A Look at Recent Federal Trade Commission and Consumer Financial Protection Bureau Initiatives Concerning Privacy and Data Security
2BInformed: Engaging with EPA, OSHA’s New Regulation, and Asbestos
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On January 31, 2024, the US Centers for Medicare & Medicaid Services (CMS) released the Advance Notice of Methodological Changes for Calendar Year (CY) 2025 for Medicare Advantage (MA) Capitation Rates and Part C and D...more
OSHA Issues Vaccine ETS - The Occupational Safety and Health Administration (OSHA) published its COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS) on November 5, 2021. The ETS, which is effective...more
On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment...more
On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more
The Big Picture - In the latest election year action to address politically salient concerns with high drug costs, President Trump on Sunday signed an “Executive Order on Lowering Drug Prices by Putting America First.”...more
• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals. • The proposed structure, called the International Pricing Index (IPI)...more
Another Presidential Administration Attempts to Change Part B Payment for Physician-Administered Drugs - On October 25, 2018, the Trump Administration released an Advance Notice of Proposed Rulemaking (“ANPRM”) entitled...more
On Wednesday, October 25th, President Trump, along with HHS Secretary Alex Azar, introduced the administration’s new proposal to lower drug prices through Medicare Part B. The announcement follows ASPE’s morning release of a...more
On October 25, 2018, the Centers for Medicare and Medicaid Services (CMS) announced an Advance Notice of Proposed Rulemaking with Comment (ANPRM) proposing to implement an international pricing index (IPI) model for Medicare...more
On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an advance notice of proposed rulemaking (ANPRM) describing a potential mandatory model to test Medicare reimbursement based on an "International...more
President Trump yesterday touted “bold” plans to lower drug prices in unspecific terms. Simultaneously, CMS issued an Advance Notice of Proposed Rulemaking (ANRPM), describing options to test Medicare reimbursement based on...more
On May 8, 2018, in its Fiscal Year 2019 (FY 2019) Skilled Nursing Facility (SNF) Prospective Payment System (PPS) Proposed Rule, Centers for Medicare & Medicaid Services (CMS) proposed a new case-mix classification system...more
On May 8, 2018, in its FY2019 SNF PPS Proposed Rule, CMS proposed a new case mix classification system that drives Medicare reimbursement for SNF inpatient services. The new system would go into effect on October 1, 2019. CMS...more
On January 3, 2018, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule to revise 42 CFR Part 2, the federal regulations governing confidentiality of certain substance abuse patients'...more
On May 4, for the first time in nearly 15 years, CMS issued an Advanced Notice of Proposed Rulemaking (ANPRM) proposing a total overhaul of the current reimbursement methodology for skilled nursing facilities (SNFs). The...more
It should come as no surprise to anyone working with skilled nursing facilities (SNFs) that CMS has been exploring ways to adjust its current payment model to reduce or eliminate skilled therapy utilization as the primary...more