Included in this newsletter
- HRSA Announces Revised 340B Rebate Model Pilot Program
- Track-and-Trace Small Dispenser Relief Extended Again; Economic Impact Study Announced
- Save the Date: Place Holder for Webinar with Attorney on PHI compliance in Medical Records for patients Part 2 records for substance abuse
- Walgreens Closes Stores Across a Dozen States
- Kroger Pharmacy Customers may Qualify for Payment in $17m Settlement
- Were You Affected by Wildfires, Tornadoes or Other Recent Natural Disasters? Apply for a Disaster Relief Grant
- More Employers are Dropping the Largest PBMs
- Arkansas Suspends Enforcement of Law Preventing Limits on Which Pharmacies can Sell Medications
- Please Review our Vaccine Guidance Document Recently Posted to our Compliance Portal & Blog
- Updated: CDC Issues Interim Guidance for 2026-2027 Influenza Vaccination Season
- Recent Blogs:
- Compliance Tip of the Month
HRSA Announces Revised 340B Rebate Model Pilot Program
Following extensive stakeholder engagement and public commentary, the 340B Rebate Model Pilot Program has received a makeover. The Health Resources and Services Administration (HRSA) created the initiative to address oversight and operational challenges associated with the federal 340B Drug Pricing Program, which requires participating drugmakers to offer certain prescription medications at a discount to safety-net hospitals and clinics that serve rural, medically vulnerable, and otherwise underserved populations. The program's rapid growth, including increased participation by contract pharmacies that fill prescriptions on behalf of hospitals without an onsite pharmacy, is driving the need for change, according to HRSA. The agency's response was the rebate model, which offers an alternative to upfront price cuts. Based on feedback from hospitals, health centers, the pharmaceutical industry, pharmacies, and patients and advocates, the revised pilot will provide timely rebates after verifying eligible claims. The approach aims to increase visibility into 340B transactions, enhance program integrity through transaction-level verification, and help avoid duplicate discounts. Manufacturers that want to participate in the pilot must submit their rebate plans no later than August 24, 2026, with new pricing taking effect at the start of 2027.
Track-and-Trace Small Dispenser Relief Extended Again; Economic Impact Study Announced
There has been some good news for the HIPAA-regulated entities that feel unprepared for the proposed changes to the HIPAA Security Rule. The Department of Health and Human Services (HHS) had proposed a May 2026 release date for a final rule implementing the proposed changes to the HIPAA Security Rule; however, the U.S. Office of Management and Budget (OMB) website has been updated, showing the final rule has been pushed back a year, with the final action due in July 2027.
HIPAA Security Rule Update Postponed: More Time Given to Implement Major HIPAA Security Rule Changes
DMEPOS Updates for Osteogenesis Stimulator Coverage – KF Modifier
The FDA is issuing exemptions from certain requirements of section 582 of the FD&C Act to small dispensers (e.g. pharmacies), and where applicable their trading partners, until November 27, 2027. This exemption allows time to complete the small dispenser assessment, publish the final assessment report for public comment, and host a public meeting on the assessment.
The FDA encourages small dispensers to complete the small dispenser assessment survey by September 22, 2026. This assessment has major implications for how you handle the dispensing of medications moving forward. More information about the survey can be found here. R.J. Hedges & Associates also encourages you to complete the survey.
A dispenser is considered a small dispenser, for the purposes of the exemptions, if, as of November 27, 2026, the company that owns the dispenser has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians.
The FDA urges small dispensers to continue their efforts to implement the necessary measures to comply with the enhanced drug distribution security requirements. Small dispensers and their trading partners who utilize these exemptions do not need to submit anything to FDA or inform the agency.
Exemptions under the Drug Supply Chain Security Act | FDA
Save the Date: October 7th @ 1pm Compliance Chat with Attorney on PHI compliance in Medical Records for patients Part 2 records for substance abuse
Join us for a Compliance Chat on October 7th @ 1pm with HIPAA Attorney Ashleigh Giovannini on PHI compliance with patient files for Part 2 records- substance use treatment. More details and registration coming soon.
Walgreens Closes Stores Across a Dozen States
Walgreens has shuttered stores across multiple states as part of a multiyear effort to reduce costs and improve profitability by focusing on stronger-performing locations. The company initially announced plans in 2024 to close approximately 1,200 underperforming stores over 3 years to help achieve $1 billion in cost savings. However, after being taken private by Sycamore Partners, it scaled back those plans and now expects to close fewer than 100 stores in 2026. More than a dozen locations have already closed this year across several states and Washington, DC. Walgreens, which operates roughly 8,500 stores nationwide, has cited factors such as weak retail sales, low prescription drug reimbursement rates, expiring leases, underperforming sales, and theft-related challenges as reasons for the closures, noting that about one-quarter of its stores were unprofitable when the restructuring plan was announced.
Walgreens closes stores in NY, New Jersey, Texas, Florida, California
Kroger Pharmacy Customers may Qualify for Payment in $17m Settlement
A proposed $17 million class-action settlement would liberate Kroger from claims that its pharmacies overcharged customers for certain generic medications, an allegation the grocer denies. The case is based on the complaint that some customers with insurance paid more out of pocket than the lower price available through the chain's Savings Club. Kroger countered that it did not factor in the discount when calculating the prices it reported to insurers because those lower prices were only available to loyalty program customers who pay an annual membership fee and are not considered "usual and customary" pricing. Although it maintains innocence of fraud, negligent misrepresentation, and unjust enrichment, Kroger has agreed to pay claimants who meet qualifying criteria. Eligible customers will have filled and paid for prescriptions at a Kroger-owned or operated pharmacy between December 9, 2018 and August 23, 2026. Claims must be submitted by December 21, 2026.
Kroger pharmacy users may qualify in $17M settlement
Were You Affected by Wildfires, Tornadoes or Other Recent Natural Disasters? Apply for a Disaster Relief Grant
In Spokane, Washington, thousands were evacuated and hundreds of structures were destroyed due to wildfires sparked on August 1, 2026. In Chicago and other areas of northeastern Illinois and northwestern Indiana, communities were affected on July 27, 2026 by destructive winds paired with heavy hail and flash flooding. Independent pharmacies in both areas facing operational, facility, or inventory losses can apply for emergency funding through the NCPA Foundation's Disaster Relief Fund. You can learn more and apply for a Disaster Relief Grant here. You can help support our disaster relief efforts here.
Affected by wildfires in Spokane, Wash. or tornadoes in Chicago? Apply for a Disaster Relief Grant | Aug 4, 2026 | NCPA
Kinney Drugs Pulls Back AI Tool After Customer Complaints
Kinney Drugs has scaled back its artificial intelligence (AI)-based phone assistant, "Burt", and returned to its previous prompt-based, touch-tone phone system after receiving hundreds of customer complaints. Customers reported medication delays, inaccurate refill information, confusion, and concerns about privacy and consent. The AI tool, which was introduced in May to improve efficiency and allow pharmacy staff to focus more on patient care, was widely criticized by customers who reported problems such as receiving unnecessary prescription refills and difficulty obtaining accurate information. Company leaders acknowledged that the technology did not deliver the customer experience they intended, although they maintained that it was secure. Going forward, AI-assisted prescription refill texts will continue but only for customers who actively opt in. Customers welcomed the change, saying the return to human interaction better reflects the personalized service they value. The episode highlights broader concerns about the rapid adoption of AI in health care and the challenges of balancing innovation, customer service, privacy, and regulation.
Kinney Drugs pulls back AI tool after customer complaints - VTDigger
Delaware Expands Health Care Access with New Laws Giving Pharmacists More Responsibilities
Delaware Governor Matt Meyer has signed a package of legislation designed to expand access to care, strengthen the health care workforce. A key measure, Senate Bill 320, broadens pharmacists' scope of practice by allowing them to prescribe certain medications, order and interpret selected tests, and provide treatment under specific guidelines, while formally recognizing them as health care practitioners. Supporters say the change will help patients, particularly those without a primary care provider, access timely care through trusted community pharmacists.
Arkansas Suspends Enforcement of Law Preventing Limits on Which Pharmacies can Sell Medications
The Arkansas State Board of Pharmacy has voted not to enforce Act 630, a 2025 law intended to prevent drug manufacturers from restricting which pharmacies can dispense their products, after a federal judge ruled the measure likely violates the U.S. Constitution’s dormant commerce clause and blocked its enforcement. The board also approved settlements in related lawsuits and will not process applications seeking distribution network limits. Supporters of the law, including practicing pharmacist and sponsor Rep. Brandon Achor (R-Maumelle) and Arkansas Pharmacists Association CEO John Vinson, expressed disappointment that drugmakers challenged the law rather than justify their limited distribution practices, arguing that such restrictions can delay patient access to critical medications, including cancer treatments. The decision comes amid broader legal battles over Arkansas’ efforts to expand prescription drug access, including another 2025 law targeting PBMs that was also blocked in federal court. While state officials are unlikely to appeal the Act 630 ruling, lawmakers and pharmacy advocates say they may pursue new legislative or market-based solutions, even as Arkansas separately continues litigation against several drug manufacturers over alleged violations of the state’s drug discount program requirements.
Major PBMs to Boost Prescription Drug Price Transparency Through Trump Rx
CVS Health, Express Scripts, OptumRx, and half a dozen other PBMs have committed to greater pricing transparency on the TrumpRx website that launched earlier this year. The companies are generally expected to list the cash price for a prescription medication on TrumpRx alongside what plan users would pay to fill the drug at an in-network pharmacy, although some PBMs may use a different approach to compare costs. The agreement, brokered through the Pharmaceutical Care Management Association, seeks to give consumers a better line of sight into potential savings. "That's the kind of transparency we need to boost competition, drive down costs, and deliver better value for American patients," said CMS Administrator Mehmet Oz, MD. In addition to the "Big Three" PBMs, CarelonRx, Humana, MedImpact Healthcare Systems, Navitus Health Solutions, Prime Therapeutics, and WellDyne have signed on to participate along with VytlOne also expected to join.
Nine major PBMs agree to display TrumpRx drug prices on benefit tools | Fox Business
Pharmacists Permanently no Longer Required to Make CTA Disclosures
The U.S. Department of the Treasury’s Financial Crimes Enforcement Network (FinCEN) issued a final rule that permanently removes the requirement for U.S. companies and U.S. persons (including pharmacies and pharmacists) to report beneficial ownership information to FinCEN under the Corporate Transparency Act (CTA). The rule is effective Aug. 14. This is a major win for NCPA members.
Under the CTA, small businesses (including pharmacies) with 20 or fewer full-time employees that did not otherwise meet an exemption were required to file a beneficial ownership information report with the U.S. Treasury's Financial Crimes Enforcement Network. Past court decisions and regulatory changes had caused the enforcement of this rule to be in flux. You can see the final rule here.
New Payment Portal coming to R.J. Hedges & Associates
Staff members who receive RJH invoices should have received an invite with in the past 2 weeks to register on the HighRadius Payment Portal. Starting in September, all R.J. Hedges & Associates invoices and statements will now be sent from no-reply-ar@harriscomputer.com. To ensure seamless communication, please add this email to your safe sender list. If you do not receive our emails, kindly check your spam or junk folders.
Our new payment portal will give you a convenient, self-service online portal where you can:
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View all invoices in one place — no more searching emails or waiting for statements.
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Download or print invoices and statements anytime, on demand.
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Pay invoices securely online using ACH or other available methods.
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Set up autopay for recurring or predictable invoices.
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Track payment status in real time, including what’s pending, posted, or overdue.
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Receive automated reminders so nothing falls through the cracks.
Please Review our Vaccine Guidance Document Recently Posted to our Compliance Portal & Blog
The document provides an update on the ongoing legal and regulatory uncertainty surrounding federal vaccine recommendations issued by the CDC and ACIP and the resulting impact on pharmacist vaccination authority and standing orders for Influenza, COVID-19, and other vaccines. https://www.rjhedges.com/blog/vaccine-guidance-uncertainty
Updated: CDC Issues Interim Guidance for 2026-2027 Influenza Vaccination Season
On September 1, 2026, the Centers for Disease Control and Prevention (CDC) issued new guidance entitled "Interim Clinical Considerations for the Use of Seasonal Influenza Vaccines in the United States." In this document, the CDC specifically addressed the ongoing legal uncertainty surrounding vaccine recommendations and clarified that, for purposes of the 2026-2027 influenza season, the seasonal influenza vaccination recommendations contained in the July 2025 CDC immunization schedule remain in effect. https://www.rjhedges.com/blog/update-cdc-issues-interim-guidance-for-2026-2027-influenza-vaccination-season
Recent Blogs:
R.J. Hedges Partnership Series with Atrium24
Central Fill, GLP-1s, and Peptides: What Independent Pharmacies Need to Know
Compliance Tip of the Month
HIPAA and Patient Privacy: Remind staff that patient information should never be visible or audible to other customers; a quick front-end walkthrough each month catches most privacy exposures before they become complaints.
