Fraud and Abuse Law Flashcards
False Claims Act
Prohibits Fraud against the Government
Known or Should have Known Standard
Actions May Be Brought by the Government or by Private Citizens (Whistleblowers/Qui Tam Realtors) on Behalf of the Government
Potential for Stiff Statutory Penalties
Civil Penalties of up to $11,000 per False Claim
3 Times Actual Damages Sustained by the Government as a Result of the False Claim
Anti-Kickback Statute
Prohibits Knowingly and Willfully Soliciting or Receiving/Offering or Paying
Any Remuneration (Directly or Indirectly, Overtly or Covertly, in Cash or In Kind)
To Induce Someone to Refer Patients, Purchase, Order or Recommend
Any Item of Service that May Be Paid for under a Federal Health Care Program
Anti-Kickback Penalties
Criminal and Civil Penalties
Each Offense Is Punishable by Fine of up to $25,000 and Imprisonment up to 5 Years
Violators Are Subject to Exclusion from Federal Healthcare Programs
Imposition of Civil Monetary Penalties for Each Violation of up to $50,000 and 3 Times the Amount in Remuneration
In Addition, Could Be the Predicate for a False Claims Action
Stark Law
Purpose: Prohibit improper referral relationships that can harm federal healthcare programs and beneficiaries.
If Physician (or an Immediate Family Member of Such Physician)
Has a “Financial Relationship” with an “Entity”
The Physician May Not Make a “Referral” to that Entity for the Furnishing of “Designated Health Services” (DHS)
For which Payment May Be Made under Medicare and Medicaid and
The Entity May Not Present a Claim for Such Services Furnished to a Prohibited Referral
Financial Relationship
Ownership or investment interest in, or
Compensation arrangement between
Referring physician and DHS entity
Stark Law Exceptions
Exceptions available for many common hospital-physician arrangements employment medical director service agreements leases electronic health records
Determining FMV Compensation
Objective, credible documentation
Reasonable compensation for services provided
Set in advance
Does not vary based on volume or value of referrals
Commercially reasonable even if no referrals
Arms-length negotiations
Stark Law Penalties
No Criminal Penalties
Substantial Financial Penalties
Must Refund Any Amounts Collected for Prohibited Services
Exclusion from Medicare/Medicaid for Violation of Billing and Referral Prohibitions
Key Stark Concepts
Physician referral Designated health services (DHS) Entity Financial relationship Exceptions
Referral
Request for DHS by a physician.
Request by physician for consultation with another physician, and any tests or procedures the other physician orders, performs or supervises.
Request for or establishmentof plan of care that includesprovision of designated healthservices.
Financial Relationship
Ownership and investment interests
Through equity, debt, or other means; and
Compensation arrangements
Includes virtually any form of remuneration
Direct and indirect relationships
Remuneration
defined (42 CFR§ 411.351) as “any payment or other benefit made directly or indirectly, overtly or covertly, in cash or in kind …”
Stark, Service Based Exceptions
Physician Services
In-office Ancillary Services
Services to Members of Prepaid Health Plans
Academic Medical Centers
Implants Furnished by ASC
Dialysis-related Drugs Furnished by End Stage Renal Disease Facility
Preventative Screening Tests, Immunizations and Vaccines
Eyeglasses and Contact Lenses Following Cataract Surgery
Intra-family Rural Referrals
Stark, Compensation Exceptions
Rental of Office Space Rental of Equipment Employment Relationships Personal Service Arrangement Physician Recruitment Isolated Transactions Services Unrelated to DHS Hospital-affiliated Group Practice Arrangements Fair Market Value Payments Made by Physicians for Items and Services (i.e., clinical laboratory services)
DHS
Clinical laboratory services;*
PT, OT, speech language pathology services;*
Radiology and other imaging services (including MRI, CAT scans);*
Radiation therapy services and supplies;*
Durable medical equipment;
Parental and enteral nutrients, equipment and supplies;
Prosthetics, orthotics and prosthetic devices;
Home health services;
Outpatient prescription drugs; and
Inpatient and outpatient hospital services (encompassing almost every type of medical procedure).
