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Health Care

VOL. II, Summer 2016


Special Masters in Health Care Antitrust
IN THIS ISSUE Merger Cases: Resolving the Conflicting
Interests
By Barbara Reeves, Esq.
Special Masters in Health
Care Antitrust Merger Cases:
Resolving the Conflicting One of the most challenging aspects of to consumers? To the parties? To health
Interests . . . . . . . . . . . . . page 1 antitrust cases in the health care field care? How can counsel sort through the
is the rich mixture of public interest conflicting interests while also zealously
Cyber-Attacks in the Health considerations, pro-competitive benefits, advocating on behalf of their clients?
Care Industry. . . . . . . . . page 1 anticompetitive concerns, the backdrop Mergers, affiliations, patent licensing
of the Affordable Care Act (ACA) and arrangements and purchasing and pricing
Why FCA Disputes Can the unknown about what will happen arrangements between pharmaceutical
Benefit from Mediation—and tomorrow. How will the courts rule in the companies, hospitals and insurers raise
Even Arbitration . . . . . . page 5 context of the ongoing developments in complex issues, and the results will have
change, consolidation and competition significant impacts on consumers and
in health care? Will the challenged businesses in the health care field.
mergers and affiliations bring benefits (Continued on page 2)

Cyber-Attacks in the Health Care


Industry
By Daniel B. Garrie, Esq.

What threats does the health care is “a type of malicious software designed
industry face? to block access to a computer system
The health care industry today faces a new until a sum of money is paid.”¹ While data
threat in the form of cyber-attacks, from breaches can have long-term negative
both internal and external actors. This effects on a huge number of patients, ran-
threat is exacerbated by a lack of institut- somware has the potential to shut down a
ional support from the government. Thus, health care institution, leaving its patients
the burden is now on health care provi- in dire need of medical aid, without any
ders to secure their own data and protect chance of getting the care they need.
their clients. Unfortunately, health care
institutions are uniquely vulnerable, not A cyber-attack can happen in the blink of
only to data breaches, where customer an eye, or more aptly the click of a mouse.
data is com-promised, but also to A mid-level patient records administrator
ransomware, which receives an email inquiring about an
(Continued on page 4)

Summer 2016 • healthcarematters@jamsadr.com • jamsadr.com/healthcare • 800.352.5267 • Page 1


Special Masters in Health Care Antitrust Merger Cases: Resolving the Conflicting Interests (Continued from page 1)

Three recent health care antitrust cases The Advocate Health and Hershey an extremely adversarial situation where
illustrate the point: FTC v. Advocate cases are just at the beginning of their time was of the essence, only to be
Health Care, et al.; FTC, et al. v. Penn saga: The FTC’s motions for preliminary followed, as ProMedica illustrates, by
State Hershey Medical Center, et al.; injunctions were denied and are on years of litigation and uncertainty.
and ProMedica Health System, Inc. v. expedited appeal, with the prospect
FTC. These cases arose out of chal- of the FTC administrative hearings still Is there a more effective, studied and
lenges by the FTC to hospital mergers ahead. ProMedica is an example of cost-efficient approach to weighing
in the metropolitan Chicago; Hershey, what may lay ahead: The FTC just these interests and resolving the dispute
Pennsylvania; and Lucas County, Ohio, approved ProMedica’s divestiture of to protect the public’s interest in both
areas, respectively. In each case, the nearby St. Luke’s Hospital, finally ending competition and affordable, quality
merging hospitals asserted that the six years of litigation and uncertainty, health care?
merger would produce economic and following an FTC determination (and
health care benefits. In Advocate Health federal court decisions affirming the Courts have recognized that the ap-
Care, the hospitals promised that the FTC) concluding that the transaction pointment of a knowledgeable, neutral
merger would create a new low-cost, violated the antitrust laws. third-party, or a special master, can
high performing network throughout streamline discovery, focus the parties on
the Chicago area, bringing benefits to These cases involve complex issues and key evidence, settle discovery disputes
consumers. In the Hershey case, the interests, in the framework of an evolv- and explore the pros and cons of settle-
hospitals argued that their merger was ing and developing health care system. ment alternatives while keeping an eye
in furtherance of finding innovative Predicting the potential outcomes of a on the various interests. Special masters,
ways to best serve patients and the merger is such a difficult task that it is as discovery masters and settlement
community by providing the “high- unrealistic to expect a judge to under- masters, serve as a knowledgeable
est-quality and most cost-effective care stand all the criticisms of an economet- neutral between the parties and a helpful
possible.” ProMedica did not advance ric study and all the nuances of provid- buffer between the parties and court to
precompetitive benefits as a justification er-payor contracts and then assess what manage discovery plans and assist in
for its merger, but rather the absence is likely to happen in the years following reaching a resolution.
of anticompetitive impact. The FTC’s the merger. Yet in these examples, the
complaints, on the other hand, alleged cases were put before judges with little Special masters are relatively common-
that the mergers would create dominant or no antitrust experience or health care place in many cases in 2016, including
providers of general acute care inpatient expertise, presented by expert teams government environmental cases,
hospital services in the relevant markets of advocates and teams of experts, in desegregation cases, water disputes
and would likely lead to increased health
care costs and reduced quality of care.

The focus of this analysis is not to


argue the pros and cons of each party’s
antitrust analysis and market definition
position, but rather to analyze a more
efficient way of approaching cases such
as these in today’s “evolving landscape
of health care” (to quote the court in
Hershey), including the ACA, changes
in Medicare and Medicaid reimburse-
ment and the transition to risk-based
contracting, to name but a few.

Summer 2016 • healthcarematters@jamsadr.com • jamsadr.com/healthcare • 800.352.5267 • Page 2


between states and prison condition 3. A special master can ing the competitive impacts of a merger
cases. Special masters, as discovery be a bridge between and could have shed more light on
masters and attorney’s fees referees, parties and develop finding a solution: (1) market definition,
are also frequently used in antitrust interim measures. including whether patients are likely to
cases. They do not appear to have been A special master can explore change their willingness to travel greater
involved in any of the recent health care alternatives with each side confiden- distances for health care as price infor-
antitrust cases, ranging from challenges tially, such as allowing some form of mation and quality of service information
to mergers to disputes involving phar- integration or alliance on an interim become more available, combined with
maceutical companies’ biosimilars and basis to test the extent to which incentives to use narrow networks;
generic product hopping. These cases prices are impacted, costs reduced, (2) the views of health insurers on the
are rich with issues that could have ben- savings passed to consumers and transaction; (3) an analysis of the rate
efited from a discovery special master quality improved. Pharmaceutical agreements entered into by the two
and/or a settlement special master. companies battling over generic hospitals with their two largest insurers;
and biosimilars issues can feel safe (4) the status of recent contract nego-
What can a special master do? exploring their issues with a special tiations between these hospitals and
master, in confidence if the parties commercial health plans, and how they
1. A special master can focus have agreed to mediation confiden- might be expected to change after the
discovery. tiality, to see if there is some option merger; (5) the proffered efficiencies;
The use of discovery masters to that will keep them out of court while and (6), everyone’s favorite, the extent to
manage and supervise complex not running afoul of the regulators. which antitrust enforcement is comple-
cases is relatively commonplace. mentary to or in conflict with the goals
The discovery master can manage a 4. A special master can of the ACA. This approach may have led
discovery plan, issue orders resolving guide the parties toward to a decision to prosecute, a decision
discovery disputes and make recom- settlement. to abandon the merger or a creative
mendations to the judge. A discovery A settlement master can enable the resolution that satisfied all parties that
master experienced in both discovery parties to consider to what extent the the public interest was being protected
procedures and computer systems competing interests of each party are as best as anyone can understand at
and software can cut through the ar- reflective of some part of the public this point in time. •
guments and objections to determine interest that could be preserved by
what information is readily accessible careful structuring of the transaction
Barbara Reeves, Esq.
or recoverable and what really or by modifying the transaction to is an accomplished
matters. How many trial lawyers have something less than a merger. In an neutral in the area of
ever used more than a small subset health care disputes. She
evolving market such as health care, is widely respected for
of all discovery gathered when it with competing public interests, can her impartiality, and her
came time to introduce exhibits anyone confidently predict the future ability to identify critical
issues quickly and focus efforts to resolve
at trial? and identify the public interest, in the disputes. She can be reached at
black-and-white terms that advocates breeves@jamsadr.com.
2. A special master can focus ask the court to find as a basis for
the issues for trial. allowing or preventing a merger?
A special master can meet with each
party, identify the respective interests The hospital mergers discussed above
and focus the trial on the issues presented perfect settings for a neutral
where there are differences, saving special master. For example, the parties
trial days, while keeping in mind might have agreed to focus discovery
the need to preserve a record for and analyze the following topics, which
appeal. would have been critical to understand-

Summer 2016 • healthcarematters@jamsadr.com • jamsadr.com/healthcare • 800.352.5267 • Page 3


Cyber-Attacks in the Health Care Industry (Continued from page 1)

employment opportunity. Although sible to back up data in more secure hacked. It is an unfortunate inevitability
he is not expecting any applications, ways and in doing so render most that with the prevalence of cyber-threats,
and he is not a point of contact for cyber-threats harmless, but it is not an any given health care provider will be
employment inquiries, the administrator easy project to undertake. The legal, forced to deal with a cyber-attack. Even
opens the resume anyway. While he is risk, and compliance teams need to the above steps, if performed perfectly,
reviewing the applicant’s credentials, work collaboratively with the IT and in- only mitigate the risk of a cyber-attack.
a cyber-criminal’s malware is delivered formation security groups to understand Thus, health care providers should take
to the hospital’s network. The malware the nuances of the company’s systems steps to prepare themselves for the fall-
quickly captures the administrator’s and develop plans that ensure critical out from a cyber-attack. While incident
login credentials, and because he has data, such as patient records, is both response is critical, as discussed above,
broad administrative rights to company secure and somewhat readily accessible your cyber-insurance provider may be
systems, the malware quickly spreads in the event of a cyber-attack. able assist in developing an incident
across the hospital’s network and response plan. One step that can be
encrypts patient data. In a matter of Cyber-insurance: Even with the two taken to help mitigate legal costs asso-
minutes to hours, patient records are above steps, it is impossible for a health ciated with a cyber-breach is to employ
not available, and health care providers care provider to eliminate the risk of arbitration as a mechanism for dispute
are unable to treat the patients they a cyber-attack, which means provid- resolution.
have and are forced to turn new patients ers should look to cyber-insurance to
away. Law enforcement is called, but mitigate and control its risk exposure. Health care providers can include arbi-
there is no solution. The hospital ends Cyber-insurance is a developing product tration clauses related to cyber-claims in
up on the front page of the next day’s in the insurance marketplace, and due patient agreements, which will allow any
New York Times, and it eventually elects to the complexities of cyberspace, there potential litigants to select an arbitrator
to pay the ransom. is little agreement as to what the product with significant technical experience,
is and what it should cover. Each insur- who will be able to expedite the reso-
How should the health care ance company builds its own product, lution of claims by utilizing his or her
industry respond to these threats? which has led to a largely heterogeneous expertise to cut away many of the pro-
marketplace and makes it nearly im- cedural and technical hurdles that may
Training: The goal of implementing a possible for a non-specialist to make an be present in educating a fact-finder
training program is to change the culture educated comparison of insurance pol- without technical expertise. Arbitration
within a company so that every employ- icies. A lawyer experienced in cyber-in- is not a magic bullet for dealing with cy-
ee believes that information security is surance can be invaluable in assessing ber-attacks, but it is certainly a tool that
their personal responsibility, not just the the coverage of a particular policy and can be utilized to help mitigate time and
responsibility of behind-the-scenes IT matching it to the requirements of the cost, as well as allow the health care
and information security personnel. With company; additionally, certain brokers provider to get back to the valuable work
proper training, the situation described specialize in cyber-insurance. Between of saving people’s lives. •
above never would have occurred. The these two specialists, a health care
employee would have understood that provider will be able to properly control ¹ Malware and Ransomware, Montana Tech,
http://www.mtech.edu/cts/security/malware.
he received a suspicious email, and he and mitigate its risk exposure. Further, it htm.
would have forwarded it to the individu- is important to note that many insurers
als responsible for information security, provide services along with the insur-
who would promptly detect the threat. ance when an incident occurs.
Daniel B. Garrie, Esq.
Backing up and securing data: This What should you do if your is an arbitrator, forensic
sounds simple, but the sophistication of security is breached? neutral and technical
special master at JAMS,
modern attacks threatens the security To paraphrase FBI Director James available in Los Angeles,
of traditional data backups. Even when Comey, there are two kinds of compa- New York and Seattle.
He can be reached at
backing up into the cloud, company nies: those who’ve been hacked and
dgarrie@jamsadr.com.
data still faces some risks. It is pos- those who don’t know they’ve been

Summer 2016 • healthcarematters@jamsadr.com • jamsadr.com/healthcare • 800.352.5267 • Page 4


Why FCA Disputes Can Benefit from Mediation—and
Even Arbitration
By R. Wayne Thorpe, Esq.

Among the most difficult disputes health law practice after years of prac- recovered more than $2.5 billion in
facing participants in the health care tice in white collar criminal prosecution 2010 and $4.6 billion since January
industry are False Claims Act (FCA) and defense work with little 2009 in health care fraud cases.
cases brought by federal or state ADR experience. Several reported recoveries against
agencies (often initiated by relators) pharmaceutical and device companies
for alleged fraud in connection with Some private lawyers in fraud cases have exceeded $100 million. According
payments under government health are skeptical about whether government to the DOJ, “Fighting fraud committed
care programs, including Medicare agencies are genuinely interested in me- against public health care programs
and Medicaid. The high stakes involved diating fraud cases, although anecdotal is a top priority for the Obama Admin-
in these cases is one important reason interviews with both private and govern- istration.” Recent legislative changes
why parties should carefully consider ment lawyers, as well as our experience have enhanced the ability of the federal
attempting settlement through with these cases at JAMS, reflect both government and FCA qui tam relators to
mediation. genuine interest and successful experi- pursue claims:
ences regarding both federal and state
Despite the fact that at least three governments in mediating appropriate • The Affordable Care Act (ACA)
organizations (JAMS, American Arbitra- health fraud cases. § 6402 amended the federal
tion Association and American Health Anti-Kickback Statute to make
Lawyers Association) offer panels of The stakes are high in federal FCA clear that violations of that statute
mediators and arbitrators specializing cases, which can result in civil penalties, can be brought under the FCA.
in health care, there has historically corporate and individual criminal liability
been resistance to mediating health and exclusion from government health • The Fraud Enforcement and
care disputes. One possible explanation care programs. Most states provide for Recovery Act imposed FCA
is that health care lawyers, especially similar liabilities. The U.S. Department liability for overpayments,
in the health fraud bar, have come to of Justice (DOJ) has reported that it expanded the DOJ’s power to

Summer 2016 • healthcarematters@jamsadr.com • jamsadr.com/healthcare • 800.352.5267 • Page 5


issue civil investigative demands fraud cases, and a mediated settlement most FCA settlements to be approved
and amended the FCA anti- may allow government agencies to move at various levels of management (for
retaliation provisions to protect on to other important investigations. example, Assistant U.S. Attorneys and
contractors and agents in addition trial counsel at the DOJ cannot ordinarily
to employees. When a mediation occurs prior to the make binding settlement offers and
unsealing of a relator’s FCA complaint, commitments), this challenge should
• The ACA further defined a defendant may also have a chance rarely be significant because final,
overpayment liability to provide to vindicate an interest in privacy, or at “official” higher levels of approval are
that retention of an overpayment least in diminished public and media obtained routinely in the mediation
for over 60 days after identification scrutiny. A defendant’s settlement of and settlement of many types of cases
by a provider can become a an FCA case will be public and likely involving federal, state and local govern-
false claim. publicized with some fanfare. But on the ments.
day after the announcement, investors,
Government investigations of possible lenders, financial analysts, employees, Finally, here is a note on an unusual but
FCA cases provide opportunities to use vendors, customers and other key con- effective use of ADR for FCA matters in
mediation to satisfy important goals stituencies will start to view the issue in which multiple adverse defendants have
and interests of both the government the rear-view mirror, rather than through a common interest in settling with gov-
and the accused, while also potentially the continuing scrutiny of a pending ernments and relators. In cases of this
saving time, money and other important case with an uncertain outcome. The sort, the most difficult problem may be
resources. government in turn gets a chance to reaching agreement among defendants
make a splashy announcement, satis- on how to address the government/rela-
A mediated settlement agreement may fying the important goal of potentially tor claims. Or more to the point, which
avoid (or at least diminish) exclusion deterring future putative wrongdoers, defendant has to pay how much? One
and criminal responsibility while without the cost of a longer investigation remarkably simple solution is to make
quantifying civil monetary exposure at a and trial and without the risk of sending a tentative agreement on who pays how
known, agreed-upon level. Even where the wrong deterrence message if the much to the government/relator and
a potential FCA defendant genuinely trial is not successful. then arbitrate among two or more set-
(and perhaps correctly) views a potential tling defendants on ultimate assessment
claim as defensible, such an approach Further, use of mediation in government of liability among those defendants.
to mediation and settlement may often fraud cases provides a forum for the It can be done quickly and relatively
have some merit because, among resolution of issues with multiple inexpensively, and it avoids having the
other reasons, a defendant can utilize a parties and agencies. Settlement of private defense side controversy wreck a
mediated settlement to avoid the poten- qui tam matters under the FCA can possibly significant settlement. •
tially enormous financial cost of lengthy be particularly challenging because
further investigation, discovery, motion each settlement typically has multiple
practice and trial; the adverse impact on parties, including the DOJ, the Inspector
relationships; and the drain on the time General of HHS (which has administra-
and energy of senior management and tive authority to exclude the defendant
legal personnel. From the government’s from Medicare), the relator(s) and the R. Wayne Thorpe, Esq.,
is a JAMS neutral based
perspective, substantial and adequate defendant(s). If a defendant seeks a based in Atlanta. He
financial payments can be recovered release of any state liability for Medicaid has served as mediator,
arbitrator, special
without the time, risk and cost attendant claims, a settlement will also require master, case evaluator
to a trial against a well-heeled and the involvement of state authorities, and in other neutral
roles in more than 2,000 cases in at
committed defendant. Similarly, govern- which ordinarily include a state Assistant least 15 states involving all kinds of civil
ments can devote very substantial, but Attorney General, sometimes many disputes, including hundreds of health
care disputes. He can be reached at
nonetheless limited, financial, legal and of them. Although the DOJ and most wthorpe@jamsadr.com.
investigatory resources to health care state Attorneys General will require

Summer 2016 • healthcarematters@jamsadr.com • jamsadr.com/healthcare • 800.352.5267 • Page 6

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