performed without regard to individualized need assessment
The biggest FCA recovery in 2016 for all of healthcare
FAL
SE C
LA
IMS
AC
T
$4.7 billion – total FCA recoveries in FY 2016 – 3rd highest since the gov’t started tracking these numbers
2016 FCA RECOVERIES
Takeaway: lab testing is a fruitful target for enforcement agencies
Illegal to solicit or receive (directly or indirectly)
any reimbursement or inducement for referral
of services reimbursed by Medicare or
Medicaid
AN
TI-
KIC
KB
AC
K DEFINITION
AN
TI-
KIC
KB
AC
K EXAMPLESCash or rebates of any kind
Fax machines
Altering provider claims to obtain a higher reimbursement
Bio hazard pick-up
Personal computers (unless restricted to lab use)
Gloves and other supplies that are not exclusive to the performance of the laboratory’s work
Over-supply of specimen transport supplies
Paying someone else to recommend LabSolutions
AN
TI-
KIC
KB
AC
K EXAMPLESTrips
Tickets and other types of entertainment
Lavish meals
Gifts
i.e.,……anything of value
Anti-kickback penalties for individuals and
entities on both sides of the prohibited
transaction
AN
TI-
KIC
KB
AC
K IMPORTANT NOTE
AN
TI-
KIC
KB
AC
K CASES
Biodiagnostic Lab Services in Parsippany, NJ
Record number of prosecutions against medical professionals in a bribery case
42 guilty pleas, 28 = physicians
Most have been sentenced to jail and significantly fined (e.g., $250,000) including physicians and sales reps
AN
TI-
KIC
KB
AC
K CASESHEALTH DIAGNOSTICS LAB
MILLENNIUM HEALTH
Free POCT cups provided in exchange for urine testing referrals
Under investigation by Federal Gov’t and Cigna
Paying specimen processing fees
Inducements to order unnecessary tests
STA
RK
LAW
Stark Law = “strict liability” law – can be violated without intention to do so
AKS hinges on intent, Stark does not
DEFINITION
Prohibits physicians from referring Medicare
or Medicaid testing to a designated health
service (e.g. a lab) in which he/she has a
financial interest (ownership, investment, etc.)
STA
RK
LAW
DESIGNATED HEALTH SERVICES
Labs
Physical/Occupational Therapy
Home health Services
Radiology Services
Durable Medical Equipment
Prosthetic Devices and Supplies
STARK II
STA
RK
LAW
DESIGNATED HEALTH SERVICES
Cannot exceed aggregate of $398 per year per provider in 2017 (mugs, pens, scratch pads, meals, professional courtesy)
Cannot give a “group gift”
Cannot take into account test volume
Cannot be conditioned on referral of business
Rep cannot circumvent limit by paying out-of-pocket
Not solicited by the physician or any employee (but rep may offer)
NON-MONETARY COMPENSATION
Individual physician dollar amount should be tracked on a yearly basis
PEN
ALT
IES
ANTI-KICKBACK STATUTE
Fines up to $25k per violation
Up to 5 years in prison
Civil monetary penalties: potential $73.5k per violation and Federal program exclusion
Treble damages (up to 3 x amount of kickback)
CRIMINAL FINES
CIVIL FINES
PEN
ALT
IES
STARK LAW
CIVIL FINES
Overpayment/refund obligation
Civil monetary penalties ($24k)
Program exclusion
Treble damages (up to 3 x the amount claimed)
Up to $100,00 for attempting to circumvent the law
PEN
ALT
IES
FALSE CLAIMS ACT
CIVIL PENALTY
Between $11k - $22k for each violation
Treble damages (3x amount of damages which Gov’t sustains)
All FCA whistleblower cases will get criminal reviews
PEN
ALT
IES
NOTE
The government/state can compound laws in one investigation (e.g., combine Stark and AKS penalties)
Lab cannot provide testing for an “excluded” individual ($15k civil monetary penalty)
Sales and MARKETING
Offer bribes
Rep, senior lab management and client are at risk
Promote testing that is unreasonable and/or unnecessary
A substantial number of Federal enforcement activities have stemmed from sales and marketing activities
State LAWS
Private insurance companies can prosecute violating labs and doctors under state law
State laws may also contain their own unique provisions – even tighter than Federal laws
Many states have their own kick-back laws which may be identical to Federal statutes
Paying Clients to DRAW/PROCESS
State law dependent: lab provides someone to process specimens
Gives rise to challenges under both Anti-Kickback Statute and Stark Law
Providing EQUIPMENT
Computers, printers, label-makers must be related to lab services only
Lab should have a written loan agreement signed by client
Lab should maintain inventory
Should be tagged as property of the lab
Equipment retrieved whenever client terminates testing service
Custom PROFILEIf doctor wants custom panel, lab must provide annual written notice that:
Explains Medicare reimbursement for each component of each profile
Informs physicians using a custom profile may result in the ordering of tests which are not covered, reasonable or medically necessary
Obtain physician signature – keep on file
Just So You Know…
Doctors must document they reviewed the results, even if all results are normal
Clinics should review orders and protocols to ensure there is an individual assessment for each patient and test order
Gov’t and private commercial insurance focus on test medical necessity
Test DOCUMENTATION
If “yes”, be careful to document why all tests in the panel are needed
Suggest to providers to ask themselves, “Do I need the entire panel or not?”
Remind and encourage physicians to be cognizant of test documentation …. especially with panels
General Rules of the Road
Be cognizant of medical necessity when discussing test panels
Don’t directly or indirectly pay the provider for referrals
Don’t pay others to recommend or arrange for referrals
SUMMARY
Contact between sales reps and clients = risk for tripping
into laws regulating conduct between those who refer and
those who receive referrals
CMS aggressively on lookout for fraud