FDA may be letting medical device makers fudge safety reports, study finds
Long COVID as a Disability under Federal Anti-Discrimination Laws
Pass Go and Collect Regulatory Scrutiny: The Biden Administration Takes Aim at Consolidation & Anti-Competitive Business Practices in Health Care
Given the current political dynamic within Congress, the chances of the Biden Administration enacting significant, substantive health care legislation appear slim in the short-term. Thus, the Biden Administration has sought alternative routes to advance its policy priorities, mainly through budget reconciliation (see here for a comprehensive explainer from the Congressional Research Service) and agency regulation. For example, we have previously written here and here about the “No Surprises Act”, enacted through the legislative short-cut of…
Health Care Provisions in the Infrastructure Investment and Jobs Act
On August 1, 2021, the Senate released the legislative text of the bipartisan infrastructure bill, the “Infrastructure Investment and Jobs Act,” H.R. 3684. The Senate is expected to vote this week, before a month-long recess beginning on August 9, 2021. The 2,702 page legislation contains several relevant health care-related provisions, including a delay of the implementation of the rule eliminating the Anti-Kickback Statute (“AKS”) safe harbor protection for Medicare Part D rebates.
Rebate for Discarded…
Authority to administer vaccine: Parens patriae jurisdiction.
Re Marlie [2021] NSWSC 973 (on Caselaw) concerned an order sought by a hospital to administer Hepatitis B vaccine and immunoglobulin injection to a baby.
The mother of the child was diagnosed with Hepatitis B, but the parents withheld consent for treatment of the child primarily on religious grounds. The risk of the child becoming infected with Hepatitis B was noted to be as high as 31%.
In exercising the parens patriae jurisdiction, the overriding criterion to be applied is the best interests…
PMPRB excessive price decision quashed by Federal Court of Appeal
The Federal Court of Appeal has quashed an excessive-price decision of the Patented Medicine Prices Review Board (PMPRB) in a proceeding concerning the drug SOLIRIS. The matter has been remitted to the PMPRB for redetermination.
Procedural background
The PMPRB issued a decision in 2017 finding that Alexion Pharmaceuticals Inc. sold SOLIRIS (eculizumab) at an excessive price in Canada and ordering Alexion to remit excess revenues earned between 2009 and 2017. Alexion’s application was dismissed by…
Bay Area Reinstates Indoor Masking Mandate
On August 2nd, seven Bay Area counties and the city of Berkeley joined the ranks of Los Angeles, Sacramento, and Yolo counties in issuing local ordinances that reinstitute indoor masking mandates. The orders require all individuals, regardless of vaccination status, to wear face coverings when indoors in public settings, with limited exceptions, beginning on August 3rd.
The following counties are included in the joint mandate:
Alameda
Contra Costa
Marin
San Francisco
San Mateo
Santa…
Connecticut Governor Signs Bill Limiting Hospital Billing and Collection Efforts and Revising Connecticut’s Facility Fee Laws
On July 7, 2021, Connecticut Governor Ned Lamont signed into law Public Act 21-129 entitled “An Act Concerning Hospital Billing and Collection Efforts By Hospitals And Collection Agencies” (“the Act”). The Act expands the types of entities to which billing and collection restrictions apply, places further limitations on collection efforts by such entities, and makes several changes to Connecticut’s existing laws concerning facility fees.…
New Facebook Policy Requires Certification and Pre-Approval for Telemedicine Company Advertisements
Telemedicine companies seeking to advertise on Facebook’s social media platforms will first need special approval and certification before running advertisements. In a recently-announced policy, Facebook introduced additional pre-approval requirements for telemedicine providers, pharmaceutical manufacturers, and online pharmacies looking to promote prescription drugs on social media. The new policy is effective August 25, 2021.
Under the policy, before promoting prescription drugs in ads on Facebook, telemedicine providers and online pharmacies must present written certification from …
Summer optimism wilts as contagious Delta variant rages in unvaccinated
