Included in this newsletter
- Office Closure- Memorial Day
- Rite Aid Files a Second Chapter 11 Bankruptcy
- OIG/SAM Addition
- New Administration with a New Outlook on Healthcare
- Medicare Part D and PBM Reform
- Patient Care and Vaccinations
- CMS Issues Final Version of CY2026 MA and Part D Rule, Includes MPPA and MDPNP-Related Changes
- Eli Lilly Lawsuits Against Two Compounders for Selling Tirzepatide Products
- Important Update: Completed Assessment of Risk (AoR) Solution Relaunch
- Dexcom G7 15-day CGM Receives FDA Clearance
- Ozempic Copies Restricted After U.S. Judge Denies Injunction
- Enforcement
- Blogs & Articles
Office Holiday Closure
Our office will be closed for Memorial Day starting Friday May 23rd @ 5pm EST and Reopening Tuesday May 27th @ 8am EST.
Rite Aid Files a Second Chapter 11 Bankruptcy
On May 5, Rite Aid filed for Chapter 11 bankruptcy protection for the second time in two years. The company currently has approximately $2.5 billion in bank loans. As part of its restructuring efforts, Rite Aid has agreed to sell an undisclosed number of its pharmacies in the Northwestern United States to an unnamed buyer. The financial strain and operational challenges raise concerns about the viability of its remaining stores, which may face closure if no sustainable plan is implemented.
The broader pharmacy landscape in the United States is also undergoing significant shifts. Independent pharmacies continue to close or consolidate and major chains like Walgreens and CVS have announced plans to scale back their retail presence. These trends contribute to the expansion of so-called "pharmacy deserts", areas with limited or no access to pharmacy services. In Pennsylvania, for example, several counties reportedly have no remaining chain or independent pharmacies.
Given this evolving environment, healthcare organizations and community leaders should assess how pharmacy reductions affect service delivery. This may also be an opportune time to evaluate workforce needs, including the potential recruitment of pharmacists and pharmacy technicians. Assess your area's needs today and soon. Develop an action plan to grow your business, which includes assisting patients in the fall with the Part D plan selection, immunization base, DMEPOS equipment and supplies, LTC @ Home, and many more.
Meanwhile, federal lawmakers are working toward finalizing a reconciliation bill that includes pharmacy benefit manager (PBM) reform provisions. The bill is expected to be voted on in both chambers of Congress by the end of June.
OIG/SAM Addition
Connecture, Inc. our parent company has been added to all OIG/SAM Exclusion Verification
New Administration with a New Outlook on Healthcare
As the new administration takes hold, Robert F Kennedy, Secretary of HHS, and Dr Mehmet Oz take over at CMS, new directives are going out that all current foods, pharmaceuticals, and vaccines be reevaluated and research reviewed by a panel of experts to ensure there is no bias in current practices. The only thing we know for sure is that steps are being taken to evaluate many areas of healthcare. Work with your state boards and be ready for changes.
https://www.cms.gov/newsroom/press-releases/dr-mehmet-oz-shares-vision-cms
Medicare Part D and PBM Reform
Congress and the FTC are still advancing legislation to rein in the PBMs. Lobbying by the PBMs is intense. The FTC Commissioner has no longer recused himself from the FTC lawsuit. This suit will continue and both houses of Congress are moving forward with their legislation. This PBM reform bill will be added to the reconciliation bill, which has been pushed back to June.
Patient Care and Vaccinations
Pharmacy operations are rapidly changing. Many states have or are working on granting pharmacists provider status. In addition, with the measles outbreaks and other preventable diseases, each pharmacy needs to assess its operations and prepare for changes. The push for vaccines is here; however, the public perception of vaccines is very poor thanks to COVID. Pharmacies can play a key role in vaccinations, especially childhood vaccines. These vaccines have been extremely effective for decades. Marketing materials are available for use in the immunization program.
Provider status: Each state sets its standards; however, the changing environment is the most important. Work with your state association and push for medical services you can provide within the pharmacy. As discussions begin, aggressively examine what requirements the pharmacy will need to complete for new services and treatments.
CMS Issues Final Version of CY2026 MA and Part D Rule, Includes MPPA and MDPNP-Related Changes
The Centers for Medicare & Medicaid Services issued a final version of the Contract Year (CY) 2026 MA and Part D final rule. It implements changes related to the Medicare Prescription Payment Plan, the Medicare Drug Price Negotiation Program, prescription drug coverage, dual eligible special needs plans, Star Ratings, and other programmatic areas. It also codifies existing sub-regulatory guidance for Medicare Advantage and Part D. See More…
Eli Lilly Lawsuits Against Two Compounders for Selling Tirzepatide Products
Eli Lilly has filed suit against two companies – Strive Pharmacy LLC and Empower Clinic Services LLC – for selling products claiming to contain tirzepatide, the primary ingredient in Lilly's Mounjaro and Zepbound medications. Although compounding pharmacies had been allowed to produce large quantities of these drugs while the FDA had said there was a shortage, a U.S. federal judge recently ruled that compounding pharmacies could not keep making them. See More…
Important Update: Completed Assessment of Risk (AoR) Solution Relaunch
With the release of the 2024 NIOSH list, the RJHedges Completed AoR list has grown to over 265 AoR and many have seen changes. To help our clients remain compliant, we’ve rebuilt the entire AoR Table of Contents to reflect the latest NIOSH structure and drug updates. Any previously executed AoR’s may need retired and retained for 10 years. The New version of the AoR’s will need reviewed and signed based on your current Hazardous Drug Inventory. Pharmacies will need to review their inventory and sign each AoR annually, they are designed with 5 years’ worth of reviews.
For additional information about Assessments of Risk, please visit our website. If you would like to order the new Completed Assessments of Risk please go to our order form.
Dexcom G7 15-day CGM Receives FDA Clearance
FDA has cleared a 15-day version of Dexcom's G7 continuous glucose monitor (CGM) for use by individuals aged 18 years and older with diabetes. According to the company, the Dexcom G7 15-Day Continuous Glucose Monitoring System is the longest-lasting CGM wearable, with an overall mean absolute relative difference of 8.0%. The extended-wear version of the CGM will include features of the current one, including Apple Watch compatibility, automated meal and activity logging, a 12-hour grace period for replacing finished sensors, and the ability for remote sharing of glucose data. The G7 15-Day CGM System will be available in the second half 2025. Dexcom is working with its insulin pump partners to ensure the product will be compatible with automated insulin delivery systems at launch. See More… This will be a DME dispensable item under Continuous Glucose Monitors. Please reference the DEMPOS program under Section 2A Supplement- Dispensing Documents, item 10 for more details.
Ozempic Copies Restricted After U.S. Judge Denies Injunction
A federal judge has rejected a bid by compounding pharmacies to continue making copies of semaglutide (Ozempic/Wegovy, Novo Nordisk). Compounders had been permitted to make copies of the drugs while there was a shortage of semaglutide; however, after it was no longer in short supply, the FDA gave outsourcing facilities until May 22 to end production. According to court documents, the Outsourcing Facilities Association had sought a preliminary injunction to delay FDA's enforcement of that deadline. The decision by U.S. District Judge Mark Pittman in Texas means that the May 22 deadline stands. In a statement, Novo Nordisk noted it has filed more than 100 lawsuits in federal courts in 32 states against entities unlawfully marketing or selling compounded semaglutide products. See More…
Note: If you compound any GLP-1 Compounds, the 503A pharmacy must stop compounding these products.
Enforcement
- Texas Pharmacist Sentenced to Over 17 Years in Prison and Ordered to Forfeit $405M in Assets for Defrauding the Department of Labor (Compounding/Worker’s Comp)
- Walgreens Agrees to Pay Up to $350M for Illegally Filling Unlawful Opioid Prescriptions and Submitting False Claims to the Federal Government.
Blogs and Articles
Is Your Pharmacy Eligible for the Medicare DMEPOS Accreditation Exemption?
If your pharmacy has been Medicare-enrolled for at least five years and DMEPOS sales make up less than 5% of your gross revenue, you may qualify for an accreditation exemption—a move that can save you thousands in fees and simplify your compliance workload.
Eligible pharmacies can avoid costly accreditation renewals, reduce administrative burdens, and focus on core services—all while maintaining Medicare billing privileges. Key requirements include maintaining a $300,000 liability policy, an active PTAN, and financial documentation showing low DMEPOS sales volume. Read More Here
