On June 15, 2022, after many years of ongoing litigation1, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain outpatient prescription drugs provided to Medicare patients for fiscal years 2018 and 2019, totaling an estimated $1.6 billion across all affected entities. While the Supreme Court ultimately remanded the decision to the U.S. Court of Appeals to craft the appropriate remedies, this decision will likely result in a very positive financial outcome for the affected 340B hospitals. Given the ongoing 340B Program turmoil related to contract pharmacy arrangements, this is some excellent news for 340B Program hospitals affected by the Part B payment reductions.
This controversy began in 2017, when the Centers for Medicare & Medicaid Services (CMS) finalized a proposal relating to CY2018 outpatient prospective payment system reimbursement rates to reduce reimbursement by almost 27% for separately payable drugs purchased at reduced prices under the 340B Program by certain types of 340B Program hospitals. Specifically, this payment cut represented a significant change for disproportionate share hospitals, rural referral centers, and urban sole community hospitals (the “Affected 340B Hospitals”). The reduction does not impact Medicare drug reimbursement for: i) critical access hospitals; ii) rural sole community hospitals; iii) children’s hospitals; iv) PPS-exempt freestanding cancer hospitals; (v) HRSA grantee clinics; or vi) non-excepted off-campus provider-based departments established after November 2, 2015 that are paid under the Medicare Physician Fee Schedule.2 This new reimbursement rate resulted in significant losses in reimbursement for the Affected 340B Hospitals. In its Medicare hospital outpatient prospective payment system (OPPS) rulemaking, CMS justified the reduction by stating that CMS was currently “overpaying” Affected 340B Hospitals for drugs purchased at 340B prices.
Not surprisingly, Affected 340B Hospitals and their industry groups quickly struck back and filed responsive litigation to attempt to enjoin or overturn the payment adjustments. One of the key arguments advanced by these groups involved the fact that CMS failed to conduct a survey of the hospitals’ actual drug acquisition costs so as to allow CMS to adjust the reimbursement based on survey data.
Now, after roughly five years of litigation, the Supreme Court appears to generally agree with the Affected 340B Hospitals, finding that “the statute allows the United States Department of Health and Human Services (HHS) to set reimbursement rates based on average price and affords the agency discretion to “adjust” the price up or down. However, the statute does not permit HHS to vary reimbursement rates by hospital groups unless the agency conducts a survey of hospitals’ acquisition costs.3
While this is good news for Affected 340B Hospitals, there are a few caveats to keep in mind moving forward:
- The Court’s decision was limited solely to reimbursement adjustments in fiscal years 2018 and 2019, before CMS conducted a drug pricing survey.
- While the Court’s decision did not address the merits of “discriminating against” the 340B Program hospitals, the decision seems to suggest that CMScould havemade such adjustments had it complied with the statutory survey requirement. This suggests that the 2020, 2021, and 2022 payment reductions, done in accordance with hospital survey data, may still hold.
For now, Affected 340B Hospitals can enjoy this win and await the scope and parameters of the remedy. Additionally, and although not directly applicable to its decision, it is also noteworthy that the U.S. Supreme Court had some positive comments about the 340B Program as follows:
“Of course, if HHS went to Congress, the agency would presumably have to confront the other side of the policy story here: 340B hospitals perform valuable services for low-income and rural communities but have to rely on limited federal funding for support. As amici before this Court, any 340B hospitals contend that the Medicare reimbursement payments at issue here “help offset the considerable costs” that 340B providers “incur by providing health care to the uninsured, underinsured, and those who live far from hospitals and clinics.” As the 340B hospitals see it, the “net effect” of HHS’s 2018 and 2019 rules is “to redistribute funds from financially strapped, public and nonprofit safety-net hospitals serving vulnerable populations—including patients without any insurance at all—to facilities and individuals who are relatively better off.” In other words, in the view of those hospitals, HHS’s new rates eliminate the federal subsidy that has helped keep 340B hospitals afloat. All of which is to say that the 340B story may be more complicated than HHS portrays it. In all events, this Court is not the forum to resolve that policy debate.”4
UPDATE: (updated on 7/18/22)
In a move sure to please Affected Covered Entities, CMS stated that it “fully anticipate[s] adopting, in the final rule, a policy of paying ASP+6 percent for 340B-acquired drugs and biologicals” for CY2023 in its recently released CY2023 OPPS Proposed Rule. This signals a massive shift in policy that will increase reimbursement for certain pass-through 340B drugs by almost 30% for Affected Covered Entities beginning at the start of 2023. CMS acknowledged that this change is a direct result of the recent Supreme Court decision, even though the decision did not necessarily bar CMS from implementing reimbursement cuts for 340B drugs in future years.
Moreover, the Proposed Rule contemplates potential repayments to Affected Covered Entities for ALL years that the 340B reimbursement reductions have been in place (2018-2022), even though the Supreme Court decision only overturned the cuts implemented in 2018 and 2019. CMS is specifically soliciting feedback from Covered Entities, stating that it is “interested in public comments on the best way to craft any proposed, potential remedies affecting calendar years 2018-2022 given that the Court did not resolve that issue.”
With this in mind, Affected Covered Entities have a unique opportunity to provide input on how they should be repaid for previous reimbursement reductions and potentially impact the ultimate methodology used by CMS.
UPDATE: (Updated on 9/29/22)
In another positive development for Affected Covered Entities, a U.S District Court judge ruled that CMS must immediately begin paying affected 340B hospitals the full ASP + 6% Medicare Part B reimbursement rate for 340B drugs for the remainder of CY2022. Despite the Supreme Court’s decision in June and CMS’s subsequent acknowledgement that the CY2022 cuts would need to be repaid, the agency was still reimbursing Affected Covered Entities at the reduced ASP – 22.5% rate for 340B drugs billed. The Court agreed with the plaintiff group advocating for Affected Covered Entities, stating that CMS “should not be allowed to continue its unlawful 340B reimbursements for the remainder of the year just because it promises to fix the problem later.”
The Court is still considering potential remedies for the historical payment cuts and indicated that it will make a determination on that issue at a later date.
CMS is expected to formally revert back to an ASP + 6% reimbursement rate for 340B medications when its CY2023 OPPS Final Rule is released in the coming months.
1 For our earlier analysis and additional background related to this litigation, please see 340B Litigation Updates and Other Program Developments.
2 Note: The reimbursement reduction began to also apply to non-excepted off-campus provider-based departments of disproportionate share hospitals, rural referral centers, and urban sole community hospitals beginning in CY2019.