September 2025 - Newsletter

Included in this newsletter

1. Judge Orders Temporary Hold on Contract Termination Between Martella's and Express Scripts
2. Now Available: Long Term Care at Home Compliance Program
3. Carl's Drug Store in Greencastle, PA Celebrates its 200th Anniversary
4. CMS Considering Changes to Accreditation Surveys
5. CMS Issues Change Request for Noninvasive Positive Pressure Ventilation
6. Senate confirms Susan Monarez to Lead CDC
7. Pharmacy Benefit Managers Expand Their Reach into DME
8. Synapse Health Reimbursements Are Not Equal to CMS Fee Schedule
9. FDA Begins Real-Time Reporting of Adverse Event Data
10. CMS phasing out paper CLIA certificates.
11. Medicare Transaction Facilitator (MTF-DM)
12. LTC at Home - PBM Audits
13. Spotlight on October Task List Requirement: Performance Improvement vs Performance Management
14. Enforcement
15. New & Updated P&P and Forms

 

Judge Orders Temporary Hold on Contract Termination Between Martella's and Express Scripts

Martella’s has been a long-standing client and is local to many of our R.J. Hedges employees. Express Scripts attempted to terminate its contract with Martella’s. Their patients have filed a class-action lawsuit in Cambria County, PA, on behalf of Martella's pharmacies and its customers against Express Scripts, as well as the Highmark and UPMC insurance companies. We have not previously seen patients join in a lawsuit with a pharmacy to fight PBMs.  We wish the owners, staff, and patients of Martella's good luck in this fight!

A Pennsylvania judge has issued a temporary injunction preventing Express Scripts from terminating its contract with Martella's pharmacies. The injunction allows the pharmacies to stay in network and patients to have access to their medications while the class-action lawsuit is litigated. See More…

Express Scripts is challenging this ruling, stating the case should be decided in federal court.

Now Available: Long Term Care at Home Compliance Program

We’re excited to announce that our LTC at Home Compliance Program is officially available for purchase!

If your pharmacy delivers monthly medications, provides compliance packaging, and coordinates care for Medicare patients in their homes, you’re already providing Long Term Care at Home services! Now let’s make sure you’re getting paid for it.

Designed specifically for independent pharmacies, this self-service solution helps you:

• Access audit-ready policies, procedures, forms, and documentation
• Align with CMS and Part D plan expectations
• Bill LTC-level dispensing fees for eligible homebound patients
• Implement quickly with minimal disruption

Client-Exclusive Offer: 50% Off Through September 30, 2025

• Offer available to current RJ Hedges clients only
• Use Coupon Code: RJHClient50 to save $300
• https://fs27.formsite.com/zjhD3s/LTC/index

Carl's Drug Store in Greencastle, PA Celebrates its 200th Anniversary

Congratulations to Wayne Myers and the entire staff at Carl's Drug Store for celebrating their 200 anniversary! They opened in 1825 and are one of the oldest continuously operated pharmacies in the country! Their celebration included awards from NCPA, the local Mayor, the Pennsylvania Pharmacists Association, and state legislators. As one of our longest clients at R.J. Hedges & Associates, we wish the fine folks at Carl's Drug Store many more wonderful years as a staple in their community.

CMS Considering Changes to Accreditation Surveys

CMS is considering a change to DMEPOS accreditation by increasing on-site surveys from every three years to annually. If the number of accreditation surveys increases, it is easy to assume so will the fees. Surveyors are paid for travel, meals, and expenses, plus the accreditation organization’s reviews and documentation will increase threefold. These costs will be assessed by the accredited facility. In addition, CMS wants to restart competitive bidding.

• If your pharmacy is exempt, there will be no additional costs.
• If your pharmacy is accredited and is eligible for exemption, we strongly suggest that the pharmacy complete the exemption form found in the Checklist for Inspection & Surveys link on the Compliance Portal’s^® home page.
  • Eligibility requirements: The pharmacy’s EIN, LBN, and PTAN must match and be active for a minimum of five years and you must have less than 5% of your total sales coming from DMEPOS products.
• AA Homecare’s DMEPOS Related Proposals from CMS-1828-P See More…
  • We strongly suggest you review this document. If you have concerns- PLEASE contact your U.S. Senators and U.S. Representatives and list your concerns for additional expenses and limited capability.

CMS Issues Change Request for Noninvasive Positive Pressure Ventilation

CMS has issued a Change Request (CR) is to inform contractors that effective June 9, 2025, contractors shall pay claims for Respiratory Assist Device (RADs) with or without a backup rate feature and Home Mechanical Ventilators (HMVs), in the home, as treatment for patients with Chronic Respiratory Failure (CRF) consequent to Chronic Obstructive Pulmonary Disease (COPD). The implementation date is October 22, 2025. See More…

 Senate confirms Susan Monarez to Lead CDC

After 4 months without permanent leadership, CDC has a new director in Susan Monarez. A scientist for the federal government for many years, she was nominated by the president and narrowly confirmed by the Senate on July 29^th. Monarez inherits a former powerhouse in the public health space that is now facing deep budget cuts, growing criticism, a narrowing mission, and intense scrutiny amid a controversial shift in U.S. vaccine policy under HHS Secretary Robert F. Kennedy Jr. During her confirmation hearing, the first for a CDC director nominee under a 2023 law, she pledged to regain public trust in the agency, modernize data systems, and enhance preparedness for infectious-disease events.

 Pharmacy Benefit Managers Expand Their Reach into DME

Beginning Aug. 1, 2025, the Durable Medical Equipment (DME) ordering and fulfillment process in Alabama, South Carolina, Tennessee, and Virginia will be managed by Synapse Health for members with individual HMO and PPO UnitedHealthcare^® Medicare Advantage plans, as well as Chronic Special Needs Plans (C-SNP). Additionally, the DME process for C-SNP plans in Georgia will also be managed by Synapse Health.

United Healthcare previously launched a capitated DME arrangement with Synapse Health for individual UnitedHealthcare Medicare Advantage members in Georgia and North Carolina, effective Sept. 1, 2024. See More…

Synapse Health Reimbursements Are Not Equal to CMS Fee Schedule

Synapse Health’s 70-page contract (AL, GA, NC, SC, VA, TN Only) contains a section titled Fair Market Value and Commercial Reasonableness. The first sentence states: “The amounts to be paid pursuant to this Agreement have been determined by the Parties through good faith, arm’s-length negotiations to be the fair market value and are otherwise commercially reasonable.” There is a fee schedule, and a number of the products have a lower reimbursement, i.e., Blood Glucose Strips (A5253); the CMS fee Schedule is $8.32 per box; the Synapse fee schedule is $4.99 per box. Please review and know what the reimbursements are before dispensing.

FDA Begins Real-Time Reporting of Adverse Event Data

On August 22^nd, the FDA began daily publication of adverse event data from the FDA Adverse Event Reporting System (FAERS). “Adverse event reporting should be fast, seamless, and transparent,” said FDA Commissioner Marty Makary, MD, MPH. “People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public. We are closing that waiting period and will continue to streamline the process from start to finish. FAERS is the FDA's primary database for collecting and analyzing adverse event reports, serious medication errors, and product quality complaints for prescription drugs and therapeutic biologics, containing reports submitted by health care professionals, consumers, and manufacturers. The shift is one of many steps in the FDA's broader data modernization strategy to streamline all its adverse event reporting systems and increase reporting frequency across all systems to identify safety signals faster. The public can view the latest adverse event data on the FAERS Public Dashboard. Health care professionals and consumers are encouraged to report adverse events to the FDA’s MedWatch site. See more...

 CMS phasing out paper CLIA certificates. 

CMS recently announced that all laboratories, including pharmacy-based laboratories with a CLIA certificate of waiver, must switch to email notifications by March 1, 2026. After that deadline, CMS will no longer mail paper fee coupons or issue paper certificates. Read the full statement from CMS Here…

Medicare Transaction Facilitator (MTF-DM)

CMS opened enrollment in June for the MTF-DM and sent invitations to NCPDP points of contact. During enrollment, the user will complete an agreement enabling the MTF system to access your NCPDP pharmacy information. Medicare is strongly encouraging pharmacies to complete their enrollment by November 15, 2025, to ensure information is accurate and avoid delays processing refunds. We are recommended everyone enroll by August 31- but there is still time.

Please reference our Bulletin in the Message Center of the Compliance Portal for more details.

LTC at Home – PBM Audits

Be on the lookout for audits from Pharmacy Benefit Managers (PBM) as they have audit authority over Medicare Part C and Part D. Optum recently added a section for LTC Pharmacy at Home within a Fraud Waste and Abuse Audit. At this point, the information requested is more like an attestation, but as more pharmacies expand into this service, we anticipate more requirements and requests in the future.

• Have written policies and procedures. Following CMS guidance there are ten items pharmacies need to have in place prior to dispensing and billing for LTC at Home.
• It’s all about Documentation. For LTC at Home services, it is critical to have organized records detailing eligibility, packaging, delivery, and care coordination. For medications filled on a short cycle, delivery manifests and refill authorizations are essential.
• Keep retail and LTC inventory separated. Please be sure to maintain clear delineation between inventories, either virtually through your software, or physically on your shelf.
• Know your billing codes and requirements. Follow all CMS billing guidance and specific PBM requirements.

For more information on our LTC at Home Program please visit https://www.rjhedges.com/ltc-at-home

Spotlight on October Task List Requirement: Performance Improvement vs. Performance Management

These two terms are often used in Compounding, Pharmacy, and DMEPOS operations and they can be easily confused.

Performance Management (PM)

• Specific to DMEPOS dispensing.
• Mandatory only if the facility is accredited.
• Requires a quarterly report, which can be found in the Compliance Tools & Resources section on the Compliance Portal^® Home page.
• Note: This reporting process will be changing soon

Performance Improvement (PI)

• Required in both compounding and pharmacy programs.
• Compounding (Chapters 8 and 9): Includes Quality Assurance (QA) and Quality Control (QC), with detailed requirements and a stricter hierarchy.
• Pharmacy (Chapter 7): Focuses more on patient safety and Continuous Quality Improvement (CQI)

Key Points

All these programs include specific tasks that must be completed throughout the year. If your facility operates across multiple disciplines (Compounding, Pharmacy, DMEPOS), you must complete all tasks for each discipline.

Enforcement

• Allentown-Area Pharmacy and Its Owner Agree to Pay $825,000 to Resolve Allegations of False Claims Act Liability
• Middletown Resident Charged in Health Care Fraud Scheme Involving Durable Medical Equipment
• Clay County Pharmacy Investigation and Prosecution Ends in Guilty Pleas
• HHS’ Office for Civil Rights Settles HIPAA Ransomware Security Rule Investigation with BST & Co. CPAs, LLP

Updated and New Policies and Procedures

Updated and New Form:

Immunizations:

• Standing Orders:
• Respiratory Syncytial Virus Vaccine (RSV) to Adults
• Zoster Vaccine to Adults

DME:

• Detailed Product Descriptions:
• Ankle-Foot/Knee-Ankle Foot Orthosis
• Automatic External Defibrillator
• Commodes
• External Infusion Pumps
• Glucose Monitors and Supplies
• High Frequency Chest Wall Oscillation Devices
• Hospital Beds and Accessories

Pharmacy:

• Immunosuppressive Drugs