Physician-Owned Medical Device Distributors: A Controversial Business Model
By John E. Kelly and Anne P. McNamara, Bass, Berry & Sims PLC, Washington, D.C.1
Financial arrangements in the healthcare industry are complicated and constantly evolving. Nothing exemplifies this more than the recent growth in the formation of physician-owned medical device distributors, or PODs. Although the PODs business model has been gaining in popularity, opponents criticize it for operating in the grey in terms of legality and creating conflicts of interest. Conversely, proponents of PODs say that it is a legal and beneficial business model when it is properly structured. Recent government and public scrutiny has led stakeholders to question whether the rewards of PODs are worth the risks.
What Are PODs?
PODs are business arrangements involving physician ownership of a medical device distributor or company. Typically, in a POD arrangement, a physician purchases a share or ownership interest of a medical device company in exchange for a cash investment and with the promise of the potential to earn returns at a far higher rate than more traditional investments.2 Although there is no requirement that POD owners be doctors, physicians – especially surgeons – are considered ideal POD investors because they can generate referrals that benefit the company. For this reason, a POD is often formed by a group of physicians to sell and distribute devices to hospitals or surgical centers where the physician-investors perform procedures utilizing the same devices distributed through the POD.3 Therefore, PODs enable surgeons to have greater control over what medical devices are used during a procedure, and to share in the profits generated by the sale of those devices.
POD Business Models
In a traditional supply business model, medical devices are sold to hospitals and surgery centers directly by manufacturers. That sale is transacted through employee representatives or independent contractor distributors. The manufacturer and its representatives then typically provide to the buyer the device as well as a number of services including order and delivery; stocking and restocking; sterilization; selection; delivery and deployment of external instrumentation; and assistance to surgeons in the operating room.
The role of a POD can vary widely depending on the business model. For example, in a “physician distributor” model, the POD acts as a product distributor that buys devices from manufacturers, and then resells them to the hospitals where the physician-investors refer their patients for procedures. In a “physician manufacturer” model, the POD claims to be a device manufacturer; it develops products that are produced by an outsourced manufacturer and then distributed by the POD. Finally, in a “physician group purchasing organization” model, the POD acts as a Group Purchasing Organization (“GPO”). Proponents of this model claim that it enables GPOs to negotiate lower prices from a wide variety of manufacturers via its aggregated buying power, though opponents question whether the volume of membership is significant enough to create bargaining leverage and whether GPOs reliably lead to optimal discounts for their members.4
Although there are a variety of business models and compliance issues to consider with PODs, the Department of Health and Human Services’ Office of Inspector General (“OIG”) has not issued specific guidance concerning PODS, nor have PODs been subject to the same state, federal and public licensure and regulatory oversight as say, for example, a joint venture involving a physician-owned provider of ancillary healthcare services.5 This lack of oversight and meaningful guidance creates greater potential for problematic POD arrangements, since such guidance can provide a roadmap for POD compliance. Without guidance, more aggressive POD models may take advantage of this lack of clarity and grey area of the law to maximize profits in ways that would not be permissible for other types of ancillary service arrangements.
The Recent Growth of PODs
The formation and use of PODs has become increasingly common in the last few years. Currently, at least 20 states have multiple active PODs, including more than 40 PODs operating in California.6 The focus of PODs tends to be in the surgical arena, with a particular emphasis on orthopedic implants (spine and joint) and cardiac implants (pacemakers and defibrillators).7 Rural areas have also experienced a particularly marked increase in the formation of POD distributor models.8
As physicians continue to see dramatic reductions in reimbursements, increased demands on their time, hospital cost initiatives, and growth in patient and procedure volumes, they often look for sustainable ancillary revenue sources. Correspondingly, hospitals may feel pressure to do business with PODs to avoid the risk of losing referrals from their surgeons.9
Polarized Opinions: Are PODs Good or Bad?
Proponents of PODs often cite the potential such arrangements create for substantial cost savings. They argue that the POD business model saves hospitals millions of dollars when compared to more traditional medical device distribution channels. This is because the POD is able to negotiate lower pricing, since the manufacturer will arguably not need to spend time or effort marketing its product. When a POD engages in arms-length price negotiations with a device manufacturer, the POD usually receives a lower purchase price than that which is offered to other purchasers, including hospitals. The POD is then able to share such savings with hospitals in which the device is eventually used. For example, at the 2009 American Association of Orthopedic Surgeons annual meeting, a California POD asserted that it helped save the hospital it was affiliated with 34 percent over a two-year period on the purchase of implantable devices, with total savings of more than one million dollars.10
Opponents of PODs raise a number of concerns, especially when it relates to PODs that lack operating history or experience, or those that fail to offer secondary services like traditional supply models do. Critics argue that most PODs act as shell entities, with no real infrastructure or capital investment, that have been developed for the unlawful purpose of directing remuneration to physicians for their ability to control the selection of surgical devices or implants sold through the arrangement.11 Their specific concerns generally fall into the five categories set forth below.
- First, opponents argue that PODs create an ethical conflict of interest that can distort medical decision making by incentivizing doctors to order devices that will benefit them financially, rather than order the product that is best for patients. In many POD scenarios, the surgeon is acting as the buyer, seller and person making the decision about what device is most beneficial for the patient. Arguably, this can impact the quality of care provided to the patient.
- Second, opponents state that PODs incentivize overutilization, because the more procedures that a physician performs, the more commissions that physician can earn from the sale of the product. This increases the likelihood of unnecessary, or unnecessarily device-intensive, procedures. For example, a June 2011 Senate Committee Report on PODs included testimony about elderly patients with herniated disks who had 8-10 fusions on their backs despite serious health risks associated with the procedures. The report also chronicled patient deaths allegedly due to multiple operations. Similarly, the Quality Implant Coalition reported that in 2007, spinal fusion revision rates increased more than 300 percent after a POD spinal product distributor moved into the hospital’s service area.12
- Third, opponents state that PODs have an unfair effect on competition because hospitals that want a physician-owner to perform procedures at the facility, and manufacturers that want those doctors to use their products, may have to use a referring doctor’s POD even if it is more expensive to do so.
- Fourth, there are concerns that PODs increase the cost or lower the quality of available devices because problematic PODs are middlemen shell entities with no independent value. They merely perpetuate inefficiencies in the traditional supply chain model. For example, i f the commission payment is part of the sale price, the POD has no incentive to negotiate a lower sale price. Opponents also note that although PODs may initially save money through negotiations, this might be a false metric because it doesn’t take into account other factors in a true cost analysis, such as the original decision to operate on the patient, or the number of revision surgeries performed to fully treat the patient’s condition. Opponents of PODS also cite to the fact that many investor-physicians have no expertise in the medical device supply chain prior to joining a POD.
- Fifth, opponents argue that allowing physicians to financially profit from the devices their patients require may violate the federal Anti-Kickback Statute (“AKS”)13 or the Stark law14 prohibition on compensation arrangements.
Legal Analysis, Guidance and Recent Developments
Little regulatory guidance currently exists for PODs, and it remains unclear to some whether PODs are legal. On the one hand, some lawyers have opined that properly structured and operated PODs are perfectly legal.15 They argue that if structured correctly, PODs do not create a conflict of interest, do not incentivize the use of substandard products, and will not be eliminated by the government.16 However, others in the legal field believe that PODs are inherently unlawful and that physician ownership of PODs does not reflect a legitimate investment.17 Opponents to PODs claim that physician-investors in a POD, and the hospital and implant manufacturers who deal with them, risk substantial liability under such laws as the AKS, the Stark Law, and the False Claims Act (“FCA”) for participating in this business model. Although a number of laws touch upon the PODs business model and the debate concerning its legality, much of the debate has been concentrated on the AKS because it is most easily associated with the issues concerning the PODs model, and the government is focused on eliminating improper influence and the impact it may have on the quality of patient care.
Most fraud and abuse questions with PODs focus on the federal AKS. The AKS is an intent-based statute, and a person may violate the AKS if just one purpose of a POD arrangement is to induce referrals for services or purchases of items reimbursable under a federal healthcare program. Accordingly, by way of example, the AKS may be violated if one purpose of a hospital doing business with a POD is to ensure patient referrals by the physician POD investors through the purchase of devices that are reimbursed by Medicare. Further, in a September 2011 letter, the OIG wrote that its “ability to issue guidance about the application of the AKS to POD business models is limited because the AKS's intent requirement renders the legality of each POD highly dependent on each entity's particular characteristics, including its legal structure, operational safeguards, and the actual conduct of its investors.”18 Although a POD could arguably be structured in accordance with one of the regulatory safe harbors, this protection is not available for situations where there is physician ownership of PODS, due to limitations of the amount of gross revenue permitted to be derived from referrals or business generated by referrals.19
The Stark law is a federal statute that prohibits physicians who have financial relationships with entities from making referrals to those entities for the furnishing of “designated health services” (“DHS”) reimbursable by a federally-funded healthcare program. Although POD arrangements seem potentially problematic under the Stark law, CMS has repeatedly declined to include physician-owned device or implant companies within the definition of a “DHS entity” for purposes of the Stark law.20 Nonetheless, CMS has written that “[i]n many instances, the arrangement would not satisfy the requirements of the exception for indirect compensation arrangements in § 411.357(p), and would, therefore, run afoul of the physician self-referral statute.”21 Shortly after issuing this opinion, CMS was asked by a large medical device manufacturer to ban PODs under the Stark Law. CMS expressly declined to make the requested change, and stated so within its publication regarding changes to disclosure of physician ownership in hospitals and physician self-referral rules.22
Hospitals also face risk under Stark when they utilize PODs. When hospitals purchase devices from PODs, this is considered DHS as defined by the Stark law.23 However, hospitals are protected by the statute’s “indirect compensation” exception if they can demonstrate that any compensation provided from the hospital to the referring physician is fair market value for services and items actually provided, and if such compensation is not determined in any manner that takes into account the value or volume of physician referrals.24
Violations of the AKS or Stark laws can form the basis for a violation of the FCA. Separate and apart from that, PODs create financial incentives that could lead to overutilization, and force patients to undergo unnecessary and invasive procedures. If these procedures are found to be not medically necessary, or are found to improperly increase Medicare costs, this could implicate the FCA. Additionally, hospitals that permit doctors to undertake and bill federally funded healthcare programs for medically unnecessary procedures could be viewed as acting with “reckless disregard” or “deliberate ignorance” under the FCA.25
- Physician Payment Sunshine Act
According to the Sunshine Provisions of the Patient Protection and Affordable Care Act, also known as the Sunshine Act, medical device and medical supply manufacturers must report to HHS the payments or transfers of value that they made to covered recipients. On Dec. 14, 2011, CMS published a proposed rule that addresses how it intends to implement these provisions.26 The Sunshine Act defines a GPO, in relevant part, as a “group purchasing organization (as defined by the Secretary) that purchases, arranges for or negotiates the purchase of a covered drug, device, biological, or medical supply.” According to CMS’ proposed rule, the definition of GPO includes traditional GPOs that negotiate contracts for their members, as well as entities that purchase products for resale or distribution to third parties. Based on this definition, arguably PODs would be considered GPOs for purposes of the Sunshine Act, and therefore subject to the reporting obligations if the rule is finalized as proposed. However, critics could respond that Congress expressly excluded distributors from the Sunshine Act and that CMS is overreaching because a POD would not be considered a GPO under any common definition of that term. Although CMS received numerous comments on this issue, to date CMS has not retreated from its interpretation in the proposed rule.
While federal regulators have yet to issue a decisive statement on the overall legality of PODs, a handful of states have enacted or attempted to enact legislation that would increase oversight of PODs or prohibit PODs entirely. For example, on January 1, 2012, California law A.B. 378 went into effect, increasing the restrictions on PODs by prohibiting PODs from supplying medical devices for workers’ compensation patients.27 The New Hampshire House of Representatives also recently passed legislation intended to prohibit PODs, although the New Hampshire Senate effectively voted down the House-passed bill on May 9 and sent it to further study.28 This uptick in state activity suggests that, unless resolved, the questions concerning PODs will remain in the spotlight at multiple levels of government.
Recent Governmental Developments
Over the past year, there has been a sharp increase in the government’s scrutiny of PODs. The OIG is monitoring these business arrangements and has promised that guidance will be issued.29 However, it remains to be seen how such guidance will impact the use of PODs.
On June 9, 2011, five members of the Senate Finance Committee (the “Committee”) sent a report and letter to OIG requesting that the OIG investigate the legality of PODs under the AKS.30 The report described the recent proliferation of PODs and the Committee expressed concerns about the potential abuse associated with this business model, which the Committee viewed as being significant. Specifically, the Committee wrote that “we are worried that OIG's existing guidance, which is largely focused on physician-owned providers of ancillary healthcare services, and its expressions of concern, is not adequate to protect against the risk of PODs abuse.”31 This may be because the guidance is more broadly directed to the provision of secondary services, rather than to the sale and implantation of a device. Although some of the potential risks are the same for both ancillary healthcare services and PODS, they are not an exact match. For this reason, the Committee asked for specific guidance directed to PODS.
On September 13, 2011, OIG Inspector General Daniel Levinson issued a response to the Committee’s letter and report.32 Levinson promised that the OIG would conduct a review of PODs operating in the spinal implant arena. According to Levinson, the review will seek to determine the extent to which hospitals purchase spinal implants from PODs, the types of services that PODs offer to hospitals, whether PODs save hospitals money in the acquisition of implants, and whether PODs are associated with high use of spinal implants. Not surprisingly, both the 2012 and 2013 OIG Work Plans identified Physician-Owned Distributors of Spinal Implants as an area that the OIG plans to carefully review.33 For 2013, the OIG is focused on the high-utilization of orthopedic implant devices used in spinal-fusion procedures. The OIG also specifically noted that “Congress has expressed concern that PODs could create conflicts of interest and safety concerns for patients.” Such concerns are particularly worrisome for high-risk cardiovascular and spinal surgeries, both of which have seen a recent increase in the number of PODS involved. This is especially disconcerting for high-risk surgeries.
The Committee also sent a companion letter to the Centers for Medicare & Medicaid Services (“CMS”) concerning PODs and how they will be addressed in relation to the Sunshine Act and in the context of those Accountable Care Organizations (“ACOs”) in the Medicare Shared Savings Program that are in a position to purchase products and services from entities owned by ACO physicians.34 The October 3, 2011 letter from U.S. Senators Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) to CMS was particularly focused on creating transparency on the financial interests involved in the PODs arrangement and preventing inadvertent loopholes with ACOs. On October 28, 2011, CMS’ Donald Berwick issued a response to the Committee’s letter and stated that CMS is “actively engaged in developing proposed regulations to support implementation of the [Sunshine Act],”35 and that CMS “appreciated the Senate’s suggestions regarding defining GPOs as potentially including PODs and would consider the issue carefully.”36 In addition, Berwick responded to the Senate Finance Committee’s request that ACOs be prohibited from purchasing products from entities owned by ACO physicians and request that ACO waivers not extend to PODs. He declined to provide much detail, simply noting that CMS was currently reviewing comments received in response to its April 7, 2011, notice of Waiver Designs in connection with the Medicare Shared Savings Program. On November 2, 2011, CMS published an Interim Final Rule regarding Final Waivers in Connection With the Shared Savings Program, and finalizing the details of the program implementation are ongoing.37
What Factors Suggest a “High Risk” POD Investment?
The PODs that are likely to be the most scrutinized or highest risk are those that distribute substantial returns to physicians based on a small investment, limit their business only to physician investors, guarantee high returns on investment, and result in more surgeries being performed by investors than were performed prior to the POD’s involvement.38 If a POD investment involves little or no financial risk for the physician, government regulators will be more likely to question the arrangement. From a compliance perspective, concern is also merited where aggregate return on investment is related to the volume or value of investor referrals, even if individual return is based on a purchased fair market value investment interest. Finally, particular scrutiny is also likely for investment opportunities that are offered to referring investors with no experience or management expertise in the device business. Specifically, if the only investors chosen for a POD are surgeons who have an ability to influence the sale and use of medical devices for their patients, the arrangement appears to be a cloaked way to incentivize unlawful referrals (i.e. ordering implants). Compliance-focused stakeholders should question whether the business, when selecting investors, is looking to legitimately raise capital or to lock in referral sources.
Best Practices for Mitigating Risk
PODs should be structured to ensure that regulatory risks are minimized and that the POD is operating within the parameters of applicable state and federal laws. To this end, the best POD structures will include significant inventory purchase, substantial surgeon investment, financial risk for POD investors, active surgeon involvement, transparency with disclosures, written contracts with all hospitals and vendors, and compliance with all applicable laws including the Stark law and AKS. The OIG recently emphasized that it continues to apply “key factors” in its analysis of physician joint ventures (including PODs).39 These factors include the opportunity for a referring physician to earn a profit; the terms under which a physician may invest in the entity and/or may be required to divest his or her interest; the return on the physician's investment; and the amount of revenues generated for the entity by its physician-investors.
Although it is not possible to eliminate all risk related to the POD business model, it is possible to incorporate certain best practices into the arrangement. For example, physicians involved in PODs should never change referral patterns based on distributorship acceptance. They should also keep prices similar among all hospitals involved. Physicians should see themselves as investors creating a real business that may provide a return on investment, rather than doctors who will be paid for generating business.
In addition, a lower-risk POD model will compensate equally each physician-investor irrespective of individual usage, or carve out the individual physician-investor’s personal usage from the profits he/she receives. If a POD is not permitted to do business with its own investors, their partners, or affiliated hospitals, presumably the POD would act as a traditional distributor. Likewise, there has been praise for PODs that limit product use to procedures that are not federally reimbursable, and for multi-state PODs that only allow physician investors from one state to profit from physician investor usage in the other state(s).
Many physicians, hospitals, and medical device companies have expressed confusion over how to determine whether to participate in or do business with a POD. There is currently very little guidance from regulatory agencies in relation to PODs, which has allowed them to flourish. Given the lack of clarity and increased scrutiny concerning PODs, it is important to carefully weigh the benefits and costs of these business models prior to becoming involved in such arrangements. It is also important to work closely with experienced counsel to effectively structure the POD business model to mitigate risk. If you must proceed, proceed with caution.
Mr. Kelly is the managing partner of Bass, Berry & Sims PLC’s Washington, D.C. office. Ms. McNamara is an attorney who also practices in the of Bass, Berry & Sims PLC’s Washington, D.C. office.
|2||Senate Finance Committee Report, Physician Owned Distributors (PODs): An Overview of Key Issues and Potential Areas for Congressional Oversight (June, 2011). Available online at: www.finance.senate.gov, or click here.|
See 1989 OIG Special Fraud Alert on Joint Venture Arrangements, available here or on the OIG’s website at http://oig.hhs.gov/fraud/docs/alertsandbulletins/121994.html; see also 68 Fed. Reg. 23148, OIG Special Advisory Bulletin on Contractual Joint Ventures (April 30, 2003).
Senate Finance Committee Report, Physician Owned Distributors (PODs): An Overview of Key Issues and Potential Areas for Congressional Oversight (June, 2011). Available online at: www.finance.senate.gov, or click here.
See Deyon TA, Mirza SK, Martin BI; et al. “Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults.” JAMA 2010; 303 (13); 1259-1265 (noting a marked fifteen fold increase in the number of spinal fusion surgeries from 2002-2007 and highlighting the significant financial incentive to both hospitals and surgeons to perform such complicated surgeries.)
See Senate Finance Special Committee on Aging and Judiciary Committees, Letter to OIG Inspector General Levinson, June 9, 2011 at 2.
Senate Finance Committee Report, Physician Owned Distributors (PODs): An Overview of Key Issues and Potential Areas for Congressional Oversight (June, 2011). Available online at: www.finance.senate.gov, or click here.
|11||Id., at 6.|
U.S. Senate Finance Committee Report on Physician-Owned Distributors, June 2011, at 5-6.
See 42 U.S.C. § 1320a-7b
|14||See 42 U.S.C. § 1395nn et seq. The Stark Law is also known as the Physician Self-Referral Law or the Ethics in Patient Referrals Act.|
See Hooper, Lundy & Bookman, P.C., Letter to the Editor, Orthopedics This Week, “Re: Physician Owned Device Companies,” May 20, 2011,
For example, legal proponents of PODS are likely to explain that optimal POD structures will include significant inventory purchase, substantial surgeon investment, financial risk for POD investors, active surgeon involvement, transparency with disclosures, written contracts with all hospitals and vendors, and compliance with all applicable laws including the Stark law and AKS.
See Hogan & Hartson LLP, Physician-Owned “Distributors” of Spinal Implants: The Impropriety of Physicians as Commissioned Sales Representatives, Nov. 2009.
See OIG Response to Senate Finance Committee (Sept. 2011). “The legality of any individual physician-owned entity under the Federal Anti-Kickback Statute is highly dependent on each entity's particular characteristics, including the details of its legal structure; its operational safeguards; and, importantly, the actual conduct of its investors, management entities, suppliers, and customers during the implementation phase and ongoing operations,” Levinson said. “For these reasons, OIG's ability to issue guidance about the application of the statute to these business structures is limited.”
See 42 C.F.R. § 1001.952(a)(2); see also 42 C.F.R. § 1001.952(a)(2)(v).
|20||See Department of Health and Human Services, Centers for Medicare & Medicaid Services, Medicare Program; Changes to Disclosure of Physician Ownership in Hospitals and Physician Self-Referral Rules, 73 Fed. Reg. 48434, 48727 (Aug. 19, 2008) (“we are not adopting the position that physician owned implant or other medical device companies necessarily ‘perform the DHS’ and are therefore an ‘entity’” under Stark, but “[w]e may decide to issue proposed rulemaking on this [POD] issue in the future”).|
|21||See 73 Fed. Reg. 23527, 23695 (Apr. 30, 2008).|
|22||See 73 Fed. Reg. 48,727 (Aug. 19, 2008).|
|23||42 C.F.R. § 411.353(a).|
|24||42 C.F.R. § 411.357(p)|
|25||See 31 U.S.C. § 3729(b)(1)(A)(ii)-(iii).|
|26||Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests, 76 Fed. Reg. 78742 (Dec. 19, 2011).|
|27||CAL. LAB. CODE § 139.3(a)|
|28||N.H. HB 1725 (March 29, 2012), available online at http://gencourt.state.nh.us/legislation/2012/HB1725_HA.html|
|29||Letter from Daniel R. Levinson, Office of Inspector General, U.S. Department of Health and Human Services to Senators Orrin G. Hatch (R-Utah) et al. (September 13, 2011)|
|30||Letter from Senators Orrin G. Hatch (R-UT), Max Baucus (D-MT), Herb Kohl (D-WI), Bob Corker (R-TN), and Charles E. Grassley (R-IA) to Administrator Donald Berwick, CMS, June 9, 2011, available at http://finance.senate.gov/newsroom/ranking/download/?id=1e6e609a-20ae-46cf-b85e-ea567a7ecc8c (last visited July 14, 2012).|
|31||See Senate Finance Special Committee on Aging and Judiciary Committees, Letter to OIG Inspector General Levinson, June 9, 2011 at 2.|
|32||Letter from Daniel R. Levinson, Office of Inspector General, U.S. Department of Health and Human Services to Senators Orrin G. Hatch (R-Utah) et al. (September 13, 2011).|
|33||U.S. Department of Health & Human Services 2012 Office of Inspector General Work Plan, available at http://oig.hhs.gov/reports-and-publications/archives/workplan/2012/Work-Plan-2012.pdf.|
|34||See PPACA § 6002, 42 U.S.C. 1320a-7h.|
|35||Letter from Donald M. Berwick, CMS Administrator, to Herb Kohl, Chairman, Senate Special Committee on Aging (Oct. 28,, 2011).|
|37||76 Fed. Reg. 67991 (November 2, 2011).|
|38||This analysis is based on factors first raised in the OIG’s Special Fraud Alert on Joint Venture Arrangements (1989) and its Special Advisory Bulletin on Contractual Joint Ventures (2003). In October 2011, the OIG issued Advisory Opinion No. 11-15, and the OIG’s negative analysis of the proposed physician owned company arrangement echoed these same historical factors. See 1989 OIG Special Fraud Alert on Joint Venture Arrangements, available on the OIG’s website at http://oig.hhs.gov/fraud/docs/alertsandbulletins/121994.html ; see also 68 Fed. Reg. 23148, OIG Special Advisory Bulletin on Contractual Joint Ventures (April 30, 2003); see also OIG Advisory Opinion No. 11-15, a vailable online at http://oig.hhs.gov/fraud/docs/advisoryopinions/2011/AdvOpn11-15.pdf.|
|39||See OIG Response Letter to the Senate Finance Committee (September 13, 2011).|
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