November 2026 - Newsletter

The FDA has announced an enforcement discretion policy permitting 503A compounding pharmacies, under specified conditions, to compound using six peptide bulk drug substances: BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500. The agency has not specified how long this enforcement discretion will remain in effect.

This action follows the FDA Pharmacy Compounding Advisory Committee's July 2026 recommendation that these six substances be added to the 503A Bulks List, which identifies certain bulk drug substances that may be used in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. The committee did not recommend adding emideltide.

Pharmacies should note that final rulemaking has not yet been completed, and the enforcement discretion policy should not be interpreted as final inclusion of these substances on the 503A Bulks List.

For additional information see: HHS enforcement discretion policy and the FDA Pharmacy Compounding Advisory Committee meeting materials.

The Advance Beneficiary Notice of Noncoverage (ABN), Form CMS-R-131, was recently updated. The transition period for the previous version ended May 12, 2026. For dates of service on or after May 12, 2026, suppliers must use the current OMB-approved form, which has an expiration date of March 31, 2029, when issuing a new ABN. Using a previous version of the form for dates of service on or after May 12, 2026, will invalidate the ABN. Current English, Spanish, and large-print versions, along with form instructions, are available through CMS.

The ABN is provided to beneficiaries before furnishing certain items or services when Medicare payment is expected to be denied. It allows the beneficiary to make an informed decision about whether to receive the item or service and accept potential financial responsibility.

Take a moment to review your ABN processes and verify that the current Form CMS-R-131 is being used. Discard or destroy blank copies of previous versions, follow the current completion and delivery instructions, and apply the appropriate claim modifiers when billing. Visit the Advance Beneficiary Notice of Noncoverage (ABN) page for additional guidance and educational resources or the CMS FFS ABN webpage to access the current form and instructions.

On October 14, 2026, Medline announced the voluntary removal, discontinuation, and market exit of all Medline-branded beds, including homecare, bariatric, and long-term care beds, along with associated hand controls, accessories, and replacement parts. The action is related to potential electrical/fire hazards and entrapment risks that could result in serious injury or death. American Health Care Association/National Center for Assisted Living notice.

Recommended Actions for Providers:

• Review equipment inventories to identify affected Medline beds and accessories.
• Notify impacted patients and caregivers and provide applicable safety instructions.
• Coordinate with patients and equipment suppliers regarding removal and replacement options.
• Review Medline's safety instructions before continued use of affected equipment.

Medline advises users to unplug affected beds and battery packs, discontinue electrical functions, and stop using bed accessories, including side rails. Beds may continue to be used with a mattress in manual mode only until replacement.

Providers that have supplied Medline beds should review the manufacturer's notice and the FDA guidance carefully and take appropriate action to protect affected patients.

The DME Medicare Administrative Contractors (DME MACs) and the Pricing, Data Analysis and Coding (PDAC) contractor released several important coding updates effective October 1, 2026 that may impact suppliers billing for durable medical equipment (DME) and orthotic devices.

HCPCS Code Changes Effective October 1, 2026

• The October 2026 HCPCS quarterly update includes new HCPCS codes and modifiers, discontinued codes and modifiers, and revisions to existing code descriptors. Suppliers should review the official update carefully and ensure billing systems are updated, as discontinued codes may not be used for dates of service on or after October 1, 2026. There is no grace period for the use of deleted codes.

Clarification on Custom Fitted vs. Off-the-Shelf Orthotics

The DME MACs and PDAC also issued revised guidance addressing the correct coding of prefabricated orthotic braces. The guidance reinforces that code selection depends on both:

• The amount of adjustment required at the time of delivery, and
• Whether those adjustments require the expertise of a trained orthotics professional.

An orthosis should be billed as off-the-shelf (OTS) when it requires only minimal adjustments that can typically be performed by the supplier, beneficiary, or caregiver. In contrast, a custom fitted orthosis requires more extensive modifications to achieve an individualized fit and must be performed by a certified orthotist or another individual with specialized orthotic training.

The contractors also emphasized that the use of CAD/CAM technology, 3D printing, or other advanced manufacturing techniques alone does not automatically qualify an orthosis as custom fabricated.

Special Coding Considerations

The revised guidance highlights that certain HCPCS codes designated as custom fitted orthotics do not have corresponding off-the-shelf codes. When these products are delivered without the level of fitting required for a custom fitted device, suppliers may need to bill an appropriate miscellaneous HCPCS code instead. Accurate documentation supporting code selection remains essential.

What Pharmacies and DME Suppliers Should Do

• Review the October 2026 HCPCS code update and implement all applicable coding changes.
• Verify that orthotic products are billed according to the actual level of fitting provided at delivery.
• Ensure supplier documentation clearly supports whether an item was provided as off-the-shelf or custom fitted.
• Educate staff involved in orthotic dispensing and billing on the revised coding guidance.

Because these publications contain extensive code listings, crosswalks, and classification tables, suppliers should refer to the original articles for the specific HCPCS codes and coding algorithms applicable to their products.

The federal 340B drug pricing program is exploring offering manufacturer rebates instead of upfront discounts to hospitals and other providers that cater to low-income and otherwise underserved populations. The Health Resources and Services Administration (HRSA) recently disclosed 21 prescription medicines that will be included in the 340B Rebate Model Pilot Program, which goes live on January 1. They include therapies from drugmakers such as Pfizer, AstraZeneca, Merck, and AbbVie. The pharmaceutical companies believe the reform will widen oversight and preserve the integrity of the 340B initiative, but providers remain opposed to the rebate approach even after HRSA went back to the drawing board following resistance to its earlier proposal. In their opinion, the new system will increase financial pressures on participating hospitals and clinics and could allow manufacturers to improperly withhold funds.

The FDA-approved modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) are now scheduled to take effect on November 15, 2026. These changes are intended to reduce administrative burden on patients, prescribers, and pharmacies while maintaining the safeguards designed to prevent fetal exposure to isotretinoin.

Key Changes Affecting Pharmacies:

• Elimination of the 30-Day prescription window for patients categorized as "Patients Who Cannot Get Pregnant". Pharmacists will no longer receive a "Do Not Dispense After Date" when obtaining a Risk Management Authorization (RMA). This means prescriptions will not automatically expire in the iPLEDGE system after 30 days. However, if a prescription is not picked up and is returned to stock, the pharmacy must reverse the authorization in the iPLEDGE system.
• New prescriber verification requirement when obtaining an RMA for a patient who cannot get pregnant. Pharmacists will be prompted to enter the prescriber's National Provider Identifier (NPI) to verify that the prescriber remains certified in iPLEDGE. Pharmacies should ensure workflows and staff training are updated before implementation.
• Enhanced training requirements; authorized representatives must ensure that all staff involved in dispensing isotretinoin receive training at enrollment and annually thereafter. Pharmacies are expected to maintain records documenting this training.
• Authorized representatives should inform all trained pharmacists interacting with the iPLEDGE REMS system that they should* create a personal account by calling the REMS Contact Center.

(*Trained pharmacy staff interacting with the iPLEDGE REMS system are not required to create personal accounts and will not lose access if they continue to use the account established by the Authorized Representative. However, the iPLEDGE REMS encourages individual trained pharmacy staff involved in dispensing to create a personal account when convenient.)

Indirect Effects on Pharmacy Operations: Several changes primarily affect prescribers and patients but may alter pharmacy workflows:

• Prescribers may allow patients who can become pregnant to use at-home pregnancy tests for monthly and post-treatment testing. Initial pre-treatment pregnancy testing must still be performed in a medical setting.
• Patients who miss the 7-day prescription pickup window may obtain a repeat pregnancy test immediately rather than waiting through an additional mandatory waiting period.

What Is Not Changing: Despite these modifications, several important pharmacy requirements remain unchanged:

• Pharmacies must continue to obtain a valid Risk Management Authorization (RMA) before dispensing isotretinoin.
• Only a maximum 30-day supply may be dispensed per prescription.
• Isotretinoin prescriptions remain non-refillable and require a new prescription and new RMA for each dispensing.
• Pharmacies and pharmacists must remain enrolled and compliant with all iPLEDGE REMS requirements.

Bottom Line:

• The November 2026 iPLEDGE updates represent the most significant operational changes for pharmacies in several years. While the program's patient safety objectives remain intact, pharmacies should prepare for revised authorization workflows, new NPI verification requirements, annual training documentation responsibilities, and changes surrounding prescription validity for patients who cannot become pregnant. Updating pharmacy policies, training staff, and coordinating with pharmacy software vendors before November 15 will help ensure a smooth transition.

The Kentucky Department of Insurance issued a bulletin announcing a commercial market dispensing fee requirement of $16.31, effective Jan. 1, 2027. In 2024, legislation was passed that established a reimbursement floor in the commercial market of NADAC plus a $10.64 dispensing fee, with a requirement that the department analyze data collected by the Board of Pharmacy. The Board of Pharmacy's first-of-its-kind commercial market analysis was built upon the Kentucky-specific results from a national cost to dispense survey jointly produced by NCPA, NACDS, and NASP in 2020.

Per the 2024 law (SB 188), the reimbursement applies to all Kentucky pharmacy locations, excluding mail-order only pharmacies and distributors. The bulletin details its enforcement policy and expectations for compliance. The bulletin can be found here.

Healthcare providers and public health officials are reporting an unusually early start to this year's influenza season. While flu activity typically begins to increase in November, surveillance data indicate that influenza circulation started rising as early as August in many parts of the country.

Recent monitoring shows a steady increase in positive influenza tests nationwide, with influenza activity expected to continue expanding throughout the fall. Wastewater surveillance is also detecting significantly higher levels of influenza A compared to the same period last year, suggesting broader community spread earlier than usual.

As of early October, influenza activity was increasing across all 50 states, with some of the highest levels reported in western states, including Alaska, Arizona, California, Hawaii, Idaho, Nevada, Oregon, and Washington.

The Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), the American Academy of Pediatrics (AAP), and the Infectious Diseases Society of America (IDSA) continue to emphasize annual influenza vaccination as the most effective way to reduce the risk of illness, complications, hospitalization, and transmission.

With flu activity arriving earlier than expected, pharmacies should encourage eligible patients to receive their influenza vaccine as soon as possible, review vaccine inventory levels, and prepare for increased demand throughout the remainder of the season. Early vaccination remains one of the most effective tools for protecting patients and communities during the upcoming flu season.

The Trump administration has announced a 90-day hold on new import rules that will make it more difficult for Americans to procure less expensive medications from licensed pharmacies in Canada and other countries. The proposal aims to close a loophole that has long allowed U.S. patients to fill their prescriptions outside the national border and bring them back into the United States without tariff and documentation burdens. The crackdown was initially slated to take effect on October 22, but the administration has pushed back the timeline in response to outcry from consumers, patient advocacy organizations, and U.S. lawmakers. However, the pause is intended only to give patients time to adjust to the new import requirements, not to consider walking back the plan. Advocates say the rule change contradicts the administration's campaign to lower drug costs and could have serious health repercussions for Americans who can only afford imported medications as the cost of most prescription drugs continues to escalate in the United States. Meanwhile, consumers have flooded the Campaign for Personal Prescription Importation to express concerns about having to pay exorbitant prices for their treatments or go without them.

Medicare suppliers and providers have an annual opportunity to change their participating or non-participating status for the upcoming calendar year. The enrollment window runs from November 15 through December 31, 2026, with changes effective January 1, 2027.

Participating suppliers agree to accept Medicare-approved amounts as payment in full for covered services. Non-participating suppliers may choose whether to accept assignment on certain claims, potentially allowing additional reimbursement opportunities. However, mandatory assignment requirements still apply to specific items and services.

Considering a change? Suppliers wishing to switch from participating to non-participating must submit written notice to the appropriate Medicare contractor by December 31. Those wishing to become participating must submit Form CMS-460. No action is necessary if you wish to maintain your current status. If you need assistance, please reach out to your Project Manager.

CVS Health recently agreed to pay $315 million to resolve allegations related to its dispensing of controlled substances and subsequent billing to federal healthcare programs. Federal authorities alleged that between 2013 and 2025, CVS pharmacies dispensed certain controlled substance prescriptions that lacked a legitimate medical purpose and then sought reimbursement for many of those prescriptions from Medicare and other federal healthcare programs.

According to the allegations, problematic prescriptions included excessive opioid quantities, early refill requests, the dispensing of so-called "trinity" combinations (opioids, benzodiazepines, and muscle relaxants), and prescriptions originating from prescribers suspected of operating pill mills. Regulators contended that these prescriptions were filled despite the presence of warning signs that warranted additional scrutiny.

The government further alleged that certain corporate performance expectations, staffing models, and incentive structures may have limited pharmacists' ability to adequately evaluate prescribing concerns and identify potentially inappropriate controlled substance prescriptions. As part of the settlement, CVS has agreed to implement enhanced compliance safeguards, including strengthened monitoring of dispensing practices, mechanisms for reporting concerns, and additional review processes for prescribers exhibiting potential high-risk prescribing patterns.

The settlement also resolves a whistleblower lawsuit filed under the False Claims Act by a former CVS employee. The agreement was reached without an admission or determination of liability.

This enforcement action highlights the ongoing expectation that pharmacies maintain robust controlled substance compliance programs and ensure pharmacists have the resources and authority necessary to exercise corresponding responsibility. Pharmacies should regularly review opioid dispensing practices, document due diligence activities, investigate red flags, monitor high-risk prescribing patterns, and maintain sufficient staffing and oversight to support compliance with both the Controlled Substances Act and federal healthcare program requirements.

The FDA issued a warning letter to Empower Pharmacy after a November 2025 inspection found that it had produced large quantities of compounded semaglutide and tirzepatide products that were essentially copies of FDA-approved drugs, in violation of the conditions under Section 503A of the Federal Food, Drug, and Cosmetic Act. The formulations combined GLP-1 drugs with B vitamins, tirzepatide with niacinamide and semaglutide with cyanocobalamin, but the FDA said these differences appeared pretextual. Consequently, the products lost their Section 503A exemptions and were considered unapproved and misbranded. The FDA also cited insanitary conditions that could compromise sterile products, including inadequate airflow validation, insufficient aseptic process testing, and deficiencies in environmental monitoring, equipment maintenance, and quality control oversight. Although some corrective actions were adequate, others were not. Empower has 15 working days to respond.

Walgreens is reportedly scaling back its planned store closures following its acquisition by private equity firm Sycamore Partners, with the company now expected to close fewer than 100 U.S. stores this year rather than pursue the broader shutdown strategy previously announced. Before the August 2025 acquisition, Walgreens had outlined plans to close approximately 1,200 underperforming locations nationwide as part of a turnaround effort, and projections had suggested hundreds more closures could follow.

Amazon is urging businesses, including pharmacies and pharmaceutical companies, to review their website security following recent attempts by hackers to exploit critical vulnerabilities in PHP, software commonly used to power websites.

The identified vulnerabilities could potentially allow an attacker to compromise a vulnerable web server without first needing to log in. Pharmacy owners and operators should contact their website administrator, IT support provider, or web-hosting company to confirm that applicable PHP security updates and patches have been installed, including updates released following the reported October 17 attempted exploitation.

In addition to confirming that the website is fully patched, pharmacies should ask their IT or hosting provider to review website and server activity for signs of suspicious or unauthorized activity that may have occurred before the additional security protections were implemented.

Recommended Action: Contact your website or hosting provider and request written confirmation that:

• The PHP installation supporting your website is fully updated and patched.
• Applicable security recommendations have been implemented.
• Server and website logs have been reviewed for suspicious activity or indications of compromise.