DAYS TO PREPARE FOR EXPANDED REIMBURSEMENT

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Congress did their part by expanding reimbursement for non-opioid postsurgical options. Now it’s your turn.

Join the movement to choose the best non-opioid options for your Medicare patients—without added financial barriers.

Starting January 1, 2025, the NOPAIN Act will mandate that Medicare provide ASP+6% reimbursement for qualified non-opioid options used in all outpatient surgeries.1,2

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ASP+6% = reimbursement of 106% of the average sales price

ABOUT THE NOPAIN ACT

The NOPAIN Act mandates that Medicare reimburse for qualified non-opioid options for all outpatient surgical procedures1

With Congress's passing of the NOPAIN (Non-Opioids Prevent Addiction in the Nation) Act, you can now provide branded non-opioids to your Medicare surgical patients for improved management of postsurgical pain - while minimizing financial barriers.1,3

reimbursement

Congress has mandated that Medicare provide ASP+6% reimbursement for qualifying non-opioid options1,2

ambulatory center

The NOPAIN Act will expand access across ASC and HOPD settings1

fda-approved

NOPAIN reimbursement will only be available for FDA-approved and proven options shown to replace or reduce the use of opioids in managing postsurgical pain1,3

Removing Barriers

Why did Congress pass this Act?

The bipartisan and bicameral NOPAIN Act was designed to increase patient and provider access to non-opioid pain management options by removing the barriers associated with reimbursement for the Medicare population. This Act is the direct result of the dedicated work of more than 100 patient advocacy and professional societies that support patient choice in postsurgical pain management.1,3

According to one of its congressional sponsors, this Act will take steps to stop future addiction before it can begin by ensuring Medicare patients have access to non-opioid options while dealing with postsurgical pain.1,3

[We] urge CMS to... separate payment for non-opioid pain management drugs in the HOPD… As the largest payer, Medicare’s policy change in this area would influence the entire health care system and meaningfully impact the opioid epidemic.4

- AHIP, 2021

Qualifying Non-Opioids

What’s covered?

CMS published their proposed ruling on July 10, 2024, in order to make the NOPAIN Act a reality this coming January.* The rule specifies that the NOPAIN Act will cover reimbursement for drugs and devices that have demonstrated the ability to reduce or avoid intraoperative or postoperative opioid use. Specific qualifications include5,6:

  • Non-opioid medications indicated to reduce postoperative pain or produce postsurgical regional analgesia without acting upon the body’s opioid receptors
  • Devices used to deliver a therapy or reduce postoperative pain or produce postsurgical or regional analgesia

Brand Name5-13

Indication

EXPAREL®7

(bupivacaine liposome injectable suspension)

Indication

  • Postsurgical local analgesia via infiltration in patients aged 6 years and older
  • Regional analgesia via an interscalene brachial plexus nerve block in adults
  • Regional analgesia via a sciatic nerve block in the popliteal fossa in adults
  • Regional analgesia via an adductor canal block in adults

OMIDRIA®8

(phenylephrine and ketorolac intraocular solution) 1%/0.3%

Indication

Addition to ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain

DEXTENZA®9

(dexamethasone ophthalmic insert) 0.4 mg

Indication

Corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery

Ketorolac tromethamine injection10

Indication

Short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting

XARACOLL®11

(bupivacaine hydrochloride) implant

Indication

Postsurgical analgesia for up to 24 hours following open inguinal hernia repair in adults

ZYNRELEF®12

(bupivacaine and meloxicam) extended-release solution

Indication

Postsurgical analgesia for up to 72 hours in adults after:

  • Soft tissue surgical procedures
  • Orthopedic surgical procedures
    • Foot and ankle procedures
    • Other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided

ON-Q Pump13

Indication

Provides continuous delivery of medication (such as local anesthetics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative, and postoperative regional anesthesia and/or pain management

*Expected final rule to be released in November 2024.6

IMPORTANT DATES

Make the pact TODAY and commit to bringing the NOPAIN Act to your health system, starting January 1, 2025

Dec 2022

NOPAIN Act passed as part of the Consolidated Appropriations Act of 20231,3

Jul 2024

CMS’ preliminary OPPS rule issued, defining qualifying non-opioids5

Nov 2024

CMS’ final OPPS rule expected to be issued,
finalizing coverage rates and reimbursement codes5

Jan 2025

A new day for patient and provider access to qualifying non-opioids1

stay informed

Support the use of non-opioid pain management in your organization!

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References

  1. Congress.gov. One hundred seventeenth Congress of the United States of America. Accessed June 12, 2024. https://www.congress.gov/117/bills/hr2617/BILLS-117hr2617enr.pdf
  2. CMS.gov. Medicare part B drug average sales price. Updated April 2, 2024. Accessed June 12, 2024. https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price
  3. Voices for non-opioid choices. Voices for non-opioid choices coalition applauds Congress for expanding access to non-opioid pain management options in end-of-year legislative package to combat addiction crisis. Published December 23, 2022. Accessed June 12, 2024. https://nonopioidchoices.org/wp-content/uploads/2022/12/Voices-Press-Statement-NOPAIN-Act-Passage-12.23.22.pdf
  4. AHIP Letter/Brooks-LaSure 2021. Accessed June 12, 2024. https://www.regulations.gov/comment/CMS-2021-0124-18296
  5. CMS.gov. Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; etc. Accessed July 18, 2024. https://www.federalregister.gov/public-inspection/2024-15087/medicare-and-medicaid-programs-hospital-outpatient-prospective-payment-and-ambulatory-surgical
  6. CMS.gov. CY 2025 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule (CMS 1809-P). Published July 10, 2024. Accessed July 31, 2024. https://www.cms.gov/newsroom/fact-sheets/cy-2025-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center
  7. Exparel (bupivacaine liposome injectable suspension). Prescribing Information. Pacira Pharmaceuticals, Inc. https://www.exparelpro.com/prescribing-information.pdf
  8. Omidria (phenylephrine and ketorolac intraocular solution). Prescribing Information. Rayner Surgical Inc. https://www.omidria.com/documents/2/OMIDRIA-Prescribing-Information.pdf
  9. Dextenza (dexamethasone ophthalmic insert). Prescribing Information. Ocular Therapeutix, Inc. https://www.dextenza.com/wp-content/uploads/DEXTENZA-Full-Prescribing-Information-1.pdf
  10. Ketorolac tromethamine injection. Prescribing Information. Hospira, Inc. https://labeling.pfizer.com/ShowLabeling.aspx?format=PDF&id=4487
  11. Xaracoll (bupivacaine hydrochloride). Prescribing Information. Innocoll Pharmaceuticals Limited. https://xaracoll.com/xaracoll_pi.pdf
  12. Zynrelef (bupivacaine and meloxicam). Prescribing Information. Heron Therapeutics, Inc. https://zynrelef.com/prescribing-information.pdf
  13. ON-Q* pump. Prescribing Information. Avanos Medical, Inc. https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181360.pdf

ASC, ambulatory surgical center; ASP, average sale price; CMS, Centers for Medicare and Medicaid; FDA, US Food and Drug Administration; HOPD, hospital outpatient department; NOPAIN Act, Non-Opioids Prevent Addiction in the Nation Act; OPPS, outpatient prospective payment system.

EXPAREL® (bupivacaine liposome injectable suspension) and Pacira are registered trademarks of the respective subsidiaries of Pacira BioSciences, Inc. All other trademarks referenced herein are the property of their respective owners.

Indication

EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block. Safety and efficacy have not been established in other nerve blocks.

Important Safety Information
  • EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
  • Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via nerve block were nausea, pyrexia, headache, and constipation.
  • Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.
  • Do not admix lidocaine or other non-bupivacaine local anesthetics with EXPAREL. EXPAREL may be administered at least 20 minutes or more following local administration of lidocaine.
  • EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for nerve blocks, and/or pregnant patients.
  • Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.
Warnings and Precautions Specific to EXPAREL
  • Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL.
  • EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block, or intravascular or intra-articular use.
  • The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.
Warnings and Precautions for Bupivacaine-Containing Products
  • Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression.
  • Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death.
  • Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients.
  • Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.
  • Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.

Please refer to full Prescribing Information.

See More

EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block. Safety and efficacy have not been established in other nerve blocks.