Cryopreserved Placental Membrane Allograft Reduces the Likelihood of Developing a New or Recurring Foot Ulcer and All-Cause Mortality in Diabetic Patients When Compared with Other Cellular- and Tissue-Based Products.

Objective: To compare outcomes for Medicare patients with diabetic foot ulcer(s) (DFU) receiving cryopreserved placental membrane containing viable cells (vCPM) to other Cellular- and Tissue-Based Products (CTPs). Approach: Patients with DFU and CTP use were selected in Medicare claims (2013-2017) by using a strict definition of DFU with demonstrated diabetes etiology. We compared the effectiveness of vCPM with other CTPs on: (1) reduction of post-treatment ulcer occurrence, and (2) reduction in 1 year mortality. We controlled for selection bias and differential risk characteristics between comparison groups in a two-stage inverse probability treatment weighting model. Results: Overall, 7,869 DFU episodes with CTP use met inclusion criteria: 786 received vCPM, 4,546 received another "cellular" CTP, and 2,537 received "acellular" CTP. For ulcer occurrence, we examined: 30-, 90-, 180-, and 365 days post-treatment. We found a significant reduction in ulcers at each period for vCPM compared with either alternative CTP-results range from a 36.7% percentage point reduction in ulcer occurrence at 30 days compared with cellular CTP, and a 58.5% percentage point reduction at 365 days compared with acellular CTP. Further, the application of vCPM reduces mortality within 1 year by 2.3 percentage points (13-13.8% change) compared with other CTPs. Innovation: This study examines the differences in ulcer occurrence and mortality for Medicare DFU patients receiving vCPM and other CTPs. Our strict DFU definition excludes beneficiaries without foot ulcer with demonstrated diabetes etiology. Conclusion: Among CTPs, vCPM users have reduced ulcer rates (recurrent or new) and reduced all-cause mortality compared with other "cellular" and "acellular" CTPs.

Impact of liposomal bupivacaine and provider choice on opioid use and service outcomes in Medicare outpatient surgical patients.

AIMS: There is wide variation in opioid prescribing patterns after common surgical procedures. This study examines outcomes for beneficiaries undergoing hospital outpatient department (HOPD) procedures using liposomal bupivacaine (LB) for control of post-surgical pain. As a non-opioid surgical analgesic, LB may afford beneficial outcomes for reducing subsequent opioid use and improving post-surgical service use outcomes. METHODS: This retrospective cohort comparison study analyzed 100% Medicare claims data from 2014-2019. HOPD claims were matched to approximately 100 of the most common surgical procedures where LB was utilized. Within these procedures, a one-to-many, with replacement propensity score matching model was used to control for possible selection bias. By procedure, those claims which were identified as using LB for control of post-surgical pain were matched to those not receiving LB. Outcomes were the probability of a subsequent Part D opioid prescription fill, emergency department (ED) visit, and short-term acute care hospital admission. RESULTS: Higher provider use rates of LB are significantly correlated with a decrease in post-HOPD opioid use and a reduction in post-operative ED visits. For each 10% increase in LB use rate by a given provider, Part D opioid events by Day 30 decreased by 2.6 percentage points and by 2.1 percentage points by day 90 (p < .01). Similarly, for each 10% increase in provider LB use rate, there is a 0.4 percentage point reduction in post-operative ED use by day 30 (p < .01) and a 0.3 percentage point reduction by day 90 (p < .05). LIMITATIONS: Part D data only indicate that a prescription was filled, not whether the drug was taken. CONCLUSIONS: Increased provider use of LB is correlated with improved patient outcomes in real-world provider experience with the Medicare population for many outpatient procedures. Policies that support increased provider use of LB should reduce reliance on opioid drugs for post-surgical pain management.