Newsletters

August 2026 - Newsletter

Written by Becky Templeton | Aug 10, 2026, 7:27:56 PM

Included in this newsletter

  1. New Payment Portal coming to R.J. Hedges & Associates
  2. HIPAA Security Rule Update Postponed: More Time Given to Implement Major HIPAA Security Rule Changes
  3. DMEPOS Updates for Osteogenesis Stimulator Coverage – KF Modifier
  4. Hazardous Drug Program Updated
  5. Partnership for Safe Medicines Releases Action Plan to Protect Patients from Unapproved Compounded GLP-1s
  6. GLP-1 Bridge Reject Code Cheat Sheet
  7. FDA Advisory Committee Nominates Six Peptides for Pharmacies to Compound
  8. Disaster Relief Grants for Southern Texas, Southeastern Missouri
  9. Trump Plans Generic Drug Tariffs
  10. Save the Date: Partnership Series with Atrium24 Wednesday August 19th @ 11amEST
  11. Compliance Tip of the Month

New Payment Portal coming to R.J. Hedges & Associates

We are excited to announce the launch of our new Electronic Presentment & Payment (EIPP) portal through HighRadius.  *Please watch out for a registration link from HighRadius to get started with the new 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.

Please continue to use AR_RJHedges@harriscomputer.com, or email at madeniyi@harriscomputer.com.  Please note that replies to no-reply-ar@harriscomputer.com will not be monitored.

Our new payment portal will give you a convenient, self-service online portal where you can:

• View all invoices in one place — no more searching emails or waiting for statements.
• Download or print invoices and statements anytime, on demand.
• Pay invoices securely online using ACH or other available methods.
• Set up autopay for recurring or predictable invoices.
• Track payment status in real time, including what’s pending, posted, or overdue.
• Receive automated reminders so nothing falls through the cracks.

Why We’re Excited

This transition brings a modern, user-friendly experience designed to save you time and give you complete visibility into your account. You’ll no longer need to reach out for copies of invoices, confirmations, or account balances, the portal puts everything at your fingertips.

We’re confident this upgrade will make your billing experience smoother than ever, and we truly appreciate your partnership as we roll out this improvement.

HIPAA Security Rule Update Postponed:  More Time Given to Implement Major HIPAA Security Rule Changes

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

For claims billed with dates of services prior to May 18, 2026, devices coded E0747, E0748, and E0760 are classified by the Food and Drug Administration as Class III devices; therefore, all claims for codes E0747, E0748, and E0760 must include the KF Modifier. For claims billed with dates of service on or after May 18, 2026, devices coded E0747, E0748, and E0760 are reclassified by the Food and Drug Administration as Class II devices; therefore, any claims billed with the KF Modifier on or after May 18, 2026, will be rejected for incorrect billing.

Osteogenesis Stimulator - JA DME - Noridian

Hazardous Drug Program Updated

We're excited to announce an enhancement to our Hazardous Drug Program! To better align with USP <800>, we've consolidated our hazardous drug resources into one comprehensive program. Whether your pharmacy is retail, long-term care, closed-door, or performs non-sterile compounding, you'll now have access to the same complete set of hazardous drug policies, procedures, forms, and implementation tools.

What's New?

  • One unified Hazardous Drug Program for all eligible clients (Those enrolled in Pharmacy or Compounding automatically have access as well as those who purchased the Hazardous Drug Program).
  • Easier access through its own Hazardous Drug Program tile on the Compliance Portal home screen
  • Expanded hazardous drug exposure resources, including new incident reporting, post-exposure evaluation, and corrective action tools

Beginning August 12, hazardous drug content will no longer appear as a chapter within the Pharmacy Compliance Program or Non-Sterile Compounding Program. If your subscription includes hazardous drug resources, your access has already been updated automatically, you'll simply access them through the dedicated Hazardous Drug Program tile.

Reminder: Pharmacies performing non-sterile compounding should continue to implement a comprehensive Non-Sterile Compounding Program to address all applicable USP <795> requirements in addition to USP <800>.

Partnership for Safe Medicines Releases Action Plan to Protect Patients from Unapproved Compounded GLP-1s

The Partnership for Safe Medicines has released a report calling for stronger safeguards in the rapidly expanding market for compounded GLP-1 drugs. The organization warns that weak enforcement has allowed telehealth companies and compounders to produce and promote large volumes of unapproved medications that bypass the FDA's rigorous safety and efficacy standards. The report highlights risks such as dosing errors, poor quality, and lack of transparency, arguing that patients may be misled about these products and face serious health consequences. It urges stricter enforcement against illegal compounding, deceptive marketing, and unsafe imports, as well as new policies to better protect consumers. The group calls on policymakers, regulators, and partners to strengthen oversight and uphold the integrity of the U.S. drug safety system.

Partnership for Safe Medicines releases action plan to protect patients from unapproved compounded GLP-1s – Partnership for Safe Medicines

GLP-1 Bridge Reject Code Cheat Sheet

You can download this helpful chart provided by CMS. It contains all GLP-1 Bridge program reject codes for easy reference. Some of the reject codes will have specific messages to the pharmacy from the Bridge central processor, and the chart includes information on how to resolve each of the reject codes.

FDA Advisory Committee Nominates Six Peptides for Pharmacies to Compound

The Food and Drug Administration’s Pharmacy Compounding Advisory Committee (PCAC) voted to recommend that the FDA include peptides BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax on the 503A Bulks List, which outlines the bulk drug substances that compounding pharmacies can use in creating medications. The committee also rejected adding emideltide to the list.

PCAC’s votes are recommendations and are not binding on the FDA. Secretary of Health and Human Services Robert F. Kennedy, Jr. will still need to formally approve the substances’ addition to the 503A Bulks List. Pharmacies will not be permitted to compound them until the final rulemaking is in place, even if companies release pharmaceutical-grade active pharmaceutical ingredients. Kennedy has expressed support for compounding peptides.

FDA advisory committee nominates six peptides for pharmacies to compound | Jul 31, 2026 | NCPA

 

TRUST LLC Sues Prime Therapeutics Over Price-Fixing Scheme

TRUST LLC brought a lawsuit against Prime Therapeutics alleging an illegal price-fixing scheme with Express Scripts Inc. The complaint alleges that Prime entered into an anticompetitive agreement with Express Scripts to fix pharmacy reimbursement rates and fees, effectively allowing Prime to "rent" Express Scripts' market power to impose lower reimbursement rates and higher fees on independent pharmacies.

According to the filing, this arrangement suppressed competition, harmed thousands of pharmacies nationwide, and violated federal antitrust law as well as Prime's contractual obligations, resulting in significant financial injury to participating pharmacies. You can read the complaint here.

TRUST LLC sues Prime Therapeutics over price-fixing scheme | Jul 7, 2026 | NCPA

DEA to Temporarily Schedule 7-OH and Related Substances to Protect Public Safety

Today, the U.S. Drug Enforcement Administration filed its intent to temporarily place 7-hydroxymitagynine (7-OH) and three related substances into Schedule I of the Controlled Substances Act (CSA). Prior to DEA issuing this notice, the Department of Health and Human Services (HHS) confirmed synthetic 7-OH and the three related substances have no accepted medical use and a high potential for abuse. Once the temporary scheduling orders take effect, the manufacture, distribution, sale, and possession of covered 7-OH substances will become subject to criminal, civil, and administrative provisions of the Controlled Substances Act.

7-OH is a psychoactive substance with opioid-like effects and similar risks. In its botanical form, 7-OH is found in trace amounts in the Mitragyna speciosa plant, a tropical evergreen tree indigenous to Southeast Asia that is commonly used in religious or communal ceremonies.

This temporary scheduling action does not apply to botanical kratom products that contain naturally occurring 7-OH below the specified threshold. Instead, it targets synthesized products and those containing elevated concentrations of 7-OH as outlined in the temporary scheduling order. DEA believes these substances pose an imminent threat to public safety given their effects are highly unpredictable.

The United States has seen a proliferation of commercial products containing semi-synthetic 7-OH. These products are widely marketed online and sold in gas stations, convenience stores, and smoke shops in a variety of forms, including powders, tablets, capsules, gummies, and dissolvable strips. DEA laboratory findings indicate commercial products often contain higher amounts of 7-OH than what is found in natural-occurring, botanical kratom.

DEA to Temporarily Schedule 7-OH and Related Substances to Protect Public Safety

Disaster Relief Grants for Southern Texas, Southeastern Missouri

Recent disasters have impacted communities across southern Texas and southeastern Missouri. Severe flash flooding has hit the South Texas Hill Country, including Uvalde, Kerrville, and San Antonio, with Gov. Greg Abbott issuing a disaster declaration for 59 counties. In Southeast Missouri, a historic 1-in-1,000-year rainfall event brought catastrophic flash flooding to Reynolds, Iron, and Crawford counties, prompting a state of emergency. NCPA Foundation disaster relief grants are available for independent community pharmacies in these areas.

The NCPA Foundation Disaster Relief Fund was established to provide financial assistance to independent community pharmacy owners to repair their pharmacies in the event of disaster or catastrophic events.

If your pharmacy was impacted, apply here. If you would like to donate to the disaster relief fund, visit the website and click “Make a Gift”. For more information contact ncpaf@ncpafoundation.org.

Disaster relief grants for southern Texas, southeastern Missouri | Jul 17, 2026 | NCPA

Alabama and Louisiana add Enforcement Muscle

The Alabama Department of Insurance recently hired Thomas McCarthy as senior PBM regulatory counsel for its PBM Compliance Division. This addition builds upon the hiring of Kelli Littlejohn Newman to lead the division. Similarly, the Louisiana Department of Insurance is currently looking to fill a pharmacist chief compliance officer position and a pharmacist compliance officer position to oversee PBMs.

We urge you to submit complaints to your state departments of insurance.

Alabama and Louisiana add enforcement muscle | Jul 13, 2026 | NCPA

Pharmacists Beware:  Diverted HIV Medicines are Being Sold on Online Pharmacy-To-Pharmacy Platforms

The Partnership for Safe Medicines and ADAP Advocacy are issuing a warning today that discounted HIV products bought from online, pharmacy-to-pharmacy (P2P) marketplaces qualify as suspicious products under U.S. Food and Drug Administration guidelines and the Drug Supply Chain Security Act.

Any HIV medicines available for sale on these platforms or any medicine you have bought and not yet dispensed should be considered a suspect product; any HIV products bought through these channels in your possession should be quarantined and verified before dispensing.

  • Pharmacists should cease buying HIV medicines from these platforms and quarantine and verify all medicine in inventory obtained from them.
  • Boards of Pharmacy should study this alert and consider warning their licensees about the danger of purchasing HIV medicines from these platforms.
  • P2P platforms should disallow sales of HIV medicines on their platform.

Pharmacists beware: Diverted HIV medicines are being sold on online pharmacy-to-pharmacy platforms – Partnership for Safe Medicines

Alibaba Group and AUS Merchant Services Agree to Pay $600 Million to Resolve Allegations that they Failed to Prevent Illegal Sales of Pharmaceuticals, Pharmaceutical Equipment, and Other Illegal Products

Alibaba Group Holding Limited (Alibaba), one of China’s largest companies, and its U.S.-based payment processor, AUS Merchant Services Inc. (AUS, and formerly known as Alipay US), have entered a non-prosecution agreement to pay $600 million to resolve the Justice Department’s allegations that they violated the Federal Food, Drug, and Cosmetic Act (FDCA) by failing to prevent merchants from selling and importing illegal pharmaceuticals, controlled substances, listed chemicals, and pill presses into the United States through the Alibaba.com and AliExpress.com e‑commerce platforms.

Office of Public Affairs | Alibaba Group and AUS Merchant Services Agree to Pay $600 Million to Resolve Allegations that they Failed to Prevent Illegal Sales of Pharmaceuticals, Pharmaceutical Equipment, and Other Illegal Products | United States Department of Justice

Trump Plans Generic Drug Tariffs

The Trump administration is increasing pressure on the generic drug industry to shift production to the United States, with plans to phase in increasingly higher tariffs on pharmaceutical imports over the next few years. Under the plan announced on social media on July 21, generic drugs, most of which are manufactured overseas, will enjoy a grace period for the next 2 years starting on August 1, 2026. However, a 100% levy will go into effect in August 2028 before doubling to 200% in August 2029. The administration is leveraging the threat of tariffs to encourage U.S. onshoring of pharmaceutical products and ingredients. The ramifications of the policy are particularly significant for India, which routes fully one-third of its drug exports to America. By the same token, the United States would find it difficult to simply displace India, which supplies about half of the U.S. generic drug market.

Trump plans high generic-drug tariffs in 2028 to spur U.S. production

 

Save the Date: Partnership Series with Atrium24 Wednesday August 19th @ 11amEST

Just scheduled!! Atrium24 helps independent pharmacies grow through AI-powered tools, strategic purchasing power, expert guidance, and a connected community built for what’s next.

Offer Sterile Compounds Without Becoming a Sterile Compounding Pharmacy

Sterile compounded medications represent a growing opportunity for independent pharmacies but building an in-house sterile compounding operation can require significant investments in facilities, staffing, accreditation, and ongoing compliance.

The good news? There are alternative pathways.

Join Dr. Nicolette Mathey, PharmD, Founder & CEO of Atrium24 Technologies, pharmacist, pharmacy owner, and nationally recognized industry speaker, as she explores how independent pharmacies can expand their offerings through trusted partnerships, allowing them to meet patient and prescriber demand without the complexity of operating a sterile compounding pharmacy.

During this webinar, you'll learn how to:

    • Expand your pharmacy's service offerings without building a sterile cleanroom
    • Access vetted sterile compounding partners through the Atrium24 GPO
    • Create new revenue opportunities while minimizing operational and compliance burdens
    • Use Dotti AI, Atrium24's pharmacy-specific CRM, to strengthen prescriber relationships and track business development opportunities
    • Position your pharmacy for sustainable growth through strategic partnerships

Whether you're exploring new clinical services, looking for additional revenue opportunities, or simply curious about what's possible, this session will provide practical insights you can take back to your pharmacy.

Wed, Aug 19, 2026 11:00 AM - 12:00 PM (UTC-05:00) Eastern Time (US & Canada)

We look forward to having you attend the event! Click Here to Register

Compliance Tip of the Month

Biennial Inventory Reminder: Is your biennial controlled substance inventory on your calendar? The DEA requires an inventory of all controlled substances every two years. The date you complete it is up to you, but missing it entirely is a common audit finding. Pick a date, put it on your calendar as a reminder, and keep the completed and signed count easily retrievable.