Anti-Kickback Statute Jess Smith

Transcription

1 Anti-Kickback Statute Jess Smith

2 Overview Enacted Violation became a felony Expanded to include all Federal Health Care Programs Health Care Fraud Prevention and Enforcement Action Team (HEAT)

3 Federal Anti-Kickback Statute 42 U.S.C. 1320a-7b. Is a criminal statute that prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce (or reward) the referral of federal health care program business.

4 One Purpose Test Established United States v. Greber (U.S. v. Greber (3d Cir. 1985)) Definition if one purpose of the payment was to induce future referrals, the Medicare statute has been violated.

5 Application Applies to anyone who solicits, receives, offers or pays with intent to induce or reward referrals for federal program business. Providers Vendors Managers or administrators Marketing personnel Anyone else Applies to participants on both sides of the transaction!

6 Applies to referrals for items or services covered by a federal health care program Medicare Medicaid Other federal programs Limiting to non-medicare/medicaid or other Federal programs does not necessarily insulate the arrangement States have AKS and many apply to any source of patients.

7 Applies to any form of remuneration in exchange for referrals for federal program business Money Contracts for services Free or discounted items or services Over/under payments (i.e. not fair market value) Waivers of copays or deductibles Anything of value

8 AKS Violations are a Felony

9 AKS Penalties 5 years in prison per offense $25,000 fine per offense (42 USC 1320a-7b(b))

10 AKS Violation = Civil Monetary Violation

11 Civil Monetary Penalties $50,000 civil monetary penalties per violation AND 3 times the payments received AND Exclusion from ALL Federal Healthcare Programs Medicare/Medicaid/Tricare/etc (42 USC 1320a-7a(a)(7))

12 Federal Health Care Programs Exclusion (i.e.: Medicare, Medicaid, TRICARE, VA) Impact items or services that are furnished, ordered, or prescribed will not be covered Entity may not bill directly for treating Medicare and Medicaid patients Services cannot be billed indirectly through an employer or a group practice No order or prescription that is provided to a private-pay patient will be reimbursable by any Federal health care program.

13 AKS Violation = False Claims Act Violation

14 False Claims Act violation (Civil Violation) Preponderance of Evidence Standard $ $11000 per violation 3 x damages Qui tam lawsuit

15 STARK LAW: Lou Paravate

16 1) "Stark" is a set of United States federal laws named after US Congressman Pete Stark. (Example: "Fulbright Scholarships" or "Monroney Stickers.") Stark prohibits referrals by a physician of Medicare or Medicaid patients to an entity that provides any of 12 designated health services in which the physician or immediate family member has a financial relationship. Stark is otherwise known as "The Federal Physician Self-Referral Prohibition" or "The Ethics In Patient Referrals' Act." Because of it's maze-like complexity, I prefer to (sarcastically) call Stark the "Healthcare Attorney Full Employment Act."

17 2) The bill was introduced in Congress in 1988 and became law in 1990, effective January 1, Subsequent amendments and additions were passed in 1993 (Stark II), 2001, 2004, 2007 (Stark III) and ) The concept behind Stark is that "a doctor should never receive financial gain for recommending a treatment that the doctor does not personally provide." And that a "self-referral" is an inherent conflict of interest which encourages overutilization of services, which in turn drives up health care costs.

18 Those who oppose Stark argue that physicians who own, invest in or operate medical facilities are responding to a need which might otherwise not be met, particularly in medically underserved areas. In addition, physician owned entities often offer a lower cost alternative to facilities that are located in hospitals, because hospitals usually have higher overhead costs. It is my personal opinion that Stark discourages creativity and innovation in health care. Doctors are on the front lines of patient care and are the first to spot a medical need and better respond to that need.

19 4) Acting alone, a physician (or those within his office or group) cannot violate Stark Law through the in-house treatment of a patient, because there is no "outside referral" to someone else. 5) Numerous other laws and regulations may overlap or apply: fee-splitting prohibitions, notice requirements, Medicare conditions of participation and billing rules like Anti-Markup. Your own state's fraud and abuse statutes may or may not mirror the federal rules.

20 6) Stark initially only applied to clinical laboratory services. Now Stark applies to a large number of services or "Designated Health Services" (DHS). Please remember that term, "DHS." A would DHS include but not be limited to one of these 12 categories: Clinical labs, physical therapy, occupational therapy, outpatient speech pathology, radiology and some imaging, radiation therapy, durable medical equipment, nutrients, prosthetics, home health series, outpatient prescription drugs and inpatient and outpatient hospital services.

21 7) Stark penalties could be: A) Denial of payment, B) Three times refund of payment, C) $15,000 penalty per service, D) $100,000 per circumvention scheme and E) Exclusion from Medicare/Medicaid programs. Multiple federal entities oversee Stark enforcement including Department of Justice, Centers for Medicare and Medicaid Services (CMS) and Department of Health and Human Services Office of Inspector General (OIG). 8) Stark applies to doctors, dentists, optometrists and chiropractors.

22 9) "Immediate family members" goes as far out as grandparents, grandchildren and in-laws, whether they be natural or adoptive. 10) "Financial relationship" includes ownership, investment interest or compensation arrangements. 11) Stark contains several exceptions including physician services, in-office ancillary services, ownership in publicly traded stock, rental of office space and equipment and bona fide employment relationships. A recent Stark exception is for imaging services to be provided within a group practice. Even then, the practice must provide the patient with a list of alternate sources for the service offered where the patient resides.

23 12) There are seven "Safe Harbors" in contracts between physicians and hospitals: A) The contract must be for a least a year B) In writing signed by both parties C) Specific aggregate payment which is set in advance D) Payment is reasonable fair market value E) Payment not related to volume or value of business F) Exact services to be performed must be outlined G) Must be commercially reasonable

24 13) The concept of Stark, but not necessarily Stark itself, has four levels: A) The federal level which covers federal programs like Medicare/Medicaid. B) The state level which may add regulations on top of the federal regulations (but almost always cannot diminish them) and may extend Stark type regulations to commercial insurance. Please see your individual state laws regarding self-referral prohibitions. C) Individual in-state commercial insurance contracts may contain self-referral prohibitions. D) National commercial insurance contracts (i.e. Humana) may contain self-referral prohibitions.

25 14) Just as we have 10,000 laws to enforce the Ten Commandments, use your common sense regarding Stark. If it seems unethical, it probably is.

26 Quiz