Our office will be closed for Independence Day starting Thursday July 3rd @ 5pm EST and Reopening Monday July 7th @ 8am EST.
We have received reports of individuals claiming to be CMS inspectors entering pharmacies and DMEPOS facilities without presenting proper credentials.
Please remember that under Medicare Part B, Part C, and Part D regulations, CMS inspectors are required to properly identify themselves upon arrival. Without valid credentials, they have no authority to conduct inspections or access any information. You should deny entry and access and not assume the individual is who they claim to be.
Additionally, HIPAA regulations strictly limit access to Protected Health Information (PHI) within your facility. Only trained employees, authorized business associates, state and federal inspectors with proper identification, and payor auditors are permitted access to PHI.
If someone presents themselves without credentials:
Please send this documentation to the agency the individual claimed to represent and to HHS/OIG. The Fraud Hotline poster provides contact information and your Fraud, Waste, and Abuse (FWA) program materials.
Remember, PHI within your facility is a valuable target for fraudsters. Remain vigilant and protect your patients’ data.
Medicare Drug Price Negotiation Program (MDPNP) officially starts Jan. 1, 2026. CMS is emailing the primary points of contact (or "authorized officials") in the National Council of Prescription Drug Programs dataQ Pharmacy Database ("NCPDP Pharmacy Database") to provide information about enrollment into the Medicare Transaction Facilitator (MTF), which is expected to begin in June 2025. Read more here…
Click Here for Medicare Explanation Video Enroll in the Medicare Transaction Facilitator (MTF)
The Ohio Medical Board has released the following on retail IV therapy clinics. This statement is the first of its kind, but other states will review and possibly issue their own guidance. If you have or are thinking about adding IV Therapy to your operation, please review this document. Click Here
On June 9th, APhA withheld its endorsement of the ACIP Audit Immunization Schedule. See More…
On June 10th, Health Secretary RFK Jr. abruptly fired the CDC Vaccine Advisory Panel. The Health Secretary took the extraordinary step of firing the expert panel that advises the Centers for Disease Control and Prevention on immunizations, saying the action was needed to restore faith in vaccines. RFK Jr. ousts ACIP group that advises CDC on vaccines | AP News
“A clean sweep is needed to re-establish public confidence in vaccine science,” Kennedy said in an op-ed published Monday afternoon in the Wall Street Journal.
With the nationwide closure and sell-off of Rite-Aid pharmacies, many independent and community pharmacies are seeing increased patient inquiries about transferring prescriptions. This shift presents a strong opportunity to expand your patient base. Since Rite-Aid did not provide adequate support for Medicare Part C and Part D plans, it's important to be familiar with the best plans available in your area and prioritize accepting patients who are enrolled in them. These patients often have a better understanding of their benefits and will likely be easier to serve efficiently. However, it’s also essential not to overlook patients enrolled in less favorable plans. Take the time to educate them about how their insurance works and let them know that you will reach out during the Medicare Open Enrollment period in October to help them make better-informed decisions that benefit them and your pharmacy.
In addition to gaining new patients, there is also a significant opportunity to strengthen your team. With so many Rite-Aid locations closing, highly skilled pharmacists and pharmacy technicians may be looking for new positions. Proactively seek out and interview top talent from these closing stores. Hiring staff who are already familiar with the patients transferring from Rite-Aid can help provide a smooth transition and foster a sense of continuity and trust. Overall, this is a key investment in both the growth of your customer base and the strength of your staff to build a more resilient and patient-focused pharmacy.
In the wake of the COVID-19 pandemic, public confidence in vaccines and government-led health initiatives has significantly declined. This growing mistrust has led many parents to forgo routine childhood immunizations. Consequently, diseases once considered eradicated in the United States, such as measles, which had been eliminated by 2000, are now re-emerging and spreading across communities.
Pharmacies and pharmacists are uniquely positioned to be a trusted voice in restoring confidence in vaccines. As accessible healthcare providers, pharmacists can play a vital role in educating families about the safety and importance of childhood immunizations.
Community Engagement Opportunity
This public health crisis presents an important opportunity for pharmacies to lead outreach efforts. By partnering with local organizations such as Parent Teacher Associations (PTAs), YMCAs, YWCAs, and youth centers, pharmacies can:
Resources for Support
Pharmacies can utilize the Vaccine Information Statements in Chapter 2 of their Immunization Program. These materials are also readily available through the Immunization Action Coalition.
The PBS film “Protecting Health: Saving Lives” is a powerful resource for broader public education. This documentary, supported in part by R.J. Hedges & Associates, highlights the importance of vaccines and public health initiatives in safeguarding communities.
By stepping into this leadership role, pharmacies can significantly improve vaccine hesitancy and protect public health, starting with our youngest and most vulnerable.
The Labor, Health and Human Services, and Treasury departments took action today to advance President Trump’s directive to ensure Americans have clear, accurate, and actionable information about healthcare prices.
The departments jointly issued a Request for Information (RFI) seeking public input on improving prescription drug price transparency. The RFI seeks input regarding the prescription drug price disclosure requirements, including information on existing prescription drug file data elements and information on implementation generally, such as the ability of health plans to access necessary data for reporting, as well as state approaches and innovation. See More…
Some R.J. Hedges & Associates clients may have received an email from BOC with the following statement, “The Centers for Medicare and Medicaid Services (CMS) directed BOC to temporarily stop accepting new DMEPOS applications for reaccreditation and accreditation services from facilities located in California, Florida, New York, and Texas facilities.”
A BOC surveyor was indicted for obstruction, but no criminal action was taken against BOC, however, they are not surveying. See the Enforcement section below “Miami Inspector Pleads Guilty…”.
R.J. Hedges & Associates’ DMEPOS, Pharmacy, and Compounding programs comply with CMS and Accreditation Commission for Health Care (ACHC) standards. DMEPOS and Pharmacy accreditation with ACHC require the facility to submit certain policies and procedures for review before the accreditation survey. We are working toward an exemption from this requirement for our clients.
Compounding accreditation requires no policy and procedure submission, since our compounding program went through a detailed review to receive ACHC compounding certification.
The Food and Drug Administration has approved Novavax’s COVID-19 vaccine, but with unusual restrictions.
Novavax makes the nation’s only traditional protein-based coronavirus vaccine and, until now, the FDA has granted emergency authorization for use in people 12 and older.
On May 15th, the FDA granted the company full approval for its vaccine for use only in adults 65 and older, or those 12 to 64 with at least one health problem that puts them at increased risk from COVID-19. See More
FDA officials have outlined the rationale behind the shift in U.S. policy on COVID-19 vaccination, which until now has been recommended for all persons aged 6 months and older. FDA Commissioner Martin A. Makary, MD, MPH, and Center for Biologics Evaluation and Research Director Vinay Prasad, MD, MPH, point to evidence suggesting annual boosters may not be necessary to protect against the most clinically important health outcomes See More
We are beginning a series of articles based on next month’s task list. We have had regulations within the DMEPOS Compliance Program for performance management and Compounding Compliance Program for quality assurance, quality control, and performance improvement. Regulators have a long history of reviewing accreditation organization’s requirements and adding some of those items to inspection checklists. These programs aim to identify potential problems or work practices that could endanger patients and/or employees and work to prevent and mitigate those events. Virtually every healthcare specialty has some type of requirement(s) for Quality Improvement. There are three parts to a quality improvement program:
To fully implement a Quality Improvement program, employees must be trained on your facility's specific protocols, the entire staff should review processes to learn and improve the overall operation and mitigate issues.
Pharmacy:
Compounding:
HIPAA:
FWA:
Hazardous Drugs:
DME:
Human Resources:
OSHA:
DEA:
Diabetic Shoes:
FWA:
Immunizations:
Pharmacy:
DME:
With the release of the 2024 NIOSH list, the RJHedges 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 may need retired and retained for 10 years. The New version of the AoR’s will need reviewed and signed based on your current Hazardous Drug Inventory. Pharmacies will need to review their inventory and sign each AoR annually, they are designed with 5 years’ worth of reviews.
For additional information about 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.