McSweeny Joins FTC as Fifth Commissioner as Republican Commissioners Continue to Make Waves – Federal Trade Commission

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On April 9, 2014, Terrell McSweeny was confirmed by the Senate as the fifth and final Federal Trade Commissioner. She joins fellow Democrat appointees Chairwoman Edith Ramirez and Commissioner Julie Brill. It is the two Republican appointees, Commissioners Maureen Ohlhausen and Josh Wright, however, who have been making the most news in the last several months with dissents and speeches. Now that the FTC is at full-strength, clients should be on the lookout for a more active discussion of new FTC initiatives.

McSweeny is a relative newcomer to the antitrust community, serving as Senior Counsel for Competition Policy in the Justice Department’s Antitrust Division since 2012. She held several positions supporting Vice President Joseph Biden, both as Vice President and Senator, and worked on earlier Democratic presidential campaigns. At her confirmation hearing, she pledged to “continue the [FTC’s] tradition of collegiality and consensus-oriented decision making,” but described no specific initiatives she planned to pursue. She received support from the few Senators present at the hearing and her confirmation vote was 95-1.

During the many months when there were two Democrat and two Republican Commissioners, the FTC continued to be very active in clearing mergers, challenging fraudulent activities and issuing rules and guidance for businesses of all types. Almost all those actions that required votes of the Commissioners received unanimous support. The two Republican Commissioners, however, have publicly dissented from some current and past FTC actions involving intellectual property, FTC Act Section 5 and particular mergers. Also, the lack of a fifth vote caused a rare 2-2 split on claims of collusion in the recent McWane case.

On intellectual property, Ohlhausen vigorously dissented to a portion of the Commission’s late 2012 Robert Bosch consent agreement resolving merger issues. She objected only to the finding of an unfair method of competition when the patent holder sought injunctive relief on a standard essential patent over which there was dispute about a fair, reasonable and non-discriminatory license (FRAND). Ohlhausen saw that issue as one better left to courts or standard setting organizations adjudicating contract provisions. She similarly dissented early in 2013 when the FTC obtained a consent agreement in Google/Motorola Mobility that again required a patent holder to forego unrestricted use of injunction actions as part of a FRAND dispute. While Wright took no part in those actions, he reiterated his earlier academic writing in an April 2013 speech that patent and contract law were better than antitrust law in dealing with FRAND disputes involving standard essential patents. In a March 2014 speech, he called those decisions deviations from the principle embedded in past FTC decisions and guidelines that the antitrust analysis should be symmetrical whether the rights were for intellectual property or real property.

Wright has taken the lead on the Section 5 issues. As explained in our earlier alert, FTC Section 5 allows the FTC to go beyond the Sherman Act and prevent “unfair methods of competition,” but opinions about the extent of that power have varied with the identities of the commissioners. Wright proposed specific guidance to be issued by the FTC that would tether the FTC’s power here to modern antitrust’s “harm to competition” concept. In a July 2013 speech, Ohlhausen endorsed the concept of guidance from the FTC and suggested a limited use of Section 5 similar to Wright’s. Brill questioned the need for such guidance, pointing to the limited number of recent Section 5 actions and no groundswell from business for such guidance, and thought it only made sense when the Commission was back to full strength. On several occasions, Chairwoman Ramirez has said that the periodic Commission actions and Commissioners’ speeches were sufficient guidance on the issue.

Finally, Wright dissented (Ohlhausen was recused) from the September 2013 challenge to the Nielsen/Arbitron merger. The Commission was concerned about the effect of the merger on a market that does not now exist. While acknowledging that merger review necessarily involves some level of prediction, he thought the effects of a merger on such a “future market case” beyond the ability of any enforcer to predict. Finally, Wright was the lone dissent from the December 2013 decision to require changes in the Fidelity National/Lender Processing merger before allowing it to proceed. Wright would have allowed the merger to close with no changes, observing that “modern economics” required something more before concluding that the mere reduction in competitors would increase the likelihood of post-merger collusion in the industry.

In the McWane matter, FTC complaint counsel claimed the company excluded some competitors from a slice of the ductile iron pipe fitting market through a loyalty rebate program while also colluding with those same competitors to raise prices in the overall market. The FTC Administrative Law Judge found exclusion but not collusion. The four sitting commissioners missed two deadlines to issue an opinion because, according to media reports, they were deadlocked. Finally, the deadlock was broken but only on exclusion — Wright dissented from a finding that there was sufficient evidence that the rebate program constituted anticompetitive exclusive dealing. The commissioners deadlocked 2-2 on the collusion claims so the ALJ’s finding of insufficient evidence was allowed to stand and those claims were dismissed.

These dissents and deadlocks can overstate the differences among the commissioners. Since Chairwoman Ramirez rose to her current role last year and the Commission was left shorthanded, the FTC’s enforcement and education activities have continued apace, usually supported by unanimity from the four commissioners. Also, Ramirez has not publicly indicated any particular initiatives she had been unable to pursue because of the lack of a third Democratic vote. Still, the McSweeny addition will give her the opportunity to regain the initiative from her Republican colleagues. Clients should be alert for any changes in the debates or new initiatives now that the Commission is back to full strength.

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The Department of Justice Continues to Bring the "Heat" in Pursuing Health Care Fraud

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The False Claims Act (31 U.S.C. §§ 3729 – 3733) (the FCA) penalizes individuals and companies (often government contractors) who defraud the government by either submitting a false request for payment or avoiding payment of an obligation to the government. In May 2009, the Department of Justice (DOJ) and Department of Health and Human Services jointly announced the formation of the Health Care Fraud Prevention and Enforcement Action Team, or the “HEAT” initiative, to specifically target fraud in the health care industry, and using the FCA as a primary tool.

 

According to the DOJ’s own estimates, the HEAT initiative has been successful. Indeed, the DOJ claims that in only five years, it has recovered more than $13.4 billion based on its pursuit of FCA and other claims against alleged perpetrators in the health care industry.

 

It is no shock based on those numbers that the DOJ remains as determined as ever to bring the “HEAT” against the health care industry. For example, on Feb. 25, 2014, the DOJ announced a $15.5 million settlement under the FCAagainst a chain of diagnostic testing facilities in New Jersey and New York. The DOJ alleged that the facilities falsely billed federal and state health care programs for tests that were not performed or not medically necessary and by paying kickbacks to physicians. Three whistleblowers received over $2.5 million in connection with the settlement.

 

On Feb. 10, 2014, the DOJ announced the settlement of FCA allegations against an addiction clinic, clinical lab, and two doctors in Kentucky for $15.75 million, approximately $12 million of which represent funds to be refunded to the federal government. The settlement arose out of allegations that the targets defrauded Medicare and Kentucky Medicaid by seeking reimbursement for unnecessary tests or tests that were more expensive than those performed.

 

These and other settlements demonstrate the DOJ’s ongoing commitment to aggressively pursuing allegations of fraud in the healthcare industry.

Article by:

Kathleen L. Matsoukas

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Barnes & Thornburg LLP

 

FDA (Food and Drug Adminsitration) Releases Final Electronic Medical Device Reporting (eMDR) Rule and Deadline for Compliance

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The Food and Drug Administration (FDA) announced and is promulgating today the Final Rule on Electronic Medical Device Reporting (eMDR). Originally proposed in 2009, the rule is now final and a deadline for compliance has been identified. The rule impacts device manufacturers and importers and mandates electronic submission of individual medical device adverse event reports. User facilities may continue to submit only written reports.

As of August 14, 2015, postmarket medical device adverse event reports by manufacturers and importers must be submitted only electronically to the FDA’s Center for Devices and Radiological Health via the Electronic Submissions Gateway (ESG). The ESG is used for all forms of electronic filing to the FDA; information specific to medical device submissions is available here. Guidance about the eMDR is available here.

It is recommended you review your current system for submitting reports, and if you are not already utilizing the ESG for all reporting, develop a plan now for integrating the electronic process into your operations.

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Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

December New Jersey 2013 Health Care Regulatory Developments

Here are the most recent health care related regulatory developments as published in the New Jersey Register in December 2013:

  • On December 2, 2013 at 45 N.J.R. 2478, the Board of Medical Examiners published notice of its adoption of new rules which create the Genetic Counseling Advisory Committee and will require licensure of genetic counselors in the State of New Jersey.
  • On December 2, 2013 at 45 N.J.R. 2465, the Department of Health published notice of its cancellation of certificate of need calls for the following services:  (1) pediatric long-term care; (2) specialized long-term care; and (3) pediatric intensive care beds and services.  In addition, the Department of Health published notice that it was also postponing its certificate of need call for applicants for maternal and child health consortia changes in membership and intermediate and intensive bassinettes.
  • On December 16, 2013 at 45 N.J.R. 2602, the Department of Human Services published notice of its readoption of its rules governing community mental health services.
  • On December 16, 2013 at 45 N.J.R. 2602, the Department of Human Services published notice of its readoption of its rules governing payment for dental services under Medicaid.
  • On December 16, 2013 at 45 N.J.R. 2607, the Board of Physical Therapy Examiners published notice of its readoption of its rules governing the licensure and regulation of physical therapists and physical therapist assistants.
  • On December 16, 2013 at 45 N.J.R. 2618, the State Board of Dentistry published notice of its action on a petition for rulemaking filed by the New Jersey Dental Association requesting that the Board adopt a rule to establish regulatory guidance with respect to the corporate and/or unlicensed practice of dentistry in New Jersey.  This petition was filed following the issuance of a joint staff report on the corporate practice of dentistry by the U.S. Senate Committee on the Judiciary which found that corporations not owned by dentists operated dental clinics under the guise of providing administrative and/or financial management support to licensed dentists.  The Board referred the matter to its Rules and Regulations Committee for further deliberation.

Article by:

Beth Christian

Of:

Giordano, Halleran & Ciesla, P.C.