Policy & Compliance

Expert Analysis

• Contact Lens Rule's Evolution Steers FTC Guidance Program

  

  The history of the Federal Trade Commission's Contact Lens Rule illustrates the goals of the FTC's recently announced guidance program, which aims to strengthen consumer protection and safeguard competition, say attorneys at Wilson Sonsini.

• Abbott FCA Deal Shows Enforcement Adequacy Quandaries

  

  Abbott Laboratories’ recent False Claims Act resolution illustrates several tricky questions that both prosecutors and defense counsel must address when weighing whether a civil enforcement action alone adequately addresses allegedly wrongful conduct, says James Koukios at MoFo.

• New DNA Screening Standard Has No Clear Playbook

  

  Although the government has not yet released promised guidance intended to support its new standards for screening mail-order DNA, companies should not read this as a reprieve from the Oct. 13 compliance deadline because the delay shifts enforcement risk to statutes that need no new authority, including false statements, the False Claims Act and fraud, says Ashwin Ram at Buchalter.

• Texas Medicaid Fraud Decision Leaves 2 Open Questions

  

  The Texas Supreme Court's decision in Laboratory Corp. of America Holdings v. Texas and NPT Associates, holding that the Texas Medicaid Fraud Prevention Act's omissions provision requires proof of materiality, creates ambiguity about the materiality requirement and about how Texas courts will treat federal precedent going forward, say attorneys at Sidley.

• 3rd Circ. Ruling Shows ADA Limits Amid Worker Misconduct

  

  In Hileman v. West Penn Allegheny Health System, the Third Circuit recently rejected a wrongful termination claim under the Americans with Disabilities Act, illustrating that disability and leave laws don't automatically insulate employees from the consequences of prior workplace misconduct, say attorneys at Bond Schoeneck.

• DOJ Policy Creates New Defense For Physicians, Health Cos.

  

  The U.S. Department of Justice's recently revised enforcement policy governing agency guidance makes clear that Medicare guidance is not the law, potentially giving healthcare organizations a stronger basis to challenge certain enforcement theories, says Jose Vela at Clark Hill.

• FDA Bill Shows Risk Of Inexact Statute Text, Post-Loper Bright

  

  A recent House bill to amend the Food and Drug Administration's drug preclusion framework reveals the increased importance of precision when drafting statutory rules in a post-Loper Bright landscape, as several minor errors in the text could lock in unintended results that will be difficult to repeal, say attorneys at Venable.

• $95M Nev. Case Provides Clues On Wound Care Enforcement

  

  Federal prosecutors’ recent U.S. v. Dubin indictment, charging a Nevada physician with healthcare fraud over an alleged $95 million Medicare billing scheme involving amniotic wound allografts, provides a clearer picture of an increasingly data-driven enforcement strategy that follows the entire wound care transaction, say attorneys at Bass Berry.

• 8th Circ. Ruling Raises Bar For Seeking Disability Benefits

  

  The Eighth Circuit's recent ruling in Post v. Bisignano signals that claimants seeking Social Security disability benefits may need to offer convincing proof of functional restrictions beyond their treating doctors' opinions and illustrates that the court's proclaimant jurisprudence no longer prevails, says Mark DeBofsky at DeBofsky Law.

• FCA Ruling May Open Door To Redacting Defendants' Names

  

  A recent Florida federal court decision may signal a shift from the long-prevailing view that False Claims Act defendants' identities must always be revealed when qui tam actions are unsealed, potentially providing important protection for healthcare fraud defendants who may face career consequences from unproven allegations, say attorneys at Holland & Knight.

• New CMS Medical Device Pathway May Have Limited Effect

  

  The Centers for Medicare & Medicaid Services' new pathway for giving Medicare beneficiaries earlier access to certain medical devices bears similarities to previous programs that did not advance coverage significantly, and thus may only benefit certain manufacturers, say attorneys at King & Spalding.

• A Road Map To Modernizing Clinical Lab Regulations

  

  The Centers for Medicare & Medicaid Services' recent request for comments on potential changes to the Clinical Laboratory Improvement Amendments provides an early indication of where CLIA is headed, and the operational, compliance, reimbursement and enforcement issues those changes will create, says Jose Vela at Clark Hill.

• 2nd Circ. Tylenol MDL Ruling Clarifies Court Gatekeeper Role

  

  The Second Circuit’s recent decision in multidistrict litigation over alleged links between Tylenol and developmental disorders, holding that the trial court improperly excluded expert witnesses, preserves meaningful judicial gatekeeping while making clear that judges may not resolve legitimate scientific disputes themselves, say attorneys at Lowenstein Sandler.