December 2025 - Newsletter

Included in this newsletter

1. CMS Final Rule: DMEPOS Accreditation Changes Coming in 2026
2. Medicare DMEPOS Accreditation Exemption: A Cost-Saving Option for Pharmacies
3. Wholesale Acquisition Cost (WAC) Decreases Coming: Take Action Now
4. Flu Activity is Low, but Experts Worry About New Strain and Vaccination Rates
5. Medicare Part B
6. CMS Modernizes Payment Accuracy and Significantly Cuts Spending Waste
7. National Plan and Provider Enumeration System (NPPES) Taxonomy
8. CMS Phasing Out Paper CLIA Certificates
9. Enforcement
10. Bulletin
11. Spotlight on December Task List Requirement 

 

CMS Final Rule: DMEPOS Accreditation Changes Coming in 2026

Summary courtesy of the Accreditation Commission for Health Care (ACHC)

CMS has released the CY 2026 Home Health Prospective Payment System Final Rule, which includes significant updates to DMEPOS accreditation requirements. These changes affect all Medicare-enrolled DME suppliers and may also impact pharmacies that bill for DMEPOS items.

ACHC has published a clear summary of what was finalized and what suppliers should expect when the provisions take effect on January 1, 2026. 

Key Changes Finalized by CMS

• Annual Accreditation Cycle

CMS is reducing the accreditation term from every three years to annually.

• • • New suppliers accredited on or after January 1, 2026, will begin on a one-year cycle
    • Suppliers surveyed on or before December 31, 2025, will retain a three-year term until their next survey, which will move to an annual cycle

• Increased Oversight of Accrediting Organizations

CMS finalized stronger expectations for accreditation organizations, including enhanced reporting, monitoring, conflict-of-interest safeguards, and clearer accountability standards.

• Unannounced Surveys Continue

CMS confirmed that all DMEPOS accreditation surveys will remain unannounced, consistent with current practice.

• Temporary Accreditation Eliminated

Beginning January 1, 2026, all new locations must be surveyed prior to accreditation. CMS removed the option for temporary accreditation without a survey.

• Ownership Change Requirements

Suppliers experiencing a change in majority ownership within 36 months of initial enrollment or a prior ownership change must enroll as a new DMEPOS supplier and complete full accreditation, unless a specific exception applies.

• Sampling for Large Suppliers Continues

CMS will continue to allow sampling methodologies for large supplier chains and plans to engage stakeholders before making future changes.

What Happens Next?  CMS has indicated that additional implementation guidance is forthcoming. At this time, suppliers do not need to take immediate action beyond reviewing the finalized provisions and preparing for the transition to annual reaccreditation surveys once their current three-year term expires.

Medicare DMEPOS Accreditation Exemption: A Cost-Saving Option for Pharmacies

Pharmacies that are enrolled in Medicare to bill for DMEPOS items may qualify for an accreditation exemption, allowing them to remain compliant without maintaining a paid accreditation. For eligible pharmacies, this can represent a meaningful cost-saving opportunity especially as CMS announces annual accreditation surveys starting in 2026.

Why Consider the Accreditation Exemption?  The most significant benefit of the exemption is financial: once approved, the pharmacy is not required to pay for DMEPOS accreditation (currently every three years, and soon annually). This can reduce ongoing compliance costs while allowing the pharmacy to continue billing Medicare for DMEPOS items.

It’s important to note that exemption from accreditation does not mean exemption from compliance. Pharmacies approved for the exemption must continue to follow all CMS DMEPOS Supplier Standards and remain subject to audits and oversight.

Who Is Eligible? According to CMS and the National Provider Enrollment East (NPEAST) guidance, a pharmacy may qualify if it meets all of the following criteria:

• The pharmacy has been enrolled in Medicare as a DMEPOS supplier for at least five years
• The pharmacy has not had an unrescinded final adverse action in the past five years in other words you are in good standing with Medicare
• Medicare billing for DMEPOS items (excluding drugs and pharmacy supplies) is less than 5% of total pharmacy sales for each of the previous three calendar or fiscal years

Additional limitations apply for pharmacies with recent ownership changes, new locations, or changes to their legal business entity.

How to Apply for the Exemption?  Eligible pharmacies must submit a signed Accreditation Exemption Attestation Statement along with supporting documentation, including:

• Proof that DMEPOS sales are under the 5% threshold (such as CPA verification or tax returns for the prior three years)
• A copy of the pharmacy’s comprehensive liability insurance showing at least $300,000 per incident
• Signature from the Authorized or Delegated Official listed on the pharmacy’s Medicare enrollment (CMS-855S)

The completed materials are submitted to Novitas Solutions (NPEAST) or Palmetto GBA (NPEAST) for review. Pharmacies that are currently accredited are strongly advised not to terminate accreditation until they receive written confirmation that the exemption has been approved, as loss of accreditation without approval could result in revoked Medicare billing privileges.

For pharmacies that maintain a DME PTAN but generate minimal DMEPOS revenue, the accreditation exemption can be a practical way to reduce expenses while remaining compliant. With accreditation requirements becoming more frequent, now is a good time to evaluate whether your pharmacy qualifies and whether exemption status aligns with your long-term compliance strategy.

If you have questions about eligibility or need help navigating the exemption process, please reach out to your Project Manager or a member of the sales team.

Wholesale Acquisition Cost (WAC) Decreases Coming:  Take Action Now
 

Wholesale Acquisition Costs (WACs) for a number of popular drugs are coming down, with the biggest WAC reductions in the history of the pharmaceutical industry happening now.  Some industry experts are estimating that manufacturers are reducing WACs by as much as $50 billion.

You should have received notices from your wholesaler(s) about specific products with upcoming WAC decreases and these include some big names like Eliquis, Jardiance, and Farxiga.  Depending on the wholesaler’s policy, pharmacies are in danger of being stuck with the higher priced drug versus the same drug with a lower WAC.

Review your inventory, cross-check the products with WAC decreases, and streamline your inventory immediately!  Not doing so could cost you tens of thousands of dollars!  Read more here…

Flu Activity is Low, but Experts Worry About New Strain and Vaccination Rates

The U.S. flu season is starting slowly, and it's unclear if it will be as bad as last winter's, but some health experts are worried as U.S. Centers for Disease Control and Prevention data posted Friday shows a new version of the virus has emerged.

An early analysis suggests current vaccines may still be somewhat effective against the new version of the flu, which has been the main driver of recent infections, CDC data shows.

Some scientists and medical professionals are more worried about disappointing vaccination rates, a main reason why flu hospitalizations and deaths were unusually bad during last year's flu season — one of the deadliest this century.

Last winter, the overall flu hospitalization rate was the highest seen since the H1N1 flu pandemic 15 years ago.  Flu was the underlying or a contributing cause of more than 18,000 deaths, and one seven-day stretch early this year saw more than 1,800 deaths — the highest one-week spike in at least a decade.  Child flu deaths also were far higher than usual.  Read more here…

Medicare Part B

The annual deductible for all Medicare Part B beneficiaries will be $283 in 2026, an increase of $26 from $257 in 2025.  Read the full fact sheet for more information.

R.J. Hedges Recommendation:  Pharmacies and DME facilities generally are the first claims for a patient with the change of the year.  We recommend collecting the full reimbursement fee in January and February, to ensure you receive what is owed rather than chasing money later.  It is so much easier to issue a refund check or a credit to the patient's account.

CMS Modernizes Payment Accuracy and Significantly Cuts Spending Waste

The Centers for Medicare & Medicaid Services (CMS) is increasing the quality of care for Medicare beneficiaries while significantly reducing unnecessary spending and promoting payment accuracy.  The calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) final rule advances primary care management through improved quality measures, reduces waste and unnecessary use of skin substitutes, and introduces a new payment model focused on improving care for chronic disease management.

“The new Medicare fee schedule delivers a major win for seniors, protects hometown doctors, and safeguards American taxpayers,” said Health and Human Services Secretary Robert F. Kennedy, Jr.  “It realigns doctor incentives and helps move our country from a sick-care system to a true health care system.”

“CMS is working to strengthen and transform Medicare for the current and future generations while cracking down on waste and abuse that drives up costs,” said CMS Administrator Dr. Mehmet Oz.  “The actions we are taking will improve seniors’ access to high-quality, preventive care that will help them to live longer, healthier lives.”  See More…

National Plan and Provider Enumeration System (NPPES) Taxonomy

Please check your data in NPPES and confirm that it still correctly reflects you as a health care provider with the appropriate taxonomy and correctly reflects your current practice address.  Incorrect data in NPPES may lead to unnecessary inquiries about your credentials and delay enrollment with Medicare and health plans.

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.

For more information about the three options for making the switch to electronic notifications see this document.

Enforcement

• CVS Pharmacy pays $18.2 million to resolve alleged False Claims Act violations
• Michigan Pharmacist Sentenced to 46 Months in Prison for $4M Health Care Fraud Scheme
• Pharmacist and Brother Sentenced to Prison for $15M Health Care and Wire Fraud Scheme
• Mississippi Businessman Pleads Guilty to $19M Health Care Fraud Conspiracy

Bulletin

Spotlight on December Task List Requirement

The January Task List focuses on setting up files for 2026.  Each item needs to be set up for the new year.  The OIG-SAM list, the Performance Management Report, the DEA Power of Attorney for DEA Forms 222, and Electronic Orders need to be reviewed for accuracy.  This is a fairly simple process and is perfect for a technician to complete on a Saturday afternoon.