Included in this newsletter
- ACHC Certifies R.J. Hedges Non-Sterile Compounding Program
- Change Healthcare Cyber-Attack
- CDC Changes COVID Quarantine
- HHS/Office of Civil Rights Issued New Regulations and Requirements for the HIPAA Security Rule
- Lymphedema Compression Treatment Items - Correct Coding and Billing – Revised
- FDA Clears First OTC Continuous Glucose Monitor
- CMS NP East and NP West – Application Requirement Cont
- DSCSA Implementation
- R.J. Hedges Bulletin Releases/Webinars/Podcasts
- New & Updated Policies & Procedures
- New & Updated Forms and Support Documents
- Meet our Staff- Karly
ACHC Certifies R.J. Hedges Non-Sterile Compounding Program
The R.J. Hedges Compounding Program has now received ACHC Certification as a Non-Sterile Compounding Program. Pharmacies using our Compounding Program will receive a discount when applying for ACHC/PCAB accreditation and workshops (Click Here for flyer) and will be able to bypass the P&P submission process during the accreditation application. 3 R.J. Hedges & Associates staff members achieved Certified Consultant status in 2020, and we are now the first and only company to provide a Certified non-Sterile Compounding Program.
“From Strategic Partners, to Certified Consultants, and now having the 1st Certified Non-Sterile Compounding Program, we are very thankful for these opportunities and excited to see this partnership with ACHC evolve. The review process of our Compounding Program was extensive, we are glad to have their certification to enhance our services and greatly appreciate the benefits and discounts they are extending to our clients. We look forward to additional programs being reviewed for certification in the future.”
–Jeff Hedges-
Change Healthcare Cyber-Attack
The cyber-attack on Change Healthcare has permeated through numerous pharmacies, Durable Medical Equipment (DME) providers, physicians, practitioners, and hospitals, highlighting the severe repercussions of such security breaches. Change Healthcare now faces the difficult task of rebuilding its system from the ground up. The "Black Cat" hackers exhibit patience, waiting until their victims are nearly incapacitated before demanding a ransom. For more details, refer to this link: KFF Health News Article
Claim processing should resume, but challenges will continue. One concern is payment to wholesalers, which should be extended. Be proactive with your vendors and don’t assume they will advance your credit.
Our healthcare system is like a delicate house of cards, and right now, it's shattered. This cyber-attack shows just how fragile and interdependent it is. Change Healthcare plays a crucial role for many healthcare providers, and the damage from this attack is just starting. With United Healthcare's dominance in the marketplace as a giant of healthcare billing processing, the danger continues to grow as billing remains at a standstill for so many practitioners who cannot switch to other processing companies.
CDC Changes COVID Quarantine
The CDC has updated their requirements for COVID-19 quarantine. The CDC believes individuals can resume normal routines while limiting close contact with others if affected individuals have avoided fever for at least 24 hours without the help of medication and their symptoms are clearing up.
HHS/Office of Civil Rights Issued New Regulations and Requirements for the HIPAA Security Rule
A week before the cyber-attack on Change Healthcare, the Office of Civil Rights (OCR) issues new requirements for HIPAA Security Rules that were postdated for effect January 1, 2024. Many are now experiencing firsthand the devastating consequences of cyber-attacks. The U.S. Department of Health and Human Services (HHS) introduced changes to the HIPAA standards, with an emphasis on bolstering the protection of computer systems and networks.
The HHS Office for Civil Rights (OCR) in the National Institute of Standards and Technology (NIST) announced the Special Publication (SP) 800-66 Revision 2, Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide effective 02/16/2024. The previous version was last updated almost 16 years ago on 10/23/2008. The updated version is a collaborative effort between NIST and OCR, and includes resources for HIPAA-covered entities (most healthcare providers, health plans, and healthcare clearinghouses) and their business associates to help their understand the HIPAA Security Rule, drive compliance with the law, and bolster security.
HHS, released a Department-wide Cybersecurity strategy for the healthcare sector in December of 2023, and voluntary performance goals to enhance cybersecurity across the health sector in January 2024.
What does this mean to you? Risk Assessments and cyber security is being expanded within the HIPAA rule. Each Covered Entity (CE) and Business Associate (BA) must work with their internet service provider, or software provider to coordinate a “Continuous Monitoring Surveillance Program.” More information will be forthcoming as we are still reviewing the updates.
U.S. Health & Human Services recently co-published a cybersecurity notice. It has lots of technical information, but we would recommend reviewing the list of mitigations starting on page 7. Talk to your IT vendor, your dispensing system vendor, or even a consultant on ways you can tighten security. The evolving landscape of cyber threats necessitates proactive measures on the part of healthcare organizations to mitigate risks and fortify defenses against potential breaches.
Lymphedema Compression Treatment Items - Correct Coding and Billing – Revised
The policy article for Lymphedema Compression Treatments has been revised. Click here for the updated information: https://dmepdac.com/palmetto/PDACv2.nsf/DID/DFVAPRN0L
FDA Clears First OTC Continuous Glucose Monitor
The FDA cleared Dexcom's Stelo Glucose Biosensor System, the first Over-the-Counter (OTC_ continuous glucose monitor (CGM) on March 5th. The integrated CGM is intended for adults with or without diabetes who do not use insulin but want to better understand how diet and exercise may affect blood glucose levels. "Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition," FDA noted. It will take one to two months before the Local Coverage Determinations (LCD) are updated to dispense the OTC monitor.
CMS NP East and NP West – Application Requirement Changes (Not for the Better)
We were informed at the NSC Advisory Council meeting on Friday, January 19th that suppliers will no longer be able to submit Corrective Action Plans for missing documentation on the CMS 855S and CMS 855B applications and revalidations. If an application is missing anything at the survey date NP East and West; the application will be revoked.
Please review RJH Bulletin 20424-001 for additional information.
DSCSA Implementation
The one-year delay for the implementation of the DSCSA, was to provide manufacturer’s additional time to get their bar code systems in place. On the Retail/Community/LTC pharmacy side, implementation should be well underway or completed at each pharmacy. If you have not begun or completed the transition, please do so as quickly as possible. You should have a goal of full implementation at the pharmacy level by July 1, 2024. We recommended RxScan to aid in this process; We recorded a Partnership Series with Max from RxScan last year, it can be found on the Compliance Portal under “Presentations”.
R.J. Hedges Bulletin Releases/Webinars
- RJH Bulletin 2024-001 – CMS Changes for CMS form 855S, Medicare Enrollment Application and Revalidation
New and Updated Policies & Procedures
DMEPOS-
- Authorization to Conduct Business
- Financial Management and Reports
- Health Literacy and Culturally Appropriate Communication Requirements
- Reconciliation
- Scope of Services and Practices
Compounding
-
- Adverse Event Reporting
- Authorization to Conduct Business
- Creating Master Formulation Records
- Compounding Pharmacist-In-Charge
- Non-Sterile Compounding
- Notification About and Recall of Dispensed Products
- Performance Improvement Program
- Personal Protective Equipment
- Pharmacy Compounding Definitions
- Procedures and Documentation
- Quality Assurance and Quality Control
- Quality Assurance Testing
- Shipping Procedures
- Standard Operating Procedures
- Transport
- USP 1075 Good Compounding Practices
-
- Pest Control
-
- Authorization to Conduct Business
- Financial Management and Reports
- Health Literacy and Culturally Appropriate Communication Requirements
- Notification About and Recall of Dispensed Products
- Reconciliation
- Scope of Services and Practices
- Shipping Procedures
New and Updated Forms & Support Documents
DMEPOS-
- Scope of Services and Practices
Compounding
-
- Compounding Compliance Task Assignment
- Compounding Record
- New and Revised Standard Operating Procedure Inventory
- Performance Improvement Quarterly Meeting Template
- Performance Improvement Self Assessment
-
- Pest Management Assessment
-
- Standing Orders
- Meningococcal (ACWY) to Children and Teens
- Pneumococcal (PCV) to Children and Teens
- Nirsevimab RSV Preventive Antibody to Infants
- Standing Orders
-
- Opioid Treatment Plan Request
Hazardous Drugs
-
-
Hazardous Drug Designee
-
Meet our Staff- Karly Lupacchini
Meet Karly! If you’ve phoned into the office lately her warm cheery voice has been on the other end. She joined our company at the beginning of the year and has been a great addition to our support staff.
Karly is supporting our office manager, Alisa, with inbound phone calls, maintaining office supplies, and has become a master at printing on our giant copy machines and the laminator. She is also supporting our Project Manager staff by creating personnel folders for their clients, assembling all new compliance program binders, and preparing items to ship out to clients. She has quickly become our go to person for support projects as she learns all the ropes at R.J. Hedges & Associates.
An avid dog lover, she enjoys spending time with her dog Brelynn. At 2 years old she is still very much a puppy and enjoys playing ball and has a special fondness of water and much like a little kid can’t resist splashing in them on rainy days.
When away from work she enjoys spending time with her nieces Harlyn (4) and Jayde (2), vegetable gardening and canning those fabulous items from her garden especially tomato sauce and pickles.
