Healthcare and Life Sciences Industry Group: Legal Updates - Q2 2019

Please find below a listing of client newsletters and legal updates published by our member firms during Q2 2019. 

Canada, Alberta, Ontario, Quebec (Blake, Cassels & Graydon LLP)

• Health Canada Introduces Cannabis Health Products, A Budding Category (June 24, 2019)
• Significant Changes to Canada’s Cannabis Licensing Process (June 4, 2019)

China (JunHe LLP) 

• State Council Publishes Regulations for the Management of Human Genetic Resources (June 21, 2019)

Ireland and Northern Ireland (Arthur Cox)

• Doctors and healthcare providers – what are your disclosure obligations to patients? (June 10, 2019)
• Health Check for Health Research Regulations 2018 (May 29, 2019)

Jamaica (Myers, Fletcher & Gordon)

• A Cure for the Canna-Biz? (May 1, 2019)

New Zealand (Simpson Grierson) 

• OPINION: Medical marijuana - where is the regulator? (May 27, 2019)

Poland (Wardynski & Partners)

• Use of criminal law to combat drug distribution (June 13, 2019)
• Will there be more transactions on the pharmacy market? (May 9, 2019)
• No supplementary protection for a new form of an active substance (April 4, 2019)

Singapore (Rajah & Tann Singapore LLP)

• Occupational Safety and Health Law (May 2019)

Switzerland (Pestalozzi)

• The International Comparative Legal Guide to Pharmaceutical Advertising 2019 (June 19, 2019)
• Life Sciences - Switzerland: Law and Practice 2019 (April 10, 2019)

Thailand (Tilleke & Gibbins)

• Amendments to Thailand’s Drug Act (May 21, 2019)

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

• Arizona Supreme Court Finds Medical Marijuana Includes Cannabis Extracts and Resin (June 5, 2019)
• Appellate Court Affirms Medical Marijuana Variance in Phoenix (May 13, 2019)

USA, California (Morrison & Foerster LLP)

• Supreme Court Decides Prescription Drug Preemption Case in Favor of Drug Manufacturer (June 5, 2019)

USA, Connecticut (Murtha Cullina LLP)

• Health Care Group News: But, I'm Just a Business Associate . . . Think Again. (June 3, 2019)

USA, District of Columbia (Steptoe & Johnson LLP) 

• FDA Issues Final Guidance on FCNs for Substances Used in Contact with Infant Formula (May 8, 2019)

USA, Florida (Akerman LLP)

• Paper Prescription Pads to go the Way of the Horse and Buggy as Prescribers Will Soon Be Required to Electronically Transmit Prescriptions –Sometimes (July 1, 2019)
• Florida Patient Brokering Act Amended – Does it Clarify or Create New Issues? (June 28, 2019)
• FTC Prevails in Physician Merger Case Before the 8th Circuit (June 24, 2019)
• A Wake-Up Call for Hospital Boards (June 24, 2019)
• Georgia Leads the Way with Enactment of Pharmacy Anti-Steering Law (May 29, 2019)
• Caution: Curb Your Enthusiasm for the Reduced HIPAA Annual Limits (May 22, 2019)
• 2019 Legislative Session – The Passage of Telehealth (HB 23) (May 9, 2019)
• Florida Legislature Repeals its “Certificate of Need” Law (April 30, 2019)

USA, Georgia (Alston & Bird LLP)

• Health Care Advisory: The Primary Cares Initiative: What to Know and How to Prepare (June 27, 2019)

USA, Indiana and Minnesota (Faegre Baker Daniels LLP)

• Executive Order on Health Care Prescribes Change Ahead for Providers and Insurers (June 25, 2019)
SCOTUS Doesn’t Clarify Application of Pharmaceutical Conflict Preemption (June 7, 2019)

USA, Kentucky (Stites & Harbison, PLLC)

Healthcare facilities construction contracts (April 30, 2019)

USA, Louisiana (Jones Walker LLP) 

• Executive Order Issued to Improve Transparency in Healthcare Pricing (July 2019)

USA, Massachusetts (Foley Hoag LLP)

• Medicaid and the Law: Medicaid and Non-Emergency Medical Transportation (June 28, 2019)
• New Employee Benefit Rules Expand Health Reimbursement Arrangement Options for Employers (June 19, 2019)
• Massachusetts Senate Ways and Means Budget Maintains Drug Price Rebate Language (May 16, 2019)
• CMS Final Rule Requires Prescription Drug Pricing Transparency in DTC Advertising (May 13, 2019)
• The History of Rebates in the Drug Supply Chain and HHS’ Proposed Rule to Change Safe Harbor Protection for Manufacturer Rebates (April 2, 2019)

USA, Michigan (Butzel Long)

• HHS Announces Reduction in Maximum Penalties for HIPAA Violations (April 29, 2019)

USA, Nebraska (Baird Holm LLP)

• Iowa Passes Law Recognizing Lay Caregivers Following Inpatient Stay (June 5, 2019)
• Expanded Protections for Health Care Persons and Entities with Conscience Objections (June 5, 2019)
• Permanent Relief or the New SGR? Proposed Legislation Would Permanently Extend Enforcement Instruction for Outpatient Therapeutic Services in Cahs (May 3, 2019)
• Something New—The Preclusion List (May 3, 2019)
• HHS Announces Reduction of HIPAA-Related Civil Monetary Penalty Caps (May 3, 2019)
• OIG Speaks to Importance of Compliance in Changing Health Care Environment (May 3, 2019)

USA, New Jersey (Day Pitney LLP)

• OCR Releases Guidance on Direct Liability for Business Associates Under HIPAA (June 28, 2019)
• New FDA Guidance on Review of Drug Promotional Materials (June 27, 2019)
• New Medicare Part D e-Prescribing Proposed Rule Meant to Help Providers and Patients (June 25, 2019)
• Opportunity for Doctors to Tell Medicare How to Reduce Burdens (June 17, 2019)
• July 1 Deadline for Hospitals to have Matching Addresses to Avoid Non-Payment (June 3, 2019)
• CMS Updates PACE Regulations (May 30, 2019)
• Another Anti-Kickback Law to be Aware of in Clinical Treatment Facility Deals (May 30, 2019)
• CMS Provides More Flexibility for Medicare Part D Plans on Prior Authorization and Step Therapy for Certain Drugs (May 23, 2019)
• SCOTUS Ruling Extends FCA Filing Deadline for Private Qui Tam Claimants (May 20, 2019)
• CMS Proposes Rule on Promoting Interoperability Programs (May 15, 2019)
• CMS Launches “Primary Cares” Initiative (May 14, 2019)
• CDC Provides Clarification Guidelines for Prescribing Opioids (April 30, 2019)
• HHS Exercises Discretion to Modify HIPAA Penalties Based on Culpability (April 29, 2019)

USA, Pennsylvania (Pepper Hamilton LLP)

• Third Circuit Provides Defense for FCA Claims Concerning Pre-2010 Conduct (June 24, 2019)
• New Jersey Employers May be Required to Accommodate an Employee's Use of Medical Marijuana Outside the Workplace (June 19, 2019)
• New York and New Jersey Consider Health Insurance Reforms (June 3, 2019)
• Supreme Court Clarifies Scope of Implied Preemption in Prescription Drug Cases (May 22, 2019)
• Washington Becomes First State to Create Public Option Health Insurance (May 15, 2019)
• HHS to Require Manufacturers to Disclose Drug Pricing in Television Advertisements (May 9, 2019)

USA, Puerto Rico (McConnell Valdés LLC)

• Puerto Rico Department of Health Adopts New Certificates of Need Regulation (June 11, 2019)

USA, Tennessee (Bass, Berry & Sims PLC)

• The Philosophy for Investing in Urology: Key Regulatory Risks (February 5, 2019)
• Matt Curley and John Eason Examine Healthcare Fraud Enforcement in Long-Term Care Industry (June 14, 2019)
• Reminder – Annual Deadline (July 31) to Report and Pay PCORI Fee is Approaching (May 29, 2019)

USA, Vermont (Downs Rachlin Martin PLLC)

• Vermont Legislative Update 05-03-2019: An analysis from DRM's Government & Public Affairs Team (May 3, 2019)

USA, Wisconsin (Michael Best & Friedrich LLP)

• Supreme Court Empowers Judges to Resolve Preemption Defenses in Failure-to-Warn Drug Labeling Cases (May 22, 2019)

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