8-K: InfuSystem Pumps Gain NOPAIN Act Separate Payment

InfuSystem Holdings, Inc. announced that two of its electronic infusion pumps used in pain management will receive separate payment under the NOPAIN Act, effective January 1, 2026.

Summary

• The Centers for Medicare and Medicaid Services (CMS) has added two electronic infusion pumps utilized by InfuSystem within its Pain Management services business to the list of qualifying products for separate payment under the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act.
• The two pumps are the CADD-SolisTM manufactured by ICU Medical, Inc., and Eitan Medicals SapphireTM pump.
• The NOPAIN Act mandates that CMS provide separate payment for qualified non-opioid treatments through December 31, 2027, when provided with a covered surgical procedure.
• This decision, effective January 1, 2026, means Hospital Outpatient Departments (HOPDs) and Ambulatory Surgical Centers (ASCs) using these products will receive separate Medicare reimbursement in addition to related APC payments.
• Both pumps received unique, brand-specific Healthcare Common Procedure Coding System (HCPCS) codes: C9815 for the CADD-SolisTM and C9811 for Eitan's SapphireTM pump.
• The payment limitation calculated and published by CMS is up to $1,997.16 per claim.
• This initiative is part of a broader strategy by CMS to combat the opioid crisis by promoting safer pain management alternatives.

Sentiment

Score: 7

Explanation: The announcement of separate Medicare payment for key products is a significant positive, potentially boosting revenue and market penetration. However, the tempered outlook due to uncertainty around reimbursement requirements and customer adoption, along with the temporary nature of the NOPAIN Act (through 2027), introduces some caution.

Positives

• Two key electronic infusion pumps (CADD-SolisTM and SapphireTM) now qualify for separate Medicare payment under the NOPAIN Act, effective January 1, 2026.
• This decision has the potential to act as a catalyst for volume growth in the Pain Management business by encouraging healthcare providers to consider InfuSystem's service.
• Healthcare providers (HOPDs and ASCs) will receive additional Medicare reimbursement for using these qualifying non-opioid items.
• The separate payment can be up to $1,997.16 per claim, providing a significant incentive for adoption.

Negatives

• The forward outlook is tempered until InfuSystem gains further understanding surrounding the requirements for reimbursement and sees adoption by current and potential customers.
• The NOPAIN Act mandate for separate payment for qualified non-opioid treatments is currently set to expire on December 31, 2027.
• CMS will review and approve eligible products on an annual basis during the 3-year program, introducing potential for future changes.

Risks

• Ability to successfully execute on growth initiatives and strategic partnerships.
• Ability to enter into definitive agreements for new business relationships on expected terms or at all.
• Ability to generate estimated potential revenue amounts under new or existing contracts.
• Dependence on estimates of collectible revenue.
• Potential litigation.
• Changes in third-party reimbursement processes.
• Changes in law.
• Global financial conditions and recessionary risks.
• Rising inflation and interest rates.
• Supply chain disruptions.
• Systemic pressures in the banking sector, including disruptions to credit markets.
• The Company's ability to remediate its previously disclosed material weakness in internal control over financial reporting.
• Contributions from acquired businesses or new business lines, products or services.

Future Outlook

The rule change, together with the approved reimbursement, has the potential to act as a catalyst for volume growth in the Pain Management business. However, the forward outlook will continue to be tempered until further understanding surrounding the requirements for reimbursement is gained and customer adoption is observed.

Management Comments

• "We are very glad to see that CMS has expanded upon its initial decision from last year and acknowledged that electronic infusion pumps such as the CADD-SolisTM and the SapphireTM are effective non-opioid options for reducing opioid use after surgery." Carrie Lachance, CEO
• "We will continue to work in partnership with healthcare providers and device manufacturers to advocate for proven non-opioid treatments for pain." Carrie Lachance, CEO
• "This rule change, together with the approved reimbursement, has the potential to act as a catalyst for volume growth in our Pain Management business by encouraging health care providers to consider adding our service to their formulary." Carrie Lachance, CEO
• "However, our forward outlook will continue to be tempered until we gain further understanding surrounding the requirements for reimbursement and until we see adoption by our current and potential customers." Carrie Lachance, CEO
• "We will continue to work closely with these customers on this opportunity and will provide updates should we see any material new developments." Carrie Lachance, CEO

Industry Context

This initiative is part of a broader strategy by CMS to combat the opioid crisis by promoting safer pain management alternatives, aligning with national efforts to reduce reliance on opioids in postoperative care. The NOPAIN Act aims to increase patient access to non-opioid drugs and devices used to manage pain in Hospital Outpatient (HOPD) and Ambulatory Surgical Center (ASC) settings.

Comparison to Industry Standards

• NA

Stakeholder Impact

• Shareholders: Potential for increased revenue and volume growth in the Pain Management business, which could positively impact share price.
• Healthcare Providers (HOPDs & ASCs): Will receive separate Medicare reimbursement for using InfuSystem's qualifying pumps, encouraging adoption of non-opioid pain management solutions.
• Patients (Medicare beneficiaries): Enhanced access to clinically proven non-opioid treatments for pain management in HOPD and ASC settings.
• Device Manufacturers (ICU Medical, Eitan Medical): Increased demand for their CADD-SolisTM and SapphireTM pumps due to favorable reimbursement changes.

Next Steps

• InfuSystem will continue to work in partnership with healthcare providers and device manufacturers to advocate for proven non-opioid treatments for pain.
• InfuSystem will continue to work closely with current and potential customers on this opportunity.
• InfuSystem will provide updates should any material new developments occur.
• CMS will review and approve eligible products on an annual basis during the 3-year NOPAIN Act program.

Key Dates

Recommendation

The Centers for Medicare and Medicaid Services' decision to provide separate payment for InfuSystem's CADD-SolisTM and SapphireTM infusion pumps under the NOPAIN Act is a significant positive catalyst. This directly addresses a key market need for non-opioid pain management and provides a clear financial incentive (up to $1,997.16 per claim) for healthcare providers to adopt InfuSystem's services. While management prudently tempers the immediate outlook pending full understanding of reimbursement requirements and customer adoption, the fundamental shift in reimbursement policy creates a strong tailwind for the Pain Management business segment, indicating potential for substantial volume and revenue growth. This development positions InfuSystem favorably within the evolving healthcare landscape focused on combating the opioid crisis.

Keywords

InfuSystem, NOPAIN Act, CMS, Medicare, Pain Management, Infusion Pumps, Non-Opioid, Healthcare Reimbursement, CADD-Solis, Sapphire Pump, 8-K