The 2026 OPPS Drug Acquisition Cost Survey: Additional Considerations as Deadline Nears

Hospitals reimbursed under the Outpatient Prospective Payment System (OPPS) must decide by the end of March whether to respond to the Centers for Medicare & Medicaid Services (CMS) OPPS Drug Acquisition Cost Survey (ODACS), a decision that carries significant weight given CMS’s purposes for collecting the information. As discussed in our December 2025 alert, CMS will use ODACS responses to reduce reimbursement to hospitals for separately payable drugs, particularly for 340B Drug Pricing Program (340B) drugs. Having lost at the US Supreme Court the last time they tried to make this payment cut, this time CMS is trying to adhere to the statute by conducting the statutorily mandated survey. CMS will meet that burden only if the survey results in a “statistically significant estimate” of drug costs, leaving hospitals to struggle with the decision of whether to participate. Not responding in large numbers would deny the agency the ability to impose its payment cuts, but CMS has intimated that there may be consequences for nonresponders. CMS has thus far left unanswered the serious questions regarding the lawfulness of those proposed consequences. As the deadline for participation approaches, this decision has been further complicated by additional information released by CMS regarding the survey, which may tip the scales in favor of not responding for a number of health systems. 

CMS Reiterates Its Position That Participation Is Mandatory

In FAQs released in December 2025, CMS states that all hospitals paid under the OPPS “are to respond to the survey” and that “CMS is considering the assumptions it would be reasonable to make in the event a hospital does not adhere to the statute, including how those assumptions might be reflected in that hospital’s future payment rates.” This position seemingly contradicts CMS’s stated position in the 2026 OPPS Final Rule, where CMS agreed that the statute itself does not mandate specific consequences on hospitals for failing to respond. In the FAQs, CMS is taking a stronger stance that participation is mandatory, but it has identified no additional statutory or regulatory basis for this position. Nevertheless, CMS believes that the statute implicitly imposes the obligation on hospitals to complete the survey. 

CMS Has Not Committed to Implementing Any Reduced Reimbursement in a Budget-Neutral Manner

When CMS previously reduced OPPS reimbursement for separately payable drugs—a decision overturned by the US Supreme Court in American Hospital Association v. Becerra—CMS implemented the reductions in a budget-neutral manner. This is because the OPPS statute clearly required CMS to do so. However, CMS has recently expanded its use of its authority to “control unnecessary increases in the volume of outpatient services” in the hospital outpatient department, such that it now has reduced payment for drug administration services. CMS may similarly determine that the drug reimbursement has incentivized overutilization of drugs purchased under 340B in the hospital outpatient department. Thus, there would be no offsetting benefit to a payment cut. Hospitals considering whether to respond to the survey may want to work through their legislators, trade associations, and others to seek assurances of a budget-neutral adjustment before committing to a response.

CMS’ Survey Instructions Lack Clarity

Though CMS released FAQs and other materials with instructions on how to complete the survey, CMS does not provide a methodology for data submission. CMS provides a template spreadsheet for hospitals to input by National Drug Code: 

• Total Units Purchased – Non-340B
• Total Units Purchased – 340B
• Total Net Acquisition Cost – Non-340B
• Total Net Acquisition Cost – 340B. 

CMS instructs hospitals to exclude purchases intended for inpatient use only, but it does not provide instructions on how to exclude such purchases. This is particularly complicated because hospitals do not always distinguish between inpatient and outpatient when purchasing drugs. 340B hospitals subject to the group purchasing organization (GPO) prohibition will have separate inpatient (GPO) and outpatient (340B) purchasing accounts. However, they will also have wholesale acquisition cost (WAC) accounts used to purchase both inpatient and outpatient drugs. It will be challenging, if not impossible, to identify which drugs purchased on the WAC account are for inpatient use compared to outpatient use. Without instructions from CMS, it is also unclear how hospitals should incorporate WAC purchases and pricing into survey responses.

It could be even more challenging for 340B hospitals not subject to the GPO prohibition to exclude inpatient purchases from survey responses. These hospitals will not have a WAC account, and the GPO account is used for both inpatients and outpatients. The GPO account will likely have significantly more volume than a WAC account would, making it even more burdensome to attempt to analyze the purchasing data for inpatient versus outpatient status. 

Further, CMS does not provide instructions on how to define “inpatient” versus “outpatient,” and a patient could be an outpatient for 340B purposes but an inpatient for Medicare billing purposes because these terms are not uniformly defined across government agencies.

This lack of clarity adds additional burden to an already burdensome survey as hospitals are put in a position of trying to develop a methodology that accurately represents outpatient drug purchasing by using systems and processes that may be incompatible with CMS’s request. 

Required Attestation and Implied Consequences

Perhaps what will give hospitals the greatest pause is the last required step before data submission should the hospital choose to respond to the survey: the attestation (the Attestation). This last step requires the signatory to attest to the truth, accuracy, and completeness of the hospital’s data submission and adds that the signer “acknowledge that this attestation may be relied upon by CMS and other regulatory agencies for program integrity, reimbursement, compliance, and enforcement purposes. [The signer] understand[s] that knowingly providing false information may result in criminal prosecution, civil monetary penalties, exclusion from federal healthcare programs and other sanctions.” On its face, the Attestation demonstrates CMS’s position that data submission raises False Claims Act implications and other severe civil and criminal liabilities, putting hospitals in a position of weighing the potential negative consequences of not participating against the risk that CMS may use the data to seek civil or criminal repercussions against survey participants, including those without any ill intent. The Attestation also states data accuracy is an ongoing obligation, requiring prompt notification to CMS of any material changes or corrections to the submitted information.

Again, it is unclear from where CMS is deriving this expansive authority to interpret or otherwise rely on the data provided in the ways described in the Attestation. But nonetheless the implications are significant. CMS does not provide meaningful guidance as to exactly what lengths hospitals are required to go to ensure “accuracy” and “completeness” of the information before it is submitted. And, as noted above, there are a number of significant, open areas where CMS’s guidance is still less than clear. Though a hospital may ultimately succeed in subsequent legal or regulatory action, should there be any, such defense is likely to carry significant cost.

Hospitals Face a Difficult Choice

While CMS has not committed to pursuing a specific penalty for nonresponsive hospitals, it remains clear that nonparticipation is not without its risks. But what has become clearer with the release of these additional materials and FAQs is that participating in the survey is also not a risk-free choice. 

As stated in our prior alert, for any entity not responding, it should consider filing a submission to CMS that states that the burden to obtain and present the requested data is far larger than CMS had estimated. And, in light of the above, nonresponders can also add that they do not believe that they can meet the heightened accuracy standards that CMS has set for these submissions.

Given the potential consequences of each option, hospitals should consult with their advisors and peers to determine the decision that is most appropriate for their organization.

The firm’s 340B Program and Pharmacy practice group practitioners will continue to closely monitor developments on this issue.