Pharmacies need to be looking at some of their options for becoming a Medicare Part B Provider/Supplier as a large part of the United States population are becoming Medicare Beneficiaries.  This blog will discuss four practice areas payable by Medicare Part B that Pharmacies need to consider to diversify and increase profits.  These areas are:


As a Pharmacy, drugs and biologics are in your wheelhouse.  Except for Immunizations, drugs & biologics are the easiest of the four areas we will discuss to successfully integrate into your pharmacy practice.  Naturally, the first step is to be a licensed Pharmacy and then complete either the CMS-855S or PECOS Enrollment application per their instructions.  Once approved, you can start billing.

Medical necessity and documentation are two potentially complicated areas that need to be addressed with drugs and biologics.  Medicare Part B does not pay for medication just because the prescriber wrote a prescription.  The Local Coverage Determinations (LCDs) provide you with the medical necessity information, quantity limits, and other items you need to know before billing a medication to Medicare Part B.  You will need to ensure your employees are trained on the LCDs and their documentation requirements to help ensure payments for these claims.


This area has the same process as Drugs & Biologics with one significant difference – you must be accredited for DMEPOS. Medicare requires all DMEPOS Providers to become accredited. However, some Pharmacies can be exempt from the accreditation requirements if:

  • The Pharmacy has been enrolled in Medicare as a DMEPOS supplier for at least five years.
  • The Pharmacy has not had a final adverse action during the past five years that was not rescinded on appeal.
  • The Pharmacy’s Medicare billing for DMEPOS, other than drugs and pharmaceuticals, which are not subject to accreditation, is less than 5 percent of pharmacy sales for the previous three calendar or fiscal years. Pharmacy sales are those that are in a separate pharmacy account(s) for entities whose accounting system has such a breakout. For pharmacies whose accounting system does not provide a breakout of pharmacy items versus non‐pharmacy items (usually small pharmacies), the total gross sales of the Pharmacy shall be considered to be the pharmacy sales.

With DMEPOS Accreditation, CMS will require Pharmacies to contract with a CMS deemed Accreditation Organization.  The Pharmacy will then create and implement Policies and Procedures to comply with the Accreditation Organizations Standards.  Once the Policies and Procedures are implemented, the employees are trained, and the Pharmacy has gathered some patient files while following the Accreditation Organizations’ standards, the Pharmacy will then go through an accreditation survey.  The survey will be scored, and provided there are no significant deficiencies, the Pharmacy will obtain an accreditation certificate and then complete the Medicare Application for DMEPOS.

The overall DMEPOS Accreditation Process can take months as you create Policies and Procedures, collect patient files, and wait for the survey.  Only then can you apply to Medicare and wait another 90 days or so to get approved – completing the PECOS application will speed up the process. The Accreditation Organization will then conduct an onsite survey before final approval.  Medical necessity and documentation are again two potentially complicated areas (as they were with drugs and biologics) that need to be addressed with DMEPOS.


Immunization is a more straightforward process when compared to DMEPOS or Drugs and Biologics.  You will need to become qualified in your State to begin providing immunizations, then complete the CMS-855B or PECOS.  The one important area to understand is what vaccines Medicare Part B covers?  Medicare covers influenza, pneumonia, COVID-19, and Hepatitis B (for moderate and high-risk patients).  Medicare Part B will also pay for Diphtheria, Tetanus, and the Rabies Vaccines in special situations such as injuries and direct exposures.  All other payable vaccines are paid for by Medicare Part D benefit.

Here are some previous blogs related to Immunization:


Point of Care Testing (POCT) has become popular in Pharmacy over the past few years, and with COVID-19 testing this trend has continued to grow.  Over the past few years, we have written a few blogs related to POCT, so I will cover some basic information and links to those blogs below.  Becoming eligible to bill Medicare Part B for POCT will be a two-part process. First, you will need to obtain your CLIA Certificate of Waiver, and then you will submit your application to get your Medicare billing privileges.

POCT requires Pharmacies to obtain a CLIA Certificate of Waiver by completing the CMS-116 and any State Applications that may exist.  The Application(s) are then submitted to your local state agency.  It is essential to know that while CMS has no complicated requirements for CLIA Waived Tests, your State may, and you will need to make sure you comply with them.

The next step is to obtain your billing privileges.  For this, you will need to complete the CMS-855B or PECOS.

Here are some previous blogs related to POCT:

How can PRS Help?

General Medicare Part B Compliance

The MEDBTrack Program is designed to help those Pharmacies exempt from the Medicare DMEPOS accreditation requirements and those Pharmacies that are only billing Medicare Part B for Drugs and Biologicals (e.g., inhalation solutions, immunosuppressants, and antiemetic medications).  The Program provides an easy-to-follow set of policies, procedures, forms, and training to comply with the Medicare DMEPOS Supplier Standards and the Medicare Part B Documentation requirements.

To learn more about the PRS MEDBTrack Program, go here.

DMEPOS Accreditation

The NASI Accreditation Program has assisted over 8000 Pharmacies through the Medicare Part B accreditation process in the past 12 years.  The NASI Program provides you with the Policies, Procedures, and Forms you need to become compliant.  You will also have a dedicated Accreditation Specialist to walk you through the Program’s implementation and be available to answer questions and point you in the right direction when it comes to Medicare Part B DMEPOS Compliance.  The fee you pay to NASI also includes the Accreditation Organizations fees.

To learn more about the NASI, go here.

Immunization and Exposure Control Plan

PRS’s IMMUTrack is designed to walk you through the process of setting up an efficient, effective, and safe immunization program in your Pharmacy. The Program provides Policies, Procedures, and Forms following best practice guidelines for the intake, storage, administration, documentation, and notification requirements.  The IMMUTrack program also contains an Exposure Control Plan, Forms, and Employee Training required for compliance with the Exposure Control Plan and OSHA Bloodborne Pathogen Standards. It will help you meet State and Federal requirements as they relate to COVID-19.

To learn more about the PRS IMMUTrack Program, go here.

Point of Care Testing

The POCTTrack program by PRS helps Pharmacies with the best practices and meeting any State requirements. The Program supplies you with the guidance, policies, procedures, and forms to set up the Pharmacy to provide Point of Care Testing. Additionally, the Program will provide the questions you need to ask the State Agency responsible for Clinical Laboratories and the State Board of Pharmacy related to state-specific rules.

The COVID-19 and Bloodborne Pathogen Exposure Control Plan by PRS helps Pharmacies meet OSHA’s Bloodborne Pathogen Standards. The Program supplies you with the guidance, policies, procedures, template, forms, and employee training to ensure compliance.

To learn more about the PRS POCTTrack Program, go here.

Exposure Control Plan

PRS’s COVID-19 and Bloodborne Pathogen Exposure Control Plan is designed to help Pharmacies implement their Exposure Control Plan.  The Program provides Policies, Procedures, Exposure Control Plan, Forms, and Employee Training required for compliance with the Exposure Control Plan and OSHA Bloodborne Pathogen Standards. It will help you meet State and Federal requirements as they relate to COVID-19.

To learn more about the PRS COVID-19 and Bloodborne Pathogen Exposure Control Plan, go here.

If you have any questions related to these or any service offered by PRS Pharmacy Services, please do not hesitate to give us a call at 1-800-338-3688.