Included in this newsletter
- Compounding Documentation
- Assessment of Risk Update
- LTC @ Home Development
- DMEPOS and Part B Pharmaceutical Billing Service Solution
- FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
- Trump-Era Policy Changes
- CMS Adding a New DMEPOS Product Code
- U.S. Department of Justice Takes Aim at Walgreens
- Enforcement
- Hazardous Drug Spill Kits
- Compliance Portal Updates
- New and Updated Policies & Procedures and Forms
Compounding Documentation
We have been receiving questions concerning master formulation records (MFR) and compounding documentation. Master formulation records are signed by the pharmacist-in-charge (PIC) or the primary compounder. Can a certified pharmacy technician sign a MFR? The answer is normally NO. However, highly qualified compounding technicians sometimes manage the formulation records in the compounding lab. In rare cases, the PIC can permit this individual to sign them, but the PIC must understand that their pharmacist license is on the line if an adverse event occurs.
Compounding preparation is on the rise. The formulation record or monograph must be followed in complete detail. Every ingredient must be weighed and documented on the compounding record or within the compounding software. Minor discrepancies can have serious consequences. Compliance with USP guidelines is required. However, the state pharmacy boards are lax in their enforcement until an incident occurs. Don’t be complacent.
Assessment of Risk Update
The draft NIOSH list has been finally approved for release. We are in the process of updating the Assessments of Risk (AoR) to reflect the changes made to the NIOSH list. We will be providing updates and processes for implementing the new set of Assessments of Risk (AoR) in the near future. Stay tuned for more details.
We have received some questions regarding the AoRs:
- What type of signature is permitted on each AoR?
- A wet signature or a stamped signature is permitted and is to be performed by a pharmacist. Electronic signatures are not specifically mentioned, but this method is not recommended.
- How Long do we need to retain AoRs
- The forms allow annual review and sign off for up to 5 years
- Signed AoR’s should be retained for 5 years after the last signature date
- Are AoRs permitted to be used in the compounding lab?
- NO! AoRs are for conventionally manufactured products dispensed through a community retail or long-term care pharmacy, not a compounding lab.
LTC @ Home Development
With more retail pharmacies looking to take advantage of LTC at Home for their patients, we are developing a compliance solution to meet the requirements set forth by Medicare. It is being peer reviewed by pharmacists and a GPO as we speak. More details for launch date, pricing, and implementation will be coming in the future. Stay tuned.
DMEPOS and Part B Pharmaceutical Billing Service Solution
Finding a vendor who can effectively and correctly bill Medicare Part B claims is hard. CMS has a “PC-ACE” program for direct billing from the pharmacy and DMEPOS facility. This is a free software program.
The PC-ACE version 6.5 upgrade is now available for download from this link: www.ngscedi.com/pcace or go to the CEDI website www.ngscedi.com and navigate to PC-ACE.
Start the upgrade by clicking the blue button labeled PC-ACE Software Downloads. This will redirect you to the PC-ACE Download Page. You must enter your CEDI Trading Partner ID, Requestor's Name, ZIP Code, and Email Address. Select the radio button for “PC-ACE Software—Upgrade version 6.5” and the “Submit Request” button to begin the download process.
Note: The installation code needed for the upgrade will be sent to the email address entered on the download page.
An Upgrade Instructions for PC-ACE document is available on the CEDI website to assist you with upgrading the software.
If you have any questions or need assistance in downloading the PC-ACE Upgrade from the CEDI website, please contact the CEDI Help Desk at ngs.cedihelpdesk@anthem.com or at 866-311-9184.
FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
The U.S. Food and Drug Administration approved Journavx (suzetrigine) 50-milligram oral tablets, a first-in-class non-opioid analgesic, to treat adults’ moderate to severe acute pain. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system before pain signals reach the brain. See More
Trump-Era Policy Changes
President Trump has started making changes to our healthcare system. The first two items are canceling study methods of lowering prescription costs (Executive Order 14087) and changing the definition and diagnostic criteria of clinical obesity. We anticipate many more changes, especially regarding the Pharmacy Benefit Managers (PBM). Some programs must be canceled before revised programs can begin. The Reconciliation bill, set for early April, is to contain the start of the PBM reform.
U.S. Department of Justice Takes Aim at Walgreens
The Justice Department settled with Walgreens Boots Alliance, Inc. False Claims regarding false claims for prescriptions that were never dispensed. Walgreens agreed to pay $106.8 million to resolve allegations that they billed government health care programs for prescriptions that were processed but never picked up by beneficiaries.
In another action, the Justice Department filed a nationwide lawsuit alleging Walgreens had knowingly filled millions of prescriptions that lacked legitimate medical purposes.
CMS Adding a New DMEPOS Product Code
CMS added another product code for multi-function respiratory devices (excluding ventilators). Manufacturer’s training is required to add this item. If you would like to add this product code, contact your Project Manager.
Enforcement
Food City Agrees to Pay Over $8M to Settle False Claims Act Allegations Related to Opioid Dispensing.
- DEA continues an aggressive enforcement of opioid dispensing. Ensure the appropriate treatment is used on all initial fills of all C-IIs.
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
New and Updated Policies & Procedures and Forms
Policies and Procedures:
- None
Forms and Support Documents
Immunizations:
- Notification of Vaccination
- Screening Questionnaire for Adult Immunization
- Screening Questionnaire for Child and Teen Immunization
- Screening Questionnaire for Live Attenuated Intranasal Influenza Vaccination
