June 2022 - Newsletter

Included in this newsletter


R.J. Hedges & Associates Brokerage and Valuation Services

R.J. Hedges & Associates can also provide our compliance customers with assistance for Business & Pharmacy Valuations, Business Brokerage (Acquisitions&Mergers), Representation during acquisition sales, and Business Management Consulting. Please talk to your Project Manager to get more information.

CMS Medicare Part D Final Rule

CMS Medicare Part D Final Rule on DIR fees is a webinar that every pharmacy owner and Pharmacist-In-Charge needs to listen to.
Time Overlap in 2024:
2023 DIR fees will be collected in 2024, and reimbursements will be at the lowest net price. 2024 will feel like a double DIR collection. Everyone needs to save as much as possible and talk to your PSAO.
Four key factors in preparing for January 2024

  • Prepare for a change in cash flow with the point of sale based DIR
  • Prepare to operationalize your workflow around the lowest net price
  • Watch for 2023 implementation by some Part D Sponsors
  • Discuss with your PSAO or other contracting experts

HHS/Office of Civil Right Updates HIPAA Communications Requirements

OCR updated the HIPAA Rules to permit the use of remote communication technologies. The roots of this rule began with waivers for HIPAA compliance during the COVID-19 pandemic. The HIPAA Rules require a covered entity to enter into a business associate agreement (BAA) with a telecommunication service provider (TSP) only when the vendor is acting as a business associate. In other words, the vendor stores communications within their system, i.e., Spruce. What is truly weird is this applies to Audio-only, and the OCR has no plans to enforce this rule. The OCR has not realized that telehealth services are normally audio/visual. This release may be a quick response before the COVID waivers expire in July and before the new HIPAA statutes are posted. A few policies and procedures must be updated, and they should be posted in early July.

Eliminating Certificates of Medical Necessity & DME Info Forms

All Certificates of Medical Necessity (CMNs) and Durable Medical Equipment (DME) Information Forms (DIFs) will be discontinued effective for dates of service January 1, 2023 and after. If CMNs or DIFs are included on any claims with dates of service on or after January 1, 2023, the claims will be rejected. Claims with dates of service prior to January 1, 2023 should still include CMN and DIF information in accordance with DME MAC processing and policy guidelines.

Enforcement Actions

Owner of Northeast Philadelphia Pharmacy Charged with Conspiracy to Distribute Oxycodone and Fraud | USAO-EDPA | Department of Justice

Updated Forms

HIPAA Compliance

  • Breach Response Checklist
  • Unsecured PHI Breach Reporting Checklist
  • Potential Breach Analysis Evaluation

Updated Policies & Procedures

DEA Compliance

  • Pharmacy Drug Diversion Due Diligence
    • A major change in DEA Expanding Scope of Influence of controlled substances
    • Enforcement begins July 1, 2022
  •  DMEPOS Compliance
    • FDA Approved DMEPOS Products
  •  HIPAA Compliance
    •  Potential Breach Investigations
  •  Pharmacy Compliance
    •  Patient Counseling Practices

Medicare Beneficiaries Get Free OTC COVID-19 Tests

On April 4, The Biden-Harris Administration announced that more than 59 million Americans with Medicare Part B, including those enrolled in a Medicare Advantage plan, now have access to FDA approved, authorized, or cleared over-the-counter COVID-19 tests at no cost. People with Medicare can get up to 8 tests per calendar month from participating pharmacies and health care providers for the duration of the COVID-19 public health emergency. People with Medicare Part B (including those enrolled in a Medicare Advantage plan) will now have access to up to 8 FDA-approved, authorized or cleared over-the-counter COVID-19 tests per month at no cost. You may have to show your red, white & blue Medicare card to get the tests.

Continuous Glucose Monitors Now Available as a TriCare Pharmacy Benefit

TriCare has updated its Continuous Glucose Monitors (CGM) policy to permit patients to use these devices and is approved for reimbursement. The TRICARE Pharmacy Program now covers two brands of CGMs. These are the Abbott FreeStyle Libre 2 and the Dexcom G6. Previously, CGMs were only available as durable medical equipment (DME) under the TRICARE medical benefit. CGMs continue to be covered as a DME medical benefit, but they’re also now available as part of your pharmacy benefit. TriCare Released 06/16/2022
Additionally, the American Pharmacist Association has re-released its virtual roundtable for CGM Association (msgfocus.com)

CBD Expert Advice for Getting Started

RJ Hedges mailed every client of ours a new book that will complement and assist the pharmacists, physicians, and chiropractors with understanding CBD and serve as a tool for patients, new and old, to understand what to look for when purchasing CBD drug interactions, and legal requirements. The CBD book is to go to the Owner or Pharmacist-In-Charge; if they don’t have it, check with the staff who manages the mail. This book is designed to help you with CBD sales and make the pharmacy a profit.