Company News, General

October 2025 - Newsletter

Becky Templeton / Oct 7, 2025 3:41:59 PM

Included in this newsletter

  1. HHS Issues Final Health, Technology, and Interoperability Rule
  2. Health care deal creates $6 billion company aiming to upend drug middlemen
  3. Confusion Concerning Immunization Requirements
  4. Lawmakers Urge HHS to Discard 340B Rebate Pilot
  5. HHS’ Office for Civil Rights Settles HIPAA Ransomware Security Rule Investigation
  6. CMS Reminder of DMEPOS Proof of Delivery Requirements
  7. Medicare Transaction Facilitator (MTF-DM)
  8. Medicare Open Enrollment
  9. LTC at Home Program
  10. Enforcement
  11. Medicare Open Enrollment – Pharmacy
  12. Updated Policies and Procedures
  13. Updated Forms
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HHS Issues Final Health, Technology, and Interoperability Rule

HHS has issued its Health Data, Technology, and Interoperability (HTI-4) final rule, which promises to give physicians and patients an unmatched line of sight into prescription drug information. Beginning on October 1, providers using certified health IT systems will be empowered to submit prior authorizations electronically, choose appropriate medications covered under a patient's insurance plan, and share electronic prescription information with pharmacies and insurers. The reforms lay the foundation for faster care and prevent insurers from blocking physician-approved care, according to HHS, which says prescribers will also gain the ability to compare drug prices in real time while they are with patients and identify more affordable treatment options available under their health plans. Additionally, greater transparency will deliver a clear understanding of out-of-pocket financial obligations. See More…

 

Health care deal creates $6 billion company aiming to upend drug middlemen

Eversana, a company that helps drug manufacturers sell their medicines, has acquired Waltz Health which helps employers and health insurance companies purchase cheaper drugs, in a bid to build an alternative to traditional PBMs. The combined company is valued at $6 billion, according to Mark Thierer, who will lead it. Thierer says bringing Eversana and Waltz together will create a formidable competitor. “Over time, what we’re going to do is eliminate the barriers and the misaligned incentives that exist,” he said. It’s meant to be an alternative, he said, to “the existing oligopoly that I helped build” and that it will eventually force the industry to change. Thierer led a PBM that UnitedHealth Group Inc. purchased for about $13 billion in 2015 and stayed on to lead the company’s Optum Rx pharmacy division until 2017. Thierer co-founded Waltz with his son Jonathon Thierer 4 years ago. The goal, he said, was to lower drug prices for Americans. He described Waltz as a software company that connects a series of marketplaces that use competition to drive drug prices lower. The software steers prescriptions to pharmacies in Waltz’s network that offer the lowest price for a particular drug, while weighing factors like how quickly they can dispense the drug. By combining Waltz Health’s connections to health-care purchasers with Eversana’s relationship to drug manufacturers, they say the company will be positioned to cut out middlemen who drain money from the system. See More…


Confusion Concerning Immunization Requirements 

Mistrust with the Centers for Disease Control and Prevention (CDC) continues regarding guidance on vaccinations. Four states, CA, HI, OR, and WA, have formed the West Coast Health Alliance (WCHA) to provide public health guidelines separate from the CDC, including access to vaccines. In addition, ten Northeastern states have formed the Northeast Public Health Collaborative to issue vaccine guidance and coordinate public health independent of the federal government. We are monitoring the situation and will update the appropriate documents as more information becomes available. If your state department of health or Board of Pharmacy issues a requirement, use your professional judgement to determine the course of action. If you disagree with the state or CDC or both, consider having the patient’s physician write a prescription for the vaccine or modify your standing order with a concurring physician. See the following links for more information.

Lawmakers Urge HHS to Discard 340B Rebate Pilot  

A bipartisan group of lawmakers has sent a letter to the Department of Health and Human Services, asking the agency to cancel an upcoming rebate pilot for drugs purchased by hospitals under the 340B Drug Discount Program.

If the pilot remains in effect, the lawmakers are asking for more information on how HHS intends to protect hospitals against additional administrative costs.

According to the group of about 163 lawmakers, Congress intended the 340B Program to enable safety net providers to stretch scarce federal resources as far as possible – reaching more eligible patients and providing more comprehensive services.

An "unchecked" model, the lawmakers said, "would severely undermine that purpose."

In particular, they're concerned that the pilot program will cause damage to community health centers, safety net hospitals, and other providers that rely on the 340B program.

What's the impact? The rebate model pilot program will require all covered entities to purchase drugs on the Centers for Medicare and Medicaid Services' Medicare Drug Price Negotiation Selected Drug List at the wholesale acquisition cost. Lawmakers said this is the highest sticker price that manufacturers offer, which is rarely actually paid by purchasers in the healthcare system.

This, according to the letter, will require 340B providers to front substantial amounts of cash to drug companies in hopes that a rebate will be paid. See More…


HHS’ Office for Civil Rights Settles HIPAA Ransomware Security Rule Investigation

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced a settlement with BST & Co. CPAs, LLP (“BST”), a New York public accounting, business advisory, and management consulting firm, concerning a potential violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. BST is a HIPAA business associate and receives financial information that also contains protected health information (PHI) from a HIPAA covered entity.

Under the terms of the resolution agreement, BST agreed to implement a corrective action plan that will be monitored by OCR for two years and paid $175,000 to OCR. Under the corrective action plan, BST has agreed to take a number of steps to ensure compliance with the HIPAA Security Rule and protect the security of ePHI, including:

  • Conduct an accurate and thorough risk analysis to determine the potential risks and vulnerabilities to the confidentiality, integrity, and availability of its ePHI;
  • Develop and implement a risk management plan to address and mitigate security risks and vulnerabilities identified in its risk analysis;
  • Develop, maintain, and revise, as necessary, written policies and procedures to comply with the HIPAA Privacy and Security Rules; and
  • Augment its existing HIPAA and security training program and provide annual training for all workforce members to whom the HIPAA policies and procedures apply, including workforce members with access to PHI.

OCR recommends that HIPAA-covered health care providers, health plans, health care clearinghouses, and business associates implement the following steps to mitigate or prevent cyber threats:

  • Identify where ePHI is located in the organization, including how ePHI enters, flows through, and leaves the organization’s information systems.
  • Periodically conduct, and update as needed, a risk analysis and develop and implement risk management measures to address identified risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI.
  • Ensure audit controls are in place to record and examine information system activity.
  • Implement regular review of information system activity.
  • Utilize mechanisms to authenticate users seeking access to ePHI.
  • Encrypt ePHI in transit and at rest to guard against unauthorized access to ePHI when appropriate.
  • Incorporate lessons learned from incidents into the organization’s overall security management process.
  • Provide workforce members with regular HIPAA training that is specific to the organization and to the workforce members’ respective job duties.

Read the Resolution Agreement.

Note: All of these requirements are contained in the HIPAA Compliance Program and Monthly Task Reminders to help ensure the facility’s compliance.


CMS Reminder of DMEPOS Proof of Delivery Requirements  

Suppliers must maintain proof of delivery documentation in their files for 7 years (starting from the date of service). Proof of delivery is a supplier standard as noted in 42 CFR Section 424.57(c)(12). See Section 8 starting on page 13.

Proof of delivery and delivery methods when delivering DMEPOS items to beneficiaries:

  • Supplier delivering directly to the beneficiary or designee
    • Use Receipt of Goods and Services
  • Supplier utilizing a delivery/shipping service to deliver items
    • Use carrier’s delivery receipt with signature. Save/attached to the Receipt of Goods and Services or Delivery Ticket
  • Delivery of items to a nursing facility on behalf of the beneficiary
    • Use Receipt of Goods and Services 

Medicare Transaction Facilitator Data Module (MTF-DM)

CMS opened enrollment in June for the MTF-DM and sent invitations to NCPDP points of contact.  This program is how the pharmacy will receive refunds from the drug manufacturers.  All pharmacies must enroll in the MTF-DM.  This CMS requirement ensures pharmacies are eligible to service all Medicare Part D beneficiaries in 2026.  Failure to enroll will result in exclusion from the Medicare Part D program.  Medicare is strongly encouraging pharmacies to complete their enrollment by November 15, 2025, to ensure information is accurate and avoid delays in processing refunds.

Before enrollment:

  • Ensure that your NCPDP profile is accurate and updated if needed.
  • Pharmacies need to know which functions, such as central pay or reconciliation services, they want to assign to any third-party support entities, such as PSAOs or reconciliation vendors.

During enrollment:

  • The user will complete an agreement enabling the MTF system to access your NCPDP pharmacy information.
  • Pharmacies will need to sign a legal agreement.  Proceed with caution and be sure to review and have your legal counsel review carefully.
  • Identify as having “material cashflow concerns” as manufacturers can provide pharmacies with a plan for mitigating their cashflow concerns.

Here are some helpful links:

  • Watch an intro to the MTF on CMS's dispenser homepage here.  Note that you may have to sign in to CMS.gov first.
  • Review the CMS MTF User Guide to help with the enrollment process.
  • Cardinal has provided a helpful Enrollment Guide.
  • View an FAQ from CMS on the MTF here.
  • View a Fact Sheet from CMS here.
  • NCPA has shared their webinar and other great resources.  Click here to see more.

You can contact CMS at MFPMedicareTransactionFacilitator@cms.hhs.gov with any questions.

In addition, it appears the pharmacy’s reimbursement will be processed through the Pharmacy Benefit Managers (PBM) and they will take an administration fee.

NCPA has posted their webinar and other great resources within the Inflation Reduction Act: Resources and Advocacy website. Click here…

Medicare Open Enrollment

Medicare Open Enrollment begins this month on October 15th. Everyone needs to identify the plans that benefit both your pharmacy and the patient. Once the good plans are identified, we recommend placing a sign near the pickup window stating the pharmacy will be accepting the following plans as of January 1, 2026.

LTC at Home Program

Our LTC at Home program is now available on the Compliance Portal®. If you have not started this program or if you are not sure you are following all of the requirements, this program is ready for you to implement at your pharmacy. Basic components are completing a LTC at home attestation, ensuring that medications are packaged in adherence or compliance packaging, providing delivery service to the patient’s residence, and entering the correct Place of Service code. The LTC at Home program costs only $600.00 annually. To get more information and order your program Click Here. Be sure to check out latest blog “Why Independent Pharmacies Should Consider Long Term Care at Home” for more information on LTC at Home.


Enforcement

Medicare Open Enrollment – Pharmacy 

Some think the most important time of year for seniors is, October 15th to December 7th, when patients make their choices for Medicare Part C and Part D plans.  At a minimum, the pharmacy should have a sign(s) posted indicating what plans will be accepted on January 1, 2026.  Patients are seeking guidance, but they are unaware how DIR fees and reimbursement rates affect pharmacies.  Several systems support the pharmacy and its staff in identifying the most suitable plans for patients and the pharmacy.  Bag stuffers and newspaper ads can also be used if there are multiple plans for the patient to choose from.  It’s time to make your decisions and spread the word to your patients.


R.J. Hedges & Associates Clients have access to Policies & Procedures, Support Documents, Trainings and other items through the Compliance Portal.  Items are reviewed and updated as regulations change.  Here's a list of items that were added or amended in the last 30 days.

Updated Policies and Procedures

  • LTC at Home

Updated Forms

Immunizations:

  • Standing Orders:
    • NEW – Clesrovimab RSV Preventive Antibody to Infants
    • Pfizer RSV (Abrysvo) Vaccine During Pregnancy
    • RSV Preventive Antibody (Nirsevimab) to Infants
    • Seasonal Influenza to Adults
    • Seasonal Influenza to Children and Adolescents

DMEPOS:

  • NEW – Lymphedema Compression Treatment Detailed Product Description