Health Policy Report – June 11, 2024

CMS Extends Enhancing Oncology Model

On May 30, the Centers for Medicare and Medicaid Services Innovation Center (CMMI) announced that it is seeking applications for a second cohort of participants in its Enhanced Oncology Model (EOM). The new cohort will start its 5-year model performance period on July 1, 2025, and expire at the same time as the first group. 

The agency also announced updates to the model, responding to oncologists’ concerns that the model did not include sufficient payment. The adjustments will extend the initial EOM performance period from 2028 to June 30, 2030. Further, CMS is increasing monthly pay from $70 to $110 per beneficiary (or $140 for people enrolled in Medicare and Medicaid). Finally, the new threshold for the performance-based recoupment will increase to 100%.

CMS created the EOM in 2022, incorporating lessons learned from the Oncology Care Model (OCM) that ran from 2016-2022, and it launched with 67 participants in July 2023. The application portal for interested applicants will open from July 1, 2024 to September 16, 2024.

To read more, CLICK HERE. 

To read a fact sheet, CLICK HERE. 

House Lawmakers Ramp Up Oversight of 340B Program 

The House Energy & Commerce Oversight and Investigations Subcommittee held a hearing on June 4 to hear from academic and healthcare industry experts on whether the 340B drug discount program is operating as intended. The hearing showcased partisan division on the issue, as Republicans continue to push for more reporting requirements and clarified language, while Democrats worry such changes would hinder patient access. 

“I am a supporter of the overall 340B program. There are many hospitals, including in my district, who are appropriately using the 340B dollars to keep their doors open and heavily rely on this program. Yet, we see reports about entities taking advantage of the system,” subcommittee Chair Morgan Griffith (R-VA) said in his opening statement.

Meanwhile, the full committee’s ranking Democrat, Representative Frank Pallone (D-NJ) shared concerns that reform proposals will not reduce prescription drug costs. “Restricting 340B does not save taxpayer money or lower health care costs for patients. In fact, undermining 340B would severely weaken the health care safety net, creating greater obstacles for people who already struggle to receive accessible, affordable care,” Representative Pallone said. 

The hearing comes after Representative Larry Bucshon (R-IN), member of the House Energy & Commerce Committee, introduced the 340B Affording Care for Communities and Ensuring a Strong Safety-Net (ACCESS) Act, which seeks to clarify 340B statute to ensure savings produced by the 340B program are used to benefit patients. The bill would clarify the intent of the 340B program, address where low-income and uninsured patients can receive their prescriptions at 340B prices, codify the definitions of a 340B “patient” and “contract pharmacy,” and establish new eligibility criteria for hospitals.

While legislative proposals have received mixed reactions from program stakeholders and lawmakers, it’s clear that transparency within the 340B program remains a topic of discussion in Congress. 

To watch the hearing, CLICK HERE. 

To read more, CLICK HERE.

To read the 340B Affording Care for Communities and Ensuring a Strong Safety-Net (ACCESS) Act, CLICK HERE. 

To read more about the bill, CLICK HERE. 

Lawsuit Challenges FDA’s Controversial LDT Rule

The American Clinical Laboratory Association (ACLA) and its member company HealthTrackRx filed a recent lawsuit challenging the U.S. Food and Drug Administration’s (FDA) authority to regulate laboratory-developed tests (LDTs) as medical devices. Filed in the Eastern District of Texas, the lawsuit argues that the FDA’s final rule on LDTs, issued this spring, violates the Administrative Procedure Act (APA).

The ACLA and HealthTrackRx contend that LDTs are properly regulated by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). Further, the lawsuit argues that legislation is the only way to change the regulatory approach to LDTs. The ACLA and HealthTrackRx further assert that the FDA’s regulation of LDTs as devices imposes significant costs and regulatory uncertainty on laboratories, which may force many labs to discontinue their LDTs.

“For years, ACLA has worked collaboratively with Congress, FDA and other stakeholders to develop legislation that would establish an appropriate regulatory framework for diagnostics,” ACLA wrote. “Rather than continue that dialogue, FDA chose instead to act unilaterally and impose an ill-fitting device regime on laboratory testing services. Given the far-reaching negative impacts on our nation’s laboratory community, ACLA believes it must bring this lawsuit to clarify that FDA’s Final Rule exceeds its authority.”

To read the lawsuit summary, CLICK HERE.

To read the ACLA’s statement, CLICK HERE.

New Study Shows Patients Who Live Farther from Comprehensive Cancer Center are More Likely to Receive Late-Stage Diagnosis

A recent study published in JAMA Network Open found that patients who live farther away from a comprehensive cancer center may be more likely to receive a late-stage cancer diagnosis. The study examined over 94,000 patient records from 2010 to 2019 and examined numerous factors, including insurance status and other socioeconomic determinants of health.

The study found that patients residing outside the primary catchment area of a comprehensive cancer center were more likely to receive a late-stage cancer diagnosis, especially if their treatment or diagnosis occurred exclusively at a center. Furthermore, individuals without insurance, with unidentified insurance, on Medicaid, and non-Hispanic Black patients were also more likely to be diagnosed at a late stage, regardless of their proximity to the cancer center.

“These findings suggest that disadvantaged populations and those living outside of a comprehensive cancer center’s main catchment area may face barriers to screening and treatment, resulting in higher odds of receiving a diagnosis of late-stage cancer,” the authors write.

To read more about this study, CLICK HERE.