Included in this newsletter
- CDC to end free COVID vaccine program for uninsured early
- DEA Proposes Rule Rescheduling Marijuana to Schedule III of CSA
- States Expanding Pharmacy Scope of Services
- Fraud, Waste, and Abuse – State Verification
- NCPA asks CMS for Remedies After ESI Found to Violate Medicare Part D/DIR Final Rule
- Diabetic Shoes: Prevent Claim Denials
- Compliance Portal Updates
- Important Reminders for Your EDI Enrollment
- Enforcement
- R.J. Hedges Bulletin Releases/Webinars/Podcasts
- New & Updated Policies & Procedures
- New & Updated Forms & Support Documents
- Meet our Staff- Jeff
CDC to end free COVID vaccine program for uninsured early
Funding for the Centers for Disease Control and Prevention’s (CDC) Bridge Access Program has been depleted, meaning uninsured and underinsured Americans will lose access to free COVID-19 vaccinations sooner than expected. The temporary initiative rolled out in September 2023 with plans to dismantle this December, but the CDC confirmed the service is ending in August instead. The premature wind-down comes after legislators rescinded billions of dollars of COVID-19 funding in the fiscal 2024 appropriations bill. Some of that money was being used for the Bridge program, under which the CDC purchased vaccines from manufacturers and distributed them to local health departments and pharmacies that would then administer them to qualified recipients. Since its launch, the campaign has provided more than 1.4 million vaccine doses, but the early shutdown will leave underinsured populations with few coverage options for this fall when vaccine makers introduce updated formulations to combat the newest COVID variants. CDC is working on a replacement initiative included in the fiscal 2025 budget but, even if approved, the appropriations process would not be completed before the fall vaccines become available. See more...
DEA Proposes Rule Rescheduling Marijuana to Schedule III of CSA
The Drug Enforcement Administration (DEA) issued a proposed rule to transfer marijuana from Schedule I of the Controlled Substances Act (CSA) to Schedule III, consistent with the view of The Department of Health and Human Services (HHS) that marijuana has a currently accepted medical use as well as its views about marijuana’s abuse potential and level of physical or psychological dependence. The DEA is soliciting comments on this proposed rule, which are due on July 22. Read More...
Things to think about on this probable rule change
Overall, moving medical marijuana to a Schedule-III is smart. It will have a big impact on the illegal market. DEA will now regulate marijuana as any other controlled substance. Medical marijuana will have to be dispensed from a community or online pharmacy. The physicians will need to treat their patients with the same medical due diligence as other patients with a disease. Individual states will not be able to adapt or modify federal regulations in the community setting.
In addition, insurance payors will be required to enter this type of dispensing. National Drug Codes (NDC) and Healthcare Common Procedure Coding System (HCPCS) codes will be assigned. DEA and HHS will regulate the manufacturers. If the proposed rule is implemented, it will be a good day for community pharmacies. Cash or insurance will drive business to licensed pharmacies.
Now is the time to start thinking about the advantages if the Schedule -III marijuana market opportunities will be made legal. This rule change can very easily shut down all marijuana dispensers.
States Expanding Pharmacy Scope of Services
The pharmacy landscape is undergoing significant changes, expanding the scope of services that pharmacists can provide. These changes, which vary from state to state, aim to enhance healthcare accessibility and leverage the expertise of pharmacists beyond traditional roles. Changes include all forms of immunizations, clinical testing, opioid antagonists, epinephrine auto-injectors, post-exposure prophylaxis (PEP) for exposure to HIV infection, and hormonal contraception. In addition, pharmacists are moving from a supplier to a provider. Each state has its own set of regulations that dictate services that can be provided. As these changes occur, each pharmacy must review its professional and general liabilities to ensure the services that are permitted are covered by the pharmacy’s liability insurance carrier.
Fraud, Waste, and Abuse – State Verification
If your state requires state verification process for employee and entity exclusions, Verify Comply may be a solution. We are not endorsing them; we are simply providing a recommendation since we do not do state level verifications.
Verify Comply includes most states, but there are a few that do not offer an exclusion verification process. They do have a free version that permits 5 single individual or single entity verification searches every 30 days, but if most pharmacies would need their paid subscription, pricing is on their website. https://www.verifycomply.com/.
All states are required to report exclusions to HHS/OIG, so the national report should suffice, but some states require their own searches. The R.J. Hedges & Associates Compliance Portal® OIG/SAM report is included with our Fraud, Waste, & Abuse Prevention Program.
NCPA asks CMS for Remedies After ESI Found to Violate Medicare Part D/DIR Final Rule
Unsurprising to pharmacy owners, Express Scripts, Inc. (ESI) was found to be ignoring the CMS rule that requires point-of-sale transparency of the negotiated price paid by Part D plans. NCPA first notified CMS of fees ESI withheld, only reported in aggregate on the remittance advice, on Jan. 8, 2024. Read more ...
Diabetic Shoes: Prevent Claim Denials
In 2022, the improper payment rate for diabetic shoes was 51%, and insufficient documentation accounted for 69% of improper payments (see 2022 Medicare Fee-for-Service Supplemental Improper Payment Data (PDF), Appendices D, E, and G). Learn how to bill correctly for these services. Review the diabetic shoes provider compliance tip for more information, including:
- Codes
- Coverage limitations and requirements for therapeutic shoes
- Documentation requirements and example of improper payment
- Resources
The R.J. Hedges & Associates Diabetic Shoe program on the Compliance Portal® has all the documents needed to dispense diabetic shoes correctly and all the documentation a supplier needs to bill and be reimbursed.
Compliance Portal Updates
We apologize for the Background Check feature being unavailable for short periods of time in May and again in June. US ISS updated features on their end and everything appears to be in working order right now.
Enforcement
R.J. Hedges Bulletin Releases/Webinars
New and Updated Policies & Procedures
None at this time
New and Updated Forms & Support Documents
None at this time
Meet our Staff- Jeff Hedges
Jeff is our primary owner and name's sake. He proudly served our country in the U.S. Air Force for 27 years, after retirement he transitioned into the private sector, developing software to help independent pharmacies understand and become compliant with HIPAA. In 2006 he founded R.J. Hedges & Associates to support healthcare providers with compliance services and software solutions. Today his company offers comprehensive customized healthcare compliance, Business & Pharmacy Valuations, Brokerage and Representation during sales and Business Management consulting for independent pharmacies, home health care facilities, medical supply companies, physicians and other small practices throughout the United States.
Jeff enjoys shooting sports, hunting, teaching, mentoring and has a fondness for Woodford Reserve, German Chocolate, and Tiramisu! He says his true joys are his family: 6 grandchildren, 3 adult children and wife of 43 years, Mary.
Jeff is an active member of the Pittsburgh Entrepreneurs' Organization (EO) Chapter where he has served as membership Chair and is the current President Elect and Governance Chair. He is a proud supporter of all branches on the armed forces and makes contributions to several organizations that support both our troops and veterans on a monthly basis. He has often said he would return to the Air Force if he wasn’t too old!
He is our Compliance Guru, a true Compliance Guide and helps not only our staff and clients, but several organizations navigate the complexities of Regulatory Compliance within healthcare, especially when it applies to Independent Pharmacy operations. Outside of the office Jeff enjoys being outdoors and spending time with his Grandchildren Clayton (10), Ava (10), Maggie (8), Miles (8), Lane (6) and Jameson (5).
