Session: What to expect from healthcare policy, regulation in 2024

Editor's Note

Since the pandemic, the view of the healthcare industry in congress has essentially gone from “hero to zero” – a shift with potentially big implications for the healthcare business leaders gathered at yesterday’s closing session from Soumi Saha, PharmD, JD, senior vice president of government affairs at Premier Inc.

“COVID became a four-letter word overnight,” she said, to the point that the Pandemic All Hazard Preparedness (PAHPA) act, which created the national stockpile in 2006, was allowed to expire in September. Meanwhile, what began as an anti-hospital sentiment has morphed into an anti-physician and provider sentiment. For example, Congress allowed a 3.4% provider cut to go into effect December 31, the “first time in a long time” that such a cut has been allowed to go through, Saha said.   

The shift in sentiment on Capitol Hill could create an uphill battle for healthcare providers. From their perspective, reimbursement is not keeping pace with the cost of care, resulting in financial distress. The power of big payers and private equity continues to grow. Meanwhile, continually intensifying labor and supply chain challenges are straining an already operationally burdensome industry.  

However, payers, manufacturers, patient advocacy groups and others with significant influence among lawmakers paint a very different picture. They say providers are the primary drivers of rising costs, and that their finances are essentially “smoke and mirrors,” Saha said. They claim hospitals are bad stewards of 340B program funding and community benefit dollars and often fail to comply with price transparency laws.  

How this battle will play out amid extreme gridlock in Congress remains to be seen. However, Saha cited a number of regulatory and legislative developments for healthcare leaders to watch as we move into 2024. These include:  

• The Environmental Protection Agency (EPA) is expected to finalize proposals on upgrading equipment throughout the country for ethylene oxide sterilization by March 1. Large facilities put communities at risk with their emissions. However, Saha pointed out that this must be balanced by the risk of shortages for sterile surgical equipment if facility shut-downs for this purpose all happen at once. Work continues with EPA and FDA on timelines. Surgeons are particularly concerned about surgical packs, which are often sterilized at these facilities.   
• Medicare probably will not be able to begin negotiating drug prices in 2026, at least not according to the terms of a law authorizing the practice that passed last year, Saha says. With two years to go, competing lawsuits, the outcome of this year’s election, and other attempts to reverse or weaken the legislation leave significant doubt.
• A change in administration often results in a “whiplash” effect in regulations. This was the case with the Inpatient Only (IPO) List, which outlines procedures that Medicare will pay as an inpatient procedure in the acute hospital setting. The IPO List was abolished by the Trump administration and reinstated by the Biden administration. However, there has been more continuity in other areas, such as the CMS National Quality Strategy’s focus on electronic measurement, outcome-based measurement, and “patients over paperwork,” all of which Saha said have been priorities of both administrations. 

Among other topics, Saha’s wide-ranging presentation also highlighted recent efforts to improve supply chain resiliency, regulatory efforts surrounding artificial intelligence (AI), and details on three pending health packages (The Better Mental Health Care, Lower-Cost Drugs and Extenders Act; the Primary Care and Health Workforce Expansion Act; and the Lower Costs, More Transparency Act).

Saha concluded by urging attendees to get involved by sharing successes and best practices, building support through coalitions and advocacy organizations, and signing up for alerts from CMS, FDA and other federal agencies.