Guidance for Second Medicare Drug Price Negotiation Released

The U.S. Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), has released final guidance outlining the process for the second cycle of negotiations under the Medicare Drug Price Negotiation Program. The guidance also explains how CMS will help ensure people with Medicare can access drugs at the negotiated […]
CMS Issues Final Rule on 2025 Home Health Prospective Payment Systems

The Centers for Medicare and Medicaid Services (CMS) issued a final rule on its 2025 home health prospective payment system, which updates Medicare payment policies and rates for home health agencies. This rule will also provide updates to the intravenous immune globulin (IVIG) items and services’ payment rates for durable medical equipment suppliers. With this […]
HHS Proposes Rule to Advance Health Equity

A rule has been proposed by the U.S. Department of Health and Human Services (HHS) to advance health equity and support whole-person care. The proposed rule would also strengthen primary care, expand access to behavioral health, oral health and caregiver training services, maintain telehealth flexibilities and expand access to screening for colorectal cancer and vaccinations […]
HHS Announces Price Cuts for 10 Medicare Drugs

The U.S. Department of Health and Human Services (HHS) has negotiated lower prices for 10 of the most expensive and widely used drugs covered under Medicare, which is expected to save the Medicare program $6 billion in the first year and reduce out-of-pocket costs for beneficiaries by $1.5 billion.
CMS Proposes Payment Cut for Physicians

CMS issued a proposed rule that announces and solicits public comments on proposed policy changes for Medicare payments on or after Jan. 1, 2025.
FDA Modernizes Informed Consent Guidance, Aligning with Common Rule Changes

FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand.
SAMHSA Releases Annual National Survey on Drug Use and Health

SAMHSA released the results of the 2023 National Survey on Drug Use and Health (NSDUH), which shows how people living in the United States reported their experience with mental health conditions, substance use and pursuit of treatment.
HHS Releases Final Rules Protecting Consumers Purchasing Short-Term Health Plans

The Departments of Health and Human Services, Labor and the Treasury have released the Short-Term, Limited- Duration Insurance and Independent, Noncoordinated Excepted Benefits Coverage, or “Junk Insurance,” final rules. Short-term, limited-duration insurance (STLDI) is a type of health insurance that is typically designed to fill temporary gaps in coverage when an individual is transitioning from one source of coverage to another.
CMS Finalizes Rule to Advance Health Equity

CMS finalized policies to support primary care, advance health equity, assist family caregivers and expand access to behavioral and certain oral healthcare.
Biosimilars and the Fight Against Inflation

New legislation promised to increase patient access to critical drug products by lower costs. Will it work?