September 2022

Included in this newsletter


news-september-2022

Preparation for the End of the COVID-19 Public Health Emergency (PHE)

CMS is preparing for and has created a Roadmap for the End of the COVID-19 Public Health Emergency.  The first step in this process is to move all items that fall under the Emergency Use Authorization (EUA) to Food and Drug Administration (FDA) authorized products.  Pfizer and Moderna have formally requested full FDA approval of their COVID-19 vaccines.

Open Enrollment Season

Open enrollment for Medicare Part C and D begins next month.  It is important to start planning and to ensure your patients select the best plan for them and you.  Contracts will be posted at any time.  EnlivenHealth (formerly FDS Amplicare) and Prescribe Wellness provide platforms so you can determine the best plans for your area.

New COVID-19 Chapter in the Immunization Compliance Program

We have created a COVID-19 chapter in the Immunization Compliance Program that contains all of the testing and vaccine policies and procedures and forms, including medical and religious exemption forms

Seasonal Influenza Vaccines Pricing

The Medicare Part B payment allowance limits for seasonal influenza (flu) vaccines are 95% of the Average Wholesale Price (AWP), as reflected in the published compendia. Payment Allowances and Effective Dates by Flu Season. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/VaccinesPricing

All COVID-19 boosters must be the new bivalent product

The COVID-19 bivalent booster products from Pfizer and Moderna were given emergency use authorization yesterday and FDA no longer authorizes the monovalent product for boosters.  If you have booster appointments scheduled in the next few days, you should reschedule for when you have the bivalent product.  The combination of date of service, NDC for a monovalent product, and submission clarification code for a booster dose make claims easy to flag for an audit.  Read more about the authorization here.  ACIP is expected to update its recommendation for COVID-19 vaccine boosters during meetings scheduled today and Friday.  Source: NCPA 08/31/2022

Variant Influenza Virus Infections:  Recommendations for Identification, Treatment, and Prevention for Fall 2022

CDC has issued a health advisory on variant influenza virus infection, usually limited to pigs, that have been documented in at least five humans during the month of August.  The clinical presentation in these cases — including cough, fever, headache, myalgia, and pharyngitis — was similar to that observed with seasonal influenza infections.  While none of the patients appears to have spread the novel influenza A virus to other people, CDC wants clinicians, public health departments, laboratory workers, and the public to be on the alert against potential transmission.  All but one of the August cases was preceded by exposure to swine or attendance at an agricultural fair, where the virus can more easily pass between animals and humans.  As more of these events kick off during the late summer and early fall, CDC recommends that people who have an elevated risk for influenza complications avoid exposure to pigs or wear a face covering and wash or sanitize their hands often.  Clinicians are advised to investigate variant influenza virus infection as a likely culprit in patients with acute respiratory illnesses and exposure to swine or agricultural fairs before they developed influenza symptoms.  The CDC recommends antiviral therapy in patients suspected of having this type of infection, severe illness, or a member of a high-risk population. (Read More)

DMEPOS Standard Written Order Requirements

CMS is still receiving outdated documentation from before the January 1, 2020 requirements change.  The Compliance Portal® has all of the updated documentation that the facility needs.

Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers, follow the requirements for Standard Written Orders (SWOs):

  • Keep the SWO from the treating practitioner on file
  • Get the SWO before submitting a claim for all DMEPOS items
  • Get the SWO before delivering certain items
  • Submit completed SWOs for all DMEPOS services billed if there's an audit

Review MLN Matters Article SE20007 (PDF) to learn what elements to include in the order and related documentation:

  • Beneficiary name or Medicare Beneficiary Identifier (MBI)
  • General description of the item
  • The quantity you'll dispense, if applicable
  • Order date
  • Treating provider name or National Provider Identifier (NPI)
  • Treating provider signature

Looking Ahead to November 2023 - Drug Supply Chain Security Act (DSCSA)

Next year the DSCSA (Track and Trace) will go into effect.  In most cases, this program will be maintained at the drug wholesaler level.  If the pharmacy is also registered as a distributor, there are additional reporting requirements.  For more information go to: For Pharmacists – Partnership for Safe Medicines.

Enforcement

Judge:  Pharmacies Owe 2 Ohio Counties $650M in Opioids Suit

Compliance Portal® Spotlight – Bloodborne Pathogens

OSHA requires every healthcare organization to have a Bloodborne Pathogen Exposure Control Plan.  Bloodborne pathogen exposures are not just blood-related incidents but cover any type of fluid expelled from the body.  The bloodborne pathogen plan includes information about how to implement controls to protect employees, sharps injury procedures to help determine what to do if an employee has a needle stick, tuberculosis screening/testing recommendations, and discusses Hepatitis B vaccination/declination, among many other important items.  This plan is in the OSHA compliance program on the Compliance Portal® and in your Compliance Binder in the OSHA tab.  There is also an annual training requirement for Bloodborne Pathogens that can be found in the training video link at the bottom of the Compliance Portal® home page.

Conventions

NCPA, October 2nd & 3rd, Kansas City, MO

Updated Policies and Procedures

DMEPOS

  • Medical Recall Procedures
  • Patient Education
  • Patient Intake Durable Medical Equipment

Immunizations

  • New COVID-19 Chapter:
    • COVID-19 Exemptions
    • COVID-19 Mandatory Vaccination
    • COVID-19 Record Keeping
    • COVID-19 Testing and Treatment
    • Delivery Procedures During a Pandemic

Pharmacy

  • Medical Recall Procedures
  • Medication Adherence Program Patient Enrollment
  • Medication Adherence Program Set-Up Procedure
  • Patient Education
  • Patient Intake – Pharmaceuticals
  • Patient Management

Updated Compliance Forms

Immunizations

  • Standing Order – JYNNEOS Smallpox and Monkeypox Vaccine 18+
  • New COVID-19 Chapter:
    • COVID-19 Log
    • COVID-19 Vaccine Medical Exemption Request
    • COVID-19 Vaccine Religious Exemption Request
    • Documentation of Patient Request for OTC COVID-19 Test