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US CMS Announces Initial Prices for Medicare Drug Price Negotiation Program

On August 15, 2024, the Centers for Medicare & Medicaid Services (CMS) released the first set of negotiated prices for the Medicare Drug Price Negotiation Program for 2026. Authorized under the Inflation Reduction Act of...more

CFPB Issues Interpretive Rule Designating BNPL Providers as Card Issuers Subject to Regulation Z

On May 22, 2024, the Consumer Financial Protection Bureau (CFPB) issued an interpretive rule stating that providers of “buy now, pay later” (BNPL) products that issue “digital user accounts” to access credit products to...more

National Telecommunications and Information Administration Seeks Comments on Dual-Use Foundation Models

The National Telecommunications and Information Administration (NTIA) announced a request for comment regarding the potential risks and benefits of dual-use foundation models with weights that are widely available. NTIA also...more

FDA Greenlights Florida’s Proposal for Importing Prescription Drugs From Canada

On Friday, January 5, 2024, the US Food and Drug Administration (FDA) authorized the Section 804 Importation Program (SIP) proposal of Florida’s Agency for Health Care Administration (FAHCA). The SIP is a pathway that allows...more

[Webinar] AI Talks series: AI + Regulatory - January 10th, 9:30 am - 10:30 am PST

This session will cover ways to navigate the US, European Union and UK regulatory and legislative risks of AI, including strategies for engaging with policymaking bodies and analyzing the business impacts of legislation and...more

US Regulatory Agencies Launching Reviews of AI

The extent to which the federal government will regulate artificial intelligence (AI) is a hot topic in Washington, DC. In September 2023, the US Senate held a closed-door forum, followed by another forum in October, with AI...more

Biden Administration Issues Sweeping AI Executive Order

On October 30, 2023, the Biden administration issued a long-awaited executive order (EO) on artificial intelligence (AI). The EO expands on previous AI initiatives, such as the Blueprint for an AI Bill of Rights, and lays out...more

Third-Party Servicer Guidance on Hold

On April 11, 2023, the US Department of Education (ED) announced that it will modify and further delay the implementation of its controversial guidance on third-party servicer (TPS) issues. This latest update comes in...more

FTC Proposes Change in Regulation, Enforcement of Data Collection and Security

Key Takeaways - On August 11, 2022, the Federal Trade Commission announced an advance notice of proposed rulemaking (ANPR) to initiate a process that would allow it to develop and enforce rules on what the FTC has termed...more

DOJ Previews Enforcement Policies Aimed at Clinical Trial Fraud

On December 9, 2021, one of the nation’s top healthcare prosecutors made clear that clinical trial fraud will be a major enforcement priority of President Joe Biden’s Department of Justice. Speaking at the Food and Drug Law...more

Blog: FTC Notice of Penalty Offense – What it is, what it isn’t, and what to do next

The FTC announced that it had issued Notices of Penalty Offense to for-profit colleges and was cracking down on unfair and deceptive conduct in the education marketplace. During a closed press conference last week, the...more

Blog: 90/10 Provisions of American Rescue Plan Act of 2021 Brings Major Change

For proprietary institutions subject to the 90/10 rule, President Joe Biden’s signing of the American Rescue Plan Act of 2021 on March 11 reflects a major change in this revenue test that provides for-profit institutions and...more

Alert: Boston Fed Releases FAQs, Operational Documents for Main Street Lending Program

Borrowers and lenders have eagerly anticipated additional details and guidance on the Federal Reserve's rollout of the $600 billion Main Street Lending Program, as there has been scant information regarding the specific...more

Alert: Fed Provides Additional Guidance on $600 Billion Main Street Lending Program

Since the Federal Reserve's announcement on April 9 of the rollout of its Main Street Lending Program1, lenders and borrowers have eagerly anticipated additional guidance on key aspects of the program. On April 30, 2020, the...more

Alert: Treasury and Federal Reserve Board Announce Details of $600 Billion Main Street Lending Program

As has been widely anticipated, the Treasury and the Federal Reserve Board released the details of their previously announced Main Street Lending Program to promote liquidity in the lending market for small to medium sized...more

Alert: Treasury Releases New Procedures and Requirements for CARES Act Loans for Airlines and Businesses Critical to National...

The CARES Act, a $2 trillion relief package signed into law on Friday, authorizes the US Treasury Department to provide up to an aggregate of $500 billion for loans, loan guarantees and other investments for eligible...more

Alert: SBA Programs Under the CARES Act: Loan Application and Information Sheet Issued

A key feature of the CARES Act $2 trillion relief package is the creation of the Paycheck Protection Program (PPP), which authorizes $349 billion for businesses to obtain loans of up to $10 million per applicant to be used on...more

Alert: SBA Programs Under the CARES Act: Are You Eligible for Federal Assistance?

As has been well publicized, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) is a $2 trillion economic relief package enacted to help individuals and businesses in the United States weather the severe...more

Alert: President Signs CARES Act

The President has signed a $2 trillion relief package, the "Coronavirus Aid, Relief, and Economic Security Act" (CARES Act). The CARES Act is intended to provide "emergency assistance and health care response for individuals,...more

Alert: Multiple Layers of Oversight in the CARES Act: The Appetite for Accountability Will Long Outlast the Current Crisis

The estimated $2+ trillion stimulus bill – the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) – is meant to address the economic crisis caused by the coronavirus pandemic. The act will pump hundreds of...more

Blog: Drug Pricing 2019 Year in Review

In 2019, Congress and the Administration set out to make strides to effectuate policies to curb the rising costs of prescription drugs. These efforts while significant in number, were few in completion. Congress, while...more

Blog: Administration releases drug importation plan but implementation questions abound

Yesterday, the Department of Health and Human Services (HHS) announced two “pathways” for drug importation. This plan is the latest step in the Administration’s push to lower prescription drug prices and one the President has...more

Blog: White House Withdraws Rebate Rule

Earlier this morning, the White House announced that they were scrapping a proposed rule (the rebate rule) that, among other items, would have [would eliminate the current safe harbor protection under the Anti-Kickback...more

Blog: No Surprise! – Drug Pricing Legislation Picking up Steam

Legislation that addresses the cost of prescription drugs is inching closer to moving out of Congress. On Yesterday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on the bipartisan Lower...more

Blog: California Presses Forward with Bill to Ban OPM Tuition Share Arrangements

Last week, the California Assembly Higher Education Committee unanimously voted to advance a bill designed to exclude OPMs and service providers from tuition share arrangements. AB 1345 would broaden California’s existing...more

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