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Aug 8, 2024 | 
jdsupra.com | Alison Andersen |Jack Bierig |Caroline English
On August 2, health care providers scored yet another significant victory when the US Court of Appeals for the Fifth Circuit affirmed the vacatur of various federal regulations regarding the arbitration procedures used to resolve billing disputes between providers and insurers under the federal No Surprises Act (NSA).
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Jan 22, 2024 | 
jdsupra.com | Alison Andersen |Jack Bierig |Caroline English
On December 18, 2023, the US Departments of Treasury, Labor, and Health and Human Services (the Departments) issued a rule finalizing the 2024 non-refundable administrative fee parties must pay to access the arbitration process established under the No Surprises Act (the Act). Once finalized, the rule will set the administrative fee at $115 per arbitration and will also finalize the permissible ranges for Independent Dispute Resolution Entity (IDRE) fees.
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Dec 8, 2023 | 
jdsupra.com | Alison Andersen |Jack Bierig |Caroline English
On October 27, the US Departments of Treasury, Labor, and Health and Human Services (the Departments) issued new proposed rules intended to revamp the negotiation and arbitration proceedings established under the No Surprises Act (the Act). Under the proposed rule, the Departments would permit broader batching of eligible claims and implement additional changes to the Open Negotiation and Independent Dispute Resolution (IDR) processes established under the Act.
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Oct 25, 2023 | 
jdsupra.com | Jack Bierig |Shoshana Golden |Wayne Matelski
On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to provide that laboratory developed tests (LDTs) are medical devices under the federal Food, Drug, and Cosmetic Act (FDCA) and are subject to all accompanying regulations.
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Oct 24, 2023 | 
natlawreview.com | Jack Bierig
On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to provide that laboratory developed tests (LDTs) are medical devices under the federal Food, Drug, and Cosmetic Act (FDCA) and are subject to all accompanying regulations.
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Oct 24, 2023 | 
afslaw.com | Jack Bierig |Shoshana Golden |Wayne Matelski
LDTs, often informally referred to as “home brews,” are in vitro diagnostic tests developed and used within a single laboratory. These tests are generally not sold to other laboratories. Rather, health care providers send a specimen to a laboratory where an LDT is utilized to help reach and provide a diagnosis. Prior to the proposed regulation, the FDA had adopted a policy of enforcement discretion.
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Oct 4, 2023 | 
jdsupra.com | Alison Andersen |Jack Bierig |Caroline English
*This is the 11th article in a series analyzing the No Surprises Act and its implementation. To view the entire series, click here. A link to the proposed rule is here. As background, Congress passed the Act to curb bills that patients receive when they are forced to obtain emergency care at an out-of-network facility or non-emergency care from an out-of-network provider at an in-network facility.
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Sep 8, 2023 | 
jdsupra.com | Alison Andersen |Jack Bierig |Caroline English
On August 24, 2023, health care providers in Texas scored yet another victory when a federal court vacated additional portions of the Biden Administration’s rulemaking under the federal No Surprises Act (the Act). This marked the second time in August alone that a federal court in Texas struck down rulemaking issued by the US Departments of Treasury, Labor, and Health and Human Services (the Departments) under the Act.
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Sep 7, 2023 | 
afslaw.com | Caroline English |Alison Andersen |Jack Bierig |David Greenberg
Off *This is the 10th article in a series analyzing the No Surprises Act and its implementation. To view the entire series, click here. As background, the Act aims to prevent surprise medical bills — bills patients receive when they are forced to obtain emergency care at an out-of-network facility or non-emergency care from an out-of-network provider at an in-network facility.
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Sep 1, 2023 | 
jdsupra.com | Alison Andersen |Jack Bierig |Caroline English
Last week, the US Court of Appeals for the Ninth Circuit, in its third opinion in the case, reversed a lower court’s decision allowing patients challenging United Behavioral Health’s (UBH) internal mental health coverage guidelines to seek reprocessing of their benefits claims as three certified classes.
