By Pat Anson, PNN Editor

As pressure grows on the Biden Administration to implement the NOPAIN Act and require Medicare to pay higher costs for non-opioid pain relievers during surgery, a new study shows that restricting the use of opioids during surgical procedures may do more harm than good.

Researchers at Massachusetts General Hospital (MGH) analyzed the health records of over 61,000 patients who had surgery under general anesthesia at MGH, and found that those who received opioids were less likely to experience post-operative pain and needed fewer opioids during recovery.

The study findings, published in in JAMA Surgery, showed that surgery patients who were given the opioids fentanyl and hydromorphone had less pain, lower rates of persistent opioid use, and fewer opioid prescription refills. They were also less likely to have chronic pain 12 months after surgery.

Researchers were particularly surprised to find that patients who received higher doses of fentanyl had fewer chronic pain diagnoses and needed fewer opioid prescriptions 30, 90 and 180 days after surgery.

“We were surprised by the extent to which intraoperative administration of opioids was associated with medium- and long-term outcomes. This may relate to the fact that if inadequate amounts of opioids are administered in the operating room, patients may emerge from general anesthesia in pain, a phenomenon that has a known association with persistent postsurgical pain,” wrote lead author Patrick Purdon, PhD, Department of Anesthesia, Critical Care, and Pain Medicine at MGH.

“The main implication of this study is that in the drive toward overall reduction of opioid usage in surgical pain management in the US, the role of intraoperative nociception in determining postoperative pain may have been overlooked to the detriment of patient outcomes.”

Researchers say their findings underscore the importance of ensuring that patients don’t emerge from general anesthesia in pain, not only for their short-term wellbeing, but to prevent long-term opioid use.

“The opioid crisis is a major motivator for mitigating the risks of opioid usage,” said co–first author Laura Santa Cruz Mercado, MD, an anesthesiology resident at Beth Israel Deaconess Medical Center and former research fellow at MGH. “But appropriate opioid administration in the operating room may reduce total opioid usage after surgery.”

Lobbying for Early Implementation of NOPAIN

Although previous studies have found that the risk of opioid misuse or overdose after surgery is rare, pressure on U.S. hospitals to reduce their use of opioids has resulted in a 50% decrease in opioid prescribing after surgery.  

Supporters of the NOPAIN Act would like it to decrease further and faster. Passed by Congress late last year, the Act requires the Centers for Medicare and Medicaid Services (CMS) to expand reimbursement policies for non-opioid treatments in outpatient surgical settings, starting in 2025. Supporters of the bill have launched a campaign to have the timetable moved up to 2024.

“Healthcare leaders must help CMS understand the inevitable damage that will result if the agency does not implement the policy in 2024. Millions of Americans will be put needlessly at risk of opioid addiction for another year,” Nirav Amin, MD, an orthopedic surgeon at Pomona Valley Hospital in Pomona, CA, wrote in a recent op/ed in Healthcare Dive. “The policy will incentivize greater use of non-opioids by creating separate reimbursements for the administration of these therapies.”

Unmentioned in Amin’s column is that he’s been paid over $360,000 in recent years as a consultant for Pacira BioSciences, a company that stands to directly benefit from the NOPAIN Act. Pacira makes Exparel, an expensive injectable formulation of bupivacaine, a non-opioid analgesic used to treat post-operative pain.

Bupivacaine is a generic drug that only costs about $35 a vial, while Exparel is priced 10 times higher, at $365 a vial. According to two recent studies that Pacira claimed were “false and misleading,” Exparel works no better than the much cheaper bupivacaine products.

Pacira has made over $32 million in various payments to Amin and other doctors to help promote Exparel, according to Open Payments, a CMS database that tracks industry payments to healthcare providers. Pacira is also bankrolling Voices for Non-Opioid Choices, an advocacy group that is leading the campaign for early implementation of the NOPAIN Act.

Pacira is also very active politically, spending over $2.6 million on lobbying and campaign donations since 2018, according to OpenSecrets. In 2019, Pacira hired former New Jersey governor and current presidential candidate Chris Christie as a consultant for $800,000 and lucrative stock options. At the time, Christie had recently chaired President Trump’s opioid commission, which recommended that Medicare and Medicaid reimbursement policies be changed to encourage hospitals to use more non-opioid pain relievers.