Included in this newsletter
- BOC Reinstated as CMS-Approved Accrediting Organization
- 15 Drugs to be Added to Medicare Drug Price Negotiation Program in 2027
- CMS announces new site inspection Contractors
- IMPORTANT – CMS Changes to DMEPOS Accreditation
- CMS Releases 2026 DMEPOS Fee Schedule
- 340B Program Costs Taxpayers, No Evidence of Patient Benefit
- The DME Final Rule has been Released; Competitive Bidding Program Restarting
- CMS Audits Focus on Proof of Delivery Documentation
- Negotiated Drug Prices Would Force LTC Pharmacists Out of Business, Cost Taxpayers Billions
- The HALT Fentanyl Act becomes effective on January 16, 2026
- Enforcement
- Bulletins
- Spotlight on February Task List Requirement
BOC Reinstated as CMS-Approved Accrediting Organization
At a hearing held Jan. 9, 2026, the Court granted BOC’s motion for a temporary restraining order (TRO) against CMS. As a result of the Court’s ruling, BOC is again authorized as a CMS-approved DMEPOS Accreditation Organization, and CMS has confirmed this status remains in effect until further notice.
What This Means for BOC-Accredited Facilities:
- Effective January 9, 2026, BOC can continue operations and is authorized to provide full accreditation- and reaccreditation-related services in 46 states.
- Effective January 9, 2026, BOC is authorized to accept new DMEPOS applications in 46 states.
- Restrictions announced in May 2025 continue to be in place for reaccreditation and new accreditation of suppliers in CA, FL, NY and TX.
Suppliers with questions should contact BOC Compliance at compliance@bocusa.org for individualized support and guidance to limit potential gaps in accreditation.
This matter is not related to and does not impact BOC’s certification programs. All BOC certification programs remain relevant and valid for the thousands of providers holding BOC credentials.
For more information about BOC, visit www.bocusa.org.
BOC's full statement can also be seen here.
15 Drugs to be Added to Medicare Drug Price Negotiation Program in 2027
CMS recently announced the maximum fair prices (MFPs) for 15 Medicare Part D drugs selected for the second cycle of Medicare negotiations, which will take effect on Jan. 1, 2027. CMS noted that approximately 5.3 million people with Medicare Part D coverage used these 15 drugs between Jan. 1, 2024, and Dec. 31, 2024, accounting for $42.5 billion in total gross covered prescription drug costs under Medicare Part D and $1.7 billion in beneficiaries' out-of-pocket spending. Medicare Part D beneficiaries are expected to save "an estimated $685 million in out-of-pocket costs" under the defined standard benefit design when these negotiated prices take effect on Jan. 1, 2027. See More…
CMS Announces New Site Inspection Contractors
CMS has announced changes to the contractors responsible for conducting Medicare enrollment site inspections. Beginning January 3, 2026, the new site verification contractors will be Arch Systems, LLC for states east of the Mississippi River and Signature Consulting Group for states west of the river. During the transition period, through February 14, 2026, current contractors may continue performing site visits, including Palmetto GBA and its subcontractors in the East and Deloitte Consulting, LLP and its subcontractors in the West.
Site inspections remain unannounced and may occur during enrollment, revalidation, reactivation, or changes to enrollment information. Suppliers should ensure posted hours, signage, inventory, and required documentation are accurate and accessible. Inspectors will carry CMS authorization and may photograph the facility and inventory, but should not copy beneficiary files. Failure to complete a site inspection or refusal to allow access may result in delays, denials, or revocation of Medicare billing privileges.
IMPORTANT – CMS Changes to DMEPOS Accreditation
Beginning January 1, 2026, CMS changed the accreditation survey to an annual requirement. See the two bulletins in the message center of the Compliance Portal, 2025-02 and 2025-03, for more detailed information.
Pharmacy exemption allows the pharmacy to be enrolled in Medicare to supply DMEPOS items that require accreditation without having an accreditation. The exemption for pharmacies from obtaining accreditation remains in place if they meet the following criteria.
- Have been enrolled in Medicare as a DMEPOS supplier for at least 5 years with the same EIN; AND
- Have no unrescinded final adverse actions in the past 5 years; AND
- Have billed less than 5% of pharmacy sales to Medicare for DMEPOS in the past 3 years.
New pharmacy locations (within 5 years of opening) or those with ownership/entity changes are not eligible and must be accredited.
CMS Releases 2026 DMEPOS Fee Schedule
CMS has published the Consumer Price Index for All Urban Consumers (CPI-U) adjustments for the Calendar Year 2026 DMEPOS fee schedule. Although the CPI-U is 2.7%, the inflation adjustment will differ depending on whether the item has been included in the competitive bidding program (CBP) and whether the patient’s zip code is in a former competitive bidding area (CBA).
Below are the CPI-U adjustments for 2026:
- CBP items in former CBAs (projected percentage change): 2.8%
- CBP items in non-CBAs (CPI-U): 2.7%
- Note: not directly stated in the change request
- Non-CBP items (CPI-U minus productivity adjustment): 2.0%
340B Program Costs Taxpayers, No Evidence of Patient Benefit
The 340B program has been a blessing and a curse for pharmacies and patients for years. Now, with the focus on costs and benefits, the future of the 340B program is in doubt. If you have a 340B program, you should prepare for significant changes.
The non-partisan Congressional Budget Office (CBO) confirms the 340B hospital markup program is costing taxpayers money. This non-partisan government report directly refutes the misleading rhetoric that big, rich hospitals continue to spew in their attempt to distract from their profiteering off the program. See More…
The DME Final Rule has been Released; Competitive Bidding Program Restarting
CMS published the 2026 Home Health/DMEPOS Final Rule. The proposed rule released this summer included significant changes to the DMEPOS Competitive Bidding Program (CBP) and also impacts to supplier accreditation processes.
You can find the full 762 page final rule here (DMEPOS section starts on page 240) and CMS’ related fact sheet here. The changes are effective January 1, 2026.
In an additional fact sheet, CMS announced their intentions to have the next CBP Round go live no later than January 2028. In preparation for it, CMS announced pre-bidding education that began in January 2025 with the bidding window to open Summer 2026. This fact sheet also includes product categories for remote item delivery. Read more…
CMS Audits Focus on Proof of Delivery Documentation
CMS audits are increasingly focused on Proof of Delivery (POD). Proof of Delivery is a required component of the Receipt of Goods and Services and must be completed for every Medicare Part B dispensing, including both DMEPOS and Part B medications.
When products are shipped via a small parcel carrier (UPS, FedEx, or USPS), the carrier’s delivery confirmation serves as the Proof of Delivery and must be retained in the patient record. In these instances, the Receipt of Documents form must also be signed and maintained on file to demonstrate proper documentation and compliance.
Negotiated Drug Prices Would Force LTC Pharmacists Out of Business, Cost Taxpayers Billions
If Congress does not pass proposed legislation to address the costs to long-term pharmacies from negotiated drug prices, it could cost taxpayers up to $4.8 billion in increased healthcare costs over the next decade, according to the Senior Care Pharmacy Coalition.
The Preserving Patient Access to Long-Term Pharmacies Act, first put forth in August, would establish a $30 supply fee per Medicare Part D prescription in 2026 and 2027, although the proposed fee could increase in 2027 due to inflation See More…
The HALT Fentanyl Act becomes effective on January 16, 2026
The Halt All Lethal Trafficking of Fentanyl (HALT) Fentanyl Act has been signed into law, permanently classifying all fentanyl-related substances (FRS) as Schedule I drugs under the Controlled Substances Act. This legislative action has significant implications for various sectors, including retail pharmacies, by heightening regulations and oversight of these substances.
A key aspect of the HALT Fentanyl Act is its distinction between fentanyl and fentanyl-related substances. The law specifically designates FRS as Schedule I, a category for drugs with a high potential for abuse and no accepted medical use. This classification means that these substances cannot be prescribed or dispensed in a medical setting.
However, it is important to note that fentanyl itself remains a Schedule II substance. This allows for its continued use in medical treatments, particularly for severe pain management, under strict regulatory control. The bill's sponsor has confirmed that the legislation is not intended to impact the legitimate medical use of fentanyl.
The legislation aims to combat the opioid crisis by giving law enforcement more tools to prosecute the trafficking of dangerous fentanyl analogues. By permanently scheduling these substances, the act streamlines the process for law enforcement to take action against illicit manufacturing and distribution. The law also imposes stricter sentencing guidelines for individuals involved in the trafficking of fentanyl-related substances.
Enforcement
- Federal Court Permanently Prohibits Tampa-area Pharmacist from Filling Opioids Prescriptions and Pharmacy Dissolved
- Michigan Pharmacist Sentenced to 46 Months in Prison for $4M Health Care Fraud Scheme
- Pharmacist Sentenced to Over Six Years in Prison for $6M Health Care Fraud Scheme
- Texas Man Charged with Conspiracy to Obtain Controlled Substances by Fraud
Bulletins:
- RJH 2025-02 – CMS Final Rule: DMEPOS Accreditation Changes Coming in 2026
- RJH 2025-03 – Medicare DMEPOS Accreditation Exemption: A Cost-Saving Option for Pharmacies
- RJH 2025-04 - BOC Terminated as CMS Accreditation Organization
Spotlight on February Task List Requirement
Medicare Parts B, C, and D require all pharmacy and DMEPOS facilities to review and sign the Conflict of Interest Certification annually. This requirement is very important to ensure that the facility’s staff understands and personally acknowledges the seven (7) points at which a conflict cannot occur. Fraudulently completed certification results in an immediate termination of the employee. The five most important items are:
- Having significant financial interests in patients, suppliers, or competitors
- Working for a competitor, without the knowledge of management
- Self-employment in competition with the organization
- Soliciting or accepting gifts or gratuities from suppliers or patients
- Using the facility’s equipment and supplies for personal gain
This document is maintained in the employee's personnel folder and a copy of the most current version is in the Compliance Binder. If a question arises, contact your Project Manager for guidance. If an employee refuses to sign the conflict of interest form, the employee is terminated for failing to adhere to company policies. Unemployment is denied if this occurs.
