On May 26, 2021, the Department of Justice (“DOJ”) announced a coordinated law enforcement action against 14 telehealth executives, physicians, marketers, and healthcare business owners for their alleged fraudulent COVID-19 related Medicare claims resulting in over $143 million in false billing.[1] This coordinated effort highlights the increased scrutiny telehealth providers are facing as rapid expansion efforts due to COVID-19 shape industry standards.

Since the outset of the COVID-19 pandemic, the DOJ has prioritized identifying and prosecuting COVID-19 related fraudulent conduct, particularly in regards to the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act[2] financial assistance programs. However, before this latest health care fraud takedown, the DOJ announced relatively little enforcement activity specific to federal healthcare programs. This renewed enforcement action may spark an increased effort by the DOJ to manage pandemic-related fraud as it relates to healthcare programs.

In addition to the DOJ criminal charges, the Center for Program Integrity (“CPI”), Centers of Medicare and Medicaid (“CMS”) separately announced penalties for over 50 medical providers for their involvement in health care fraud schemes related to the pandemic and abuse of CMS programs.[3] The CPI/CMS charges in conjunction with DOJ’s healthcare fraud takedown provide insight into DOJ’s current enforcement patterns related to the pandemic which include:

  • Telehealth Waivers: In an effort to expand patient access during the pandemic, CMS broadened the services it reimbursed for telemedicine practices while federal officials also relaxed privacy guidelines that restricted types of devices that qualified to administer telehealth services. CMS also waived patient deductibles and copayments, which otherwise would have been construed as kickbacks if used for unnecessary services. The cases announced by both the DOJ and CMS allegedly sought to exploit these expanded policies by submitting false claims to Medicare for telemedicine encounters that never actually occurred. Additionally, DOJ charged medical professionals in these cases with allegedly accepting bribes in exchange for referrals of medically unnecessary testing.[4]
  • Bundled COVID-19 Testing: In addition to filing medically unnecessary Medicare claims, the DOJ charged defendants in these cases with bundling COVID-19 testing claims with Medicare claims for additional, often more expensive laboratory tests, such as cancer genetic testing, allergy screenings, and respiratory pathogen panel tests. In many of these cases, these tests were medically unnecessary or were not even provided to the patients.[5]
  • Provider Relief Funds: The recent law enforcement activity included the third criminal case in the country targeting misuse of Provider Relief Funds. The CARES Act created this funding to support patients with healthcare related expenses or lost revenue attributable to COVID-19. In this case, the DOJ alleged that the owner of a home health agency misappropriated Provider Relief Funds for his own benefit.[6]

While the DOJ’s May announcement focused on criminal healthcare fraud actions related to COVID-19, we can expect that the DOJ’s Civil Division will also make telehealth enforcement a priority. In a February address to the Federal Bar Association’s Qui Tam conference, Acting Assistant Attorney General Brian M. Boynton stated, “I also expect a continued focus on telehealth schemes, particularly given the expansion of telehealth during the pandemic.”[7] It is likely that the expansion of telehealth services and waivers will cause the Department to see a rise in qui tam actions filed by whistleblowers, as well as False Claims Act cases as the year progresses and the economy continues to recover from the pandemic.

***

[1] Press Release, DOJ Announces Coordinated Law Enforcement Action to Combat Health Care Fraud Related to COVID-19, Department of Justice (May 26, 2021), https://www.justice.gov/opa/pr/doj-announces-coordinated-law-enforcement-action-combat-health-care-fraud-related-covid-19.

[2] The CARES Act, Pub. L. No. 116-136 (2020).

[3] Press Release, DOJ Announces Coordinated Law Enforcement Action to Combat Health Care Fraud Related to COVID-19, Department of Justice (May 26, 2021), https://www.justice.gov/opa/pr/doj-announces-coordinated-law-enforcement-action-combat-health-care-fraud-related-covid-19.

[4] U.S. v. Stein et al., 1:21-CR-20321-CMA (S.D. Fla. May 25, 2021).

[5] U.S. v. Taylor, 2:21-MJ-02003-MEF (W.D. Ark. May 21, 2021); U.S. v. Ruis et al., 9:21-CR-80080 (S.D. Fla. May 24, 2021); U.S. v. Clarkin, 3:21-CR-00438 (D.N.J. May 24, 2021).

[6] U.S. v. Hannesyan, 2:21-MJ-02562 (C.D. Cal. May 24, 2021).

[7] Press Release, Acting Assistant Attorney General Brian M. Boynton Delivers Remarks at the Federal Bar Association Qui Tam Conference, Department of Justice (February 17, 2021), https://www.justice.gov/opa/speech/acting-assistant-attorney-general-brian-m-boynton-delivers-remarks-federal-bar.

Only a few days remain before the enforcement delay that the Centers for Medicare & Medicaid Services (CMS) exercised due to COVID-19 will end and the agency will require certain payors to publish a Patient Access application programming interface (“API”) and a Provider Directory API under the requirements of the CMS Interoperability and Patient Access Final Rule. Starting on July 1, 2021, all health plans that offer Medicare Advantage, Medicaid and Children’s Health Insurance Program (CHIP) and most Qualified Health Plans offered through the Federally-facilitated Exchange will be required to make enrollee electronic health information held by the payor and the health plan’s Provider Directory (QHP Issuers on the FFEs are required to make a Provider Directory under a different CMS rule, not under this rule) available through application programming interfaces (“Open APIs”). CMS is also hopeful that when these payors see the benefit of offering easy access for their federally subsidized health care program enrollees to use and exchange their electronic protected health information, the payors will offer the same opportunity for enrollees in their commercial and Employer Sponsored plans.

The interactions between the Patient Access and Provider Directory APIs were designed to ensure that claims, encounter and certain clinical information held by payors becomes easily accessible to health plan enrollees to make it easier for them to identify which providers are in a plan’s network and to assist them in making the right care choices. However, publishing Open APIs is only one part and one step towards building the infrastructure that is needed to integrate information from multiple sources that will be able to impact both the quality and cost of health care.

Other rules, including the ONC Interoperability and Information Blocking Rules, the Hospital Transparency and Transparency in Coverage Rules, OCR’s Proposed Modifications to the HIPAA Privacy Rule and the Proposed No Surprises Act Rules also play a part in providing patients with access to a complete picture of their electronic health information and will influence the future that patient centered access plays in driving innovation, improving care, managing cost, and ensuring equitable care into the future.

While researchers have recognized the value of using claims, encounter and other health plan data in their analyses and studies for many years, individuals have rarely sought access to their own health histories through their health plan data. Payor data was considered difficult to use and consumers typically don’t find their claims histories helpful for making decisions about their future care. Through the implementation of Blue Button 2.0, CMS recognized that the longitudinal view of health plan data along with the clinical information from providers offers a complete view of a patient’s profile. Together, these data sets can inform care and benefit coordination in a way that can have a meaningful impact on both the cost and quality of care. With health care costs rising and individuals bearing responsibility for a larger portion of out-of-pocket expenses (e.g., co-pays, co-insurance and deductibles), having an integrated view of both clinical and cost information has become more important to consumers.

In addition to publishing Patient Access and Provider Directory APIs, payors are expected to develop or to engage with third parties to develop the software that will help transform health plan data that is currently hard to use and siloed, into meaningful information to enable patients, providers and payors to make the best health care choices possible. As covered entities under the Health Insurance Portability and Accountability Act (HIPAA), health plans are obligated to make an enrollee’s protected health information available to them under the HIPAA Right of Access rules.

As long as payors are developing or engaging developers directly, HIPAA would protect the electronic protected health information being collected and combined. However, Open APIs also offer the opportunity to third party developers who are not necessarily covered entities nor business associates of covered entities to offer their services directly to individuals. With the proper consent or authorization and the Patient Access API, a third party application developer acting on behalf of an individual can obtain access to that individual’s electronic protected health information and, once accessed, the HIPAA Privacy and Security Rules are no longer applicable.

Introducing third party applications that are not regulated under HIPAA as the vehicle that streamlines individuals’ access to and exchange of their electronic protected health information shifts the paradigm from covered entities deciding with whom to share protected health information to consumers making those decisions. Unless consumers know that the application they choose is not covered under HIPAA, there is the potential for them to unwittingly authorize their sensitive health information to be over-shared or to be used in ways they had not intended or anticipated. Although third-party application developers are responsible for obtaining the appropriate consent and/or authorization from individuals choosing their apps, payors may want to make sure that their enrollees are educated, informed and know what to look for from an app developer that might take advantage or hide behind convoluted language in a consent/authorization or Privacy Policy. Furthermore, to build trust with their enrollees, payors may want to collect some basic background information about the application developer that offers services to its enrollees and may be exchanging information with the payor. Some payors may offer application developers the opportunity to test their technologies and in doing so will be able to learn about the security and privacy posture of the application so that the payor can assist enrollees in choosing applications that will be beneficial to them and not put their sensitive health information at risk. Ultimately, payors should try to use this first phase of compliance with the Patient Access and Provider Directory APIs to connect and engage with enrollees and to prepare for the next step that will take place on January 1, 2022, when payors will be required to implement a payor-to-payor API to encourage more seamless information sharing between health plans at an enrollee’s request.

If you or your organization haven’t fully considered the intersections and implications of the CMS Interoperability and Patient Access Rules, with the ONC Interoperability and Information Blocking Rules, the Price Transparency Rules (Hospital and Payor), the Proposed Modifications to the HIPAA Privacy Rule and the Proposed No Surprises Act that are expected to be released soon, please contact the Epstein Becker & Green, P.C. attorney who regularly handles your legal matters, or one of the authors of this blog post.

Our colleagues Alaap Shah and Stuart Gerson of Epstein Becker Green have written an Expert Analysis on Law360 that will be of interest to our readers: “Health Cos. Must Prepare for Growing Ransomware Threat.”

The following is an excerpt (see below to download the full version in PDF format):

Ransomware attacks have become big business, and they are on the rise. And entities in the health care and life sciences space have become primary targets of opportunity for attackers.

As the recent Colonial Pipeline Co. ransomware event illustrates, a small group of black hat hackers, living in protected status in nation states hostile to U.S. interests, can create massive disruption in our country’s infrastructure and well-being, and significant economic and other benefit for themselves and for the governments that support them.

Why is it that health care is such a prime target? The reason lies in the nature of the data that health care and life sciences companies and institutions create and store, and their relative vulnerability in the way they maintain and communicate it.

Health care entities are a treasure trove of cutting-edge research and information regarding pharmaceuticals, medical devices and other intellectual property that command great value. The protected health information that they store is of immense value, less with respect to identity theft, as is the popular notion, than it is as an enabler of fraudulent billing schemes that can quickly produce millions in revenue for hacking organizations.

And in the broadest sense, imagine, for example, the societal dislocation that a hostile digital intruder, or its sponsors, could cause if hospitals couldn’t provide services because their patient records were made inaccessible by ransomware encryption code. That kind of potentiality has been the reason why so many institutions and companies have caved in to ransomware demands.

Download Epstein Becker Green’s Ransomware Checklist for tips to proactively mitigate ransomware risk and for reactive measures to respond to a ransomware attack.

Download the full article in PDF format.

The roll out of the Office of the National Coordinator’s (ONC) 21st Century Cures Act Interoperability and Information Blocking Rules is reminiscent of the way HIPAA has rolled out over the course of the past 25 years. As of May 1, 2021, Actors have been required to comply with the Information Blocking rules. However, it will take some time before all Actors know who they are and for complaints of Information Blocking to be determined to be actual instances of Information Blocking, by which time the penalties that have not yet been finalized may also need to be adjusted.

While ONC defined Actors as health care providers, health IT developers of certified health IT and health information exchanges or networks in the Final Rule and published guidance on their website, there is still uncertainty as to whom the Information Blocking Rules apply. The confusion may emanate from the lack of familiarity some health care providers and health IT developers have as never having been regulated or overseen by the ONC. There also appears to be overlap between what the ONC Information Blocking Rules protect against and what and how the Office for Civil Rights protects under the HIPAA Privacy Rule. Furthermore, providers and payers are typically regulated and overseen by CMS, however, CMS has not addressed any of the potential “dis-incentives” that providers would be subject to for Information Blocking violations and payers have never been required to use certified electronic health records. 

It is understandable that the Information Blocking prohibitions would apply to a health IT developer that develops or offers health information technology that is certified under the ONC Certification Program. In the Rules, ONC clarified that the Information Blocking prohibitions apply to a health IT developer as long as the developer has one or more health IT Modules certified under the ONC Health IT Certification Program at the time it engages in a practice that is the subject of an information blocking claim. However, ONC carved out an exception for health care providers that have developed their own health IT for its own use.

When ONC defined health care provider based on the definition provided under the Public Health Services Act (42 U.S.C. 300jj) (“PHSA definition”) it included a significant number of providers that were never before regulated by the ONC. Many of the types of health care providers that were swept into the definition of Actor and subject to the Information Blocking provisions were not included in the incentive programs that made funding available for the purchase of certified electronic health records (e.g., ambulatory surgical centers, long-term care facilities and therapists), there aren’t quality payment incentive programs for them to participate in and some don’t use certified EHRs. Health care providers should be aware that in addition to the guidance ONC published clarifying that Information Blocking applies to any health care provider that meet the definition under the PHSA regardless of whether any of the health IT the provider uses is certified under the ONC Health IT Certification Program, the “catch-all” clause at the end of the PHSA definition allows any other category of health care facility, entity, practitioner, or clinician determined appropriate by the HHS Secretary to be swept into the definition of Actor.

In the Final Rule, ONC combined two categories of Actors, health information exchange and health information networks and adopted one functional definition for both. A health information network or exchange refers to an entity that connects and exercises control over the technologies and services that enable the exchange of information between and among more than two other unaffiliated entities for treatment, payment or health care operations. Considering all the health IT developers, cloud service providers and data aggregators that are offering services to support Interoperability and communication to support health e-commerce, including care and benefit coordination, patient engagement and advancing social determinants of health to achieve care equality, there are a myriad of entities that are connecting multiple provider and/or payer organizations to coordinate the care or benefits of patients. These entities could unwittingly be performing the functions described in the definition of health information exchange or network without even knowing that they are considered Actors under the Information Blocking Rules.

If you or your organization aren’t sure if you fit into one of the definitions of Actor, or if you have any other questions about Interoperability, Information Blocking, ONC Health IT Certification, please contact the Epstein Becker & Green, P.C. attorney who regularly handles your legal matters, or one of the authors of this blog post: Karen Mandelbaum or Patricia Wagner.

In this episode of the Diagnosing Health Care Podcast:  The Departments of Labor, Health and Human Services, and the Treasury jointly released a set of frequently asked questions (“FAQs”) related to recent changes made to the Mental Health Parity and Addiction Equity Act effective as of February 10, 2021, and enacted by the Consolidated Appropriations Act at the end of 2020. Accordingly, health plans and insurers must ensure that they understand, and are prepared to provide regulators with documentation of their compliance with, parity requirements on at least a small group of specific non-quantitative treatment limits.

Special guest Henry Harbin, MD, Health Care Consultant and former CEO of Magellan Health Services, and Epstein Becker Green attorneys Kevin MaloneDavid Shillcutt, and Tim Murphy discuss how stakeholders can gain key insights into the federal enforcement approach on parity from the new set of FAQs, including where the government might get the most return on investment for enforcement.

The Diagnosing Health Care podcast series examines the business opportunities and solutions that exist despite the high-stakes legal, policy, and regulatory issues that the health care industry faces. Subscribe on your favorite podcast platform.

Listen on Apple PodcastsGoogle Podcasts,
Overcast, Spotify, Stitcher, Vimeo, YouTube.

On May 17, 2021, the U.S. Department of Justice (“DOJ”) announced the establishment of a COVID-19 Fraud Enforcement Task Force (“Task Force”) to ramp up enforcement efforts against COVID-19-related fraud.[1]

Organized and led by Deputy Attorney General Lisa Monaco, the Task Force convened its first meeting on May 28 and aims to “marshal the resources of the [DOJ] in partnership with agencies across government to enhance enforcement efforts against COVID-19 related fraud.”[2]  The Task Force will involve coordination among several DOJ components, including the Criminal and Civil Divisions, the Executive Office for United States Attorneys, and the Federal Bureau of Investigation.  “Key interagency partners” have also been invited to join the Task Force, including the Department of Labor, the Department of the Treasury, the Department of Homeland Security, the Social Security Administration, the Department of Veterans Affairs, the Food and Drug Administration’s Office of Criminal Investigations, the U.S. Postal Inspection Service, the Small Business Administration, the Special Inspector General for Pandemic Relief, and Pandemic Response Accountability Committee, among others. Continue Reading U.S. Department of Justice Announces Interagency Task Force to Combat COVID-19 Relief Fraud

Teaching hospitals should find that their Medicare reimbursement for training physicians will be a little sweeter thanks to a decision by the United States District Court for the District of Columbia.  Milton S. Hershey Medical Center, et al. v. Becerra, No. 19-2680 (D.D.C. May 17, 2021).  The hospitals challenged a 1997 regulation that set out a formula for counting the number of full-time residents and fellows. Under the Medicare statute, the government reimburses hospitals for salaries and administrative costs directly related to graduate medical education (“GME”). The statute contains a formula for determining the weighted number of full-time equivalent residents (“FTEs”) employed by the hospital.  The formula weights FTEs based on the length of their employment, and imposes a cap on the number of FTEs that a hospital can count for Medicare reimbursement. 42 U.S.C. § 1395ww(h)(3-5).  The formula also counts residents differently from fellows, who have completed a residency in a specialty and are receiving further training in a subspecialty; for purposes of the FTE count, the weighting factor for residents is 1.0 and for fellows the weighting factor is 0.5. 42 U.S.C. § 1395ww(h)(4)(C).  Congress also capped the number of FTEs that can be counted for purposes of Medicare reimbursement at the FTE count for that hospital as of December 31, 1996.

CMS waded into this accounting in 1997, when it published a final regulation that addressed those situations where a hospital exceeds its FTE resident cap. The regulation mandated that when this occurred, the hospital’s FTE count would be reduced “in the same proportion that the number of FTE residents for that cost reporting period exceeds the number of FTE residents for the most recent cost reporting period ending on or before December 31, 1996.” 42 C.F.R. § 413.79(c)(2)(iii).

This left a sour taste in the mouths of teaching hospitals because the regulation could reduce the total FTE count below the number reached by following the statute alone if it exceeded its FTE cap. Several hospitals that trained residents and employed fellows challenged the validity of the regulation, arguing that it conflicted with the statutory formula and unlawfully reduced their Medicare GME reimbursement. The District Court agreed.

The court’s decision rejected the Secretary’s arguments and the challenged regulation melted away.  The court found that the hospitals had not waived their opposition to the regulation simply because they had not submitted comments opposing it during the notice-and-comment period in 1997. Next, the court concluded that the FTE formula in the Medicare statute was not a simple confection; it did not give the Secretary the authority to change the weights assigned to residents and fellows in determining the number of FTEs for a given hospital. Rather than defer to the Secretary, the court relied on Step One of the well-established test set out in Chevron v. Natural Resources Defense Council, 467 U.S. 837, 843 (1984), which limits the analysis to the plain language of the statute when Congress has addressed the issue directly through legislation and its intent is clear. In this case, although Congress had delegated rulemaking authority to the Secretary, it did state that those rules “shall” count a resident with a weight of 1.0 and a fellow as 0.5 for all periods after July 1, 1987. Although the Secretary referred to other language in the statute that addresses various aspects of GME reimbursement in general terms and delegated authority to the Secretary to publish regulations, there were no gaps in the statute for counting FTEs that needed to be filled through rulemaking.

If the decision stands, then those hospitals that were affected by the regulation and still have pending appeals should see their Medicare reimbursement increased.  This decision is also  noteworthy because the court relied on the Chevron framework.  That decision has been under attack, but Hershey is an example that shows how Chevron remains good law and reaffirms the approach of many courts that judicial deference to agency rulemaking should not be presumed, even with a statutory scheme as intricate as the Social Security Act.

In this episode of the Diagnosing Health Care Podcast:  Federal and state cannabis regulation and enforcement appear to be moving in different directions. While the Food and Drug Administration (“FDA”) has broadened its net to target businesses making claims that their products can treat specific conditions, a growing number of states have passed bills that, among other things, legalize adult-use cannabis.

Epstein Becker Green attorneys Delia DeschaineNathaniel Glasser, and Megan Robertson discuss how developments in 2021 impact the cannabis industry and why all players, including employers, health care providers and retailers, and businesses operating in the cannabis space, need to pay close attention to the different nuances between federal and state laws.

For more, listen to our previous episode on the FDA’s cannabis regulatory rulemaking:

The Diagnosing Health Care podcast series examines the business opportunities and solutions that exist despite the high-stakes legal, policy, and regulatory issues that the health care industry faces. Subscribe on your favorite podcast platform.

Listen on Apple PodcastsGoogle Podcasts,
Overcast, Spotify, Stitcher, Vimeo, YouTube.

In a move that reminds us that successful defendants can—and should—seek attorneys’ fees in the right case, a magistrate judge in the U.S. Court of Appeals for the Ninth Circuit awarded pharmaceutical company Aventis Pharma SA (“Aventis”) attorneys’ fees in a False Claims Act (“FCA”) case brought by a competitor, Amphastar Pharmaceuticals Inc. (“Amphastar”). The FCA contains a fee-shifting component, permitting prevailing parties to recover attorneys’ fees from the opposing party—but the playing field is not equal. This fee-shifting provision entitles a prevailing plaintiff to an award of reasonable attorneys’ fees and costs, regardless of whether the government elects to intervene in the case. 31 U.S.C. § 3730(d)(1)-(2). A defendant, on the other hand, can only be awarded attorneys’ fees in cases in which the government has declined to intervene and where the defendant can show that the opposing party’s action was “clearly frivolous, clearly vexatious, or brought primarily for purposes of harassment.” 31 U.S.C. § 3730(d)(4). Continue Reading Defendant Aventis Pharma Awarded Over $17.2 Million in Attorneys’ Fees in False Claims Act Case

The U.S. Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued Advisory Opinion No. 21-02, regarding a joint investment by a health system, a manager, and certain surgeons in an ambulatory surgery center (“ASC”) (the “Proposed Arrangement”). According to a national survey, most hospitals and health systems are planning to increase their investments in ASCs and anticipate converting hospital outpatient departments to ASCs. Many hospitals with ASCs operate the ASCs as physician joint ventures. As payors and patients continue to show interest in having outpatient procedures performed in ASCs, there is an expected trend to see an increase in investments and joint ventures in ASCs therefore making the Advisory Opinion particularly noteworthy.

In their request to OIG, the health system and the manager (“Requestors”) specifically inquired whether the Proposed Arrangement would constitute grounds for sanctions under the Federal Anti-Kickback statute (“AKS”). Based upon the facts provided in the request for the Advisory Opinion and a supplemental submission, the OIG reached the favorable conclusion that due to the low risk of fraud and abuse, the OIG would not impose sanctions on the health system or the manager in connection with the Proposed Arrangement.

The Proposed Arrangement

Under the Proposed Arrangement, the health system, five orthopedic surgeons, three neurosurgeons employed by the health system, and a manager, would invest in a new ASC. The health system would own 46 percent of the ASC, the surgeons would collectively own 46 percent of the ASC, and the manager would own 8 percent of the ASC. The manager certified that no physician has had, or would have, ownership in the manager that provides management and other services to the ASC. Furthermore, the ASC would operate in a medical facility owned by a real estate company jointly owned by the health system, the surgeons, and the manager. The ASC would enter into space and equipment leases as well as service arrangements with the health system and the real estate company.

OIG’s Analysis

Based on the following criteria, the OIG determined that the following safeguards in the Proposed Arrangement would mitigate the risk and that, as such, the OIG would not impose administrative sanctions in connection with the Proposed Arrangement:

Health System and Physician Investor Interest

(1) Although one or more of the neurosurgeons would fail to meet the Hospital-Physician ASC Safe Harbor Provision requirement that a physician investor derive at least one-third of his or her medical practice income for the previous fiscal year or previous 12-month period from the performance of ASC-qualified procedures, the health system certified that the neurosurgeons would use the ASC on a regular basis as part of their medical practices. Additionally, the health system certified that the surgeons would rarely refer patients to each other.

(2) The Proposed Arrangement would contain certain safeguards to reduce the risk that the health system would make or influence referrals to the ASC or the surgeons. For example, the health system certified that any compensation paid by the health system to affiliated physicians for services furnished would be consistent with fair market value and would not be related, directly or indirectly, to the volume or value of any referrals. In addition, the health system certified that it would refrain from any actions designed to require or encourage affiliated physicians to refer patients to the ASC or the surgeons and would not track referrals made to the ASC.

Continue Reading OIG Issues Favorable Advisory Opinion on Ambulatory Surgery Center Joint Venture