[Submitted electronically at www.regulations.gov ]
Centers for Medicare & Medicaid Services
Office of Strategic Operations and Regulatory Affairs
Division of Regulations Development
Attention: Document Identifier/OMB Control Number l, Room C4–26–05,
7500 Security Boulevard, Baltimore, Maryland 21244–1850
Re: CMS–10709— Proposed Collection of 340B Costs.
ASHP appreciates the opportunity to provide feedback to the Centers for Medicare & Medicaid Services (CMS) regarding its proposed collection of hospital acquisition costs for drugs purchased through the 340B drug pricing program (the “notice”). ASHP is a national professional organization representing nearly 50,000 members including pharmacists, pharmacy residents, student pharmacists, and pharmacy technicians, who provide patient care services in acute care and ambulatory settings, including hospitals, health systems, and clinics. For 75 years, ASHP has been on the forefront of efforts to improve medication use and enhance patient safety.
ASHP strongly supports the 340B drug discount program and we are deeply troubled by CMS’s continued insistence, despite overwhelming evidence to the contrary, that the program contributes to high drug costs. Many of our members practice in 340B-participating hospitals and health systems and have seen firsthand how the federal 340B program allows providers to stretch scarce resources for the benefit of patients. We continue to oppose any cuts to 340B reimbursement and believe that CMS should immediately rescind all cuts to 340B reimbursement for hospitals and their outpatient departments.
Although ASHP supports reasonable transparency around drug pricing, we have the following serious concerns with the proposed data collection of hospitals actual acquisition costs (AAC) for 340B drugs:
- Flawed Methodology: The notice is vague, but our understanding is that CMS intends to survey all 340B-eligible hospitals. We question the need to collect data from all institutions when a simpler statistical sampling method could be used. Further, the notice’s lack of specificity raises questions about exactly which price CMS expects hospitals to report. For instance, sub-ceiling or negotiated prices are proprietary and CMS should not expect hospitals to disclose them. CMS could avoid the entire survey process by using the 340B ceiling price as the proxy for hospital AAC. CMS already has this data. Thus, the rational choice is to use it and forego an expensive, unnecessary, and burdensome hospital survey.
- Regulatory Burden: Given that this Administration is committed to reducing regulatory burden, we question the choice to conduct a survey that imposes significant burden and produces low-quality data. Based on conversations with our members, who would likely lead hospital survey responses, CMS underestimates the burden associated with the survey. It will take, at minimum, two highly-skilled FTEs 40 – 48 hours to compile the information, with a cost of $67 per hour for each – much higher than the CMS estimates. We must emphasize that this is not an easy collection – it will require manipulation of, and extreme fluency with, the data. Some hospitals have staff members who specialize in drug pricing and reimbursement, but others do not have those resources. Based on the variation in ability and methods among respondents, it is highly likely CMS will receive inaccurate, inconsistent survey results. Thus, as noted above, we question why CMS does not simply use ceiling price as a proxy for AAC.
- Damage to Patients Who Rely on the Program: CMS’ motivation for this request appears to be driven by the desire to reduce resources available to 340B hospitals. This will jeopardize care for thousands of patients who benefit from the 340B program and runs counter to Congress’ stated purpose for authorizing the 340B program.
We urge CMS to reconsider the proposed data collection based on the associated burden and the likelihood that it will not yield correct, usable data. Additionally, we reiterate our request that CMS immediately reinstate full 340B reimbursement. Thank you for your consideration of our comments. If you have any questions, I can be reached at 301-664-8696 or email@example.com .
Jillanne Schulte Wall, J.D.
Senior Director, Health & Regulatory Policy