Special Report: The Lab Kickback Risks of “Freebies”

Though it may seem innocent to offer physicians or other lab referral sources free supplies or meals as a thanks for their business, such “freebies” can pose kickback risks under both the Anti-Kickback Statute (AKS) and Stark Law, and could also bring the False Claims Act (FCA) into play. When are such gifts OK and when can they lead to compliance violations for your lab? This Special Report breaks down six common areas relating to free items and services that can cause kickback headaches for labs, and how to ensure compliance with the relevant anti-fraud laws.

Risk Area 1: Free Client Supplies

One customary lab business practice with significant AKS and Stark implications is furnishing free supplies and equipment to referring physicians. This is generally permissible as long as limitations are followed. Stark specifies that prohibited “remuneration” does not include “[t]he provision of items, devices, or supplies that are used solely to (I) collect, transport, process, or store specimens for the entity providing the item, device, or supply, or (II) order or communicate the results of tests or procedures for such entity.”¹ Although there’s no such “carve out” or safe harbor for de minimis remuneration in the AKS, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) made clear in its 1994 Special Fraud Alert that provision of supplies and equipment under those limited circumstances will not implicate the AKS.²

Even though there’s an exemption for providing client supplies and equipment, both the Centers for Medicare & Medicaid Services (CMS) and the OIG interpret it very narrowly. CMS has maintained that supplies or equipment that have uses other than to collect, transport, process, store, or report lab testing aren’t protected; nor are supplies that are reusable. CMS emphasized in a 2010 advisory opinion concerning speculums that the pivotal question under Stark is not whether the supply or equipment in question is necessary to collect, transport, process, or store specimens for the lab, but whether the supply or equipment is used exclusively for those purposes.³

CMS has identified client supplies that labs may provide to clients (because they don’t constitute prohibited remuneration under Stark) as including “cups used for urine collection or vials used to hold and transport blood to the entity that supplied the items or devices,” and “single use needles, vials, and specimen cups.” Supplies not covered, according to CMS, include free gloves⁴ and disposable, single-use speculums.³

The OIG’s most recent example of its aversion to labs providing free items or services to referral sources is a December 5, 2016, advisory opinion.⁵ This opinion indicates that a lab’s plan to provide labeling of test tubes and specimen collection containers used to collect specimens at dialysis facilities for testing at said lab would likely violate the AKS. Once again, the OIG expressed its “longstanding and clear” position on labs providing free or discounted items or services to potential referral sources: “such arrangements are suspect and may violate the Anti-Kickback Statute.”⁵

It didn’t help that the requesting lab said it would select which dialysis facilities got the free labeling services and that such selection could depend “upon whether offering such services would be necessary to obtain or retain the business of a particular dialysis facility.”⁵

The Millennium Case

The notorious Millennium Laboratories, Inc. (now Millennium Health) case is a good illustration of where the lines are drawn in terms of supply freebies. At issue was Millennium’s practice of providing physicians free point-of-care testing (POCT) cups with embedded testing strips provided that physicians agreed not to bill any insurer for the cups and return the specimen samples in each cup to Millennium for additional, often more expensive, lab testing.

Millennium also charged physicians who didn’t return the cup for further testing. Ameritox, Ltd., a competitor, claimed (among other things) that Millennium was violating the AKS and Stark and sued in federal court. The judge and the jury agreed and awarded Ameritox roughly $12 million, though this was later reduced to $8.5 million.⁶

Millennium appealed, claiming that providing the free POCT cups was not a violation because the supplies were “used solely to (I) collect, transport, process, or store specimens for the entity providing the item, device, or supply, or (II) order or communicate the result of tests or procedures for such entity.” Although not a party to the case, the U.S. Department of Justice (DOJ) took the unusual step of intervening by filing an amicus curiae (friend of the court) brief to correct what it claimed were Millennium’s “erroneous” arguments about the AKS and Stark.⁷

The DOJ brief focuses on the word “solely” in the statute. “Solely” means that the freebie may not convey to the receiving physician even a tiny benefit that’s not related to permissible collection, transport, and storage purposes. Millennium’s actions didn’t fall within the exception, the DOJ argued, because the test strips embedded in the free POCT cups weren’t integral to collecting, transporting, processing, or storing specimens; they were there to help the physicians make treatment decisions more quickly at no cost. If Millennium prevailed in its argument, the DOJ warned, an “enormous” loophole in the Stark Law would be created, enabling labs to attach anything, even five-dollar bills, to cups.⁷

According to the DOJ, “the ‘cup agreements’…create exactly the sort of intertwined financial relationships in the healthcare system that the Stark Law and AKS are designed to prohibit. The purpose and effect of this arrangement was to give doctors a significant financial incentive to obtain laboratory testing of each sample collected in a POCT cup and to obtain such testing from Millennium rather than a competitor. That is precisely the sort of inducement that the Stark Law and the AKS forbid.”⁷

On October 19, 2015, the DOJ announced that Millennium Health had agreed to pay a record $256 million to settle the kickback and other FCA charges brought by the government.⁸

Having taken care of Millennium, the feds pivoted and pursued the other side of the problematic POCT transactions, namely, the downstream physicians who accepted the test cup freebies from Millennium. A dozen settlements have been made, as illustrated by Figure 6.2.⁹

FIGURE 6.2

Millennium Free POCT Cup Physicians Settlement Scorecard

Provider(s)	Settlement Amount	Individual Physicians Also Charged?
A.R.E.B.A. – Casriel, Inc. (ACI) (New York City)	$151,057	NO
Physicians Group Services, P.A. (PGS) (Florida)	$1.128 million	NO
Anesthesia Services, P.C. d/b/a University Pain Clinic (UPC) (Michigan)	$44,900	NO
HKD Treatment Options, P.C.	$87,650	NO
Tulsa Pain Consultants, Inc.	$98,942	YES
Doctor’s Inlet Pediatrics and Primary Care, P.A., and Avenues Pediatrics and Internal Medicine (Florida)	$58,370	YES
Recovery Pathways, LLC (Michigan)	$64,555	NO
The Pain Institute, Inc. d/b/a Space Coast Pain Institute (Florida)	$95,302	YES
Addiction Medical Care of Norwalk, Practice Management Associates Norwalk, LLC, Addiction Medical Care of Columbus, and Practice Management Associates, LLC (collectively, AMC) (Ohio)	$79,880	NO
Advanced Pain Management (Arizona)	$186,210	NO
Parallax Center, Inc. (New York)	$64,203	NO

What to do

The CMS and OIG guidelines in the advisory opinions and other documents mentioned above provide helpful guidance on which supplies do and do not count as remuneration. In addition, the Millennium case is helpful because it sheds light on how the government interprets the “collect, transport, process, or store specimens for the entity providing the item, device, or supply” exception to remuneration.

With this in mind, labs need to take care to identify physician clients that perform in-office testing and regulate the provision of lab supplies accordingly. Verify that the free supplies you do provide to physician clients are items that won’t raise kickback concerns, i.e., that the supplies:

• • Are integral to performing the lab work.
  • Are used exclusively for that purpose—multiple-use supplies like sharps containers, needles, and syringes should not be provided for free.

• • Are not reusable.

• • Are not included in a bundled payment, e.g., surgical supplies.

• • Do not in any other way have a clear value to physicians independent of their use for the lab work.

In addition, don’t use the fact that you provide free supplies as a sales or marketing pitch to induce referrals of the physician client’s testing business. Last but not least, maintain and document the procedures you use to police unauthorized use of the supplies by clients. At a minimum, quantities of supplies must be carefully monitored and correlated to the volume of specimens typically sent to the lab for processing.

Risk Area 2: Free Computers and Other Equipment

The same principles governing free client supplies apply to equipment. In its 1994 Special Fraud Alert discussing supplies, the OIG indicated that providing free equipment, including free or “loaner” computers, fax machines, and other electronic equipment, may raise AKS concerns. However, the OIG continued, the AKS isn’t triggered when labs provide equipment that’s integral to, and exclusively used for, performance of the lab’s outside work.²

The OIG drilled deeper into the issue in a July 3, 1997, letter about whether providing “transtelephonic monitoring” services of fax machines to referring physicians violates the AKS. OIG noted that many suppliers make equipment available to referring customers, but usually on the condition that it be used only to facilitate the suppliers’ services. The OIG explained: If the recipient uses the equipment “for any purpose other than in connection with the ordered service, there is potential illegal remuneration and potential liability for both parties to the transaction.”¹¹

Kickback liability for telehealth equipment

With the rapid emergence of telehealth, lab compliance officers need to be aware of the AKS, Stark, and FCA risks of providing physicians and patients equipment for network interfacing, interoperability, and other technology for purposes of delivering telehealth services.

The OIG has weighed in on the issue several times, including in a 2018 advisory opinion green lighting a proposed arrangement in which a hospital would purchase equipment for a county-run clinic to provide free HIV prevention consultations, citing safeguards contained in the arrangement and the potential to benefit the community.¹² This is consistent with a 2011 opinion in which the OIG allowed a health system to provide community hospitals free telehealth equipment as part of a telestroke arrangement.¹³

In addition, proposed federal legislation designed to help relax restrictions against telemedicine in response to the pandemic adds further clarification about providing technology to physicians for free. The Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2021 (CONNECT) states that providing technology necessary for delivery of services wouldn’t be considered “remuneration” under fraud and abuse laws. However, the details will have to be ironed out. This offers labs much less comfort and room for maneuvering than previous versions of the bill that included broader liability protections. Meanwhile, CONNECT would provide the OIG $3 million to carry out telehealth audits and investigations. It also requires HHS to create training and educational resources for providers and patients on telehealth payment, privacy, and security within six months after the law takes effect.¹⁴

What to do

In vetting your own arrangements for AKS risks, apply the criteria the OIG uses (as listed in the July 1997 letter), including:¹¹

• • the criteria the supplier of the equipment uses to determine which customers receive the equipment,
  • the ownership of the equipment,
  • the location and access to the equipment at the customer’s place of business,

• • the procedures the customer and supplier use to police unauthorized use of the equipment,

• • the value added to the core service being provided by the additional general-purpose equipment, and

• • the number and extent of similar arrangements with other parties.

Risk Area 3: Client Access to Laboratory Information Services Interfaces

Labs typically use laboratory information systems (LISs) or IT systems to operate and manage patient information. Physicians, by contrast, typically use electronic health record (EHR) software and systems to perform these functions. As a result, it’s critical for labs to develop interfaces allowing their LIS to interact with the EHRs of their physicians and other referral sources. Although the practice of giving physicians access to lab interfaces promotes effective healthcare delivery, it also raises potential kickback concerns.

CMS has confirmed that it’s not prohibited “remuneration” under the Stark Law for a hospital system to license from a third-party vendor a custom software interface for use by referring physicians, provided that the custom interface:¹⁵

• • is used only to order or communicate the results of tests and procedures furnished by the [hospital],
  • cannot be modified to perform an alternate function, and
  • cannot be resold, transferred, or assigned by [the physician].

The OIG took a similar position in a December 2012 advisory opinion addressing whether a hospital could provide physicians free access to an electronic interface for transmitting lab and diagnostic test orders and receiving the results. The proposed arrangement wouldn’t implicate the AKS, the OIG said, because it doesn’t provide remuneration to the participating physicians. “Interface access would be integrally related to the [hospital’s] services, such that the free access would have no independent value to the physicians apart from the services the [hospital] provides.”¹⁶ If, however, physicians were able to use the free interface for additional functions beyond transmitting test orders, the free interface would have an independent value and could be an illegal inducement banned by the AKS, the OIG cautioned.

In 2013, CMS and the OIG affirmed that limited-use lab interfaces fall outside the AKS and Stark prohibitions. According to the agencies, free access to a limited-use interface that has no independent value to physicians wouldn’t require AKS safe harbor protection.¹⁷

Unfortunately, the OIG’s latest advisory opinion on the subject, AO 2015-04, seems to represent a reversal of course. An independent lab wanted to provide lab testing services to a physician practice’s patients on an exclusive basis. There were no financial incentives. The practice’s motivation was the convenience of dealing with one lab and getting test results in a consistent format. As part of the arrangement, the lab would provide the physicians an interface to its LIS. But it wasn’t a freebie. The lab said it wouldn’t pay the monthly subscription fees a vendor might charge the physician practices—the physician practices would need to pay them instead.¹⁸

It was essentially the kind of arrangement the OIG had signed off on in 2012 and the CMS had okayed in 2008. But the OIG said the arrangement raised potential kickback concerns since it would enable the physicians to avoid having to pay the monthly EHR maintenance fees they would have incurred if they had to deal with other labs outside the exclusive arrangement.¹⁸ Note that the lab also agreed it wouldn’t charge any fees to physician practice patients who were out of network. The OIG concluded the exclusive nature of the arrangement would reduce administrative and potentially financial burdens for the physician practices that would be incurred by working with multiple labs.

What to do

As with client supplies, you need to set policies for providing clients with the use of equipment, including a computer interface, assuring that the equipment:

• • is not provided to physicians in exchange for referrals,
  • is integral to, and exclusively used for, performance of the lab’s work,
  • does not have a clear independent value to the physician,
  • is tagged as being property of the lab, and
  • is removed or deactivated whenever testing services with the lab are terminated.

It’s also advisable for labs to confirm these limitations in a written agreement with the client.

Risk Area 4: Donating EHR Software to Clients

The issue of supplying a client with the use of a dedicated LIS interface shouldn’t be confused with the separate issue of donating EHR software to clients. The AKS has a safe harbor and the Stark Law has an exception allowing for the donation of such software. Under previous rules, labs were among the providers that could qualify. But CMS and the OIG changed the rules. Effective March 27, 2014, the EHR donor safe harbor/exception no longer applies to “laboratory companies.”¹⁷

The agencies explain that “laboratory companies” include labs that provide clinical laboratory services and those that provide anatomic pathology services, but generally don’t include hospitals with laboratory departments. However, if a hospital-affiliated or hospital-owned company with its own supplier number provides lab services that are billed under the billing number assigned to the company (and not to the hospital), the lab is considered a “laboratory company” for purposes of the safe harbor/exception and doesn’t qualify as a protected donor.¹⁷

What to do

Current Stark exceptions and AKS safe harbors allow providers—other than labs—to donate EHR products and services to physicians for purposes of interoperability. As part of its value-based proposed rules, CMS expanded the scope of the Stark EHR exception and established a new AKS safe harbor to cover cybersecurity products and services. To qualify for the new cybersecurity donation exception/safe harbor:¹⁹

• • the donation must be made under a written agreement,
  • the donated products/services must be certified as interoperable and not equivalent to products/services the physician already has, and
  • the physician must contribute 15 percent of the donor lab’s costs.

However, while covered by the new cybersecurity safe harbor, labs are excluded from the EHR safe harbor. That may be a positive thing since it means that labs can’t be pressured by physicians and EHR vendors to furnish free or low-cost equipment to their physician referral sources. However, pressure can still be exerted for cybersecurity hardware and software for which the safe harbor is available to labs.

Risk Area 5: Gifts, Meals, and Other Non-Monetary Compensation

Like many other businesses, labs have to do their share of “wining and dining” to attract and retain clients. Unfortunately, these business courtesies expose the lab to liability risks under the AKS and Stark. But as they do with the other potentially problematic business practices, the laws do provide some leeway for these activities.

The AKS focuses on the purpose of the perks offered to clients. To be permissible under the Stark Law, non-monetary compensation must not be:

• • solicited by the physician (or staff members), or
  • determined in any manner that takes into account the volume or value of referrals from the referring physician.

Stark also imposes a specific per-year cap on the non-monetary compensation that may be given by a lab to physician referral sources.²⁰ The annual cap amount is set by CMS. CMS has also made it clear that the per-physician cap applies to individual physicians and may not be aggregated to permit a greater allowance for a group of physicians.

Gift certificates are generally considered to be cash equivalents and don’t fall within the exception. CMS further requires that labs track the dollar value of the client courtesies they extend to physicians.

Exceeding the cap may result in enforcement action. But a lab that inadvertently exceeds the yearly limit may avoid violating the Stark Law if:²⁰

• • the value of the excess compensation is no more than 50 percent of the limit, and
  • the physician returns the excess by the earlier of 180 consecutive calendar days of receipt or the end of the calendar year in which it was received.

A lab may only use this option once every three years for the same referring physician.²⁰

The October 2019 HHS value-based care kickback relief proposal includes a new exception for arrangements in which a lab pays a physician less than $3,500 in a calendar year in exchange for items or services. This proposed exception wouldn’t require a written agreement, signature, or that the compensation be set in advance. Nor would it ban either or both parties profiting from the deal. But it does require that:²¹

• • the physician actually provides the services or items the compensation covers,
  • the arrangement furthers a legitimate business purpose,
  • the terms and conditions are similar to like arrangements,
  • the remuneration isn’t based on the value or volume of referrals, and
  • the remuneration reflects fair market value for the items or services.

Other restrictions on business courtesies

Finally, labs need to be aware of not just the AKS and Stark but also complementary restrictions on extending business courtesies to physicians. For example, labs owned by medical device manufacturers are subject to the Physician Payments Sunshine Act, which mandates the tracking and disclosure of payments or gifts to physicians valued at more than $10.²¹ Labs that manufacture and market assays may also belong to trade associations that have adopted stringent marketing standards, such as the Advanced Medical Technology Association’s (AdvaMed’s) Code of Ethics on interactions with healthcare professionals. The AdvaMed code restricts member companies from providing any entertainment or recreational event or activity (e.g., theater and sporting events) for healthcare practitioners, although the code allows members to provide modest meals, as long as they are incidental to bona fide presentation of scientific, educational, or business information and provided in a manner conducive to the presentation of such information.²²

What to do

To ensure compliance with these rules, labs should implement and enforce policies regulating the type and aggregate monetary value of business courtesies that are provided to their customers. Labs must also develop systems to monitor compliance with those policies.

The integration of tracking forms or software and pre-authorization requirements can help mitigate compliance risks and enable labs to curtail non-compliant gifts and non-monetary compensation. See Figure 6.3 for a list of gift items banned by Stark Law.

FIGURE 6.3

Gift Items Banned by the Stark Law

Alcohol pads	Snares
K-Y or other lubricating jelly	Cover slips
Antibacterial soap	Speculums
Microscopic slides	Examination gowns
Baggies or zip lock bags	Syringes
Parafilm	Facial tissues
Band-Aids	Table paper
Phlebotomy chairs	Gauze
Betadine swabs	Test kits
Plain paper for copier	Germicidal soap
Biopsy needles	Test tube racks
Q-tips	Gloves
Butterfly needles	Tongue blades
Reagents for in-office testing	Hazardous material labels
Catheter kits	Tourniquets
Refrigerators	Hemoccult developer
Coban wrap pressure bandage for wounds	Urine cups (nonsterile, without lid)
Rubber bands	Hypoallergenic tape
Cotton balls	Urine dip sticks
Injection needles (reusable or disposable)	Aspiration needles (reusable or disposable)

Risk Area 6: Professional Courtesy and Introductory Free Trials

Stark doesn’t include an exception allowing independent labs to provide “professional courtesy” testing to a physician (or office staff and family members). CMS elected not to approve an exception to the Stark prohibition of “compensation arrangements” for independent labs because, in its view, “such ‘courtesy’ offered by suppliers would pose a risk of program abuse.”²⁵ Moreover, in its 1994 Special Fraud Alert, OIG listed “[p]rovision of free laboratory testing for healthcare providers, their families, and their employees” as an example of an inducement offered by clinical labs that may implicate the AKS.²

A compelling business argument can be made for giving a physician or other practitioner the opportunity to assess the medical benefits of novel testing technology, or the services of a lab offering better turnaround than the provider’s current lab. However, the decision to offer free testing, even on a limited time basis, implicates both Stark and AKS, the OIG stated in the 1994 fraud alert:

“[W]here the provision of free [laboratory] services results in a benefit to the provider, the Anti-Kickback Statute is implicated…There is no statutory exception or ‘safe harbor’ to immunize any party to such a practice because the Federal programs do not realize the benefit of these ‘free’ services.”²

Since a limited free trial confers no benefit on the provider other than the opportunity to use a test to benefit its patients, it’s unclear how a limited trial would violate the Stark Law or AKS. However, the practice of offering free trials to patients may trigger the Civil Monetary Penalties (CMP) provision of AKS prohibiting inducements to beneficiaries.²⁶ The OIG has suggested that it might be permissible for a hospital to offer patients free blood screenings that were not covered by Medicare in limited circumstances. According to the OIG: “[P]rovision of a free non-covered screening test [by the hospital] would not violate [the CMP] so long as the test is not tied to provision of services by the hospital.”²⁷

Thus, for example, the screening test would be permissible where the hospital provides an individual who tests positive for diabetes with general information or literature and a recommendation that the individual contact his or her personal physician. If, on the other hand, as part of the screening program, the hospital makes appointments for individuals with one of its physicians, offers individuals discounts for additional covered services, or otherwise promotes its particular diabetes programs, an inference may be drawn that the free screening test was an inducement to choose the hospital as a provider of other services.²⁷

What to do

Based upon this commentary, and assuming the lab carefully confirms that there’s no financial benefit to the ordering provider (and that no one is billed for the testing), the key issue seems to be whether the lab implicitly or explicitly imposes any condition on patients (or providers) linking the trial test(s) to future services. Given the government’s limited tolerance for the practice, labs would be wise to use restraint on the frequency and context of any free trial programs.

Though the six categories of free items and services outlined above can pose compliance risks for labs, the following steps can help prevent issues:

5 ways to protect your lab from the compliance risks of “freebies”

1. 1. Ensure that the freebie supplies and equipment you furnish to physicians are used solely to collect, transport, process, or store specimens, are integral to those functions, and offer no value to the physician independent of those functions.
   2. Ensure that free or loaner computer equipment you supply to providers meets the same criteria that apply to free supplies.
   3. Ensure that physicians to whom you provide LIS interfaces use the service only to order tests or communicate test results and that the service cannot be modified to perform alternative functions or resold or transferred by the physician.
   4. Ban the donation of EHR software to providers—although you may furnish such equipment via arrangements that satisfy other safe harbors, e.g., leases at fair market value.
   5. Set caps and restrictions on providing physicians gifts and non-monetary compensation, including food and entertainment, and implement systems to monitor all transactions and ensure the limits are being followed.

References:

1. 1. Physician Self-Referral Law [42 U.S.C. § 1395nn]. https://www.govinfo.gov/content/pkg/USCODE-2010-title42/html/USCODE-2010-title42-chap7-subchapXVIII-partE-sec1395nn.htm
   2. OIG Special Fraud Alert. https://archives.federalregister.gov/issue_slice/1994/12/19/65371-65379.pdf
   3. CMS Advisory Opinion CMS-AO-2010-01 (June 2010). https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/CMS-AO-2010-01.pdf
   4. 66 Fed. Reg 948. https://www.govinfo.gov/content/pkg/FR-2001-01-04/pdf/01-4.pdf
   5. OIG Advisory Opinion 16-12 (December 5, 2016). https://oig.hhs.gov/documents/advisory-opinions/731/AO-16-12.pdf
   6. Ameritox Ltd. v. Millennium Laboratories Inc., Case number 8:11-cv-00775, U.S. District Court for the Middle District of Florida, Tampa Division. https://law.justia.com/cases/federal/district-courts/florida/flmdce/8:2011cv00775/256863/684/
   7. https://fcablog.sidley.com/wp-content/uploads/sites/5/2020/03/Ameritox-v.-ML-amicus-brief.pdf
   8. https://www.justice.gov/usao-ma/pr/millennium-laboratories-pay-256-million-resolve-false-billing-and-kickback-claims
   9. OIG Enforcement Actions webpage. https://oig.hhs.gov/fraud/enforcement/. More recently, a federal court ordered Calloway Laboratories, Inc. to pay $1,374,058 to settle claims of falsely billing Medicare and TRICARE for urine drug tests over a six-month period in 2014. As part of the settlement, the now defunct Woburn-MA-based lab admitted to offering free testing supplies to physicians in exchange for testing referrals. What started as an AKS offense became an FCA violation when Calloway subsequently billed Medicare and TRICARE for those tests. https://www.justice.gov/usao-edky/pr/federal-court-orders-13-million-judgment-against-toxicology-laboratory-committing
   10. OIG Advisory Opinion 17-03 (August 2017). https://oig.hhs.gov/documents/advisory-opinions/736/AO-17-03.pdf
   11. OIG Letter Re: Free Computers, Facsimile Machines and Other Goods Reference. https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/2006053221-hi-letterrefreecomputersfacsimilemachinesandothergoods.pdf
   12. OIG Advisory Opinion No. 18-03, May 31, 2018. https://oig.hhs.gov/documents/advisory-opinions/746/AO-18-03.pdf
   13. OIG Advisory Opinion No. 11-12, September 6, 2011. https://oig.hhs.gov/documents/advisory-opinions/626/AO-11-12.pdf
   14. H.R.2903 – Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2021. https://www.congress.gov/bill/117th-congress/house-bill/2903
   15. CMS-AO-2008-01 (May 2008). https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/downloads/cms-ao-2008-01.pdf
   16. OIG AO-12-20 (December 19, 2012). https://oig.hhs.gov/documents/advisory-opinions/656/AO-12-20.pdf
   17. 78 FR 79202. https://www.federalregister.gov/documents/2013/12/27/2013-30924/medicare-and-state-health-care-programs-fraud-and-abuse-electronic-health-records-safe-harbor-under
   18. OIG Advisory Opinion 15-04 (March 25, 2015). https://oig.hhs.gov/documents/advisory-opinions/693/AO-15-04.pdf
   19. 42 CFR §1001.952(y)(1)(i). https://www.ecfr.gov/current/title-42/chapter-V/subchapter-B/part-1001/subpart-C/section-1001.952
   20. 42 CFR § 411.357(k). https://www.govinfo.gov/content/pkg/CFR-2016-title42-vol2/pdf/CFR-2016-title42-vol2-sec411-357.pdf
   21. 84 FR 55766. https://www.federalregister.gov/documents/2019/10/17/2019-22028/medicare-program-modernizing-and-clarifying-the-physician-self-referral-regulations
   22. The Physician Payments Sunshine Act, Section 6002 of the Affordable Care Act of 2010. https://www.govinfo.gov/content/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf
   23. AdvaMed Code of Ethics. https://www.advamed.org/member-center/resource-library/advamed-code-of-ethics
   24. Foster Garvey. “Strictly Speaking: CMS Stark Law Guidance to Labs on Speculums and Other Supplies.” September 8, 2011. https://www.foster.com/newsroom-alerts-Strictly_Speaking__CMS_Stark_Law_Guidance_to_Labs_on_Speculums_and_Other_Supplies
   25. 72 Fed. Reg. 51064 (September 5, 2007). https://www.govinfo.gov/content/pkg/FR-2007-09-05/pdf/07-4252.pdf
   26. Section 1128A(a)(7) of the Social Security Act. https://www.ssa.gov/OP_Home/ssact/title11/1128A.htm
   27. 65 Fed. Reg. 24400 (April 26, 2000). https://www.govinfo.gov/content/pkg/FR-2000-04-26/pdf/00-10142.pdf