Policy & Compliance

Expert Analysis

• 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.

• CMS Rule, DOJ Probes Deepen Gender Care Compliance Risk

  

  The Centers for Medicare & Medicaid Services' final rule restricting Medicaid funding for hospitals that provide gender-affirming care is likely to face immediate litigation, but the CMS rulemaking is already working alongside U.S. Department of Justice's enforcement campaign to create operational risk for providers, say attorneys at Arnall Golden.

• 5th Circ. Ruling Hints At Loper Bright's Effect On OSHA Suits

  

  The Fifth Circuit's recent decision in Exxon Mobil v. Occupational Safety and Health Review Commission relied on Loper Bright to narrow the scope of illnesses that employers must record, signaling that courts may continue to scrutinize agency assertions that deference is due, say attorneys at Ogletree.

• 2 Cases Shed Light On Invoking The 5th Before Congress

  

  Given the anticipated increase in congressional investigations following the midterm elections, those who anticipate being in Congress' spotlight can draw valuable Fifth Amendment lessons from the ongoing case involving Dr. Anthony Fauci's testimony and the D.C. Circuit’s recent ruling in de la Torre v. Cassidy, say attorneys at King & Spalding.

• Vanda Ruling Offers New Guide To Generic Labeling Disputes

  

  The D.C. Circuit's recent decision in Vanda Pharmaceuticals v. U.S. Food and Drug Administration is significant for its guidance on when generic-drug labeling remains sufficiently similar to brand labeling and when a difference requires a statutory exception, says Shashank Upadhye at Upadhye Tang.

• Cannabis, Psychedelics Boom Raises IP Hurdles

  

  Recent data regarding patent filing activity and litigation in the cannabis and psychedelics markets indicates that as commercial interest accelerates, the scope of publicly accessible prior art is also expanding, setting a higher bar for novelty and nonobviousness in patent applications, say attorneys at Sterne Kessler.

• 5 Practice Tips After DOJ's Healthcare Fraud Declination

  

  In light of the U.S. Department of Justice's decision to not prosecute Campus Eye Management under the agency's new corporate enforcement and voluntary self-disclosure policy, healthcare companies should keep several considerations in mind when weighing their risk and self-disclosure strategy, including the distinctions between reporting to the DOJ versus other government agencies, say attorneys at Haynes Boone.

• FDA Closeout Letter Suggests Relaxing Stance On Wearables

  

  The U.S. Food and Drug Administration's recent decision not to pursue enforcement action against Whoop's wearable blood pressure tracker, read together with guidance released earlier this year, suggests a softer shift in the FDA's approach to regulating wearables, say attorneys at Arnold & Porter.

• Teva MDL Loss Shows DPAs Can Return To Haunt Civil Suits

  

  Teva’s recent partial summary judgment loss in antitrust multidistrict litigation reinforces the importance of carefully scrutinizing any statement of facts a company admits to in a deferred prosecution agreement, and illustrates the potential costs of resolving a criminal investigation this way, say attorneys at Sheppard.

• 11th Circ. FCA Qui Tam Revival Queues Up Next Challenges

  

  Though the Eleventh Circuit on Sept. 1 upheld the constitutionality of the False Claims Act's qui tam provision, it will probably face continued litigation since the appellate court declined to rule on other constitutional challenges and the decision will likely be petitioned to the U.S. Supreme Court, say attorneys at Sheppard.

• Prepping Health Businesses For Sale In A Data-Driven Market

  

  In a thinner market for healthcare transactions, with both regulators and buyers using artificial intelligence to inspect data in great detail, the margin for error in sellers' financials and legal diligence has narrowed, requiring more proactive compliance efforts, says Cody Dumas at FBFK Law.