Stark, AKS, FCA Primer

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1 Stark, AKS, FCA Primer December 1, 2016 Christine Savage ) by any measure CHOATE HALL & STEWART LLP choate.com

2 Physician Self-Referral Prohibition (the Stark Law ): History The Stark Law is premised on the government s belief that a conflict of interest is inherent to any arrangement where a physician refers patients to a health care entity in which he or she has a financial stake. In order to eliminate financial incentives to self-refer, the Stark Law broadly prohibits physicians from referring their Medicare patients to health care entities with which they have a financial relationship. As originally enacted in 1989, the Stark Law focused exclusively on physician referrals for clinical laboratory services. In the years since, the Stark Law has been broadened to encompass additional designated health services. CHOATE HALL & STEWART LLP 2

3 What is the Rule? If a physician (or an immediate family member) has a financial relationship with an entity, then the physician may not make a referral to the entity for the provision of designated health services paid for by Medicare, unless the financial relationship meets all of the requirements of an exception. Entities cannot bill for goods or services which have been provided as a result of an improper referral. CHOATE HALL & STEWART LLP 3

4 What Services Are Covered By Stark? Designated Health Services ( DHS ) include: Clinical lab services Physical therapy services Occupational therapy services Radiology services Home health services & supplies Durable medical equipment & supplies Radiation therapy services & supplies Parenteral and enteral nutrients Prosthetics, orthotics and prosthetic devices Outpatient prescription drugs Inpatient or outpatient hospital services CHOATE HALL & STEWART LLP 4

5 The Stark Law Who Is Covered By Stark? All physicians (M.D., D.O.), dentists (D.D.S., D.M.), podiatrists (D.P.M.), optometrists (O.D.), and chiropractors (D.C.) And immediate family members of these professionals: Spouses Parents, children and siblings (birth or adoptive) Step-parents, -children and -siblings In-laws (parents, children, siblings) Grandparents and grandchildren (and their spouses) CHOATE HALL & STEWART LLP 5

6 The Stark Law What Qualifies as a Financial Relationship? Any direct or indirect compensation arrangement, ownership arrangement, or investment relationship. Compensation arrangements can involve any payment, discount, free good or service, forgiveness of debt (loan) or other benefit made directly or indirectly, overtly, in cash or in kind. CHOATE HALL & STEWART LLP 6

7 The Stark Law Examples of Compensation Arrangements: employer-employee relationship lease of office space payment for administrative services directly provided equipment rental arrangement for consulting services donation of electronic health records provision of support staff provision of free goods or benefits of value payment for on-call coverage debt repayment or forgiveness gifts CHOATE HALL & STEWART LLP 7

8 The Stark Law What is a Referral? Broad definition: Any request by a physician for an item or service to be provided to a patient; or The establishment of a plan of care by a physician which includes some type of DHS. Does not include services personally performed by the physician. CHOATE HALL & STEWART LLP 8

9 Stark Law Need to Look at Chains of Relationships Indirect Compensation Hospital Payment Medical Group Referral Payment M.D. Employee of Medical Group Direct Compensation (Due to Stand in the Shoes Requirement) Lab Payment Medical Group Payment M.D. Owner of Medical Group Referral CHOATE HALL & STEWART LLP 9

10 Stark Law Need to Look at Chains of Relationships Why Does This Matter? If an entity enters into any new agreement with a physician, it will need to consider all of the physician s direct compensation arrangements with the entity, which includes the entity s arrangements with any Medical Group or other business the physician owns Also, different exceptions apply depending on whether the relationship between the entity and the referring physician (or physician s family member) is considered direct or indirect CHOATE HALL & STEWART LLP 10

11 Stark Law Penalties Stark is a strict liability statute: the intent of the parties is irrelevant. Any payment for services that does not fit into an exception can be recouped by Medicare. The entity furnishing DHS and receiving payment from Medicare (i.e., a hospital) generally is the liable party, not the referring physician. More recently there have been cases where prosecutors are looking to penalize physicians who are party to these arrangements - United States ex rel. Barker v. Columbus Regional Healthcare System, et al.,case No. 4:12-cv-108 (M.D. Ga.) ($450,000 penalty for physician) CHOATE HALL & STEWART LLP 11

12 Stark Law Penalties May also subject institutions or individuals to False Claims Act liability, which includes treble damages. Possible $15,000 civil monetary penalty for each service provided in violation of the Stark Law. $100,000 civil monetary penalties for a circumvention scheme. Possible exclusion from participation in Medicare and Medicaid. CHOATE HALL & STEWART LLP 12

13 Stark Law Exceptions That Permit Payments to Physicians In order to fall within an exception, all of the elements of the exception must be met. Satisfying exceptions or even choosing the right exception can be complicated. Conferring with Compliance or counsel is important given the consequences of getting things wrong. Most Commonly Relied on Compensation Exceptions: 1) Employment 2) Personal Service Arrangements (e.g., medical directors, independent contractor agreements) 3) Rental of Office Space/Equipment 4) Fair Market Value (e.g., rental of residential space, purchase of goods from physician s family member) 5) Non-Monetary Payments up to $392 (for 2016) 6) Medical Staff Incidental Benefits (up to $33 per episode in 2016) 7) Isolated Transactions (e.g., practice purchase) 8) Donations of EHR systems/software *Please note that we have not addressed all available exceptions in this presentation. CHOATE HALL & STEWART LLP 13

14 Typical Requirements of the More Common Exceptions The arrangement must be documented in writing and signed by all parties in advance of providing relevant services Services to be provided must be identifiable and clearly set out in writing Payment must be consistent with the fair market value of the services to be provided and not determined in a manner that takes into account the volume or value of referrals by the referring physician or other business generated among the parties Compensation must be set in advance and must be set forth in writing Agreements should be for at least a term of one year (though CMS has reiterated that an agreement need not state a defined term so long as either the arrangement in fact lasted a year or if the arrangement terminated during the first year, the parties did not enter into a new arrangement for the same space, equipment, or services during that first year) CHOATE HALL & STEWART LLP 14

15 How Entities Tend to Get Into Trouble Performing services before an agreement is signed Bonus payments based on volume or value of referrals Sharing of net proceeds The entity receiving referrals provides free administrative services to the referring physician Payment of fees that were not established in the agreement between the parties, especially for services not set out in the agreement (even if the services were necessary and actually provided) Performing services after an agreement has expired Failure of multiple agreements to cross-reference one another or reference a master list of contracts CHOATE HALL & STEWART LLP 15

16 The Stark Law: Cross- References The Stark Law requires that to meet the personal service arrangements exception (used for independent contractor services), the services agreement between the physician and the referring entity must include a cross-reference to all other arrangements between the parties Reinforces need for internal controls and policies to ensure any arrangement with a physician goes through a centralized office before services begin or an agreement is signed Physicians may be asked to sign amendments to existing agreements if they have or enter into multiple agreements for different services so the hospital can satisfy this requirement CHOATE HALL & STEWART LLP 16

17 2015 Stark Law Changes/Clarifications Select Clarifications (apply retroactively and prospectively) Split-billing in a hospital-based clinic does not confer remuneration to the doctor A written agreement does not need to specify an initial term of at least a year so long as the arrangement actually lasts a year or is terminated and no new arrangement is entered during that first year In writing is clarified to include a set of relatively contemporaneous documents which evidence an arrangement and which collectively satisfy an exception. In other words it doesn t all have to be set out in one document. CHOATE HALL & STEWART LLP 17

18 2015 Stark Law Changes/Clarifications Select Clarifications Examples of writings that CMS will consider when reviewing whether an arrangement satisfies an exception (assuming the various pieces of the writings pre-date referrals that would otherwise be prohibited): board meeting minutes or other documents authorizing payments for specified services written exchanges between the parties, in hard copy or electronic form fee schedules check requests or invoices with date, service and rate references time sheets coverage schedules or similar documents accounts payable or receivable records checks or other evidence of actual payments A signature for each party is required on at least one contemporaneous writing that documents the arrangement These clarifications can have a significant impact on diligence matters in an acquisition context and may alleviate a need to self-report certain issues. CHOATE HALL & STEWART LLP 18

19 2015 Stark Law Changes/Clarifications Select Changes effective 1/1/2016 Parties have 90 days to obtain required signatures, whether or not the failure to get the signature(s) was inadvertent Leases and personal services arrangements can now have indefinite holdovers (previously limited to 6 months) so long as: the holdover continues on the same terms and conditions as the prior arrangement, and the holdover satisfies all the elements of the applicable exception when the arrangement expires and for so long as the holdover exists (e.g., FMV) Additional changes made re: timeshare arrangements, physician-owned hospitals CHOATE HALL & STEWART LLP 19

20 Anti-Kickback Statute It is a felony to: 1) knowingly and willfully 2) solicit or receive any remuneration (kickbacks, bribes or rebates) 3) directly or indirectly 4) overtly or covertly 5) in cash or in kind 6) in return for: referring an individual to a person for the furnishing or arranging for the furnishing of an item/service; or purchasing, leasing, ordering or arranging for or recommending purchasing, leasing or ordering any good, facility, service or item 7) for which Medicare, Medicaid or another federal/state health care program may pay. CHOATE HALL & STEWART LLP 20

21 Anti-Kickback Statute Parties on both sides of a transaction may be in violation Violation to offer or pay Violation to solicit or receive Remuneration Not limited to traditional kickback schemes or bribes Any payment or benefit between parties in a position to make referrals may violate the statute (once again, can be direct or indirect payments, in cash or in kind) Law is potentially relevant to all contracts and arrangements, including joint ventures, between referral sources and referral recipients CHOATE HALL & STEWART LLP 21

22 Anti-Kickback Statute Unlike the Stark Law, intent is required to find a violation of the statute. However, if only one purpose of an arrangement is to induce a referral, that is sufficient. The inducement does not have to be the only reason for entering into an arrangement. For example, payments to compensate a physician for necessary services that were actually provided could violate the statute if one purpose of the relationship was to induce future referrals Does not just apply to physicians and their immediate family members Applies to any items or services paid for by any federal or state health care program (Medicare, Medicaid, TRICARE) Massachusetts has its own Anti-Kickback Statute that applies to all payers, including private third party payers CHOATE HALL & STEWART LLP 22

23 Anti-Kickback Statute Penalties $25,000 for each offense Imprisonment for up to 5 years Exclusion from Medicare, Medicaid and/or other Federal or State health care programs Civil monetary penalties of up to $50,000 per violation Both the entity paying the remuneration and the entity accepting it can be criminally liable under the statute CHOATE HALL & STEWART LLP 23

24 Anti-Kickback Statute Safe Harbors If a compensation arrangement falls within a safe harbor, it will not be in violation of the Anti- Kickback Statute. Unlike the Stark Law, a compensation arrangement does not violate the Anti-Kickback Statute if it does not meet all of the requirements of a safe harbor if there is no intent to induce/reward referrals, then there is no violation BUT if you satisfy all of the safe harbor requirements, the arrangement will not be subject to prosecution CHOATE HALL & STEWART LLP 24

25 Most Common Safe Harbors Used by Health Care Service Providers 1) Employment Agreements 2) Personal Service/Consulting Arrangements 3) Equipment and Office Space Leases 4) Sale of Practice 5) Discounts 6) Physician Recruitment * Please note that we have not addressed all available safe harbors in this presentation. CHOATE HALL & STEWART LLP 25

26 False Claims Act Prohibits a person or entity from knowingly submitting claims or making a false record or statement in order to receive payment from the federal government (Medicare). Knowingly Means: Actual knowledge of information Acts in deliberate ignorance of truth/falsity of information Acts in reckless disregard of truth/falsity of information CHOATE HALL & STEWART LLP 26

27 False Claims Act Typical False Claims Act Violations Billing for services not performed Keeping insufficient or inaccurate medical records Ordering of, and billing for, unnecessary tests Upcoding of services Liability for Retention of Overpayments Due to recent changes to the False Claims Act, the retention of an overpayment for over 60 days after determining there is an overpayment may be considered a false claim, subjecting one to treble damages and civil monetary penalties Claims submitted to the government after the determination that there is an overpayment may be considered false claims CHOATE HALL & STEWART LLP 27

28 False Claims Act Penalties Civil penalties of $10,781 $21,563 (these are the increased penalty amounts that went into effect as of August 1, 2016) Treble damages Permissive exclusion from federal health care programs Potential for imposition of a CIA CHOATE HALL & STEWART LLP 28

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