The Health Policy War Room

A recent JAMA Viewpoint article discusses how limited-supply agreements between brand name and generic drug makers could impact Medicare price negotiation under the Inflation Reduction Act (IRA). These agreements allow brand manufacturers to maintain some market exclusivity by limiting the supply of generic competitors. The article suggests these deals may increase as the Centers for Medicare and Medicaid Services (CMS) implements the IRA's price negotiation provisions. From a business perspective, it's understandable why brand manufacturers might find limited-supply agreements preferable to having their drugs subject to Medicare negotiation. Maintaining even partial exclusivity is likely better for revenue than triggering government-dictated price reductions. However, policymakers and patients are increasingly concerned that these deals keep prices high despite generic availability. The use of limited supply agreements could also produce unintended consequences.  Balancing som...

In the ever-evolving landscape of healthcare, the rising costs of prescription drugs continue to be a major concern for patients, providers, and payers alike. Drug spending is a complex issue with many different dynamics at play. While the Medicare program has recently been given authorities to control drug spending, some have expressed concern that these efforts will only shift drug cost pressures to different parts of the healthcare system. The escalating cost of prescription drugs is a significant burden on both patients and payers. As the prices of pharmaceuticals continue to soar, it is crucial to understand the myriad factors behind this trend. Pharmaceutical companies cite research and development costs, regulatory requirements, and the need for profit as justifications for the high prices. The ballooning drug costs have prompted federal interventions aimed at curbing the financial strain on the healthcare system. CMS now has the authority to negotiate the price of some prescri...

The Centers for Medicare & Medicaid Services (CMS) has recently announced a comprehensive plan aimed at ensuring the availability of new Alzheimer's drugs for beneficiaries granted full approval by the FDA. This significant development comes in response to the anticipated full FDA-approval of the first new drug for Alzheimer's disease in nearly two decades, signaling a critical milestone in the fight against this debilitating condition. CMS recognizes the urgent need to make these treatments accessible to patients, and their plan outlines several key measures to support coverage and access. Under the plan, CMS intends to provide Medicare coverage for the newly approved Alzheimer's drugs under the national coverage determination for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease.  The plan acknowledges the ongoing debate surrounding the efficacy of these drugs, and CMS emphasizes the importance of allowing patients to make informe...

Medicare is an important aspect of the healthcare system in the United States and plays a crucial role in providing medical coverage to millions of seniors. In recent years, Medicare spending and financing has been a topic of great concern and debate, with many questioning the sustainability of the program. In this article the Kaiser Family Foundation takes a look at some trends in Medicare spending and financing and what policy solutions might address these concerns. In 2020, Medicare spending accounted for 3.7% of the Gross Domestic Product (GDP), and this number is expected to grow in the future. KFF projects that Medicare spending will reach 5.8% of GDP by 2040. The main drivers of this spending growth are the increasing number of beneficiaries, rising healthcare costs, and the increasing costs of new medical technologies. This trend highlights the need for finding solutions to reduce the growth of healthcare costs and improve the efficiency of the healthcare delivery system. With...

 Earlier this week, HHS issued a press release announcing key dates for the first year of the Medicare drug price negotiation process. The Inflation Reduction Act provided Medicare with the authority to negotiate prices for a select number of prescription drugs. These negotiated prices will go into effect in 2026. HHS and the Centers for Medicare and Medicaid Services have committed to providing the opportunity for stakeholders to be engaged in the negotiation process by providing the opportunity for public feedback collection. According to CMS, they will be actively soliciting feedback on areas including: Terms and conditions contained in the manufacturer agreement, including the manufacturer’s and Secretary’s responsibilities. Approach for considering  the manufacturer-reported data elements and  evidence about alternative treatments.  Process for the offer and counteroffer exchange between the Secretary and manufacturers.  Content of an explanation for the m...