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FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices

On April 29, 2024, the US Food and Drug Administration (FDA) issued the long-awaited final rule around the regulation of laboratory developed tests (LDTs), which are in vitro diagnostic products (IVDs) that FDA describes as...more

2024 Chart of Additional Healthcare Regulations

During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more

FDA Charts Course for Regulating AI Used in Medical Products

On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,”...more

Special Report: Understanding ONC’s Health AI Transparency and Risk Management Regulatory Framework

The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more

Baby Steps Toward Implementing a Regulatory Framework for AI in Healthcare

A few weeks ago, Regs & Eggs highlighted the major issues that McDermott+Consulting is monitoring this year – and the implementation of the president’s executive order (EO) on artificial intelligence (AI) was definitely part...more

2024: The Year of the Telehealth Cliff

What does December 31, 2024, mean to you? New Year’s Eve? Post-2024 election? Too far away to know? Our answer: December 31, 2024, is when we will go over a “telehealth cliff” if Congress fails to act before that date,...more

New ONC Final Rule Expands Information Blocking Regulatory Exceptions

On December 13, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) issued the Health Data, Technology, and Interoperability: Certification...more

HHS Issues Provider Information Blocking Disincentives Proposed Rule

On October 30, 2023, the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) released a...more

The Major Regs Are Out! Will Congress Intervene in of the “Final” Policies?

A few weeks ago, Regs & Eggs discussed the constant give and take between federal agencies and Congress as they both work on overlapping policies and objectives. The major regs released last week provide an excellent example...more

Policy Update - CMS Releases CY 2024 Physician Fee Schedule Final Rule

On November 2, 2023, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2024 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B...more

Landmark Executive Order on AI: What Does It Mean for Healthcare?

On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI...more

DEA Further Extends Flexibilities for Controlled-Substance Prescribing via Telemedicine

The United States Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) have further extended flexibilities that allow providers to prescribe controlled substances...more

Laboratory-Developed Tests: FDA Publishes Highly Anticipated Proposed Rule

On September 29, 2023, the US Food and Drug Administration (FDA) published a long-awaited proposed rule on laboratory-developed tests (LDTs). If FDA finalizes this rule as proposed, FDA will regulate virtually all LDTs as...more

The Ongoing Poker Game Between Congress and FDA: Who Will Win?

Congress and federal agencies often engage in a game, each trying to see what the other is willing to do to achieve a particular policy or outcome. While Congress and federal agencies have unique authorities (legislative...more

A Look into House Efforts on Hospital and Health Plan Price Transparency

In the 118th Congress, the US House of Representatives is keenly interested in healthcare price transparency. Three House committees—Energy and Commerce, Ways and Means, and Education and the Workforce—each approved...more

Pharmacy Benefit Manager Reform: What’s on the Horizon?

The price of prescription drugs has brought scrutiny to the entire drug supply chain. Congress and other policymakers continue to seek opportunities to lower costs for patients and the federal government. Pharmacy benefit...more

Drug Payment Reform and Transparency: It’s What’s on the Menu for Policymakers

August 31, 2023 – When it comes to prescription drug costs, policymakers have set their focus on the consumer: “Let’s lower drug prices for the consumer.” “Let’s give consumers more options in paying their out-of-pocket...more

Policy Update - A Look into House Efforts on Hospital and Health Plan Price Transparency

In the 118th Congress, the US House of Representatives is keenly interested in price transparency in healthcare. Three House committees—Energy and Commerce, Ways and Means and Education and the Workforce—each approved...more

Policy Update - CMS Releases CY 2024 Physician Fee Schedule Proposed Rule

On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2024 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B...more

Short-Term, Limited Duration Insurance: How Long is Too Long?

On July 7, 2023, the US Departments of Health and Human Services, Labor, and Treasury (collectively, the departments) released a Notice of Proposed Rulemaking (NPRM) and Fact Sheet that proposes to revise the definition of...more

Key Takeaways | Regulatory Roadblocks and Opportunities: How to Thrive in a Shifting Healthcare Landscape

During this session, panelists offered insights into the regulatory action, rulemaking and legislation shaping the future of digital health, with a particular focus on artificial intelligence (AI), data privacy and the end of...more

CMS Withdraws COVID-19 Vaccination Mandate, Enhances Focus on Quality Measures

Following the May 1 White House announcement that the federal government would wind down certain remaining COVID-19 vaccination requirements, on May 31, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a final...more

Special Report - CMS Unwinds Waivers as the COvid-19 PHE Comes to an End

At the onset of the COVID-19 PHE, CMS was permitted to issue several temporary emergency statutory and regulatory waivers to help providers appropriately respond to the pandemic. On May 1, 2023, the Secretary released a memo...more

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