Healthcare and Life Sciences - Q4 2018

Please find below a listing of client newsletters and legal updates published by our member firms during Q4 2018.

Legal Updates

Clayton Utz (Australia)

• Commonwealth claims on undertakings continue to be a risk for pharmaceutical patent owners (December 20, 2018)
• No fishy business: first case on substantially transformed complementary medicine tests meaning of "Australian Made" (December 20, 2018)
• Quite an undertaking: quantifying damages from an interlocutory injunction preventing sale of a generic pharmaceutical (November 8, 2018)
• Mandatory reporting of shortages of prescription medicines comes in soon - but still some queries about what sponsors must do (October 25, 2018)

Thompson Dorfman Sweatman LLP (Canada: Manitoba)

• The Cannabis Countdown is Over (October 11, 2018)

Kromann Reumert (Denmark)

• Price Increase of 2000% Constituted an Abuse of a Dominant Position (December 14, 2018)

Noerr LLP (Germany)

• Brexit with or without a deal: Consequences for pharmaceutical companies (November 30, 2018)

Arthur Cox (Ireland and Northern Ireland)

• Cannabis Regulation in Ireland (December 3, 2018)
• Open disclosure in the healthcare sector: progress, but is it enough? (November 2, 2018)
• Portable Products: Moving your Marketing Authorisations or CE Marks to Ireland (October 15, 2018)

Basham, Ringe y Correa, S.C. (Mexico)

• COFEPRIS Authorizes the First 38 Cannabis Products in Mexico (November 22, 2018)
• Administrative and Juidicial News With Relation to the Sanitary Control of Cannabis (November 5, 2018)

Alvarado y Asociados (Nicaragua)

• Sanitary Registration of Nicaraguan Products (November 2018)

Burness Paull LLP (Scotland)

• Criminal charges for nutritional product manufacturer highlights the need for careful supply chain management (December 18, 2018)

Uría Menéndez (Spain)

• The National Markets and Competition Commission Upholds the Legality of the Free Price Policies Applied by Several Pharmaceutical Companies in Spain (October 2018)

Tilleke & Gibbins (Thailand)

• Growing Hemp in Thailand Is Now Permissible (December 6, 2018)
• Clearing the Air on Cannabis Patents (November 22, 2018)

Snell & Wilmer L.L.P. (USA, Arizona)

• Texas Judge Declares the Affordable Care Act Unconstitutional – What’s Next? (December 18, 2018)
• HHS Seeks Public Comment on the HIPAA Privacy Rule (December 12, 2018)
• A Holiday Surprise – IRS Extends Certain ACA Reporting Deadlines and Transition Relief (December 6, 2018)
• Reminder for SBCs – Yes, Please! (December 5, 2018)
• Zombie Benefits – Are Health Reimbursements Arrangements (“HRAs”) Back From the Dead? (November 7, 2018)

Morrison & Foerster LLP (USA, California)

• What Are the Top Hatch-Waxman and BPCIA Developments for October 2018? (November 6, 2018)
• FDA Announces new Efforts to Combat Cybersecurity Threats in Medical Devices (October 29, 2018)

Murtha Cullina LLP (USA, Connecticut)

• OCR Issues Anticipated RFI on HIPAA Modifications (December 13, 2018)
• Another HIPAA Breach, Another 6-Figure HIPAA Settlement (December 13, 2018)
• CMS to Seek Feedback on Reducing HIPAA Burdens (November 20, 2018)
• Anthem Agrees to Pay Largest HIPAA Settlement at $16M for Massive Breach (October 16, 2018)

Steptoe & Johnson LLP (USA, District of Columbia)

• Treasury and HHS Release Guidance on State Waivers Under Affordable Care Act (October 22, 2018)

Akerman LLP (USA, Florida)

• CVS Completes Acquisition of Aetna (November 27, 2018)
• DOJ Settles “Anti-Steering” Antitrust Case Against Atrium Health (November 19, 2018)
• New Federal Legislation Regarding Substance-Use Disorder Treatment (November 8, 2018)
• TV Drug Commercials Must Disclose the Drug’s List Price if HHS Adopts Proposed Rule (October 18, 2018)
• Drug Pricing Legislation Sent to the President for Enactment into Law (October 9, 2018)
• Court Says Employer Cannot Refuse to Hire Based on Medical Marijuana Use (October 2, 2018)

Alston & Bird LLP (USA, Georgia)

• Unclaimed Property Challenges in the Health Care Industry (December 26, 2018)
• Food, Drug & Device/FDA Advisory: New Guidance Refines FDA’s Thinking on Data Integrity (December 20, 2018)
• Environment, Land Use & Natural Resources and Food, Drug & Device/FDA Advisory: EPA Finalizes Management Standards for Hazardous Waste Pharmaceuticals (December 20, 2018)
• Final Management Standards for Hazardous Waste Pharmaceuticals Released (December 14, 2018)
• White Collar, Government & Internal Investigations and Health Care Litigation Advisory: DOJ to Dismiss False Claims Act Lawsuit After Supreme Court Review (December 14, 2018)
• Can Blockchain Deliver Secure IT Solutions For Health Care? (October 16, 2018)

Faegre Baker Daniels LLP (USA, Indiana and Minnesota)

• The Election’s Impact on Health Care Interests (November 7, 2018)
• Trick or Treat? Expected and Surprising Provisions in the New Medicare Advantage Regulation (November 1, 2018)
• For Latest Drug Pricing Proposal, It’s Back to the Future (October 26, 2018)
• INSIGHT: Drug Delivery Devices in the FDA Orange Book AfterIn reLantus (October 17, 2018)
• Beware Billing Medicare for Non-Approved Imported Drugs (October 3, 2018)

Foulston Siefkin LLP (USA, Kansas)

• HHS Issues Request for Information Seeking Input on HIPAA Improvements (December 18, 2018)

Foley Hoag LLP (USA, Massachusetts)

• Modernization of the 510(k) Pathway to Market Medical Devices (November 30, 2018)
• CMS Proposes Requiring Prescription Drug Price Disclosure in Direct-to-Consumer Advertising (October 17, 2018)
• FDA Releases Two Guidances for Innovative Drug Development (October 10, 2018
• Update to the Federal Physician Payments Sunshine Act (October 5, 2018)

Baird Holm LLP (USA, Nebraska)

• CMS Finalizes and Delays Proposed Changes to E&M; Services Coding (December 5, 2018)
• Deregulation Continues: CMS Proposes Reducing Medical History and Physical Examination ("H&P") Requirements for ASCS and Acute-Care Hospitals (October 3, 2018)

Day Pitney LLP (USA, New Jersey)

• CMS Proposes New Rule to Expand Telehealth Benefits Under Medicare Advantage Plans (November 21, 2018)
• Opioid Overprescribing – Study Shows Surgeons Prescribe Almost Four Times More Opioids Than Used (November 20, 2018)

Crowe & Dunlevy (USA, Oklahoma)

• Still work to be done on rules involving medical-marijuana physicians (October 20, 2018)

Pepper Hamilton LLP (USA, Pennsylvania)

• Why Biotech and Pharma Patents Survive IPR (November 21, 2018)
• CMS Proposed Rule Could Dramatically Increase Recoupments From Medicare Advantage Insurers (November 20, 2018)
• Future Expansion of Sunshine Act Reporting to Cover Additional Prescribers (October 29, 2018)
• Iowa Farm Bureau Health Plans to Deny Coverage for Preexisting Conditions (October 11, 2018)

Bass, Berry & Sims PLC (USA, Tennessee)

• DOJ Moves to Dismiss 11 Patient Assistance Services FCA Cases (December 21, 2018)
• Modernizing Medicare: CMS Expands Reimbursement for Virtual Care and Telehealth (December 5, 2018)
• The 2019 Part D Final Rule: Any Willing Pharmacy and Network Participation Requirements’ Relevance to Specialty Pharmacies (November 29, 2018)
• Angela Humphreys Examines Benefits of Private Equity Investment in Healthcare (November 28, 2018)
• The Eliminating Kickbacks in Recovery Act: An Unprecedented Expansion of Anti-kickback Liability to Private-Pay Referrals? (November 28, 2018)
• Looser Restrictions on HRAs on the Horizon (November 14, 2018)
• FCA Medical Necessity Cases May Stand on Firmer Footing After Recent Appellate Decisions (October 9, 2018)

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