November 2022 - Newsletter

Included in this newsletter


National Supplier Clearinghouse (NSC) Ended Its Contract on 11/6/22

CMS has awarded a new contract for DMEPOS and Part B Pharmaceuticals. There will be two contractors who have the country split. The two contractors are Novitas Solutions and Palmetto GBA. Please notify your liability insurance carrier to remove NSC as a Certificate Holder and replace it with the respective contractor listed below:

Change the Certificate Holder name and address on Liability Insurance to:

    Novitas Solutions
    P.O. Box 3704
    Mechanicsburg, PA 17055-1863

    Palmetto GBA
    P.O. Box 100142 Columbia, SC 29202-3142

CMS Sets Patients Deductible for 2023

CMS has released the new Part B beneficiary's deductible for 2023. Medicare Part B beneficiaries will pay the first $226 in 2023, a decrease of $7 from the annual deductible of $233 in 2022.

If your facility bills immediately after dispensing, Pharmacy and DMEPOS facilities, your staff needs to know the deductible to collect the full authorized amount. The deductible is mandatory as part of the Medicare Part B patient agreement. The first claims received will have the deductible applied. It is always easier to return money than to try and get it after the claim has been paid.

DEA Drug Diversion

Please ensure all pharmacy owners, Pharmacists-In-Charge, and pharmacists review the RJH Bulleting 2022-003, dated November 15, 2022.

USP General Chapters <795> and <797>

USP has released the revised USP <795> and <797>, and we are working on the Non-Sterile Compounding Compliance Program. The effective date for USP <795> and USP <797> is set for November 1, 2023. We have already started reviewing and updating the non-sterile compounding policies and procedures. There is some rollover into USP <800>. Hazardous Drugs have been in effect since March 12, 2020, and individual states have gradually increased.

USP <795> has tripled in size, plus six other USP guidelines have been added and referenced for compliance. The additional USP guidelines are:

  • <51> - Antimicrobial Effectiveness Testing
  • <1112> - Application of Water Activity Determination to Nonsterile Pharmaceutical Products
  • <1163> - Quality Assurance in Pharmaceutical Compounding
  • <1178> - Good Repackaging Practices
  • <1231> -  Purified Water

Contact your sterile water provider and have them send regular updates to their water testing. It appears there will be outside testing requirements for the purified water.

The Beyond-Use-Dating (BUD) issues appear to have reasonable requirements.

Please watch future newsletters and task lists for updated and new policies and procedures, and forms. We are estimating this review and update to take at least five months.

AstraZeneca drops plan to sell COVID-19 vaccine in US

AstraZeneca's COVID-19 vaccine, Vaxzevria, never received U.S. clearance, and the company has now withdrawn its application. The U.K.-based manufacturer was one of the first out the gate with a COVID vaccine, and it was widely deployed in dozens of low- and middle-income countries. Success in the U.S. market has been more elusive, starting with the FDA's demand for more data to support emergency authorization. AstraZeneca then decided to pursue full agency approval, a longer and more complex process that company officials suggest may no longer represent the best use of its resources.

Source: The Wall Street Journal 11/10/2022

Walmart to Pay $215M to settle Florida opioid claims

Attorney General Ashley Moody of Florida said Thursday that Walmart agreed to pay $215 million to resolve claims its pharmacies contributed to Florida's opioid addiction crisis. In addition, Walmart agreed to supply 672,000 treatment kits containing naloxone to first responders statewide. Moody said, "I'm grateful for Walmart stepping up and agreeing to partner with the state to provide law enforcement and first responders with much-needed naloxone. This will greatly help our continuing mission to end the opioid crisis and save lives." The state has now secured a total of $3.2 billion through legal action to address the effects of the opioid crisis, Moody's office said, including recent settlements of $683 million with Walgreens Boots Alliance, $484 million with CVS Health, and a combined $394 million with three drugmakers. In agreeing to settle with Florida, Walmart did not admit any wrongdoing. (Read More) - May Require Free Registration

CVS to Sell Omnicare LTC Pharmacy (Opportunity)

CVS Health will sell its long-term care pharmacy business, Omnicare, reporting a $2.5 billion loss related to it in the third quarter, McKnight's Senior Living reported Wednesday. Omnicare serves senior living communities and skilled nursing facilities. "We continue to evaluate our portfolio strategically and are making decisions around assets that don't fit into our portfolio strategically," President and CEO Karen Lynch said. CVS determined that its LTC business was "no longer a strategic asset" and committed to a plan to sell the LTC business, CVS said in a filing with the Securities and Exchange Commission on Wednesday.

Omnicare has always provided substandard patient services. This is a great opportunity to seek out the facilities and provide these facilities with superior service. Dispensing to LTC facilities will enable the pharmacy to purchase medications from GeriMed.