AHA's comments on Energy and Commerce Committee Chair Rodgers’ drug shortages discussion draft.
Letters
Throughout the year, the AHA comments on a vast number of proposed and interim final rules put forth by the federal regulatory agencies. In addition, AHA communicates with federal legislators to convey the hospital field's position on potential legislative changes that would impact patients and patient care. Below are the most recent letters from the AHA to these bodies.
Latest
AHA provides feedback on CMS' Episode Based Payment request for information.
The IRA, through the transferability provisions under Section 6418 and, in particular, the elective direct pay provisions of Section 6417, has provided new opportunities for the healthcare sector to engage in important clean energy initiatives.
The Drug Shortage Prevention Act would require manufacturers to notify the Food and Drug Administration (FDA) of increased demand of covered drugs. The AHA believes the requirement that manufacturers notify the FDA of increased demand for critical drugs will be an integral tool for shoring up the supply chain.
Pharmaceutical shortages and supply chain failures can have a devastating impact on patients. The RAPID Reserve Act would establish a program to improve supply chain resiliency for critical generic drug products, ensuring adequate supply is available even in the event of a shortage.
The Pharmaceutical Supply Chain Risk Assessment Act of 2023 would require a comprehensive risk assessment of the entire U.S. pharmaceutical supply chain. This overarching project will help provide critical information necessary to mitigate and prevent drug supply shortages.
Hospitals and health systems share concern about chronic and increasing drug shortages that have serious consequences for patient safety, quality of care and access to therapies. Addressing drug shortages is complex and costly to hospitals and health systems in terms of staff time and other resources required to manage the shortages.
AHA remains deeply concerned over the Centers for Medicare & Medicaid Services’ (CMS’) policies related to disproportionate share hospital payments in the agency’s final Inpatient Prospective Payment System rule for fiscal year (FY) 2024.
Model Letter to CMS on Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018–2022
HHS must not pursue any “budget neutrality adjustment” in the final rule. At the very least, it must pursue a far smaller one than the proposed $7.8 billion “adjustment.”
AHA is greatly disappointed that HHS chose to propose “budget neutrality adjustments” to offset this legally-required remedy. The statutes that HHS relies on in its proposed rule do not give it the authority to make a “budget neutrality adjustment.”