August 2024 - Newsletter

Included in this newsletter

1. Collaborative Pharmacist-Led Intervention Prevents Hospital Readmissions Among Elderly Patients Discharged from the Emergency Department
2. Rite-Aid is Coming Out of Bankruptcy and rolling fines into unsecured claims
3. Physician Mandatory Training for Prescribing Controlled Substances Safely – A DEA Requirement
4. Hazardous Drugs Assessment of Risk Update Complete
5. Moving Sale: Hazardous Drug Spill Kits
6. CMS DMEPOS Pharmacy Exemption Requirements
7. Enforcement
8. Bulletins, Podcasts, & Webinars
9. R.J. Hedges & Associates Office Address
10. New & Updated Policies & Procedures
11. New & Updated Forms and Support Documents
12. Meet our Staff – Kathy

Collaborative Pharmacist-Led Intervention Prevents Hospital Readmissions Among Elderly Patients Discharged from the Emergency Department

Researchers explored whether incorporating pharmacists into emergency department (ED) care models might curtail unplanned hospital readmissions and save costs, particularly among older adults whose risk may be elevated by medication management issues. The cohort study, conducted at a single Australian facility from November 2022 to February 2023, involved patients aged 65 years and older who were prescribed at least three medications and presented to the ED for falls, mobility issues, or cognitive impairment. When a pharmacist was available, participants matching these criteria received drug selection recommendations, deprescribing opportunities, identification of drug-drug interactions, discharge liaison services, and other pharmacy-led interventions. Read more...

In addition, pharmacists, along with the patient’s physician, significantly improved the patient’s health and the pharmacy’s EQuiPP Scores, Star Ratings, and DIR fee reimbursements. In today’s environment, the pharmacy must achieve a 70% medication adherence (MedSync) rate or higher.

Rite-Aid is Coming Out of Bankruptcy and rolling fines into unsecured claims

Rite-Aid’s plan to emerge from bankruptcy has been approved, but it comes with severe penalties as they are now settling not 1 but 2 different compliance issues. The fines are being listed as settlements and are having large sums rolled into “unsecured claims” as part of the bankruptcy payback.

#1 False Claims Act and Controlled Substance Act Allegations related to Opioid Dispensing: The settlement of almost $410 million for controlled substance violations is for “filling unnecessary prescriptions for powerful and addictive opioids”. U.S. Attorney Rebecca C. Lutzko for the Northern District of Ohio said, “Pharmacies and pharmacists have an affirmative legal duty to ensure that the prescriptions they fill are legitimate. When they disregard this responsibility and instead ignore red flags indicating that prescriptions for addictive painkillers are invalid, they violate the public’s trust and harm the community they are supposed to serve — all to make a buck.” Read the full article from DOJ here…

We recommend reviewing DEA Compliance Program, Chapter 1, Item 2 to ensure this does not occur at your location.

#2 Falsely Reporting Rebates causes fines with HHS-OIG. The settlement will be $101 million for Rite Aid and $20 million for its subsidiaries Elixir Insurance Company, RX Options LLC and RX Solutions LLC.

The settlement resolves allegations that, between 2014 and 2020, the defendants improperly reported to CMS portions of rebates received from manufacturers as bona fide service fees, even though manufacturers did not negotiate with the defendants to pay such fees. The United States further alleged that Elixir Insurance knew the retained rebates did not meet the regulatory definition of bona fide services fees.

“Truthful and accurate documentation in the delivery of health care goods or services is crucial to the integrity of federal health care programs,” said Deputy Inspector General for Investigations Christian J. Schrank of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “Improper submission of manufacturer drug rebates and fees by Part D Plan Sponsors for pharmaceutical products in order to make more money will not be tolerated. Collaborating with our law enforcement partners, HHS-OIG is committed to preventing and investigating health care fraud in Medicare and other taxpayer-funded health care programs.”

Read the full article from DOJ here…  We recommend reviewing FWA Compliance program, Chapter 1, Items 1 and 8.

Physician Mandatory Training for Prescribing Controlled Substances Safely – A DEA Requirement

DEA has been hitting pharmacies nationwide hard because of the lack of documentation and a treatment plans for C-II’s. When pharmacies do not have proper documentation from Physicians the pharmacy is at risk of fines and penalties if they dispense medication. Starting June 27,2023 DEA requires physicians to take a one time, eight-hour course on Prescribing Controlled Substances Safely. This training explains documentation and treatment plan requirements “The MATE Act replaced the previous X waiver program with the new training requirement that is meant to ensure all clinicians who can prescribe controlled substances have a basic understanding of evidence-based substance use disorder prevention and treatment.” From AAFP article 7-5-23 link below.

Even though this updated requirement for physicians started last summer, they have till 2026 to complete when they submit their DEA license for renewals. If you run into issues, please consider utilizing this letter from DEA and this article from the American Academy of Family Practitioners for reference.

Appropriate documentation forms can be found on the Compliance Portal^® in the DEA and Pharmacy Compliance Programs.

https://www.aafp.org/pubs/fpm/blogs/inpractice/entry/new-dea-requirement.html

https://www.deadiversion.usdoj.gov/pubs/docs/MATE_Training_Letter_Final.pdf

Hazardous Drugs Assessment of Risk Update Complete

Retail (community) and LTC pharmacies must have an Assessment of Risk (AoR) completed and signed by the “Designated Person” for all HD’s being dispensed to patients. These documents are becoming a favorite for State Board of Pharmacy inspectors to ask for. R.J. Hedges & Associates has updated our completed Assessments of Risk to match the Draft NIOSH Hazardous Drugs List – 2020, (YES! We are still waiting for it to become fully adopted). There have been several drugs that have been affected by this change which includes a reduction from three (3) tables to two (2) tables and a realignment of many HDs. The current R.J. Hedges AoR library includes 229 completed AoR’s which considers 158 individual drugs.

Clients who previously purchased AoRs will have access to the updated versions on the Compliance Portal^® at no charge. Clients wishing to purchase the AoR library can do so by emailingsales@rjhedges.com or order online https://www.rjhedges.com/usp-800-hazardous-drugs-compliance-retail-pharmacies. The entire library is available for a one-time fee of $250 and will be accessible via the Compliance Portal^®.

If you have purchased the AoR’s please review, print, and sign the new ones to ensure they are referring to the correct Table as updated in the NIOSH Hazardous Drug List – 2020.

Be sure to also print the HD inventory sheets needed to match your inventory. Place all updated and signed AoRs along with the HD Inventory sheets into a folder or binder where your staff can readily obtain these documents for state board inspectors or for the pharmacy staff to review. There may be AoRs for HDs that are not currently in your pharmacy inventory. Since drug inventories are always changing it's better to have all the AoRs signed and ready rather than trying to keep track of the documentation as new patients come and drug inventories change.

The previous AoR versions you may already have in your facility do have a 10-year retention period, just like all Medicare Part D documents. Store the old AoRs and place a destruction date of 10 years from the date the new AoRs were signed.

CMS DMEPOS Pharmacy Exemption Requirements

The pharmacy accreditation exemption for DMEPOS products has been in place since late 2009. 10% of all exempt pharmacies receive a letter each year, requesting verification that the pharmacy has less than 5% of gross sales of DMEPOS products. We have seen a recent uptick of panicked pharmacies who are at risk of losing their PTAN because they FAILED to respond to NP East (Novitas) or NP West (Palmetto GBA), the regional DMEPOS contractors. Failure to respond to these letters will result in the loss of the pharmacy’s PTAN. Depending on your state, the state’s Medicaid program may follow suit and revoke your pharmacies Medicaid number.

The verification should be a simple process which includes page 1 of the pharmacy’s tax returns, and a certification from the pharmacy’s CPA stating the “Gross Sales of DMEPOS products does not exceed 5%”. There are a couple of other small requirements that also need to be taken care of as listed in these letters.

When you receive a letter from CMS, Novitas, or Palmetto GBA that you do not understand, it is imperative that you send the letter to your Project Manager for explanation. If your CPA does not want to write this certification on their letterhead because they don’t break out Medicare Part B DMEPOS products, please advise them that we have never seen a pharmacy anywhere in the country that has made it to two percent. If they still refuse, you may need to find another CPA.

Revocation of the pharmacy’s CMS Provider Transaction Access Number (PTAN) comes at a great cost. The revocation is one year followed by the state revoking the Medicaid number. Again, this is one year without Medicare Part B and Medicaid reimbursements. The pharmacy will need to obtain a DMEPOS accreditation and apply for a new PTAN. The pharmacy needs to bill at least one Medicare Part B product per quarter, maintain its surety bond, and revalidate its Medicare Part B application every three years.

Hazardous Drug Spill Kits

 R.J. Hedges & Associates is having a Moving Sale for our Hazardous Drug Spill Kits. These kits can be used for Hazardous Drugs, Hazardous Chemicals, and Bio-Hazards containment and cleanup. Get yours while they last for $65.00 + shipping. Email sales@rjhedges.com or order online https://www.rjhedges.com/usp-800-hazardous-drugs-compliance-retail-pharmacies.

Bulletins, Podcasts & Webinars

• Blog - Ensuring Healthcare Cybersecurity: Comprehensive Guide for Providers August 2, 2024
• Blog- USP <800> Compliance Guide for Independent Community & Retail Pharmacies August 13, 2024

Enforcement

• National Health Care Fraud Enforcement Action Results in 193 Defendants Charged and Over $2.75 Billion in False Claims
  • Never purchase pharmaceuticals from an unknown wholesaler or distributor
• Pain Management Physician and Former Member of Kentucky’s Medical Board Convicted of Unlawfully Prescribing Opioids

R.J. Hedges & Associates Office Address

Did you know our company started as a fully remote company back in 2006?  We were ahead of our time!  In 2016, we purchased our office space at 163 9th St, New Florence, PA and enjoyed many events and meetings over the last 7+ years.  Since most of our employees opted to remain virtual after the pandemic, we have made the decision to go fully virtual again and allow all our employees to work remotely.  Our mailing address will remain PO Box H, New Florence, PA 15944.  You will not see any changes in your level of service, but you may hear kids and pets in the background. 😊

New and Updated Policies & Procedures

New and Updated Forms & Support Documents

Meet our Staff- Kathleen "Kathy"

Kathy has been a registered Nurse for 39 years after receiving her Bachelor's degree from Pitt. She worked as a Staff Nurse in orthopedics/trauma, then as a nursing instructor at Admiral Peary Vo Tech, Indiana Career & Technology Center, and Westmoreland County Community College.

She has 2 children: a son, Steffan, 27, also an RN, he is married and has a 2 ½ year old daughter, Sophia.  Her daughter, Kallesta is 23 and is a Vet Assistant.

Her passions and hobbies include floral arranging where she lends her talent part-time at the local market. Kathy also enjoys sewing, she even belongs to a sewing group that meets once a week to work on projects.  Additionally, she is a contributor of the Linus Project which meets monthly to make blankets for children in area hospitals.

In her retirement from nursing she can be found at the local Library helping people find their next great read.  She says “I like to knit and crochet, read mysteries and hockey, esp. going to Penguin games and Johnstown Tomahawk games”.

At RJ Hedges & Associates, Kathy is still learning the ins and outs of the company as she recently joined our team in May.  Her new role will be assisting with Medicare Applications, Revalidations, and lending a hand to the Project Manager Team.

We are certainly glad to have her helping to keep an eye on all things Medicare!