The Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (“Antitrust Division”) released their respective year-end reviews highlighted by aggressive enforcement in the health care industry. The FTC, in particular, indicated that 47% of its enforcement actions during calendar year 2016 took place in the health care industry (including pharmaceuticals and medical devices). Of note were successful challenges to hospital mergers in Pennsylvania (Penn State Hershey Medical Center and Pinnacle Health System), and Illinois (Advocate Health Care Network and North Shore University Health System). In both actions, the FTC was able to convince the court that the merger would likely substantially lessen competition for the provision of general acute-care hospital services in relevant areas in violation of section 7 of the Clayton Act. See FTC v. Penn State Hershey Med. Center, 838 F. 3d 327 (3d Cir. 2016); and FTC v. Advocate Health Care Network et al No. 1:15-cv-11473, 2017 U. S. Dist. LEXIS 37707 (N.D. Ill.Mar. 16, 2017)

The Antitrust Division, in similar fashion, touted its actions to block the mergers of Aetna and Humana, and Anthem and Cigna. Complaints against both mergers were filed simultaneously in July of 2016, and tried before different judges in the Federal District Court for the District of Columbia. After extensive trials, Judge Bates blocked the Aetna/Humana deal, and Judge Amy Berman Jackson blocked the Anthem/Cigna transaction. United States v. Aetna Inc., No. 1:16-cv-1494, 2017 U.S. Dist. LEXIS 8490 (D.D.C. Jan 23, 2017) and United States v. Anthem Inc., No. 1:16-cv-01493, 2017 U.S. Dist. LEXIS 23614 (D.D.C. Feb8, 2017).

In addition to their enforcement activities, the agencies promoted jointly issued policy guidelines, including their “Antitrust Guidance for Human Resources Professionals.” Although not specific to any industry, this guidance has particular relevance to the health care industry. Among other things, this guidance makes clear that naked wage-fixing (such as the wave of wage fixing claims relating to nurses) and no-poaching agreements (that would include agreements not to hire competing physicians) are not only per se illegal, but also subject to criminal prosecution.

While a marginal enforcement shift may be in store as a result of the change in administration, most signs point to a continued focus on the health care industry. Maureen K. Ohlhausen, appointed by President Trump as acting Chair of the FTC, reiterated in a speech recently delivered at the spring meeting of the American Bar Association’s antitrust section, that “[i]t’s extremely important we continue our enforcement in the health care space.” Likewise the Acting Director of the FTC’s Bureau of Competition – Abbott (Tad) Lipsky, appointed by Chairman Ohlhausen, applauded the FTC’s success in challenging the Advocate/Northshore Hospital merger noting, in a related FTC press release, that the “merger would likely have reduced the quality, and increased the cost, of health care for residents of the North Shore area of Chicago.”

Makan Delrahim, President Trump’s selection (awaiting confirmation) to head the Antitrust Division, recently lobbied on behalf of Anthem and its efforts to acquire Cigna, and has openly stated with respect to certain announced mergers, that size alone does not create an antitrust problem. Nevertheless, given the political climate and overall impact the health care industry has on the U.S. economy, the Antitrust Division’s efforts to open markets in the health care sector, particularly to generics and new medical technologies by challenging pay for delay deals and scrutinizing unnecessarily restrictive agreements among medical device manufacturers is likely to continue.

A wild card affecting future antitrust enforcement is increasing possibility of passage of the Standard Merger and Acquisitions Review Through Equal Rights Act of 2017 (H.R. 659 a/k/a the “SMARTER ACT”). This bill, recently approved by the House Judiciary Committee, would eliminate the FTC’s administrative adjudication process as it relates to merger enforcement, forcing the FTC to bring all such actions in court. In addition, it would align current preliminary injunction standards such that both the FTC and DOJ would face the same thresholds required of the Clayton Act rather than the more lenient standard under the FTC Act. A similar bill passed the House in 2016, but was not taken up by the Senate.

Recently, Judge Robert T. Conrad, Jr. of the United States District Court for the Western District of North Carolina (Charlotte Division), rejected efforts by The Charlotte- Mecklenberg Hospital Authority, doing business as the Carolinas Health Care System (“CHS”), to dismiss, at the pleadings stage, a complaint filed by the United States’ Antitrust Division of the Department of Justice, and the State of North Carolina, asserting that CHS’s anti-steering provisions in its payer contracts unreasonably restrain trade in violation of section 1 of the Sherman Act. Recognizing the Court’s limited review of preliminary motions, Judge Conrad, in the matter styled as United States of America et al v. The Charlotte-Mecklenberg Hospital Authority d/b/a Carolinas Health Care System, Civil Action No.3:16-cv-00311-RJC-DCK (W.D. N.C., Mar. 30,2017), ultimately concluded that the allegations of the Complaint, taken as true for purposes of ruling on the motion, asserted a claim that was “plausible,” meeting the pleading standards established by the Supreme Court in Bell Atlantic Corp. v. Twombly, 550 U.S. 544,570 (2007).

The complaint alleges that CHS is the largest hospital system in the Charlotte, North Carolina area, operating ten acute-care hospitals and garnering a market share of fifty percent (50%). CHS’s next closest competitor is alleged to have only half the number of acute-care hospitals, and less than half of CHS’s annual revenue. The complaint also alleges that “[a]n insurer selling health insurance plans to individuals and employees in the Charlotte area must have CHS as a participant in at least some of its provider networks, in order to have a viable health insurance business in the Charlotte area.” Based on these purported facts, the Complaint alleges that CHS maintains “market power” for the sale of acute care hospital services in the Charlotte area.

The complaint goes on to assert that CHS maintains anti-steering provisions in many of its payer contracts including those that collectively insure up to eighty-five percent of the insured residents in the Charlotte area. Furthermore, it is alleged that CHS is able to demand these provisions as a result of its market power.

Finally, the Complaint alleges that these anti-steering provisions impose an unreasonable restraint on competition. Among other things, these provisions have the effect of preventing payers from directing patients to lower cost, higher quality providers, and even prohibit payers from providing its enrollees with information about their health care options. The ultimate effect of these provisions is to allow CHS to maintain its dominant position in the market, and maintain supra competitive prices.

CHS filed an Answer to the Complaint, and a motion on the pleadings which is governed by the same standards as a motion to dismiss filed under Federal Rule of Civil Procedure 12 (b) (6). The essence of CHS’s motion is that the Plaintiff’s allegations were conclusory, and, in particular, the Complaint lacked factual allegations that show “actual competitive harm” resulting from the anti-steering provisions. In addition, CHS argued that: the steering restrictions were beneficial and procompetitive; CHS’s prices were higher due to superior product and consumer loyalty; payers were still able to steer and no payer had ever asked to remove the steering provisions. CHS also relied upon the recently issued Second Circuit decision in United States v. American Express Co., 838 F. 3d 179 (2d. Cir 2016), which ultimately rejected a lower Court’s finding, after a bench trial, that similar steering provisions were unlawful.

Judge Conrad ultimately concluded that while many of the allegations in the Complaint were conclusory, and not factual, the Plaintiff had sufficiently alleged anticompetitive harm. In particular, the Complaint contains plausible allegations that CHS maintains market power, and that as a result of this market power CHS is able to force the anti-steering provisions on payers resulting in CHS’s ability to charge supra-competitive prices. Judge Conrad rejected CHS’s additional factual arguments concluding that these were not appropriate arguments to address on a preliminary motion.

Finally, Judge Conrad rejected the invitation to compare the case before him with that of United States v. American Express. In doing so, Judge Conrad noted: 1) he was not bound by a decision of the Second Circuit; 2) the health care industry is different from the credit card industry; and 3) the case before him was still in the preliminary stages while United States v. American Express was decided after discovery and a full trial on the merits.

Patricia M. WagnerPaul A. GomezWest Virginia recently took a bold step to set the stage to shield an in-state hospital merger from further antitrust scrutiny by the Federal Trade Commission (FTC).  Certain healthcare stakeholders are likely watching these developments with some excitement and with some thought toward pursing similar initiatives in their respective states.  Although this may have some positive effects for healthcare mergers (depending upon one’s point of view) it is not altogether clear that state review processes that might shield a merger from federal antitrust enforcement will necessarily be less burdensome to those who want to merge.

Governor Tomblin recently signed into law a West Virginia bill to create a state authority for approval of certain healthcare mergers and other collaborations that involve teaching hospitals.  The measure would also give the state authority power to approve certain treatment cost increases, among other things.  This measure appears to have been designed to shield a particular hospital merger in West Virginia from FTC antitrust scrutiny via the state action immunity doctrine, although it will have application to certain other hospital mergers involving a teaching hospital that may be forthcoming in the state.  The state action immunity doctrine requires that the state policy must be articulated clearly and that the state must actively supervise the policy.  On March 24, 2016 in response to a joint request from the West Virginia hospitals and the FTC staff, the Commission issued an order withdrawing the matter from adjudication for thirty days.  As stated in the order, the withdrawal was to allow “the Commission to review the legislation- and to hear from both Complaint Counsel and Respondents as to the relevance of the legislation” to the pending proceeding.  That delay order expires at midnight on April 25th.

Some observers, including a former director of the FTC Bureau of Competition, believe that the FTC will most likely abandon its current action to block the pending merger for now in light of this state law development, potentially opting to wait to observe whether the state actually does actively monitor the merger and its conditions with sufficient zest to continue to confer the protection of the state action immunity doctrine over the longer run.  The FTC may also opt to wait for now and observe whether any anti-competitive effects actually manifest as a result of the merger.

This instance of West Virginia acting to protect a particular merger may be somewhat unique, with the state attorney general having already approved the merger with certain protective conditions, but the FTC electing to challenge it nonetheless.  However, some other states have also taken similar steps to potentially construct a shield against federal scrutiny of hospital or other healthcare provider mergers through the state action immunity doctrine.  And in at least some cases, it may not be clear that the state approval process for such mergers will generally be less onerous or more desirable than potential antitrust scrutiny from either the FTC or the U.S. Department of Justice.  For example, often in order to be granted such protection, the parties must submit extensive materials to the state demonstrating plans for improving access to care, quality of care, addressing patients’ needs, and lowering costs of care (and the benefit of that lower cost of care will passed on to patients).   In addition, the state maintains review authority over the parties, so that the parties must continue to report on their ability to meet the goals and benchmarks described.  The state retains the ability to revoke approval of the transaction if the parties fail to meet the commitments made as part of the approval process.

For those who may be considering pursuit of a state approval process for healthcare mergers as a potentially “better” alternative to federal antitrust scrutiny, one should also consider the political climate of the state and to what degree state politicians and regulators consider encouragement of mergers and acquisitions to be needed for better access and better integrated healthcare.  The prevailing wisdom in one state with a large rural population and a scarcity of healthcare providers may be significantly different than one with several major metropolitan areas and/or a large suburban population with multiple healthcare providers.  In sum, those who may be considering pursuit of similar measures as those enacted in West Virginia and certain other states should carefully assess political, economic and healthcare climate and market conditions of the state that they are in before investing heavily in such an endeavor.  One size does not necessarily fit all when it comes to potential use of the state action immunity doctrine.

M. Brian Hall, IV

Daniel C. Fundakowski

On October 26, 2015, the Federal Trade Commission (“FTC”) and the Antitrust Division of the U.S. Department of Justice (“DOJ”) (collectively the “Agencies”) issued a joint statement to the Virginia Certificate of Public Need (“COPN”) Work Group encouraging the Work Group and the Virginia General Assembly to repeal or restrict the state’s certificate of need process.  The Virginia COPN Work Group was tasked by the Virginia General Assembly to review the current COPN process and recommend any changes that should be made to it.

Thirty-six states currently maintain some form of certificate of need (“CON”) program.  Although there are variations in the programs, in general, new entrants and incumbent providers are required to obtain state-issued approval before constructing new facilities, or in some cases prior to offering certain health care services, or making major capital expenditures—such as expanding the number of beds in a hospital or investing in robotic surgery equipment.

In their statement, the Agencies outlined their concerns that state certificate of need (“CON”) laws fail to achieve their original conceived goals of improving access to care and reducing health care costs.  Instead, the Agencies remarked that programs like the Virginia COPN process “prevent the efficient functioning of health care markets” in numerous ways:

  • By creating barriers to entry and expansion, limiting consumer choice, and stifling innovation;
  • By allowing incumbent firms to use CON laws to thwart or delay market entry by new competitors;
  • By denying consumers of an effective remedy following the consummation of an anticompetitive merger (specifically referencing the FTC v. Phoebe Putney case, which we previously reported on here); and
  • By failing to assist states in controlling health care costs or improving care quality (based on studies referenced by the Agencies).

For these reasons, the Agencies have historically taken the position that state CON laws should be repealed or limited.

In a concurring statement, FTC Commissioner Julie Brill agreed that the FTC was capable to advise the Virginia COPN Work Group about the impact of CON laws on competition. But Commissioner Brill took exception to the FTC’s comments concerning non-competition-related public policy goals, noting that the FTC lacks evidence of the impact of repealing CON laws.

The Virginia COPN Work Group issued its final report to the General Assembly in December 2015, recommending several changes to the COPN requirement but stopping short of recommending that Virginia repeal it.  The Work Group noted that the program currently lacks a statement of purpose and urged the General Assembly to draft one.  In addition, the Work Group suggested several steps to make the current application submission and review process more efficient and streamlined, including adopting a 45-day expedited review process for projects that are non-contested and raise few health planning concerns. The Work Group also suggested making the COPN program more transparent, including improved online access to COPN filings and other related documents.

On January 11, 2016, the Agencies submitted a similar joint statement, upon the request of South Carolina Governor Nikki Haley, regarding the competitive implications of CON laws and South Carolina House Bill 3250—a bipartisan bill that ultimately would repeal South Carolina’s CON program effective January 1, 2018.  While the Agencies observed certain flaws in the legislation, they expressed broad support for the proposed repeal of South Carolina’s CON program.  FTC Commissioner Brill also issued a dissenting statement, noting in large part the commendable non-competition policy goals advanced by CON programs.

Virginia’s COPN law also survived a recent constitutional challenge in the U.S. Court of Appeals for the Fourth Circuit.  In the case, Colon Health Centers v. Hazel, No. 14-2283 (4th Cir. Jan. 21, 2015), two providers of medical imaging services alleged that Virginia’s COPN law violated the dormant aspect of the Commerce Clause.  The Fourth Circuit affirmed the district court’s holding that the COPN requirement neither discriminated against nor placed an undue burden on out-of-state health care providers (and granting summary judgment to the Commonwealth).  This recent Fourth Circuit precedent may decrease the likelihood of the Agencies formally challenging Virginia’s COPN program following their joint statement encouraging that it be repealed.

Supreme CourtWith the untimely passing of Supreme Court Justice Antonin Scalia, perhaps the best known and most controversial Justice on the Court, commentators, including this one, have been called upon to assess his legacy – both immediate and long term – in various areas of the law.

Justice Scalia was not known primarily as an antitrust judge and scholar. Indeed, in his confirmation hearing for the Court, he joked about what he saw as the incoherent nature of much of antitrust analysis. What he was best known for, of course, is his method of analysis of statutes and the Constitution: a literal textualism with respect to statutes and a reliance on “originalism” with respect to the Constitution.

Probably his most influential antitrust opinion was the 2004 decision in Verizon Communications Inc. v. Law Offices of Curtis V. Trinko LLP which limited antitrust plaintiffs’ ability to hold a company with monopoly power liable for failing to cooperate with rivals.

Taking a literalist view of the Sherman Act, Justice Scalia wrote that there was a good reason why Section 2 claims required a showing of anti-competitive conduct, not just a monopoly.

The mere possession of monopoly power, and the concomitant charging of monopoly prices, is not only not unlawful; it is an important element of the free-market system,” he wrote. “The opportunity to charge monopoly prices — at least for a short period — is what attracts ‘business acumen’ in the first place; it induces risk-taking that produces innovation and economic growth.

Thus, Justice Scalia fashioned a majority in holding that the competitive conduct of a monopolist that had earned its hegemony was not inherently suspect. This has come to be a dominant view generally in the antitrust field, but critics have argued that the decision entrenches power and judicial liberals who might succeed Justice Scalia could take a more restrictive, less literal view of the law.

In 1991, Justice Scalia led a majority in Columbia v. Omni Outdoor Advertising Inc., a case in which a competitor had claimed that an advertising rival and a municipality had conspired in passing an ordinance favoring the incumbent. In ruling against the plaintiff, Justice Scalia wrote that there was no “conspiracy exception” to Parker v. Brown, the 1943 Supreme Court case that established antitrust immunity for anti-competitive restraints imposed by state governments. On the other hand, in the recent North Carolina Dentists litigation with the FTC, Justice Scalia joined a majority that held the state action exemption did not apply to certain guild behavior where there was no active supervision by the state – again, a literalist approach.

Justice Scalia was influential in limiting class actions, enforcing arbitration agreements and requiring strict rules of pleading plausible causes of action. Cases like the antitrust actions in AT&T v. Concepcion and American Express v. Italian Colors, backing enforcement of arbitration agreements that blocked class treatment of claims, and the now often-cited cases of Twombley and Iqbal with respect to pleading currently rule the entry gate for large-case litigation, particularly antitrust.

For all of his conservative rulings, Justice Scalia was not a results-oriented judge determined to put antitrust plaintiffs in their place, I think that he would have argued that he was strictly neutral on the merits and didn’t care whether business prevailed or whether the class action plaintiffs prevailed. Whether, the conservative majority that adopted his methods will continue to hold, or whether some of these methods will be superseded by a more-elastic interpretive mode of judging will be at the forefront of the confirmation hearing of the next Justice.

On December 14, 2015, the U.S. District Court for the Western District of Texas denied the Texas Medical Board’s (“TMB”) motion to dismiss an antitrust lawsuit brought by Teladoc, one of the nation’s largest providers of telehealth services.[1]  Teladoc sued the TMB in April 2015, challenging a rule requiring a face-to-face visit before a physician can issue a prescription to a patient.  Following two recent Supreme Court cases stringently applying the state action doctrine, this case demonstrates the latest of the continued trend where state-sanctioned boards of market participants face increased judicial scrutiny with respect to the state action doctrine.

The Board Rule at Issue – “New Rule 190.8”

In April 2015 the TMB adopted revisions to various chapters of the Texas Administrative Code governing the practice of medicine.  Specifically, Section 190.8(1)(L) (“New Rule 190.8”) sets forth practices the TMB deems to be violations of the Texas Medical Practices Act and prohibits prescription of any “dangerous drug or controlled substance” without first establishing a “proper professional relationship.”  A “physician-patient relationship” is defined to require, among other things, a physical examination that must be performed by “either a face-to-face visit or in-person evaluation” (defined elsewhere to require that the patient and physician be in the same physical location).

Teladoc filed a lawsuit, alleging that New Rule 190.8 violated Section 1 of the Sherman Act, prohibiting anticompetitive agreements among competitors to restrain trade (the TMB is a group comprised of competing physicians).  Teladoc then obtained a preliminary injunction in May 2015, preventing the TMB from “taking any action to implement, enact and enforce” New Rule 190.8 until Teladoc’s claims are resolved.  In issuing the injunction, the court found that Teladoc demonstrated a substantial likelihood of success on the merits of its antitrust claims, a substantial threat of irreparable injury, that the threatened injury outweighed any damage that the injunction might cause the TMB, and that the injunction would not disserve the public interest.  The TMB then moved to dismiss, claiming, among other things, entitlement to state action antitrust immunity.

State Action Antitrust Immunity

State action antitrust immunity for professional board regulatory actions has two requirements: the actions must be conducted under “active state supervision,” and they must follow a “clearly articulated state policy” to displace competition.  The court held that the TMB could not claim state action immunity because the state did not exercise sufficient control over it.  The court did not address the second requirement.

The court’s order devotes significant attention to rejecting the TMB’s state action defense.  In North Carolina State Board of Dental Examiners v. FTC, which we previously covered, the Supreme Court reaffirmed that the state action exemption would not insulate the activities of state boards or regulatory agencies comprised of market participants absent active state supervision of the entity’s challenged conduct.

Both Teladoc and the TMB agreed that active state supervision is a state action requirement, but disagreed as to whether it existed.  The district court followed North Carolina State Board of Dental Examiners, noting that in order to constitute active supervision, “the supervisor must have the power to veto or modify particular decisions to ensure they accord with state policy.”

The TMB argued that it is indeed subject to active state supervision since its decisions are subject to judicial review by the courts of Texas, the Texas legislature, and the State Office of Administrative Hearings. The court found these purported review mechanisms to be focused on the mere validity/invalidity of rules—not allowing for an evaluation of the policies underlying the rules or bestowing the state with power to modify particular Texas Medical Board decisions to accord with state policy.  The court also rejected the TMB’s argument that state supervision exists by way of the Texas legislature’s “sunset review” process (where the legislature votes on whether there is a public need for continuation of a state agency) because the legislature has no authority to veto or modify any TMB rules.

Implications

Rules promulgated by state-sanctioned boards comprised of market participants are going to continue facing increased antitrust scrutiny when challenged in court.  These rulings continue to show that significant and meaningful state oversight mechanisms are a vital and scrutinized element for agencies seeking state action antitrust immunity. However, this case is far from over, and the TMB thus remains enjoined from implementing, enacting, or enforcing New Rule 190.8 until Teladoc’s claims are resolved.  While the Texas Medical Board has announced plans for appeal to the U.S. Court of Appeals for the Fifth Circuit, such a reversal would be highly unlikely at this point—meaning that the case can be expected to proceed into discovery and perhaps trial.

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[1] Teladoc, Inc. v. Texas Medical Board, 1-15-CV-343 RP (W.D. Tex. Dec. 14, 2015) (order denying motion to dismiss).