The Food and Drug Administration (FDA) decided not to appeal a district court decision issued on March 31 vacating the agency's final rule attempting to regulate laboratory developed tests (LDTs)...

On May 29, the American Clinical Laboratory Association (ACLA) sued the Food and Drug Administration (FDA) in an effort to vacate its recent final rule that will gradually phase out...

The COVID-19 pandemic exacerbated the already-growing mental health and substance use disorder (SUD) (behavioral health) crisis gripping children and youth in the United States.

On February 18, the New York State (NYS) Department of Health (DOH) announced that the enforcement of the health care worker booster requirement under the ...

On April 15, the White House issued a drug pricing executive order (EO), along with an associated fact sheet, with a stated goal of "providing access to prescription drugs at lower costs to American...

New York State missed its April 1 statutory deadline for an on-time budget, as the Hochul Administration and New York State Senate and Assembly leaders and staff continued to negotiate toward an agreement...

On December 31, the Internal Revenue Service (IRS) issued a proposed rule for the calculation of the excise tax under the Medicare Drug Price Negotiation Program, as enacted under the Inflation Reduction Act (IRA).

The new framework places a stronger emphasis on how proactively companies identify and mitigate risk, rather than how companies respond after issues surface, the authors explained

The Texas House and Senate are considering twin bills which would require companies offering commercial sales-based financing to provide specified disclosures and register with the Texas Finance Commission.

Employment plays a vital role in enhancing independence, economic self-sufficiency, social inclusion and overall quality of life for people with intellectual and developmental disabilities (I/DD).

In a March 28 decision, the federal district court in Colorado dismissed a suit filed by Amgen challenging the legality of Colorado Prescription Drug Affordability Board (PDAB) efforts to set upper payment limits (UPLs) on drugs that the board deems unaffordable.

A federal appeals court has handed down the first substantive appellate ruling on the validity of the Inflation Reduction Act's (IRA) Medicare Drug Price...

On May 12, CMS released draft guidance outlining how the agency will implement negotiation under the Inflation Reduction Act's (IRA) Medicare Drug Price Negotiation Program...

On May 5, the Federal Trade Commission (FTC) and Department of Justice (DOJ) Antitrust Division issued a joint letter to federal agencies directing them to identify and submit a list of anticompetitive regulations...

Support for this toolkit was provided by the State Health and Value Strategies program, a grantee of the Robert Wood Johnson Foundation. The views expressed here do not necessarily reflect the views of the Foundation.

On May 5, President Trump signed an executive order (EO) titled, "Regulatory Relief to Promote Domestic Production of Critical Medicines." The EO seeks to build...

This Roadmap was prepared by the Maryland Coalition of Families and Manatt Health in partnership with the Maryland Department of Health's Behavioral Health Administration.

On April 21, the Supreme Court heard oral arguments in Kennedy v. Braidwood Management, which could end the requirement that nearly all commercial insurers cover...

On April 29, the Supreme Court issued its opinion in Advocate Christ Medical Center et al., v. Kennedy, affirming a lower court ruling that upheld The Department of Health and Human Services' (HHS)...

Amid the ongoing congressional action related to Medicaid reform, late on Friday, June 6, the White House released a presidential memorandum directed to the HHS Secretary and CMS Administrator titled...