Included in this newsletter
- Major changes in HIPAA for 2026
- Long-Term Care (LTC) at Home Policies and Procedures
- CMS Expands Roster Billing for Hepatitis B Vaccine
- FDA to Hold Off Action on Weight-Loss Drug Copies Pending Court Ruling
- Optum Rx Further Simplifies Consumer Access to Prescription Drugs
- Important Update: Completed Assessment of Risk (AoR) Solution Relaunch
- Electronic MRNs Now Available Through NGSConnex
- Enforcement
- Policy & Procedure Updates
Office Holiday Closure
Our office will be closed for the Easter Holiday on Friday April 18th.
Major changes in HIPAA for 2026
HIPAA was last updated in January 2013. There have been minor updates since then. However, the Health and Human Services (HHS) Office for Civil Rights (OCR) has released proposed privacy and security rules that will overhaul the entire set of standards and take effect in 2026. The new privacy rules included are substance use disorder (SUD), reproductive healthcare, and ePHI on individual devices (iPhones, androids, etc.). A new notice of privacy practices will also be required next year. On the security rule side, cybersecurity is the main topic. We recommend that you begin asking your software vendors about vulnerability scans, penetration tests, safeguarding portable devices, business associates (note that all new business associate agreements will be amended), encryption, and multi-factor authentication.
Long-Term Care (LTC) at Home Policies and Procedures
R.J. Hedges has developed an LTC @ Home program and completed the peer review. This policy and procedure is very big and can be complex. To make this program easier to navigate, it is being divided into several policies and procedures. We are working very hard to get this out, but we want to ensure that when it comes out, it is easy to follow. Stay tuned for additional information. In preparation, if your pharmacy has not yet implemented or fully implemented the Medication Adherence Program (Sync), please begin the process in earnest. Both programs work well together, and this will enhance the pharmacy’s EQuiPP Scores and Star Rating, ultimately increasing reimbursement.
CMS Expands Roster Billing for Hepatitis B Vaccine
CMS has issued MLN Matters Number: MM13937. Starting January 1, 2025, CMS expanded hepatitis B vaccination coverage by revising 42 CFR 410.63(a)(2), intermediate risk groups, to include:
- Patients who haven’t previously received a complete hepatitis B vaccination series
- Patients with an unknown vaccination history.
Before this coverage expansion, the hepatitis B vaccine was available to Medicare patients at high or intermediate risk of contracting hepatitis B if ordered by a doctor of medicine or osteopathy. See More…
FDA to Hold Off Action on Weight-Loss Drug Copies Pending Court Ruling
Removal of semaglutide (Wegovy/Ozempic—Novo Nordisk) from FDA's drug shortage list means compounders can no longer produce large batches of copycat medication, but the regulator says it will not enforce the rule just yet. Instead, the agency is waiting for word from the courts on an injunction that would authorize compounding pharmacies to continue making their own versions of the popular weight-loss and diabetes medication. U.S. federal judge Mark Pittman is expected to rule on the request from the Outsourcing Facility Association — which represents compounding pharmacies — later this year. He has already handed down a decision in a similar lawsuit filed by the plaintiff for tirzepatide (Zepbound—Eli Lilly), denying the group's petition for an injunction to keep making copies of the drug even though it, too, is no longer considered in critically short supply. The Outsourcing Facility Association is appealing to overturn that ruling.
Optum Rx Further Simplifies Consumer Access to Prescription Drugs
Optum Rx is committed to making prescription drugs more affordable and the pharmacy experience simpler for consumers with chronic conditions, eliminating up to 25% of reauthorizations, which is equivalent to more than 10% of overall pharmacy prior authorizations.
“Optum Rx is taking meaningful steps to simplify patient experiences and increase access to essential medications,” said Patrick Conway, M.D., Chief Executive Officer of Optum Rx. “These changes mean easier access to medications for consumers, less work for pharmacists and physicians, and a simplified system focused on clinical quality.”
The initiative focuses first on approximately 80 drugs, and Optum Rx will work with physicians and pharmacists to expand the list over time.
Medication authorizations are important for ensuring the safe, appropriate, and evidence-supported use of drugs. Some reauthorizations are necessary for drugs that have safety concerns, need ongoing monitoring for dose adjustments, require additional tests, or may have alternative therapy considerations. See More…
Important Update: Completed Assessment of Risk (AoR) Solution Relaunch
Earlier this year, NIOSH released the updated 2024 List of Hazardous Drugs in Healthcare Settings, which brought substantial changes:
- 25 new drugs were added
- 7 drugs were removed
- Table 3 was eliminated entirely
- Nearly 100 drugs were moved between Tables 1 and 2
- Table names and descriptors were simplified—removing references to “antineoplastic” and developmental/reproductive hazard categories
Given the scope of these updates, we are officially relaunching our Completed Assessment of Risk (AoR) Solution to ensure your pharmacy remains compliant under OSHA and USP <800> guidance.
What’s Changing
When we first launched the AoR in 2019, it was provided as a one-time customized solution, printed and shipped as a complete binder. In 2021, we made those documents available through our Compliance Portal to provide easier access.
Now, with the release of the 2024 NIOSH list, the Completed AoR list has grown to over 265 AoR and many have seen changes. To help our clients remain compliant, we’ve rebuilt the entire AoR Table of Contents to reflect the latest NIOSH structure and drug updates. Any previously executed AoR’s need retained for 10 years. The New version of the AoR’s will need reviewed and signed based on your current Hazardous Drug Inventory. As before, you will need to review your inventory and sign each AoR annually, they are designed with 5 years’ worth of reviews.
As part of this relaunch:
- All previous complimentary AoR access has been removed from the Compliance Portal
- Pharmacies can now purchase the newly updated AoR Solution as an annual subscription
- The subscription includes future updates so if NIOSH makes further changes (e.g., moving drugs between tables or adding/removing drugs), your materials will be kept current
- All content will remain available 24/7 in the Compliance Portal
If your pharmacy purchased the AoR Solution within the past 6 months, you will be granted 6-month access to the new version. If you wish to continue with the updated version, you will need to sign a new agreement for the ongoing subscription.
We appreciate your trust in us as your compliance partner. Our goal is to keep your pharmacy protected without creating unnecessary burden or confusion. If you have any questions or need help determining whether this program is right for your pharmacy, don’t hesitate to contact our sales team sales@rjhedges.com
For additional information abut Assessments of Risk, please visit our website. If you would like to order the new Completed Assessments of Risk please go to our order form.
Electronic MRNs Now Available Through NGSConnex
National Government Services (NGS) has launched a new initiative to discontinue paper Medicare Part B Redetermination Notices (MRNs) for requests submitted through NGSConnex. Providers can now view and print MRNs online, allowing for faster delivery, improved tracking, and reduced paper use.
This change only applies to redeterminations submitted electronically. Beneficiaries and providers using USPS will continue to receive paper MRNs.
Key Reminders:
- Submit redetermination requests using the initial claim only.
- Only one request will be processed per claim.
- To locate an MRN in NGSConnex:
- Go to Claim Status Lookup
- Select provider and enter Medicare number and service dates
- Click on claim number → Appeal Status → View Decision Letter
NGS is offering a webinar to walk providers through the new process on April 23, 2025 | 10–11 a.m. ET. Register here.
Source: National Government Services, NGS Weekly News & Events.
Enforcement
New and Updated Policies & Procedures and Forms
Immunizations:
- Standing Orders for:
- MMR to Adults
- MMR to Children and Teens
- Zoster Vaccine to Adults Shingrix (RZV)
- State Specific Physician Protocols and Orders
