May 2022 - Newsletter
Included in this newsletter
- DIR Fees Changing- January 1, 2024
- Justice Department Combats COVID-19 Frau
- R.J. Hedges & Associates Brokerage and Valuation Services
- FDA Significantly Curtails J&J’s COVID Vaccine Clearance
- DEA Enforcement Actions
- HIPAA Enforcement Actions
- Medicare Beneficiaries Get Free OTC COVID-19 Tests
- Caremark to Amend Audit Bulk Purchase Notification Requirements
- CBD Expert Advice for Getting Started
DIR Fees Changing- January 1, 2024
On Friday, April 29, 2022, CMS issued a final rule that eliminates PBMs’ retroactive application of direct and indirect remuneration (DIR) fees, creating better transparency for pharmacies and our patients. Although the rule moves all pharmacy concessions, including retroactive DIR fees, to the “negotiated price” at the point of sale, beginning in 2024, it does not eliminate DIR fees altogether. DIR fees are price concessions negotiated between PBMs and pharmacies participating in Medicare Part D networks. Retroactive DIR fees are assessed weeks or even months after Part D beneficiaries’ prescriptions are filled, resulting in pharmacies realizing only long after the prescription was filled that they did not recoup their costs. These fees also result in patients paying more at the pharmacy counter for their prescription drugs. Between 2010 and 2020, CMS reported that retroactive DIR fees increased by a staggering 107,400%.
Justice Department Combats COVID-19 Frau
The Department of Justice announced 4/20/2022 criminal charges against 21 defendants in nine federal districts across the United States for their alleged participation in various health care related fraud schemes that exploited the COVID-19 pandemic. These cases allegedly resulted in over $149 million in COVID-19-related false billings to federal programs and theft from federally-funded pandemic assistance programs. In connection with the enforcement action, the department seized over $8 million in cash and other fraud proceeds.
“The Department of Justice’s Health Care Fraud Unit and our partners are dedicated to rooting out schemes that have exploited the pandemic,” said Assistant Attorney General Kenneth A. Polite, Jr. of the Justice Department’s Criminal Division. “Today’s enforcement action reinforces our commitment to using all available tools to hold accountable medical professionals, corporate
executives, and others who have placed greed above care during an unprecedented public health emergency.” Follow the link below for the full story.
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.
FDA Significantly Curtails J&J’s COVID Vaccine Clearance
The U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID- 19 vaccine. Click Here https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals
DEA Enforcement Actions
- DEA Chicago Suspends Registration of Suburban Chicago Pharmacy
- DEA Serves Immediate Suspension Order on Northgate Pharmacy in Waldorf, Maryland
- North Carolina Pharmacy Agrees to Pay $100,000 Fine
- Pharmacist Indicted for Tampering with a Controlled Substance
- Pharmacy Owner Convicted of Unlawfully Dispensing 1.5 Million Doses of Controlled Substances
- San Diego Pharmacy Pays $105,000 Penalty for Illegitimately Dispensing Opioids
- South Hills Pharmacist Sentenced to Prison for Prescription Drug Fraud Scheme | USAO-WDPA | Department of Justice
HIPAA Enforcement Actions
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.
Caremark to Amend Audit Bulk Purchase Notification Requirements
The COVID-19 pandemic is winding down. It is time to stop using the waivers for patient signatures. Patients need to begin signing the OBRA Log, signature capture system, and the Receipts of Goods and Services. We expect these waivers and mandates to end on April 18th; however, with the CDC’s extension for 90 days, it is time to make these operational changes regardless of the CDC or HHS. Your staff will need to be re-trained for all the signature requirements through the operation.
COVID-19 Standing orders continue to change rapidly as new variants develop. Please check the IAC standing orders weekly to make sure you are using the newest version for all the COVID-19 standing orders. For the newest IAC version, click on the standing order found on the portal. It will take you directly to the standing order. The date is found at the bottom left-hand corner.
CBD Expert Advice for Getting Started
RJ Hedges mail every client of our this new book that will complement and assist the pharmacists, physicians, and chiropractors with understanding CBD and 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.