The Health Policy War Room

Access to affordable health care is a persistent challenge for many Americans. However, a recent bill, the Protecting Health Care for All Patients Act (HR 485) , is making its way through the House of Representatives, which could hinder efforts to improve affordability of prescription drugs and other health care services. The bill seeks to block the use of quality-adjusted life-years (QALYs) and similar measures in government health care programs such as Medicare and Medicaid. QALYs are a widely accepted outcome measure used in health economic studies to assess the benefit of a therapy compared to standard care. They combine two critical health outcomes—length of life and health-related quality of life—into a single measure. QALYs are calculated by assigning weights to different health states, ranging from perfect health to death. By using QALYs, policymakers can estimate the average benefits of a treatment for a specific population. The debate over the use and impact of QALY is beyond...

Recently, much has been written about the escalating costs of drug prices in the US. Increasing drug prices are present challenges to those who struggle with affordability and access to their medications. The Inflation Reduction Act brought changes to the way the Medicare program reimburses for prescription drugs. Last year, President Biden challenged the Center for Medicare and Medicaid Innovation (CMMI) to develop and test new payment models that can support value-based payments and promote high-quality healthcare. CMMI has recently proposed three models intended to improve affordability and access to drugs as well as measuring the feasibility of implementation.       1. The Medicare High-Value Drug List Model Under this model, Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans that particip...

 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...

On June 22, Senator Ron Wyden (D-Ore.), Chairman of the Senate Finance Committee released his own set of “principles” for lowering prescription drug prices. Characterized as a step toward “comprehensive legislation” on the matter, the principles are said to guide Wyden’s work during the summer months with the ultimate goal of delivering relief from high prescription drug prices. Wyden’s principles largely reflect the concepts that have been widely circulated as parts of many prior statements on reducing drug prices. Medicare negotiation, limiting out-of-pocket costs at the pharmacy counter, controlling price increases for older drugs, and rewarding innovation are concepts that have been debated at length in the past. Wyden also suggests that any drug pricing proposals should apply to all Americans – not just those covered by Medicare. Acknowledging the work already done by the Senate Finance Committee, Wyden’s goal is to develop a legislative package, with bipartisan support, that can ...

Legislators and policymakers alike have struggled with finding effective ways to reconcile the differences between drug prices in the United States and prices for those same drugs in foreign countries. Many factors including Government price controls, varied supply chains, and differences in the volume and mix of drugs prohibit the direct comparison of drug prices between countries. The concept of developing a price index to track differences in prices over time and across markets is not new. The Medicare program has used market basket updates – a form of price indexing, to keep growth in payments under its prospective payment systems from falling behind prices in the market.  However, the concept of a price index for drugs has not been widely recognized by policy makers. That was, until President Trump released his “American Patients First” (1) blueprint to lower drug costs . In the blueprint, President Trump urged the Department of Health and Human Services to take steps to “addr...

In this week's Healthcare HotShots, I get in the wayback machine and revisit May 2018 to look at President Trump's American Patients First blueprint to see if I can figure out what a second Trump Administration might do to lower prescription drug costs.

It seems like CMS comes under constant fire for their efforts to serve as responsible stewards for the Medicare program. Lately it seems that CMS is taking fire for not going far enough with payment cuts. In this entry, I will look at the latest round of payment cuts to drugs purchased under the 340B Drug Discount Program. Read on for more... In 1992, the Veteran's Health Care Act amended the Public Health Services Act by creating section 340B and its eponymous Drug Discount Program. Originally intended to provide certain hospitals that cared for underserved populations a way to "stretch scarce federal resources" and provide funding to help provide care to their patient population. The program was originally limited to so-called Disproportionate Share Hospitals, Federally Qualified Health Centers, and Ryan White HIV Clinics. It has since been expanded to allow children’s hospitals, freestanding cancer clinics, critical access hospitals and others to participate. The progr...