Chapter 16 Kickbacks and Fee-Splitting Prohibitions
KICKBACKS AND FEE-SPLITTING
Federal Medicare and Medicaid Law
- Specific Activities that Could Violate the Kickback and Fee Splitting Prohibitions
- Billing Services
- Clinical Laboratories
- Drug Research
- Employee Placement
- Free Services
- Goodwill Payments
- Home Health
- Hospital-Based Physicians
- Joint Venture Arrangements
- Leases, Loans, & Incentives
- Marketing Compensation Arrangements
- Percentage Arrangements
- Promotional Activities
- Waiver of Copayments and Other Beneficiary Inducements
Other Laws Used to Deter Payments for Referrals
Summary of the Thirteen Safe Harbors Issued>
KICKBACKS AND FEE-SPLITTING
Nevada and federal law specifically prohibit kickbacks and fee splitting by physicians and other health care providers. These statutes recognize that payments made in return for the referral of patients could threaten patient care and increase health care costs. Penalties for engaging in these activities include exclusion from Medicare, disciplinary action by the Board of Medical Examiners, loss of license, fines, and imprisonment. This chapter discusses relevant Nevada and federal statutes, applicable case law, and general principles to guide physicians in their dealings in this area. The federal safe harbors, activities by a physician that will not violate the kickback prohibitions, are also discussed in some detail.
Nevada generally prohibits the direct or indirect receipt of any fee, commission, or rebate which tends to influence the physicians objective evaluation or treatment of a patient. Further, any division of fees, except when the patient is informed and the division is made in proportion to the services personally performed, is prohibited. Referring a patient (in violation of NRS 439B.425) to a facility in which the physician has a financial interest is similarly prohibited, as is failing to disclose to a patient any financial or other conflict of interest. NRS 630.305.
Federal Medicare and Medicaid Law
As with Nevada law, federal law prohibits any fee splitting in connection with the Medicare or Medicaid programs. The relevant statute provides, in part:
Whoever knowingly and wilfully solicits or receives any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in kind:
(A) in return for referring an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under Title XVIII (Medicare) or a State health care program, or
(B) in return for purchasing, leasing, ordering, or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole or in part under Title XVIII or a State health care program, shall be guilty of a felony and upon conviction thereof, shall be fined not more than $25,000 or imprisoned for not more than five years, or both. 42 U.S.C. 1320a-7b(b).
The same provisions and penalties apply to anyone who offers to pay any kickback or rebate in connection with the programs. In addition to the fines and imprisonment, violations will likely result in exclusion from participation in government health care programs. 42 U.S.C. 1320a-7(b)(7).
In interpreting the above statute, courts have found that even if a portion of payments to a physician fairly compensated the physician for professional services, if some other portion constituted an inducement to encourage referrals of Medicare patients, the physician was liable. That is, as long as one purpose of the payment was to induce referrals, the statute would apply. United States v. Greber, 760 F.2d 68 (3rd Cir. 1985). The federal Ninth Circuit (which includes Nevada) is in accord. The Ninth Circuit Court of Appeals reviewed an arrangement between a medical management company and a clinical laboratory, in which the laboratory returned twenty percent of the revenues obtained by the involved physicians groups referrals to the management company. The court rejected the argument that the payments represented fair compensation for specimen collection and handling services, noting that the fair market value of the services was substantially less than the amount paid, and that there was no doubt that the laboratory was paying for referrals as well as the other services. United States v. Lipkis, 770 F.2d 1447 (9th Cir. 1985).
More recent federal decisions have required that the government prove that the physicians conduct was both knowing and willful. Knowing and willful is interpreted as:
1) knowing that the anti-kickback statute prohibits the offering or paying of remuneration to induce referrals; and
2) engaging in the unlawful conduct with the specific intent to disobey the law.
Hanlester v. Shalala, 51 F.3d 1390 (9th Cir. 1995).
Specific Activities that Could Violate the Kickback and Fee Splitting Prohibitions
The OIG is concerned with medical billing companies in general, and is specifically concerned with hospital billing services. Billing services that attempt to maximize billings by discovering coding errors in return for a percentage of the increased revenue were the subject of a Medicare fraud alert. OIG 97-01. The OIG views these billing services as ripe for upcoding, unbundling, and other manipulation which increases costs to the Medicare program. Consulting and billing services of this type are therefore likely to undergo special scrutiny.
The OIG has issued a fraud alert warning that certain activities engaged in by clinical laboratories could violate the anti-kickback provisions of the Medicare and Medicaid statutes. Because the physician, not the patient, chooses the clinical laboratory, it is essential that the physicians decision is based only on the best interests of the patient.
In particular, phlebotomists employed by laboratories who are placed in physicians offices, should not perform tasks that are not directly related to the collection or processing of laboratory specimens, must be contractually prohibited from performing such tasks, and should be closely monitored. In no event should the phlebotomist perform any tasks, such as taking vital signs or performing clerical services, that are the responsibility of the physician or his staff.
Other laboratory practices that could implicate a physician include a laboratory waiver of charges to managed care patients in an attempt to induce the physician to continue to use the laboratory for non-managed care patients. Also, a laboratory that offers to perform tests encompassed within the composite rate for patients suffering from end-stage renal disease below the fair market value in return for the physicians agreement to refer all or most of the tests falling outside the composite rate to the laboratory would constitute the offering of something of value in return for the offering of additional tests. Additional practices that raise suspicion are offers to pickup and dispose of biohazardous waste products, offers to provide the physicians office with office automation equipment (unless integral to and exclusively for the performance of the office laboratorys work), and professional courtesy, such as testing the family or employees of the physician.
Physicians may not accept any valuable benefits in exchange for selecting specific prescription drugs. Specifically, when physicians are provided research grants for studies of prescription products where the studies require little or no actual scientific pursuit, an OIG investigation may be warranted. Thus payments for filling out questionnaires for new patients placed on a product or payments for simply keeping minimal notes on treatment outcomes would likely violate Medicares anti-kickback provisions.
As with placement of clinical laboratory employees at a physicians office (see subsection above), any other type of employee placement at a physicians office may raise red flags. For instance, a pharmacy company proposed placing an employee pharmacist in a hospital transplant center. Because, however, the duties of the pharmacist would include working with transplant teams to facilitate post-transplant patient care, securing insurance coverage for pharmaceuticals, and processing prescriptions, the OIG stated that the arrangement could constitute prohibited remuneration. The rationale supplied was that one purpose of the services provided by the pharmacy company was to induce referrals, the transplant center realized a tangible benefit at no cost, and the center would exercise a substantial influence over a significant source of revenue for the pharmacy company. OIG Advisory Opinion 98-16.
Physicians who accept free services for themselves, their families, or employees from other medical professionals (particularly laboratories) as an inducement for the referral of patients may violate the anti-kickback statute.
Payments for goodwill and other intangible benefits (almost always in connection with the acquisition of a practice) are not illegal per se. However, there is a suspicion that these arrangements may be sophisticated disguises to share the profits of business at a hospital with referring physicians, in order to induce physicians to steer referrals to the hospital. Whenever the value of intangible assets is inflated, the OIG becomes wary, and the payments become subject to scrutiny, especially when the seller and the buyer of the assets remain affiliated.
A physicians who orders home health services is responsible for ensuring the medical necessity of the services, and a physician who orders unnecessary services may be liable, even though he does not submit the claim himself. Further, any benefit received by the physician for a referral to a home health agency is subject to extreme scrutiny and is likely an illegal kickback. The following specific examples of illegal activity illustrate the point:
- a) Payment of a fee to a physician for each plan of care certified by the physician on behalf of the home health agency;
- b) Disguising referral fees as salaries by paying referring physicians for services in excess of fair market value;
Offering beneficiaries free services, such as meals or transportation, if they agree to switch home health providers.
According to the OIG, contracts that require hospital-based physicians to split portions of their incomes with hospitals are suspect. Contractual provisions which would appear to violate the anti-kickback statute include a hospital providing no, or only token, reimbursement to a pathologist for Part A services in return for the opportunity to perform and bill for Part B services at the hospital; or a radiologist group that pays a percent of their profits to a hospital for capital improvements.
If a hospital demands payment from a hospital-based physician ostensibly for services for which the hospital has already received reimbursement, the anti-kickback statute may be implicated.
Joint Venture Arrangements
Joint ventures, including both contractual arrangements and the creation of new legal entities, could violate the anti-kickback statute. Those that are suspect include ventures where physicians become investors in a newly formed business entity, and would then refer their patients to the entity and be paid in the form of profit distributions. The motive of these types of joint ventures would not be strictly to raise capital, but to secure a stream of referrals and compensate the physician for these referrals.
Choosing investors for a joint venture for any of the following reasons could make the entity suspect: investors are chosen because they are in a position to make referrals; physicians who are expected to make many referrals are offered a greater investment opportunity than those expected to make few referrals; the venture tracks its sources of referrals and makes this information available to the investors; investors are required (or encouraged) to divest their ownership interest if they cease to practice or generate referrals. The business structure of a joint venture, particularly shell entities, could also bring it under close scrutiny.
The manner is which the joint venture is financed and profits are distributed may raise suspicion. For instance, the OIG has pointed out the following instances which may warrant scrutiny: physician investors may invest only a nominal sum; the amount of capital invested may be disproportionately small and the returns on investment disproportionately large when compared to a typical investment in a new enterprise; physician investors may be permitted to borrow the amount of the required investment from the entity and pay it back through profit distributions; or the returns on the investment may be extraordinarily high in comparison with the risk involved.
Despite the above cautions from the OIG, the Ninth Circuit has found that the government must prove that the parties to a joint venture arrangement knowingly or willfully offered or paid remuneration to induce referrals. The court distinguished encouragement of referrals from inducement, which it explained was the intent to exercise influence over the reason or judgment of another to cause the referral of program-related business. Permissible encouragement included offering physicians, within limits, the opportunity to profit indirectly from referrals when they could not profit directly. Hanlester v. Shalala, 51 F.3d 1390 (9th Cir. 1995).
Leases, Loans, and Incentives
It is illegal for hospitals to provide financial incentives to physicians for their referrals. The OIG has identified the following ten suspect hospital incentive arrangements:
1) Payment of any sort of incentive by the hospital each time a physician refers a patient to the hospital;
2) The use of free or significantly discounted office space or equipment (usually in facilities located close to the hospital);
3) Provision of free or significantly discounted billing, nursing, or other staff services;
4) Free training for a physicians office staff in areas such as management or laboratory techniques;
5) Income supplement guarantees if the physicians income fails to reach a predetermined level; 6) Low-interest or interest-free loans which may be forgiven if the physician refers patients to the hospital;
6) Payment of the cost of a physicians travel expenses for conferences;
7) Payment for a physicians continuing education courses;
8) Coverage on the hospitals group health insurance plans at an inappropriately low cost; and
9) Payment for services (which may include consultations at the hospital) with few substantive duties or payment for services in excess of the value of services rendered.
Marketing Compensation Arrangements
The OIG looks suspiciously at marketing arrangements, especially when the marketer is in a position to influence referrals. Of particular concern are percentage-based compensation agreements, as these could provide financial incentives that would encourage overutilization of items and services. The safest approach entails ensuring that the arrangement be based on the fair market value of the services to be performed, and that it fits within one of the federal safe harbors (see discussion of safe harbors, below).
The OIG has expressly refused to provide safe harbor protection to percentage agreements between entities in a position to refer Medicare or Medicaid business, as these arrangements are generally directly tied to the volume of business or amount of revenue generated. If the entity receiving the percentage revenue is not in a position to make referrals, the agreement would likely not violate the anti-kickback statute. However, in the case of a management service that provide a physicians office with all operating services, such as accounting, billing, direct marketing, and setting up provider networks for referrals, the OIG found the arrangement problematic as it could include financial incentives that increase the risk of abusive billing practices.
If a promotional item being given or received is substantial enough to be considered remuneration, kick-back issues surface. Substantial gifts, discounts, or any free professional services should not be offered to a referring practitioner.
Waiver of Copayments and Other Beneficiary Inducements
Congress has specifically found that the waiver of coinsurance or deductibles are items of remuneration that could trigger the anti-kickback statute. If these waivers are construed as an attempt to influence a Medicare or Medicaid beneficiary to order or receive items or services, the physician may be subject, in addition to other penalties, to a civil fine of $10,000 or treble the value of the amount claimed. 42 U.S.C. 1320a-7a(a)(5).
A waiver of coinsurance or deductibles will not be considered remuneration if it is not offered as part of any advertisement or solicitation and the physician does not routinely waive these amount. Further, the physician can only waive the amounts after determining that the individual is in financial need and makes reasonable collection efforts.
Physicians are not prohibited from investing in the health care industry. However, several of the ethical provisions which may apply to potential fee-splitting situations are highlighted below.
The Current Opinions of the Council on Ethical and Judicial Affairs state:
6.02-6.04: Fee Splitting: Fee splitting between physicians is prohibited. Also prohibited are any payments for referral between a physician and a pharmaceutical company, a pharmacist, an optical company, manufacturers of medical appliance and devices, clinics, laboratories, hospitals, or other health facility.
8.09: Laboratory Services: Physicians are required to choose a clinical laboratory on the basis of medical consideration only. A physician is prohibited from lending his name to, or in any other way aiding in the misrepresentation of, laboratory services performed and supervised by a non-physician as the physicians professional services.
8.061: Gifts to Physicians: Many gifts given to physicians by companies in the industry, such as funds for educational seminars and conferences, serve a socially beneficial function. However, to avoid the acceptance of inappropriate gifts, physicians should observe the following guidelines:
1) Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value. Accordingly, textbooks, modest meals and other gifts are appropriate if they serve a genuine educational function. Cash payments should not be accepted.
- a) Individual gifts of minimal value are permissible as long as the gifts are related to the physicians work (e.g., pens and note pads).
2) The Council on Ethical and Judicial Affairs defines a legitimate conference or meeting as any activity, held at an appropriate location where
(a) the gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentations should be the highlight of the gathering), and
(b) the main incentive for bringing attendees together is to further their knowledge on the topics being presented. An appropriate disclosure of financial support or conflict of interest should be made
- c) subsidies to underwrite the costs of continuing medical education conferences or professional meetings can contribute to the improvement of patient care and therefore are permissible. Since the giving of a subsidy directly to a physician by a companys representative may create a relationship that could influence the use of the companys products, any subsidy should be accepted by the conferences sponsor who in turn can use the money to reduce the conferences registration fee. Payments to defray the costs of a conference should not be accepted directly from the company by the physician attending the conference
- d) Subsidies from industry should not be accepted directly or indirectly to pay for the costs of travel, lodging or other personal expenses of physicians attending conferences or meetings, nor should subsidies be accepted to compensate for the physicians time. Subsidies for hospitality should not be accepted outside of modest meals or social events held as part of a conference or meeting. It is appropriate for faculty at conferences or meetings to accept reasonable honoraria and to accept reimbursement for reasonable travel, lodging and meal expenses. It is also appropriate for consultants who provide genuine services to receive reasonable compensation and to accept reimbursement for reasonable travel, lodging and meal expenses. Token consulting or advisory arrangements cannot be used to justify the compensation to physicians for their time or their travel, lodging and other out-of-pocket expenses.
- e) Scholarship or other special funds to permit medical students, residents and fellows to attend carefully selected educational conferences may be permissible as long as the selection of students, residents or fellows who will receive the funds is made by the academic or training institution.
3) No gifts should be accepted if there are strings attached. For example, physicians should not accept gifts if they are given in relation to the physicians prescribing practice. In addition, when companies underwrite medical conferences or lectures other than their own, responsibility for and control over the selection of content, faculty, educational methods and materials should belong to the organizers of the conferences or lectures.
Other Laws Used to Deter Payments for Referrals
The Federal Trade Commission has had an active interest in the antitrust concerns raised by self-referrals and kickbacks, particularly when physicians leverage their position in one market to gain advantage in another. In addition, the Internal Revenue Service monitors hospitals that could jeopardize their tax-exempt status by violating Medicare fraud and abuse laws, patient dumping laws, and antitrust laws. Hospital-physician joint ventures, physician recruitment, compensation agreements, and the purchase of physicians practices also raise both tax issues and potential kickback violations.
Safe harbor regulations were mandated by Congress in an attempt to provide guidance to Medicare providers and help them comply with the federal anti-kickback statute. Because the statute prohibits physicians and others from knowingly and willfully offering, paying, soliciting, or receiving remuneration in order to induce business that is reimbursed under any federal health care program, and because all direct or indirect payments for patient referrals are prohibited, the types of transactions that could potentially be implicated are large. Currently thirteen safe harbors exist; when a physicians conduct falls fully within the provisions of one of these, his conduct will not violate the anti-kickback statute.
Simply because a physicians conduct does not fully fall within the provisions of a safe harbor does not necessarily mean that the conduct violates the law. However, that conduct will be subject to scrutiny, investigation, and possible prosecution by the OIG. Federal law requires that DHSS provide formal guidelines (advisory opinions) regarding the application of the anti-kickback statute and safe harbor provisions, when requested by parties to the arrangement, subject to certain limitations. 42 U.S.C. 1320a-7d; 42 C.F.R. 1008.5. These advisory opinions must include guidance on: what constitutes illegal remuneration under the statute; whether an arrangement falls within a statutory exception or a safe harbor; what constitutes an inducement to reduce or limit services; and whether any particular activity constitutes grounds for criminal penalties, civil penalties, or exclusion. The Secretary does not have to address whether fair market value was paid or received or whether an individual is a bona fide employee within the meaning of the IRS code. For further information, see the OIG website at http://www.hhs.gov/progrog/oig. Of paramount importance to the practitioner is the fact that the OIG has, in recent years, proposed but not yet finalized several new rules that will likely affect many of the safe harbor provisions. The prudent physician must therefore seek competent legal counsel before relying on the safe harbors outlined below.
Summary of the Thirteen Safe Harbors Issued
1) Investment Interests.
This federal anti-kickback safe harbor is divided into two parts, one for investments in large publicly-traded entities and the second for investments in smaller entities. Physicians should take note that these investment exceptions apply only to the federal kickback statute, not to the self-referral prohibitions, which contain different exceptions. For instance the self-referral prohibition contains no small entity exemption and no exemption for publicly-traded entities with less that $75 million in assets. Also, physicians should be aware that indirect investment interests (through family members and indirect ownership vehicles) are treated in the same way as direct interests.
An investment in a large publicly-traded entity falls within the safe harbor if:
- 1) The entity possesses more than $50 million in non-depreciated net tangible assets.
- 2) The investment interest must be obtained on terms equally available to the public.
- 3) The investment interest is traded on a registered national securities exchange.
- 4) If the investment is an equity security, its equity securities are registered with the SEC.
- 5) The entity does not favor investors in its marketing or services.
- 6) Potential referral sources do not borrow funds of have a loan guaranteed by the entity in order to obtain shares.
- 7) The return is proportional to the investment and not related to referrals.
The OIG is particularly concerned that the investor acquire his investment interest in the same way as members of the public, directly off a national securities exchange through a broker, and that the interest is of the same type available to the public.
Investments in smaller entities fall within the safe harbor if:
- a) No more than 40% of the entity is owned by potential referral sources or other tainted investors (defined to include anyone doing business with or capable of making referrals to the entity). Therefore 60% of the investors must be individuals or entities that do not have any ability to influence or potentially provide referrals.
- b) No more than 40% of the entities business is from investors. Therefore, 60% or more of the referrals to the entity must come from physicians or other sources who have no investment interest in the entity.
- c) The amount of investment offered to a provider cannot be linked to the amount of expected referrals.
- d) The entity does not favor investors in its marketing or services.
- e) There is no requirement for investor referrals.
- f) Potential referral sources do not borrow from the entity to obtain their investment interests.
- g) The return is proportional to the investment and not related to referrals.
- h) The terms on which passive investment interests are offered are the same for potential referrers and non-referrers.
2) Space Rentals
To fall within this safe harbor, a lease must meet the following requirements:
- a) the agreement is written, signed by both parties, and specific as to what it includes,
- b) the agreement is for a term of at least one year, with aggregate rental charges set in advance;
- c) the rent is set at fair market value, without considering the volume or value of referrals or other business generated between the parties;
- d) if the lease is for periodic intervals, rather than on a full-time basis, the lease must specify the exact schedule of the intervals and the exact rent for the intervals.
3) Equipment Rentals
These are essentially similar to the space rental provisions above. See OIG Advisory Opinion No. 98-18.
4) Personal Services and Management Contracts
Management contracts and service contracts fall within a safe harbor if:
- a) the contract is in writing and specific as to the services included;
- b) the contract has a term of at least one year with the aggregate compensation set in advance;
- c) the compensation is at fair market value without considering referrals or business generated;
- d) the services performed under the agreement do not involve the counseling or promotion of a business arrangement or any other activity that violates any federal or state law; and
- e) the agreement is intended to provide for services on a periodic, sporadic, or part-time basis, rather than on a full-time basis for the term of the agreement, and the agreement specifies exactly the schedule, such intervals, their precise length, and the exact rent for such intervals.
5) Sale of Practice
This safe harbor is designed to protect traditional sales by practicing MDs, and is specifically limited to sales from practitioner to practitioner. The sale of a practice to a hospital or other entity is not covered under this harbor. In addition the following requirements must be met: a) The time from the date of the first agreement to the completion of the sale is not more than one year; however, payments may be made beyond this period; and b) The seller is not in a professional position to make referrals to the buyer after one year from the date of the first agreement related to the sale.
6) Referral Services
All referral services, including those operated by hospitals and medical societies must:
- a) Not exclude as a participant any individual or entity that meets the qualifications established for participation.
- b) If fees are charged to providers, the fees must be based on operating costs, not referrals, and be charged equally to all providers.
- c) Not dictate how services are provided, but may require that fees charged by providers to referred patients be the same as the fees charged to non-referred patients, or that the services be furnished free of charge or at a reduced cost.
- d) Make the following five disclosures to each person seeking referral, and maintain written records certifying that such disclosure was made:
(1) The manner in which the referral service selects providers to whom referrals are made.
(2) Whether the provider has paid a fee to the service.
(3) The manner in which the referral service selects a particular provider from its provider list for that particular patient.
(4) The nature of the relationship between the referral service and the providers to whom it makes referrals.
(5) The nature of any restrictions which the referral service has in place that would exclude a provider of a group of providers from continuing to participate in the referral service.
7) Replacement of Items Under Warranty
The receipt of a replacement item by a physician, at a reduced price because it is under a recognized warranty, and that will be billed to Medicare, falls within a safe harbor if full and accurate reporting is made by the provider on the claim for payment or cost report, and the provider receives no payment for services to the beneficiary from the manufacturer or supplier.
8) Discounts to Physicians
There is a safe harbor when a physician benefits from a discount if the discount: a) is based on an arms length transaction; b) does not involve a cash payment or bundled purchase agreement (although rebate checks, credits, and coupons directly redeemable from the seller may be allowed; c) is fully and accurately reported when the discounted item or service is separately claimed (however, charge-based providers need not reduce charges for services); and d) is as available to Medicare patients as it is to other patients.
9) Payments to Employees
Any payment from employers to their bona fide employees falls within this exception, which is the most liberal of the safe harbors. A true employee may be paid on any basis, including commissions, for any bona fide services, including generating Medicare business. This safe harbor does not protect payments to contractors, nor does it protect payments from the employee to the employer.
10) Group Purchasing Organizations
Payments by a vendor to a group purchasing organization (GPO) are protected if there is a written contract between the vendor and the GPO which specifically limits these payments and the GPO meets specific disclosure requirements.
11) Waiver of Deductible and Coinsurance
This safe harbor protects hospitals that waive copayments and deductibles for inpatient services in certain limited situations. There is no safe harbor for these waivers by physicians.
12) Coverage, Cost Sharing, or Premium Adjustments Offered by Health Plans
This safe harbor protects certain incentives offered by health plans to attract beneficiaries to enroll.
13) Discounting of Fees Offered by Physicians to Health Plans
Physicians who contract with health plans to furnish items and services to enrollees of the health plan at a discount from the providers usual fee may fall under this safe harbor. The basic limitations include: a) the protected remuneration include only the reduction in price a health care provider offers to a health plan; b) the terms of the agreement between the health care provider and the health plan must be in writing; and c) the contract must be for the sole purpose of furnishing to enrollees items and services that are covered by the health plan, Medicare, or a state health care program. Specific limitations apply for each category of health plan covered under this safe harbor. Physicians are advised to seek competent legal advice when attempting to maneuver through this, or any other, safe harbor.