May 2023 - Newsletter
Included in this newsletter
- DEA Drug Diversion Changes
- HHS/Office of Civil Rights (OCR) Updates HIPAA Communications Requirements
- Centers for Medicare & Medicaid Services (CMS) Medicare Part D Final Rule
- eLearning Center Updates
- Drug Supply Chain Security Act (DSCSA) (Track & Trace) Update
- CMS Addresses Post-Public Health Emergency (PHE) CR Modifier Concerns
- Consumers Shop Pharmacies for Grocery and Household Items According to New Study
- Listen to Our Latest Podcasts!
- R.J. Hedges Bulletin Releases/Webinars
- Updated and New Forms
- Updated and New Policies & Procedures
DEA Drug Diversion Changes
DEA has changed the Schedule II (C-II) documentation requirements in conjunction with the U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC). The main change revolves around Morphine Milligram Equivalents (MME) which is the number of milligrams of morphine an opioid dose is equal to when prescribed. There are physician requirements concerning treatment goals and plans. When a patient is prescribed a dosage greater than or equal to 50 MMEs, physicians must assess and reassess individual benefits and risks, especially in combination with a benzodiazepine. A copy of the treatment plan must be available for the pharmacist starting at 50 MME. If the dosage is 90 MMEs or greater, the treatment plan must be sent to the pharmacist and maintained with the prescription record. The pharmacist has a Corresponding Responsibility to ensure the dosage requirements are valid for the patient throughout the treatment plan. In addition, Naloxone should be considered for the patient.
Patients who have chronic pain, severe pain, or are in hospice routinely will exceed 90 MME. The pharmacist should consult the physician on the treatment plan in these cases. This conversation must be added to the patient's prescription profile for future reference.
The Drug Diversion Due Diligence policy and procedure has been updated with these requirements and is found in the Compliance Portal®, DEA Compliance, Item # 3. This policy has doubled in size and every pharmacy owner, pharmacist-in-charge, and pharmacist must read this policy. DEA quietly announced these changes in enforcement on July 1, 2022. DEA has restarted its on-site inspections, including reviewing the state’s Prescription Drug Monitoring Program (PDMP). DEA appears to be very aggressive with these inspections.
- Owner of Northeast Philadelphia Pharmacy Charged with Conspiracy to Distribute Oxycodone and Fraud
- Pharmacy Owners Charged with $26 Million Health Care Fraud Scheme
HHS/Office of Civil Rights (OCR) Updates HIPAA Communications
The OCR updated the HIPAA Rules to permit use of remote communication technologies. The roots of this rule began with waivers for HIPAA compliance during the COVID-19 pandemic. The HIPAA rules require a covered entity to enter into a business associate agreement (BAA) with a telecommunication service provider (TSP) only when the vendor acts as a business associate. In other words, the vendor stores communications within their system, i.e., Spruce Health. The odd thing about this rule is that it applies to audio-only but telehealth services are normally audio and visual and the OCR has no plans to enforce this rule.
Centers for Medicare & Medicaid Services (CMS) Medicare
Part D Final Rule
CMS Medicare Part D Final Rule on DIR fees is a webinar that every pharmacy owner and pharmacist-in-charge needs to listen to. Click here to listen.
Time Overlap in 2024. 2023 DIR fees will be collected in 2024 and reimbursements will be at the lowest net price. 2024 will feel like a double DIR collection. Everyone needs to save as much as possible and talk to your PSAO.
Four key factors in preparing for January 2024
- Prepare for a change in cash flow with the point-of-sale-based DIR
- Prepare to operationalize your workflow around the lowest net price
- Watch for 2023 implementation by some Part D Sponsors
- Discuss with your PSAO or other contracting experts
eLearning Center Updates
The eLearning Center has been updated. The following training modules are now available:
- DEA Pseudoephedrine
- Fraud, Waste, and Abuse Prevention
- Health Literacy, Cultural Appropriate Communication & Limited English Proficiency
- HIPAA Compliance (Privacy, Security, Delivery Drivers, Breach processes, Law Enforcement, and Preparation for an OCR inspection)
- Fire Extinguisher Training
Drug Supply Chain Security Act (DSCSA) (Track & Trace) Update
Pharmacy software companies are starting to work with DSCSA software programs. At this time, Liberty Software and Red Sail Pharmacies will use InfiniTrak, RxScan is a stand-alone program. Naturally, there will be fees associated with using these software programs.
State pharmacy boards have begun asking how pharmacies track medications. This rule goes into effect on November 27, 2023. The pharmacy's inventory must be recorded in DSCSA tracking software on this date.
CMS Addresses Post-Public Health Emergency (PHE) CR Modifier Concerns
The DME MACs published new post-PHE directions for DME suppliers. The new instructions state that for claims impacted by the COVID-19 PHE, the CR modifier and COVID-19 narrative can be used for ongoing rental and supplies/accessories after the end of the PHE on May 11, 2023. This rescinds the announcement made in the March MLN Connects, which directed suppliers to stop using the CR modifier after the end of the COVID-19 PHE. Below is a passage from the announcement:
To address concerns for continued claims payment of DMEPOS items provided during the PHE and to identify claims for supplies and accessories associated with DMEPOS items initially dispensed, rendered, or otherwise impacted by the PHE, the DME MACs are instructing suppliers to continue the use of the CR modifier (Catastrophe/disaster related) and COVID-19 narrative. The CR Modifier and COVID-19 narrative can continue to be used for any DMEPOS item (ongoing rentals) and related supplies/accessories where the base item was initially dispensed, rendered, or otherwise impacted by the PHE (dates of service on March 1, 2020, through May 11, 2023) and specifically excluded from enforcement of the clinical indications of coverage referenced in Interim Final Rules CMS-1744-IFC and CMS-5531-IFC. The use of the CR modifier and COVID-19 narrative is intended to allow the DME MACs to implement new system editing for PHE-dispensed DMEPOS items and provide the ability to identify these claims for future review if indicated.
These directions come after AAHomecare and DME MAC Advisory Councils communicated with DME MACs and CMS about concerns with their previous decision to remove the CR modifier. The announcement should provide great relief for the DME supplier community. You can find the full instructions from the DME MACs here.
Consumers Shop Pharmacies for Grocery and Household Items According to New Study
Nationwide pharmacy sales reached $53 billion by mid-February 2023, marking the third consecutive year of growth, NielsenIQ reported in March. According to research from the Acosta Group, consumers favor pharmacies over grocery stores, mass retail stores, and online stores for pharmacy and medical needs (64%), providing an easy and convenient experience (59%) and a fast trip experience (53%). Shoppers suggested pharmacies could improve by adding more staff members, curbing out-of-stock occurrences, and enhancing the online ordering experience. The majority of shoppers at pharmacies belong to their loyalty programs, while a smaller percentage actively use pharmacies' digital apps. See more...
Listen to Our Latest Podcasts
Listen to the following podcasts for some great information by clicking the link or through the Presentation tab on the Compliance Portal
- Podcast – Navigating DEA Regulations: A Guide to Registrars, Coordinators and Power of Attorneys 05/05/2023
- Podcast – Why a 401k is Good for Business 05/05/2023
- DiversifyRx Podcast - Navigating Hazardous Drug Compliance in Pharmacy 05/04/2023
- DiversifyRx Podcast - Controlled Drugs Discussion-DEA 05/10/2023
R.J. Hedges Bulletin Releases/Webinars (found in Message Center)
The following items can be accessed through the Message Center on the Compliance Portal®:
- May Task List (05/01/2023)
- Bulletin 2023-001 - CMS Waivers, Flexibilities, and the end of COVID-19 Public Health Emergency
New and Updated Forms
- External Infusion Pump Medications Detailed Product Description
- Detailed Product Descriptions:
- Automatic External Defibrillator
- External Infusion Pumps
- Negative Pressure Wound Therapy Pumps
- Osteogenesis Stimulators
- Power Mobility Devices
- Pressure Reducing Support Surfaces Group 1
- Pressure Reducing Support Surfaces Group 2
- Pressure Reducing Support Surfaces Group 3
- Respiratory Assist Devices
- Suction Pumps
- Surgical Dressings
- Therapeutic Shoes for Persons with Diabetes
- Transcutaneous Electrical Joint Stimulation Device
- Transcutaneous Electrical Nerve Stimulators
- Detailed Product Descriptions:
- Standing Orders
- Haemophilus Influenza B to Children
- Hepatitis A to Children and Teens
- MMR to Adults
- MMR to Children and Teens
- PCV to Children
- Pneumococcal (PCV115, PCV20, and PPSV23) Adults
- Pneumococcal (PPSV) Children and Teens
- Rotavirus to Infants
- Varicella Vaccine (Chickenpox) to Adults
- Varicella Vaccine to Children & Teens
- Standing Orders
New and Updated Policies and Procedures
- Prescribing Medical Practitioner Order Changes (Medicare Part B)