October 2024 - Newsletter

Included in this newsletter

1. Drug Wholesalers Increase Their Vigilance on Controlled Substances
2. APhA Meets with FDA on DSCSA Requirements
3. FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize
4. USTR Announces Plans to Move Forward with PPE Tariffs
5. Medicare Open Enrollment
6. Pharmacists Practicing Coverage Continues to Expand
7. CMS Rescinds CR Regarding Lymphedema HCPCS Codes
8. DMEPOS Adding New Product Categories to CMS-855S Enrollment Form On October 26
9. Reminder to Report Changes to Medicare within 30 days
10. Enhancements to the Controlled Substance Ordering System (CSOS)
11. PrEP for HIV National Coverage Determination (NCD) Technical Frequently Asked Questions for Pharmacies
12. Moving Sale: Hazardous Drug Spill Kits
13. Tell Us How You Feel
14. New & Updated P&P, Forms & Support Documents

Drug Wholesalers Increase Their Vigilance on Controlled Substances

Drug wholesalers audit controlled substances differently.  If the physician or the pharmacy is “Red Flagged,” there will be an audit.  Physician assistants and nurse practitioners seem to be the focus of these audits.  The pharmacy will receive a notification that there is a red flag issue and it will list the prescribing practitioner and the number of C-II drugs dispensed.  There will be a new form in the DEA program on the Compliance Portal® to assist with this audit.  The Controlled Substance Audit Worksheet is straightforward; however, you must have a treatment plan with specific prescription requirements.  The treatment plan forms can be found under the Securing and Handling of Controlled Substances policy and procedure in the DEA program, Item # 2b-e and in the Pharmacy program, Chapter 3, Item # 4a-d.  If you do not have these completed forms in the patient file, you must contact the physician for their treatment plan.  If they don’t have one or they will not return a completed form, you cannot afford to continue filling and dispensing C-IIs from this practitioner.

APhA Meets with FDA on DSCSA Requirements

The American Pharmacists Association (APHA) and the National Community Pharmacists Association (NCPA) attended a listening session with other pharmacies, hospitals, and health-system organizations not included under the small-business dispenser (with 25 or fewer full-time employees) exemption, which APHA and NCPA helped to secure.  The goal of the session was to urge the phased implementation of the Drug Supply Chain Security Act (DSCSA), which requires drug manufacturers, wholesalers, dispensers (including most pharmacies), and repackagers to implement secure, electronic, and interoperable systems and processes for enhanced product tracing for supply chain trading partners by November 27, 2024.

APHA and NCPA emphasized points from a joint letter asking the FDA to provide a blanket waiver, exception, or exemption (WEE) for dispensers, including all pharmacies, until manufacturer-level trading partners can provide all necessary data to downstream trading partners.  Pharmacy compliance with DSCSA is fully dependent on the compliance of upstream trading partners.  In cases where manufacturers supply partial or no data, the DSCSA provides pharmacies limited recourse beyond rejecting shipments.  This may not cause serious disruption if limited to a small percentage of data or a small number of products.  However, considering the scope of the missing data, APHA and NCPA is concerned that this could potentially jeopardize patient care.  For instance, if dispensers move away from one product with a WEE, it may create a demand surge for alternate products, resulting in increased prices or even shortages.  In cases where no alternate products are available, patients could be left without medication access, posing a significant risk to their care.

APHA and NCPA’s health system pharmacies intend to be compliant by the enforcement date.  However, part of dispenser compliance relies on upstream trading partners (e.g., wholesalers, etc.) that pharmacies cannot impact.  APHA and NCPA urged the FDA to provide more guidance on what steps an individual pharmacy, as a dispenser or chain of pharmacies, and health systems should take to comply with the DSCSA.  Click here

FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize

According to the FDA, the shortage of tripeptide injection (Mounjaro/Zepbound — Eli Lilly) has been resolved.  Lilly's supply of the glucagon-like peptide 1 (GLP-1) medication can now meet current and projected national demand, the agency said.  Tirzepatide has been in short supply since 2022 due to soaring demand.  The FDA also clarified its policies regarding compounded GLP-1 drugs in its announcement.  "Compounded drugs are not approved by FDA.  FDA-approved drugs go through FDA's rigorous review for safety, effectiveness, and quality as part of the premarket approval process," the agency said.  It noted that compounded medications must meet certain conditions to be eligible for exemptions under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.  FDA reminded that compounded drugs sold by 503B pharmacies "may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on FDA's drug shortage list."  See more...

USTR Announces Plans to Move Forward with PPE Tariffs

The Office of the U.S. Trade Representative (USTR) recently finalized plans for Section 301 tariffs that include significant duties on personal protective equipment (PPE) such as exam gloves and respiratory masks.  The mask tariff rises to 25% immediately and will increase to 50% on Jan. 1, 2026, while the tariff on gloves starts at 50% on Jan. 1, 2025, and rises to 100% in 2026.  See this summary from HIDA on increases for PPE and other medical supplies and the full text of USTR’s Federal Register notice for more information.

Medicare Open Enrollment

Open enrollment has started.  Knowing the best plans available for your patients and having the lowest DIR fees is imperative.  I suggest the pharmacy post these recommended plans for patients to see, i.e., “We are accepting the following Medicare Part C plans” with the list of plans.

Pharmacists Practicing Coverage Continues to Expand

Many states have increased the pharmacy and pharmacist Scope of Practices to dispensing specific medications and vaccines and even providing “Provider” status.  However, many states have not increased pharmacy and pharmacists' Scope of Practice, hindering the growth of the pharmacy practice.  If your state has not permitted changes to the pharmacy practices, become an advocate with your state pharmacy association and legislators.  Increasing your pharmacy’s services is essential for the survivability of the industry.

CMS Rescinds CR Regarding Lymphedema HCPCS Codes

Last week, CMS released Change Request (CR) 12851.  This request rescinded a previously published CR, which placed new lymphedema HCPCS codes into consolidated billing for home health agencies (HHAs).

AAHomecare worked with the National Alliance for Care at Home (newly formed from NAHC and NHPCO) to contact CMS and question the inclusion of these HCPCS.  Lymphedema items can be expensive and concern was expressed about including these products in the episodic payment for a home health episode.

AAHomecare is thankful to CMS for providing clarification.  You can view the Change Request 12851 Click Here.

DMEPOS Adding New Product Categories to CMS-855S Enrollment Form on October 26

On October 26, 2024, CMS will add four new product categories to the electronic CMS-855S DMEPOS Enrollment Form:

• Cognitive behavioral therapy devices
• Rehabilitative therapy devices
• Urinary suction pumps
• External electrical stimulation devices (not otherwise classified).

Reminder to Report Changes to Medicare within 30 days

Just a reminder that all of the following should be reported within 30 days to avoid potential revocations:

• Ownership
• Managing employees
• Authorized Officials
• Delegated Officials
• Change in address
• Change of insurance, surety bond, and licensure.

CMS has hired a contractor (Provider Ownership Verification-POV) who search various databases for changes that should have been reported. If suppliers are waiting for updates before the change can be fully processed, CMS encourages you to reach out to the NPE and communicate the hold up with them. For example, they might check with the secretary of state website to see if there is an ownership change and if this is not reported in a timely manner, it might be grounds for revocation.

Enhancements to the Controlled Substance Ordering System (CSOS)

On December 9, 2024, DEA will launch a new, enhanced Controlled Substance Ordering System (CSOS) to ensure secure electronic ordering of Schedule I through V controlled substances without the supporting paper DEA 222 Order Form. 

The updated CSOS program will allow for the online submission of enrollment applications and certificate management (renewals and revocations), through a secure network application portal.  As part of this enhanced process, identity verification will occur through the login.gov portal.  Subsequently, DEA will stop accepting paper applications for CSOS enrollment after January 10, 2025.  The enhancement of CSOS will not impact registrant’s ability to order controlled substances utilizing a paper DEA 222 Order Form.

Beginning December 9, 2024, new registrants choosing to utilize CSOS will be required to create an account on the CSOS portal at https://www.deaecom.gov/.  Current CSOS subscribers will only need to create an enhanced CSOS account in the portal for the following task requirements:

• Approvals - If you need to approve a new subscriber or certificate renewal.
• Revocations - If you are revoking a certificate.
• Renewals - If you are renewing a CSOS certificate. It is recommended to create a new account 45 days prior to the certificate expiration date.

DEA is committed to providing the registrant population who utilize CSOS the most updated resources to effectively order controlled substances.

DEA wants to make sure you are equipped with the necessary information and training to operate the new system.  DEA will provide virtual training sessions on enhancements to its CSOS application on the following dates:

• January 16, 2025, 2pm to 4pm
• January 22, 2025, 2pm to 4pm
• January 23, 2025, 2pm to 4pm

Information on how to register for the virtual training sessions Will be posted to the DEA website.  R.J. Hedges & Associates will also keep you posted as dates draw near. 

Reference Links:

• CSOS Enhancements—Letter to Practitioners (October 16, 2024)

• CSOS Enhancements—Letter to all other registrants (October 15, 2024)

PrEP for HIV National Coverage Determination (NCD) Technical

CMS received public feedback asking that more technical information for submitting Medicare Part B

claims for PrEP for HIV be released.  Here are 2 resources FAQ for Pharmacies and Fact sheet

Moving Sale: Hazardous Drug Spill Kits

R.J. Hedges & Associates is having a Moving Sale for our Hazardous Drug Spill Kits.  These kits can be used for Hazardous Drugs, Hazardous Chemicals, and Bio-Hazards containment and cleanup. Get yours while they last for $65.00 + shipping.  Email sales@rjhedges.com or order online https://www.rjhedges.com/usp-800-hazardous-drugs-compliance-retail-pharmacies.

Tell Us How You Feel

We’d love to hear from you!  We are always looking for feedback about your experiences with R.J. Hedges & Associates as a company, your Project Manager, or a staff member.  Please send any thoughts to:  karly.lupacchini@rjhedges.com   If you’re feeling super helpful, we’re also trying to grow our Google Reviews.

New and Updated Policies & Procedures

New and Updated Forms & Support Documents