According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases.”
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On October 6th, California Governor Newsom (D-CA) signed SB 41 titled Privacy: genetic testing companies.
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The Centers for Medicare and Medicaid Services (CMS) in conjunction with the Departments of Health and Human Services (HHS), Labor (DOL), Treasury (collectively, the Departments), and the Office of Personnel Management (OPM) has issued an interim final rule with a comment period that seeks to implement the No Surprises Act aimed at surprise medical billing.
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The House of Representatives has passed by voice vote an amendment to the National Defense Authorization Act (NDAA) by adding the Secure and Fair Enforcement (SAFE) Banking Act to the legislation.
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According to a press release by Senator Warner (D-VA), a newly introduced “bipartisan bill in the U.S. Senate proposes to ensure Medicare patients maintain access to home infusion therapies that require the use of an infusion pump. The Preserving Patient Access to Home Infusion Act — introduced by Sen. Mark Warner (D-VA) and Sen. Tim Scott (R-SC) — would ensure patients with serious viral and fungal infections, heart failure, immune diseases, cancer, and other conditions can receive the intravenous (IV) medications they need while at home.”
The Preserving Patient Access to Home Infusion Act can be viewed here.
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Oral arguments have been scheduled for September 1, 2021 at 2:00 PM CST for PCMA v. Wehbi. Earlier this year, the U.S. Supreme Court vacated this 8th Circuit case formerly known as Wilke v. PCMA.
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According to the press release, Illumina announced that it has acquired GRAIL.
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FDA Approves First Interchangeable Biosimilar
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According to Governor Ned Lamont’s press release, the Governor has enacted a new law that legalizes and regulates adult-use cannabis in Connecticut. “The legislation Governor Lamont signed today is Senate Bill 1201. A proposal to legalize adult-use cannabis was initially put forward by Governor Lamont to the General Assembly earlier this year as Senate Bill 888. He also proposed similar legislation in February 2020 as Senate Bill 16.”
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The Governor has enacted Act No. 50 effective June 1, which seeks to ban “white bagging” in the state. White bagging is when a drug is delivered from an insurer’s preferred pharmacy to a physician’s office. This new law which is the first of its kind in the country provides that insurers cannot refuse to pay for physician-administered drugs to covered patients. Similar legislation has been seen in Massachusetts, New York and Texas.
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In February 2021, President Biden issued an Executive Order to direct a government-wide “approach to assessing vulnerabilities in, and strengthening the resilience of, critical supply chains.”
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According to press release, the House Committee on the Judiciary’s Antitrust Subcommittee Chairman Cicilline (D-RI) and Ranking Member Buck (R-CO) announced their antitrust bi-partisan agenda outlined below:
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At Lanton Law we are constantly on the watch for issues impacting our specialty, retail and LTC pharmacy clients including the issue of DIR fees. Clients utilize our advocacy and legal tools while discussing business strategy to combat an ever changing reimbursement environment.
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In the wake of the Colonial Pipeline attack, President Biden has signed the Executive Order on Improving the Nation's Cybersecurity.
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