Legislative and Research Efforts to Reduce Opioid Exposure: Progress, Challenges, and Emerging Threats
This article, in a slightly edited form, first appeared in Pain Medicine News on October 15, 2025.
The United States continues to face an opioid crisis marked by persistently high rates of opioid use disorder (OUD) and overdose deaths. In 2023, 8.6 million adults misused prescription analgesics. Prescription opioids can cause harm, and the risks are higher with long-term use for chronic pain, especially among individuals with co-occurring mental health conditions. There is a critical need for safer and more effective analgesic options to reduce reliance on opioids.
Most current efforts to reduce opioid-related harm focus on downstream interventions, such as limiting opioid dose and exposure through prescribing guidelines or quantity restrictions. While well-intentioned, these measures have not significantly reduced opioid mortality, which remains driven largely by illicit drug markets.
Long-term policy solutions must also address upstream drivers of substance-related harm such as poverty, unemployment, unstable housing, inadequate access to healthcare, and structural inequities. However, addressing these socioeconomic determinants requires major political and structural reforms that will take years, if not decades, to achieve.
In the near term, the most practical and achievable step is to accelerate the development and availability of safer and more effective analgesics than opioids. Finding viable alternatives to opioids inherently meets the criteria of limiting dose and exposure without depriving patients of effective pain relief. Supporting the discovery and adoption of such alternatives is an essential harm-reduction strategy.
Three notable federal initiatives have the potential to contribute to this goal: the National Institutes of Health (NIH) Helping to End Addiction Long-term® Initiative (HEAL Initiative®), the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, and the proposed Alternatives to PAIN Act. Together, they reflect a broader shift toward opioid-sparing strategies, although major gaps remain in chronic pain care.
The NIH HEAL Initiative
Launched in 2018, the NIH HEAL Initiative funds a wide spectrum of research aimed at improving pain management and preventing and treating opioid misuse, addiction, and overdose. HEAL addresses urgent unmet needs across lifespans, supporting studies that range from basic science to clinical trials. On the pain side, HEAL seeks to develop safer and more effective treatments—both pharmacologic and non-pharmacologic—to replace or reduce opioid use for both acute and chronic pain.
Examples of promising innovation include Vertex Pharmaceuticals’ suzetrigine (Journavx), a first-in-class NaV1.8 inhibitor for moderate-to-severe acute pain that has shown opioid-sparing potential without the same risks of respiratory depression or addiction. Many other analgesics targeting novel pain pathways and mechanisms are in development. Such advancements depend on sustained research investment.
Threat of DOGE to HEAL
Recently, the Department of Government Efficiency (DOGE), through its Defend the Spend Initiative, has introduced new oversight requirements for federal healthcare grants, including those funding the HEAL Initiative. This has had several reported effects:
- Grant delays and freezes: Manual reviews have caused backlogs and delayed payments to research institutions, slowing project timelines.
- Increased scrutiny: HEAL-funded organizations must now justify each withdrawal of grant funds which adds administrative burdens and diverts resources away from scientific work.
- Potential funding reductions: Broader DOGE budget-cutting discussions have raised concerns about possible reductions in NIH medical research funding, including pain and addiction research.
- Threats to innovation: Disruptions jeopardize the development of non-opioid analgesics—such as suzetrigine and other pipeline drugs—that could transform pain management.
While DOGE aims to increase fiscal accountability, these measures risk undermining the very research needed to replace opioids with safer, more effective alternatives.
The NOPAIN Act
The NOPAIN Act, effective January 1, 2025, mandates separate Medicare Part B reimbursement for certain FDA-approved non-opioid pain management drugs and devices used during surgical procedures in all outpatient settings, including hospital outpatient departments and ambulatory surgery centers. Covered drugs include agents such as EXPAREL® (bupivacaine liposome) and other long-acting local anesthetics shown to reduce postoperative opioid use.
The NOPAIN Act applies only to acute pain in surgical settings. The risk of opioid-related harm from short-term acute pain prescribing is relatively low compared to the risks associated with chronic pain therapy. Nonetheless, making non-opioid options more accessible for acute pain is important for reducing unnecessary initial exposure to opioids.
The Alternatives to PAIN Act
The Alternatives to PAIN Act (H.R. 1227/S. 475), currently under consideration in Congress, would target Medicare Part D coverage of non-opioid pain treatments. It would require certain non-opioid drugs to be placed on the lowest cost-sharing tier—making them no more expensive than generic opioids—and exempt them from prior authorization or step therapy requirements. This puts focus on affordability at the pharmacy counter and could extend opioid-sparing benefits into the home and recovery phases after surgery or injury.
Like the NOPAIN Act, this legislation primarily addresses acute pain and would need expansion to address chronic pain populations who have a greater risk of harm from prolonged opioid use and urgently need alternatives.
The Remaining Gap: Chronic Pain
The HEAL Initiative, NOPAIN Act, and Alternatives to PAIN Act collectively represent meaningful steps toward reducing opioid exposure. HEAL advances the science, NOPAIN facilitates access to non-opioids in outpatient surgery, and Alternatives to PAIN improves affordability in prescription coverage. Yet none fully addresses the population most at risk for opioid-related harm when prescribed an opioid for pain: individuals living with chronic pain.
Chronic pain management requires policies that make non-opioid treatments—whether new drugs like suzetrigine or advanced non-pharmacologic approaches—affordable and accessible. Without this, patients may be left with opioids as their only viable option, perpetuating the risk of harm.
Conclusion
While most opioid-related deaths now stem from illicit fentanyl and other street drugs, prescription opioids—particularly for chronic pain—still cause preventable harm. Most people do not benefit from chronic opioid therapy, but a subset of the population does. Everyone would benefit from safer alternatives.
The NIH HEAL Initiative is essential to discovering those alternatives, yet its progress is threatened by DOGE’s funding restrictions and delays. The NOPAIN Act and Alternatives to PAIN Act help address acute pain opioid exposure, but Congress must go further to ensure equitable, affordable access to innovative pain treatments for chronic pain. Most importantly, developing alternatives to opioids offers the fastest and most effective path to reducing both dose and exposure, while longer-term structural changes address the upstream social and economic drivers of opioid harm. Without continued investment in research, the innovation pipeline will stall, and patients will remain trapped between inadequate pain relief and unacceptable risk.
If health insurance becomes unaffordable for many of us, it won’t much matter which tier a medication we need is in. We won’t be able to afford it, anyway. We won’t be able to afford to get a prescription for it. Isn’t it lovely that, just as researchers are making progress in pain research, so many of us won’t be able to benefit from that research because of the skyrocketing costs of insurance?
There may be a critical need for alternatives, but there is an even more critical need for continued use of opioids for those who find them effective and are being denied them. The likelihood of finding an alternative is small. Those of us on opioids have gone through every alternative already available, and the “alternatives” being presented currently, like Tylenol and Ibuprofen are laughable. Ibuprofen isn’t allowed after surgery for risk of bleeding and healing issues. The dangers of high doses of Tylenol are well known, but that doesn’t stop doctors from prescribing both of those, whether out of ignorance or arrogance. God help us all is all I can say. I will not go through another joint replacement without *adequate opioid pain relief.* Opioids work for the vast majority of us and the vast majority of us do not become addicts, even on them long term. I dare not ask for an increase in dose nor do I dare ask for a more frequent dose because – DEA. It doesn’t matter that more joints are involved and the ones that were involve already are becoming worse. Degenerative joint diseases don’t go away. The pain gets worse. Nobody denies a diabetic when they need more insulin. Why do they deny a pain patient an increase in pain meds? No one knows how much OA can hurt until it happens to them. The only difference between the worst OA and the worst migraine I’ve ever had is that I can scream with OA. I can’t with a migraine.
We already know that full- agonist opioids
can be used safely and are the most effective medications we currently have for pain. I always think that more tools are better than less, so I agree that finding or creating more drugs that are effective for pain is a good idea. However, I would wholeheartedly posit that without the tools many of us know already (opioids) we are losing people to unintentional overdoses, suicide, and things like heart attacks and strokes due to uncontrolled pain. We need a government investigation of common sense.
*intervention not investigation, autocorrect did that.
I wrote a long comment then I went back and saw how much anger chronic pain has saddled me with. Can only hope there is a special place in Hell for the gatekeepers that restrict relief for those dying of cancer and chronic pain sufferers whose pain has stretched for decades and for those who saw could no longer fight and have taken their own life.
I’m all for medication that has zero chance of causing addiction. But I think the government put the cart before the horse when the CDC created its “Opioid Guidelines.” Far too many people have taken their own lives when their pain wasn’t controlled any longer, and others died by getting tainted drugs on the streets in an attempt to control their pain. The two recent non-opioid alternatives have been shown not to work much better than Tylenol, which does very little for pain, if it does anything at all. We all tried Tylenol, Ibuprofen, and aspirin for days or weeks before even going to the doctor after we experienced that first horrible pain. I have had multiple cervical and lumbar surgeries throughout the years, and I have to say that I would never go through (especially cervical) surgery without being guaranteed 3 weeks of opioid medication. That’s the average length of time I used extra pain medicine after surgery. I also believe that the only good thing that came out of the CDC Opioid Guidelines is that studies have finally been conducted on pain and pain medications over the past 10 years. Almost all studies have shown that opioid medication works and that only a tiny percentage of pain patients go on to abuse medication or graduate to illegal drugs. It makes me so sad that too many deaths, ODs, and massive suffering are the results of the CDC Opioid Guidelines.
I am a clinician and agree with Dr. Webster’s conclusions about the need to find safer alternatives to opioids given the risks of addiction which are often quoted around 8% for chronic pain. Having said that, however, I am always struck by the myriad of comments from people who are the other 92% in response to articles regarding opioids for chronic pain. The vast majority of comments are from people who are significantly benefiting from opioids without any evidence of addiction and because opioids have been vilified are forced to negotiate a very treacherous environment which threatens access to these medications. Voices of these people are unfortunately frequently left out of the conversation. In some articles which appeared in the New York times, there were thousands of comments from people who were struggling with access. Several reputable pain organizations regularly (usually daily) hear from patients who are forced off opioids or unable to access them resulting in severe pain, poor function and quality of life, chronic wasting, and suicide. This is an aspect of the opioid crisis that deserves mention, I feel in every article. How much forced tapering from opioids contributes to turning to using illicit opioids and overdoses is not well tracked, but clearly is a large issue that should not be ignored.