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How will the NOPAIN Act impact Medicare beneficiaries?

The NOPAIN Act might alter Medicare prescribing by mandating coverage and expanding access to non-opioid treatments, promoting research, and facilitating education.

Veronica Salib, Associate Editor

Published: 13 Sep 2024

The NOPAIN Act, also called the Non-Opioids Prevent Addiction in the Nation Act, is a bipartisan, bicameral act intended to expand patient and provider access to non-opioid pain management options by improving reimbursement to help navigate the potential cost of treatment. Although opioids can be effective and necessary for managing pain, these substances are highly addictive. Long-term opioid use and opioid use disorder pose longitudinal and detrimental health impacts.

According to the CDC, several other major health organizations, and existing research, there are several risks associated with opioid use. The obvious dangers include addiction and overdose. However, other risks include tolerance, physical dependence, increased pain sensitivity, constipation, nausea, vomiting, dry mouth, sleepiness, dizziness, confusion, depression, lower testosterone levels, itching and sweating.

In a report published by Voices for Non-Opioid Choices, experts estimated that in 2022, 145,000 Medicare beneficiaries were diagnosed with opioid use disorder (OUD). The condition is attributed to an additional $29,669 in healthcare costs per patient annually. With the addition of new diagnoses in 2022, approximately 1.1 million Medicare beneficiaries have OUD, accounting for $33 billion in healthcare costs annually.

"Addressing the opioid crisis requires a comprehensive approach, and expanding access to nonopioid pain management options is a crucial piece to the puzzle," said Arizona Senator Mark Kelly in the Voices for Non-Opioid Choices press release. "$33 billion in Medicare spending for opioid use disorder should be a wake-up call: addiction doesn't discriminate based on age. We need to make non-opioid pain relievers more affordable and accessible for our seniors, allowing them to choose safer treatments and help to reduce the risk of addiction before it starts."

Overview of the NOPAIN Act

The NOPAIN Act includes multiple components to offer better access to alternative pain management treatments. Some key elements include mandating insurance coverage for non-opioid pain management, including evidence-based treatments, like physical therapy and non-opioid pain medications. Additionally, the act provides funding to expand access to alternative pain treatments in underserved areas and promotes research to improve non-opioid pain therapies.

Through these provisions, the act intends to reduce opioid prescriptions, expand access to treatment, promote research and education and generally shift the standard of care. The overarching strategy is to provide patients and providers with more options and evidence-based guidance for managing acute and chronic pain without fueling opioid misuse and addiction. This multipronged approach is intended to be a significant step in the broader national effort to combat the opioid crisis.

"It is vital we continue to take steps to stop future addiction before it can begin," Senator Capito said in a press release. "This law does exactly that by ensuring Medicare patients have access to non-opioid options, which will manage their post-surgical pain, while also helping them to avoid addiction and opioid misuse by others in their households. I'm confident this new law will make significant strides in preventing future addiction."

The NOPAIN Act requires that Medicaid reimburses qualified non-opioid pain management options for patients who have had outpatient surgical procedures.

It was passed in December 2022 under the Consolidated Appropriations Act of 2023. Roughly seven months later, in July 2024, CMS published a preliminary Outpatient Prospective Payment System (OPPS) ruling to define qualifying non-opioid treatments.

In the coming months, by November 2024, CMS is expected to issue a final OPPS rule with finalized coverage rates and reimbursement codes before the act goes into effect in January 2025.

Once the act is in effect, Medicare beneficiaries can access non-opioid pain management options for managing postsurgical pain at a lower cost.

According to the No Pain Pact, this act requires Medicare to reimburse 106% of the average sales price (ASP) for qualified non-surgical options. Other implications of this act include expanded access to non-opioid pain management options in ambulatory surgical centers (ASCs) and hospital outpatient departments (HOPDs). However, the act specifies that only FDA-approved and proven pain management options will be covered under this act.

Non-opioid treatments

On July 10, 2024, CMS issued a proposal specifying the different drugs and devices it will cover to help minimize intraoperative or postoperative opioid use.

Multiple non-opioid drugs and treatments will be covered under this act, including Exparel, Omidria, Dextenza, ketorolac tromethamine injection, Xaracoll, Zynrelef and the On-Q Pump.

Exparel

Exparel (bupivacaine liposome) is a non-opioid post-surgical anesthetic that can provide local pain relief through local infiltration for individuals ages six and older or regional analgesia in adults through an interscalene brachial plexus nerve block, a sciatic nerve block in the popliteal fossa or an adductor canal block.

This medication, approved in October 2011, blocks nerve impulses for up to 72 hours. It delivers bupivacaine using DepoFoam's proprietary multivesicular liposome (pMVL) technology.

Omidria

Omidria is the brand name for a ketorolac and phenylephrine injection that gained FDA approval in June 2014. The medication is diluted with an ophthalmic irrigating solution for cataract surgery or intraocular lens replacement. It contains a nonsteroidal anti-inflammatory drug (NSAID) that manages inflammation, swelling, and pain during and after surgery. According to the manufacturer, using Omidria during surgical procedures can ease pain during and after surgery and reduce the need for pain medications, such as opioids.

Dextenza

Dextenza is an ophthalmic insert approved for eye inflammation and pain after surgery. The insert was first approved in November 2018. It can also be used to manage eye itching and allergic conjunctivitis. The insert is placed in the tear duct and releases dexamethasone, a corticosteroid, for up to 30 days.

Ketorolac tromethamine injection

Ketorolac tromethamine injection is an NSAID for short-term pain management that can replace opioids to manage moderately severe acute pain, typically after surgery. Although the branded version of the drug is unavailable, generic alternatives are available for individuals 17 and older.

Xaracoll

Xaracoll is an implant that delivers bupivacaine hydrochloride that can be used after an open inguinal hernia repair to prevent or manage pain up to 24 hours after surgery. The implant was approved for adults in August 2020.

Zynrelef

Zynrelef is an extended-release solution comprised of bupivacaine and meloxicam that can be delivered via instillation. The therapy was approved in May 2021 to manage postoperative pain for 72 hours within specific medical procedures.

On-Q Pump

The On-Q Pump is a balloon pump filled with medication to manage or treat pain for approximately three days. This device delivers continuous medication, including local anesthetics, to surgical wound sites or nerves, helping to manage preoperative, perioperative, or postoperative pain.

Veronica Salib has covered news related to the pharmaceutical and life sciences industry since 2022.