Monthly Archives: September 2012

September 24, 2012

Carving Out Federal Programs Does Not Preclude Anti-Kickback Liability

by Kim C. Stanger, Holland & Hart LLP

The federal Anti-Kickback Statute ("AKS") prohibits offering, paying, soliciting or receiving remuneration to induce referrals for items or services payable by federal health care programs unless the transaction fits within a regulatory safe harbor. 42 U.S.C. § 1320a-7b. AKS violations are felonies, resulting in penalties of $25,000 per violation and up to 5 years in prison in addition to civil penalties. AKS violations are now also False Claims Act violations, resulting in additional civil penalties.

To avoid AKS concerns, some transactions have been structured to carve out federal health care programs, e.g., remuneration is paid for non-Medicare or Medicaid business, but the remunerative arrangement does not apply to items or services payable by Medicare or Medicaid. The theory is that because the remuneration does not apply to federal healthcare programs, the AKS does not apply.

The Office of Inspector General ("OIG") recently reaffirmed that such "carve out" arrangements do not necessarily protect the participants from AKS liability:

The OIG has a long-standing concern about arrangements under which parties "carve out" Federal health care program beneficiaries or business generated by Federal health care programs from otherwise questionable financial arrangements. Such arrangements implicate, and may violate, the anti-kickback statute by disguising remuneration for Federal health care program business through the payment of amounts purportedly related to non-Federal health care program business.

OIG Advisory Opinion No. 12-06 at p.6-7. Accordingly, the OIG declined to render a favorable opinion as to an arrangement that would have allowed certain payments for only those patients referred for non-federal program business.

Unless the transaction can fit within one of the AKS regulatory safe harbors in 42 C.F.R. § 1001.952, the test for an AKS violation remains whether "one purpose" of a transaction is to induce referrals for items or services payable by Medicare, Medicaid or other federal health care programs. United States v. Greber, 760 F.2d 68 (3d Cir. 1985), cert. denied, 474 U.S. 988 (1985). While carving out federal programs may help, it does not insulate participants from AKS violations. Healthcare providers and other potential referral sources or recipients may want to review any "carve out" arrangements to ensure that they truly satisfy the AKS.


For questions regarding this update, please contact
Kim C. Stanger
Holland & Hart, U.S. Bank Plaza, 101 S. Capitol Boulevard, Suite 1400, Boise, ID 83702-7714
email: kcstanger@hollandhart.com, phone: 208-383-3913

This news update is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This news update is not intended to create an attorney-client relationship between you and Holland & Hart LLP. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.

September 18, 2012

Restrictive Covenants in Idaho

by Kim C. Stanger, Holland & Hart LLP

In this time of healthcare consolidation, many if not most employment or contractor agreements with healthcare professionals contain clauses that prevent the professional from competing with or soliciting patients from the employer for a certain period of time after termination. The status of such non-competition or non-solicitation clauses ("restrictive covenants") is somewhat ill-defined in Idaho.

Unlike some states, restrictive covenants involving physicians and other healthcare professionals are not per se illegal in Idaho, but they must satisfy the requirements for a valid non-competition clause. Intermountain Eye & Laser Centers, P.L.L.C. v. Miller, 142 Idaho 218, 127 P.3d 121 (2005). Traditionally,

    Covenants not to compete … are 'disfavored' and 'strictly construed' against the employer. Non-competition provisions must be reasonable, which is to say they must not be more restrictive than necessary to protect a legitimate business interest, must not be unduly harsh and oppressive to the employee, and must not be injurious to the public.

Id. 142 Idaho at 224, 127 P.3d at 127. Non-competition clauses may not be enforced if doing so would unduly restrict access to needed health care. Dick v. Geist, 107 Idaho 931, 693 P.2d 1133 (Ct. App. 1985).

In 2008, Idaho enacted a statute intended to define the parameters of enforceable restrictive covenants. Under the statute:

    A key employee or key independent contractor1 may enter into a written agreement or covenant that protects the employer's legitimate business interests and prohibits the key employee or key independent contractor from engaging in employment or a line of business that is in direct competition with the employer's business after termination of employment, and the same shall be enforceable, if the agreement or covenant is reasonable as to its duration, geographical area, type of employment or line of business, and does not impose a greater restraint than is reasonably necessary to protect the employer's legitimate business interests.

I.C. § 44-2701. "Legitimate business interests" include, but are not limited to:

    an employer's goodwill, technologies, intellectual property, business plans, business processes and methods of operation, customers, customer lists, customer contacts and referral sources, vendors and vendor contacts, financial and marketing information, and trade secrets…

Id. at § 44-2702(2). Section 44-2704 creates a rebuttable presumption that a non-competition or non-solicitation agreement is reasonable and enforceable if (1) it only restricts competition in the line of business conducted by the key employee while working for the employer, (2) it has a term of eighteen months or less, and (3) it is restricted to the geographic areas in which the key employee provided services or had a significant presence or influence. Id. at § 44-2704(2)-(5). Terms in excess of 18 months require additional compensation. See id. at § 44-2701.

Although the statute sets forth general parameters, it does not definitively resolve the validity of any particular restrictive covenant. By its express terms, compliance with the statutory standards only creates a presumption of validity. Theoretically, a party could rebut the presumption by establishing that a particular restrictive covenant is unreasonable as to duration, geography or scope, or that it otherwise "impose[s] a greater restraint than is reasonably necessary to protect the employer's legitimate business interests." Id. at § 44-2701. Conversely, the status of non-compliant covenants is unclear. Since compliance with the statutory standard creates a statutory presumption of validity, does non-compliance create a presumption that the restrictive covenant is unenforceable? Although that would seem to be the logical result, it is not clear how courts would apply the standard.

Traditionally, Idaho courts have been remarkably hesitant to modify (i.e., "blue pencil") an unreasonable restrictive covenant to make it enforceable, opting instead to forego enforcing unreasonable covenants. See, e.g., Insurance Ctr., Inc. v. Taylor, 94 Idaho 896, 899, 499 P.2d 1252, 1255 (1972); Pinnacle Performance, Inc. v. Hessing, 135 Idaho 364, 370, 17 P.3d 308, 315 (App. 2001). However, § 44-2703 now expressly authorizes courts to "blue pencil" unreasonable agreements. It is not clear whether the newly confirmed authority contained in § 44-2703 will motivate courts to modify overly-broad restrictive covenants so as to make them enforceable.

Finally, § 44-2701 applies to employment or contractor agreements. It is not clear to what extent a court might apply it to restrictive covenants in other types of arrangements, e.g., purchase agreements for practices. In the past, courts have been more willing to enforce broader restrictive covenants in purchase agreements given the nature of the transaction.

Until we receive further clarification from a court, employers who wish to maximize the chances that the restrictive covenant will be enforced should structure their restrictive covenants in services contracts to comply with the § 44-2704 standards.

Endnotes

1Per the statute,

    "Key employees" and "key independent contractors" shall include those employees or independent contractors who, by reason of the employer's investment of time, money, trust, exposure to the public, or exposure to technologies, intellectual property, business plans, business processes and methods of operation, customers, vendors or other business relationships during the course of employment, have gained a high level of inside knowledge, influence, credibility, notoriety, fame, reputation or public persona as a representative or spokesperson of the employer, and as a result, have the ability to harm or threaten an employer's legitimate business interests.

I.C. § 44-2702(1).


For questions regarding this update, please contact
Kim C. Stanger
Holland & Hart, U.S. Bank Plaza, 101 S. Capitol Boulevard, Suite 1400, Boise, ID 83702-7714
email: kcstanger@hollandhart.com, phone: 208-383-3913

This news update is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This news update is not intended to create an attorney-client relationship between you and Holland & Hart LLP. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.

September 10, 2012

Health Care Transactions: Beware Stark, Kickbacks, and More

by Kim C. Stanger, Holland & Hart LLP

Anytime you structure a transaction involving healthcare providers, you must beware federal and state statutes unique to the healthcare industry, including laws prohibiting illegal kickbacks or referrals. Those laws may affect any transactions between health care providers, including employment or service contracts, group compensation structures, joint ventures, leases for space or equipment, professional courtesies, free or discounted items or services, and virtually any other exchange of remuneration. Violations may result in significant administrative, civil and criminal penalties. The Affordable Care Act ("ACA") dramatically increased exposure for violations by expanding the statutory prohibitions, increasing penalties, and imposing an affirmative obligation to repay amounts received in violation of the laws.1 The following are some of the more relevant traps for the unwary.

Anti-Kickback Statute ("AKS"). The federal AKS prohibits anyone from knowingly and willfully soliciting, offering, receiving, or paying any form of remuneration to induce referrals for any items or services for which payment may be made by any federal health care program unless the transaction is structured to fit within a regulatory exception.2 An AKS violation is a felony punishable by a $25,000 fine and up to five years in prison.3 Thanks to the ACA, violation of the AKS is an automatic violation of the federal False Claims Act4, which exposes defendants to additional civil penalties of $5,500 to $11,000 per claim, treble damages, and private qui tam lawsuits5. The AKS is very broad: it applies to any form of remuneration, including kickbacks, items or services for which fair market value is not paid, business opportunities, perks, or anything else of value offered in exchange for referrals. The statute applies if "one purpose" of the transaction is to generate improper referrals6. It applies to any persons who make or solicit referrals, including health care providers, managers, program beneficiaries, vendors, and even attorneys7. Despite its breadth, the AKS does have limitations. First, it only applies to referrals for items or services payable by government health care programs such as Medicare or Medicaid8. If the parties to the arrangement do not participate in government programs or are not in a position to make referrals relating to government programs, then the statute should not apply. Second, the statute does not apply if the transaction fits within regulatory exceptions9. For example, exceptions apply to employment or personal services contracts, space or equipment leases, investment interests, and certain other relationships so long as those transactions satisfy specified regulatory requirements10. Third, interested persons who are concerned about a transaction may obtain an Advisory Opinion from the Office of Inspector General ("OIG") concerning the proposed transaction. Past Advisory Opinions are published on the OIG's website, www.hhh.oig.hhs.gov/fraud. Although the Advisory Opinions are binding only on the parties to the specific opinion, they do provide guidance for others seeking to structure a similar transaction.

Ethics in Patient Referrals Act ("Stark"). The federal Stark law prohibits physicians from referring patients for certain designated health services to entities with which the physician (or a member of the physician's family) has a financial relationship unless the transaction fits within a regulatory safe harbor11. Stark also prohibits the entity that receives an improper referral from billing for the items or services rendered per the improper referral12. Unlike the AKS, Stark is a civil statute: violations may result in civil fines ranging up to $15,000 per violation and up to $100,000 per scheme in addition to repayments received for services rendered per improper referrals13. Repayments can easily run into thousands or millions of dollars. Stark is a strict liability statute; it does not require intent, and there is no "good faith" compliance14. Stark applies only to financial relationships with physicians, i.e., M.D.s, D.O.s, podiatrists, dentists, chiropractors, and optometrists15, or with members of such physicians' families; it does not apply to transactions with other health care providers. Finally, unlike the AKS, Stark applies only to referrals for certain designated health services, ("DHS"), payable by Medicare;16 it does not apply to referrals for other items or services. If triggered, Stark applies to any type of direct or indirect financial relationship between physicians or their family members and a potential provider of DHS, including any ownership, investment, or compensation relationship17. Thus, the statute applies to everything from ownership or investment interests to compensation among group members to contracts, leases, waivers, discounts, professional courtesies, medical staff benefits, or any other transaction in which anything of value is shared between the parties. If Stark applies to a financial relationship, then the parties must either structure the arrangement to fit squarely within one of the regulatory safe harbors18 or not refer patients to each other for DHS covered by the statute and regulations.

Civil Monetary Penalties Law ("CMP"). The federal CMP prohibits certain transactions that have the effect of increasing utilization or costs to federally funded health care programs or improperly minimizing services to beneficiaries19. For example, the CMP prohibits offering or providing inducements to a Medicare or Medicaid beneficiary that are likely to influence the beneficiary to order or receive items or services payable by federal health care programs, including free or discounted items or services, waivers of copays or deductibles, etc20. This law may affect health care provider marketing programs as well as contracts or payment terms with program beneficiaries21. The CMP also prohibits hospitals from making payments to physicians to induce the physicians to reduce or limit services covered by Medicare22. Thus, the CMP usually prohibits so-called "gainsharing" programs in which hospitals split cost-savings with physicians.23 Finally, the CMP prohibits submitting claims for federal health care programs based on items or services provided by persons excluded from health care programs.24 As a practical matter, the statute prohibits health care providers from employing or contracting with persons or entities who have been excluded from participating in federal health care programs.25 Violations of the CMP may result in administrative penalties ranging from $2,000 to $50,000 per violation.26

State Anti-Kickback, Self-Referral, or Fee Splitting Statutes. Many states have their own versions of anti-kickback27 or self-referral laws28 that must also be considered. State versions vary widely; they may or may not parallel federal versions. In addition, most states also prohibit fee splitting or giving rebates for referrals, which might also apply to some transactions between referral sources.29 Providers should check their own state statutes to ensure compliance.

Medicare Reimbursement Rules. The Centers for Medicare & Medicaid Services ("CMS") has promulgated volumes of rules and manuals governing reimbursement for services provided under federal health care programs. The rules govern such items as when a health care provider may bill for services provided by another entity, supervision required for such services, and the location in which such services may be performed to be reimbursable. In addition, the amount of government reimbursement may differ depending on how the transaction is structured, e.g., whether it is provided through an arrangement with a hospital or by a separate clinic or physician practice. The rules concerning reimbursement and reassignment should be considered in structuring health care transactions if the entities intend to bill government programs for services or maximize their reimbursement under such programs.

Corporate Practice of Medicine Doctrine ("CPOM"). Some states impose the so-called "corporate practice of medicine" doctrine by statute or case law, i.e., only certain licensed health care professionals (e.g., physicians) may practice medicine; corporations may not employ physicians to practice medicine due to the risk that such an arrangement would improperly influencing medical judgment.30 There are often statutory exceptions, e.g., professional corporations or employment by hospitals or managed care organizations. In those states that apply or enforce the CPOM, transactions may need to be structured around the CPOM, including services contracts with physicians or other healthcare providers.

Certificates of Need ("CON"). Finally, to avoid over-saturation and resulting overcharges, some states require that providers obtain a certificate authorizing the construction or expansion of certain types of facilities, e.g., hospitals, ambulatory surgery centers, or skilled nursing facilities.31

Conclusion. The foregoing is only a brief summary of some of the more significant laws and regulations that may affect common health care transactions. As in all cases, the devil is in the details (as well as the Code of Federal Regulations and CMS Medicare Manuals). Providers and their advisors should review the relevant laws and regulations whenever structuring a health care transaction, especially if that transaction involves potential referral sources or implicates federal health care programs.

Endnotes
1 42 U.S.C. § 1320a-7k.
2 42 U.S.C. § 1320a-7b(b).
3 42 U.S.C. § 1320a-7b(b)(2)(B).
4 Patient Protection and Affordable Care Act Pub L. No. 111-148 § 6402(f)(1), 124 Stat. 119 (2010); see 31 U.S.C. § 3729 et seq.
5 See, e.g., 42 U.S.C. § 1320a-7a(5); 42 U.S.C. § 1320a-7(b)(7); 31 U.S.C.§ 3729-3733; United States ex rel. Thompson v. Columbia/HCA Healthcare Corp., 20 F. Supp. 2d 1017 (S.D. Tex. 1998).
6 United States v. Kats, 871 F.2d 105 (9th Cir. 1989); United States v. Greber, 760 F.2d 68 (3d Cir.), cert. denied 474 U.S. 988 (1985).
7 United States v. Anderson, Case No. 98-20030- 01/07 (D. Kan. 1998).
8 See 42 U.S.C. § 1320a-7b(b)(2)(B).
9 42 U.S.C. § 1320a-7b(3); 42 C.F.R. § 1001.952.
10 42 U.S.C. § 1320a-7b(3); 42 C.F.R. § 1001.952.
11 42 U.S.C. § 1395nn; 42 C.F.R. § 411.351 et seq.
12 42 C.F.R. § 411.353(b).
13 42 U.S.C. § 1395nn.
14 See 42 C.F.R. § 411.353(a)-(b).
15 Id. at § 411.351.
16 The "designated health services" covered by Stark include clinical laboratory services; physical therapy, occupational therapy and speech-language pathology services; radiology and other imaging services; radiation therapy; durable medical equipment and supplies; prosthetics, orthotics, prosthetic devices and supplies; home health services; outpatient prescription drugs; inpatient and outpatient hospital services; and parenteral and enteral nutrients. Id. at § 411.351.
17 Id. at § 411.351.
18 Id. at § 411.355 to 411.357.
19 42 U.S.C. § 1320a-7a.
20 42 U.S.C. § 1320a-7a(a)(5).
21 See OIG Special Advisory Bulletin, "Offering Gifts and Other Inducements to Beneficiaries" (August 2002); OIG Special Fraud Alert, "Routine Waiver of Part B Co-Payments/Deductibles" (May 1991).
22 42 U.S.C. § 1320a-7a(b).
23 See, e.g., OIG Special Fraud Alert, "Gainsharing Arrangements and CMPs for Hospital Payments to Physicians to Reduce or Limit Services to Beneficiaries" (July 1999).
24 42 U.S.C. § 1320a-7a(a)(1)(C) and (2).
25 OIG Special Advisory Bulletin, "The Effect of Exclusion from Participation in Federal Health Care Programs (Sept. 1999). 26 See id. at § 1320a-7a(a) and (b).
27 See, e.g., Colorado Revised Statutes ("CRS") § 25.5-4-305; Idaho Code ("IC") § 41-348(1); Nevada Revised Statutes ("NRS") 439B.420; New Mexico Statutes Annotated ("NSMA") §§ 30-41-1 to -3, and 30-44-7(A)(1); Utah Code § 26-20-4.
28 See, e.g., CRS § 25.5-4-414; NRS. 439B.425; New Mexico Administrative Code ("NMAC") 439B.5205-.5408; NMSA §§ 24-1-5.8(C)(6); NMAC 7.7.2.8(B)(3) and 7.7.2.8(N); Utah Code §§ 58-67-801, 58-68-801, 58-69-805.
29 See, e.g., CRS §§ 12-36-125 and 12-36-126; IC § 54-1814(8)-(9); NMSA §§ 61-6-15(D).
30 See, e.g., CRS §§ 12-36-117(m) and 6-18-301 et seq.; Worlton v. Davis, 73 Idaho 217, 221, 249 P.2d 810 (1952).
31 See, e.g., NRS 439A and NAC 439A.