Included in this newsletter
- FDA Increases Oversight of GLP-1 Compounding
- Details on Weight Loss GLP-1 Coverage for Medicare
- CLIA-Related Notifications Now Fully Electronic
- NCPA Launches Multi-Million-Dollar National Ad Campaign to Promote Independent Pharmacies
- CMS Announces Temporary Nationwide Moratorium on Enrollment of DMEPOS Supply Companies — Pharmacies NOT Included
- CMS Releases Updated Advance Beneficiary Notice (ABN)
- HHS Weighs Replacing CDC Vaccine Advisers
- Senate Introduces the Rx ACCESS Act for Tricare Beneficiaries
- Owners and CEO of Wholesale Pharmaceutical Company Sentenced for Distributing More Than $92M of Black-Market HIV Drugs
- ACHC Continues Strategic Partnership with R.J. Hedges & Associates
- Mark Your Calendar
- Compliance Tip of the Month
FDA Increases Oversight of GLP-1 Compounding
On February 6, 2026, the U.S. Food and Drug Administration announced its intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies, including Hims & Hers and other compounding pharmacies, as similar alternatives to FDA-approved drugs. These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.
The FDA is also taking steps to combat misleading direct-to-consumer advertising and marketing following warning letters that were sent in the fall of 2025. In promotional materials, companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA. They also cannot state compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient.
The FDA will use all available compliance and enforcement tools within its authorities to address unsubstantiated claims and associated public health concerns. Entities engaged in the manufacture, distribution, or marketing of unapproved compounded GLP-1 products should be aware that failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
FDA Intends to Take Action Against Non-FDA-Approved GLP-1 Drugs | FDA
Details on Weight Loss GLP-1 Coverage for Medicare
CMS announced the Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) Model to cover certain GLP-1 drugs for weight loss to start in 2027. It also mentioned a second, short-term demonstration project to give Part D enrollees coverage as soon as July 2026. CMS acknowledges that many questions don't have answers yet but tries to provide some details on this Medicare GLP-1 Bridge.
Click here for a CMS Frequently Asked Questions document.
Details on weight loss GLP-1 coverage for Medicare | NCPA
CLIA-Related Notifications Now Fully Electronic
On March 1, 2026, the Centers for Medicare & Medicaid Services officially transitioned the CLIA program to a fully electronic system. Pharmacies with a CLIA certificate of waiver should add noreply-cms-ccsq@ccsq.cms.hhs.gov to your priority inbox or safe senders list to prevent notifications getting marked as spam. You must also ensure your email address is up to date with CMS to receive important notifications and billing information. For more information on complying with this new electronic system, please refer to this FAQ sheet provided by CMS.
Tips for switching to electronic CLIA-related notifications | NCPA
NCPA Launches Multi-Million-Dollar National Ad Campaign to Promote Independent Pharmacies
On March 2, 2026, The National Community Pharmacists Association (NCPA) launched a nationwide ad campaign aimed at consumers looking for a better experience than the one they’re getting from big-box stores or mail-order outfits. The multi-million-dollar, multi-year campaign will splash across national television over the next two weeks, including on CNN, Fox News, HGTV, TBS, and TLC, and then move to local cable, streaming TV, social media and online sites. You can watch two of the spots by clicking on the following links: Watch the 1st spot here and watch the 2nd spot here.
NCPA Launches Multi-Million-Dollar National Ad Campaign to Promote Independent Pharmacies | NCPA
CMS Announces Temporary Nationwide Moratorium on Enrollment of DMEPOS Supply Companies — Pharmacies NOT Included
The Centers for Medicare & Medicaid Services announced a temporary moratorium on medical supply companies enrolling as certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers on Feb. 25. The agency specifically called out that pharmacies are considered non-medical supply company DMEPOS suppliers (unless their principal function is the provision of DMEPOS) and will still be able to participate in the program or can newly enroll/open practice locations during the moratorium. Read the full press release from CMS here and the full statement published in the Federal Register here.
CMS Releases Updated Advance Beneficiary Notice (ABN)
On March 13, 2026, the Centers for Medicare & Medicaid Services (CMS) announced that the Office of Management and Budget (OMB) approved the control number for the Advance Beneficiary Notice of Noncoverage (ABN), Form CMS-R-131.
The newly updated ABN is effective immediately and is valid through March 31, 2029. DME suppliers may continue to use the expired version of the ABN until May 12, 2026, but must fully transition to the OMB approved form no later than that date.
ABNs are issued to Original Medicare (fee for service) beneficiaries when it is believed Medicare is likely to deny payment for an item or service, for example, when coverage criteria may not be met or frequency limits may apply. Proper use of the ABN helps ensure beneficiaries understand potential financial liability and allows suppliers to shift liability appropriately when Medicare denies the claim.
Key Reminders:
- Only the official CMS‑R‑131 ABN may be used; expired versions must be replaced by May 12, 2026.
- The ABN applies to Original Medicare and should not be used for Medicare Advantage (Part C) or Part D items and services.
- The ABN must be provided before the item is furnished and far enough in advance for the beneficiary to make an informed decision.
The updated ABN, instructions, and alternative formats (including large print and Spanish versions) are available on the CMS FFS ABN webpage. DME suppliers should review internal processes, update forms, and educate staff to ensure timely compliance with the newly updated ABN.
FDA Launches New Adverse Event Look-Up Tool
The U.S. Food and Drug Administration today launched a new unified platform for analyzing adverse event reports. This platform, called the FDA Adverse Event Monitoring System (AEMS), represents a major achievement in the agency’s mission to modernize and provide radical transparency into the safety of regulated products. The FDA’s previous adverse event reporting systems were outdated and fragmented and made important data difficult to access. With the new system, adverse event reports submitted to the FDA for drugs, biologics, vaccines, cosmetics, and animal food can be displayed in a single streamlined dashboard. By the end of May 2026, AEMS will contain real-time adverse event reports for all FDA-regulated products.
Legacy systems to be replaced by AEMS now include:
- FAERS (FDA Adverse Event Reporting System) — containing reports for drugs, biologics, cosmetic products, and color additives.
- VAERS (Vaccine Adverse Event Reporting System) — containing reports for vaccines. Note: The FDA will display VAERS data in AEMS. VAERS is co-managed by the FDA and Centers for Disease Control and Prevention.
- AERS (Adverse Event Reporting System) — two databases containing reports for animal drugs and animal foods.
FDA Launches New Adverse Event Look-Up Tool | FDA
New Alabama PBM Oversight Off and Running
The Alabama Department of Insurance's new PBM Compliance Division issued its first enforcement actions. The administrative action called out Express Scripts (ESI) on three counts.
- ESI charged pharmacies a wide array of illegal fees.
- ESI did not reimburse pharmacies serving patients in the commercial market at the Medicaid reimbursement rate, per the law.
- ESI was consistently unresponsive when the department sought information from ESI to engage complaints from pharmacies.
ESI’s license could be suspended until they show willingness to comply with the regulatory regimen, if found in violation of the law. The Office of the Insurance Commissioner (OIC) can also issue civil penalties or seek other forms of relief. The full complaint can be found on the department’s new PBM Actions webpage.
New Alabama PBM oversight off and running | NCPA
If Your Pharmacy was Impacted by Recent Severe Weather, Consider Grant Relief
There has been some crazy weather over the past few weeks. Severe storms have impacted Illinois, Indiana, Michigan, Louisiana, and other states. A historic winter storm brought blizzard conditions to the Midwest on March 15. If your pharmacy was affected, you may be eligible for a disaster relief grant through The NCPA Foundation. You can learn more and apply with this link, click here.
Was your pharmacy impacted by recent severe weather? | NCPA
New Additions Offered and Help Navigating TrumpRx
The Trump administration announced that Amgen’s Humira biosimilar Amjevita, migraine medication Aimovig and cholesterol drug Repatha along with several of GSK’s Ellipta inhalers (Anoro, Arnuity, and Incruise) and its flu treatment Relenza were added to TrumpRx on Monday, March 16, 2026. Then on Friday, March 20, 2026, the White House also announced three additional medications from Boehringer Ingelheim. Jentadueto, and Jentadueto XR, for Type 2 diabetes, as well as the COPD drug Striverdi Respimat were added. The new additions bring the total of medications offered through TrumpRx to 57.
NCPA developed a one-pager tailored to independent pharmacies. The document outlines what the program is, how it works, and contains links to the TrumpRx official FAQ and drug list. Access it here.
Meds from Amgen, GSK now offered through TrumpRx DTC platform
White House expands TrumpRx with three new drugs
Essential info to help your team navigate TrumpRx | NCPAStrait of Hormuz Standoff Puts Supply of America’s Generic Drug Prescriptions at Risk
Key points from the linked article and something to keep an eye on if the war drags on.
- Nearly half of U.S. generic prescriptions originate in India, which relies on the Strait of Hormuz for the arrival of key inputs in drug manufacturing including petroleum-based materials and for shipping finished medicines to the U.S.
- People should not be worried about their medications yet, including high-volume ones for diabetes and hypertension, statins and antibiotics, as most medical distributors keep a 30- to 60-day supply on hand to withstand disruptions.
- President Donald Trump is pressing other nations including NATO allies and China to help protect ships using the vital global marine traffic route. The risks from higher oil prices and potential for drug shortages and delays, get more real every day.
How Strait of Hormuz closure hits America's generic drug prescriptions
HHS Weighs Replacing CDC Vaccine Advisers
Secretary Robert F. Kennedy Jr. dismissed sitting members of the Advisory Committee on Immunization Practices (ACIP) last June, replacing them with hand-picked appointees, including some with anti-vaccine leanings. Now, after a federal judge declared that current advisors lack the relevant expertise to make immunization recommendations for the country and were not properly vetted, HHS reportedly is considering bringing in a new group of experts once again.
The federal court also issued a preliminary injunction staying most vaccine recommendations approved by HHS through CDC and ACIP since May 2025 while litigation proceeds. This means pharmacists should continue referencing the appropriate 2025 CDC immunization schedules when vaccinating under CDC/ACIP‑based authority.
HHS weighs replacing CDC vaccine advisers
Senate Introduces the Rx ACCESS Act for Tricare Beneficiaries
Senators Tom Cotton (R-Ark.) and Tim Kaine (D-Va.) introduced the “Rx Access, Choice, Cost Equity, and Supply Stability (ACCESS) Act” (S. 4106) on March 17, 2026. It would enable greater pharmacy access for Tricare beneficiaries by allowing them to fill non-generics at the pharmacy of their choice, protect independent pharmacies from unfair reimbursement practices, and increase transparency across Tricare's pharmacy contractor system by requiring an annual audit of the program.
Representatives Jen Kiggans (R-Va.), Maggie Goodlander (D-N.H.), Morgan Luttrell (R-Texas), and Chrissy Houlahan (D-Pa.) introduced the House version (H.R. 6400) in December 2025.
Senate introduces the Rx ACCESS Act for Tricare beneficiaries | NCPA
Owners and CEO of Wholesale Pharmaceutical Company Sentenced for Distributing More Than $92M of Black-Market HIV Drugs
Two owners of a pharmaceutical wholesale company, Safe Chain Solutions located in Maryland, were recently sentenced to a total of 38 years in prison for orchestrating a complex, nationwide drug diversion scheme that harmed vulnerable HIV-positive patients, placed countless others at risk, and corrupted the supply chain for prescription drugs in the United States. HHS-OIG and FBI investigated the case.
Between April 2020 and September 2021, Patrick and Charles Boyd bought and resold more than 28,000 bottles of these black-market HIV drugs. They paid more than $92.8 million for the drugs, which they sold to pharmacies for a profit. Medicare, Medicaid and commercial insurers were billed and paid for these illicit drugs.
In October 2025, Patrick and Charles Boyd were convicted at trial of conspiracy to introduce misbranded drugs into interstate commerce; conspiracy to traffic in medical products with false documentation; conspiracy to commit wire fraud; two counts of introducing misbranded drugs into interstate commerce; and two counts of wire fraud. Patrick Boyd was sentenced to 18 years in prison. Charles Boyd was sentenced to 20 years in prison. In addition to the prison sentences, the defendants were ordered to pay $21,850,000 in forfeiture.
ACHC Continues Strategic Partnership with R.J. Hedges & Associates
Leading accreditor Accreditation Commission for Health Care (ACHC) announced today it is renewing its strategic partnership with R.J. Hedges & Associates, a trusted leader in independent pharmacy compliance solutions.
“Independent pharmacies and DME suppliers are navigating increasingly complex requirements, often with limited time and resources,” said Caroline Girardeau, ACHC Program Director. “This continued partnership helps bridge that gap by pairing ACHC’s accreditation standards with practical guidance pharmacies can actually use. Together, we help organizations move beyond checking boxes and toward building sustainable, compliant operations that support safe patient care.”
“ACHC has been a valued partner for many years, and we are excited to renew our collaboration,” said Becky Templeton, Director of Operations at R.J. Hedges & Associates. “Our teams work closely together to support independent pharmacies and DME facilities as they navigate CMS requirements, accreditation, and ongoing compliance. We especially appreciate ACHC’s review and certification of our Non-Sterile Compounding Program and the shared commitment we have to providing practical, trusted resources for our clients.”
This collaboration gives R.J Hedges & Associates’ clients special pricing on ACHC Pharmacy Accreditation, including PCAB, Specialty Pharmacy and Community Retail (DMEPOS). Discounts on select ACHCU educational resources are also available. RJHedges Clients can use the discounts on the attached flyer.
About ACHC:
ACHC, the nation's top accreditor for specialty, infusion, and compounding pharmacy services, offers a comprehensive suite of pharmacy accreditation and distinction options, including Ambulatory Infusion Center/Suite, Infusion, Specialty, and Mail Order Pharmacy Accreditation and PCAB Accreditation for sterile and non-sterile compounding.
With over 35 years of experience, ACHC has a history of driving success with industry-leading programs. ACHC develops solutions for healthcare providers worldwide and remains committed to delivering a customized, collaborative accreditation experience.
To learn more, visit achc.org, email customerservice@achc.org, or call (855) 937-2242.
Mark Your Calendar
DEA's Drug Take Back Day on April 25, 2026Compliance Tip of the Month
Review access to pharmacy systems regularly.
- Terminated or transferred staff should lose access immediately.
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Periodic access reviews protect patient privacy and demonstrate HIPAA diligence.
