February 2024 - Newsletter

Included in this newsletter

1. CMS NP East and NP West – Application Requirement Changes
2. NCPA Submits Comments to FDA’s Interim Compounding Policy
3. ACHC Compounding Surveys Start June 1, 2024
4. DEA “Improves” Their Website
5. DEA Shifts its Focus to Physician and Pharmacy Registrants
6. Medical Billing – DMEPOS and Part B Pharmaceuticals
7. Continuous Glucose Monitors (CGM)
8. Exclusion to founder and CEO of Theranos, Inc.
9. New State Regulations for DMEPOS Products
10. Lymphedema Compression Treatment
11. Corporate Transparency Act Requirement
12. Time for Change- Sync Program
13. Enforcement
14. Updated Policies & Procedures and Forms
15. Compliance Corner- Safety Data Sheets (SDS)
16. Meet our Staff- Ally

CMS NP East and NP West – Application Requirement Changes (Not for the Better)

National Provider (NP) West is processing applications as normal and there are no delays.  NP East is a different story.  At this moment, applications that are pending are at an average of 200 days.  If a license, insurance certificate, or surety bond expires while the application is in progress, the document must be uploaded to the CMS “gateway” and the burden of proof of submission is on the supplier.  We are actively participating in the NSC Advisory Council and are hoping to find additional information and answers in the future.

Here is some background on the issues we are finding.  We were informed at the NSC Advisory Council meeting that suppliers will no longer be able to submit a Corrective Action Plan for missing documentation on the CMS 855S and CMS 855B.  If an application is missing anything at the submission date for NP East and West, the application will be revoked.

We can submit a Request for Reconsideration to have the application reviewed.  Our main issue has been the analysis, especially at NP East where they just close the application, even when we have provided all the required and requested information.  In these cases, we must prove beyond a reasonable doubt that the information was submitted and received at NP East and West.

Surety Bond and Liability Insurance policies that expire will be an automatic revocation for three years.  When a new application or a revalidation is being prepared, it is imperative that all documents are valid and in CMS’ possession.  Surety bonds and Certificates of Liability Insurance renew annually.  These must be updated on PECOS to avoid any revocations.  If the revocation is issued, the pharmacy will also lose its DMEPOS exemption.  During the revocation, a supplier cannot submit a new CMS 855S and/or 855B.

CMS has made a series of changes, all of which make it more difficult to operate within the Medicare Part B world.  There are no more corrective action plan submissions or deficiency letters.  All deficiencies now move directly to a revocation and will require the supplier to request a reconsideration.  This request is not automatic nor guaranteed and, if revocation stands, it is for a minimum of 1 year.

Examples of how a supplier can be revoked from Medicare:

• • Not providing all requested information during a site inspection
  • Not providing a Certificate of Insurance before expiration
  • Not providing updated licenses: facility and professional
  • Not responding to a CMS analyst’s phone call/message
  • Not maintaining accreditation, when required
  • Not maintaining the Pharmacy Exemption, which includes the 5% document review when requested by CMS.
    • Revocation of a PTAN by an exempt pharmacy will require accreditation to re-enroll after one year

These new rules are completely unreasonable.  It would help if these analysts had a working knowledge of a pharmacy or DMEPOS supplier.

If the patient is enrolled in a Part C Advantage Plan, then the rules above do not apply.  However, several states require an active PTAN for Medicaid.

We will be sending out a bulletin soon on some new information received from NP East and their Provider Enrollment Gateway System.

NCPA Submits Comments to FDA’s Interim Compounding Policy

NCPA submitted comments to the FDA’s Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act.  FDA is issuing this interim guidance stating that, until a substance has been evaluated and is identified in a final rule as being included or not included on the 503A bulks list, the FDA does not intend to take action against a state-licensed pharmacy, federal facility, or licensed physician compounding a drug product using a bulk drug substance that is not a component of an FDA-approved drug product and that is not the subject of an applicable USP or NF monograph, provided that certain conditions are met.  Read more.

ACHC Compounding Surveys Start June 1, 2024

ACHC is extending the date for compliance with new USP requirements to June 1, 2024. Before that date, compounding pharmacies have the option to be accredited either under PCAB Standards that include USP requirements but don’t incorporate new USP updates or revised standards that do include recently updated USP requirements. 

The R.J. Hedges & Associates Non-Sterile Compounding program is complete and ACHC certification is due at any time.  ACHC-accredited pharmacies using our program will not need to submit policies and procedures to ACHC with the accreditation application.

DEA “Improves” Their Website

On January 16, 2024, DEA redesigned its website.  The design is different but there are also some changes.  The most significant is the medication-assisted treatment. The Consolidated Appropriations Act of 2023 enacted a new one-time, eight-hour training requirement for all DEA-registered practitioners on the treatment and management of patients with opioid or other substance use disorders. “Click here to review.”  This requirement is NOT for pharmacists!  The DEA Pharmacist Manual has not been updated.    The links within the DEA Compliance program are updated on the Compliance Portal®.

DEA Shifts its Focus to Physician and Pharmacy Registrants

We have been advising everyone on DEA’s approach towards pharmacies and physicians. The attached article explains in more detail the DEA’s authority, regulations, and penalties. Click here

Medical Billing – DMEPOS and Part B Pharmaceuticals

Billing for DMEPOS and Part B medications has been a challenge for everyone.  The online, computer interface programs are not capturing the HCPCS codes and modifiers.  Medical billing companies have also presented challenges because they don’t process claims in a timely manner.  As patients move to Medicare Advantage Part C programs, regular Part B dispensing has slowed dramatically and audits continue to be denied because the claim was processed without the proper HCPCS codes, modifiers, and required dispensing requirements.

The project we worked on with TransactRx (RedSail) is up and running.  There will be a Bulletin Release this month on the processes.

Continuous Glucose Monitors (CGM)

CMS has changed the dispensing requirements for CGM to a 90-day supply only.

Exclusion to founder and CEO of Theranos, Inc.

Inspector General Christi A. Grimm announced that the Department of Health and Human Services (HHS) Office of Inspector General (OIG) excluded Elizabeth Holmes for 90 years from participation in Federal health care programs due to her January 2022 conviction in the United States District Court, Northern District of California for wire fraud and conspiracy to commit wire fraud against Theranos, Inc. (Theranos) investors.

New State Regulations for DMEPOS Products

We are aware of two states that are proposing or have approved regulations that limit access to patients and limit what DMEPOS suppliers can dispense. These products do fall into the Pharmacist's Scope of Practice. We recommend that affected pharmacies contact their state pharmacist association and state board of pharmacy.   CMS will deny applications for these products without a change from the individual state.

Ohio

• • • Diabetic Shoes – Can only be dispensed by a Prosthetist
    • Nebulizers – Can only be dispensed by a Respiratory Specialist

Kentucky

• • • Proposed rule where a pharmacy can only dispense:
      • Diabetic Strips
      • Lancets

Lymphedema Compression Treatment

CMS has pulled Lymphedema out of the surgical dressing.  PECOS has not been updated.  If you are accredited with BOC, there is an application plus a $150.00 fee for the change.  If you are exempt from accreditation, there is nothing to do at this time.  Please contact your Project Manager for the application or, if you are providing lymphedema services/supplies, so PECOS can be updated when it becomes available.

At this time there are no certification requirements but we strongly recommend training to prevent any liability issues.  There are several courses available, however, Klose Training seems to be the best.  Klose continues to innovate without compromising the quality of its lymphedema certification. Their recently updated course program consists of 135 hours (75 hours online + 60 hours live) of lymphedema education.

Corporate Transparency Act Requirement

The Corporate Transparency Act went into effect with little information.  If you have 21 or more full-time employees, you are exempt from this new law.  However, if you have 20 or fewer employees, annual reporting is required.  All companies formed before January 1, 2024, have one year to report.  Part II, Company Applicants only applies if the company is registered as a sole proprietor.  It is not an easy online application to complete.  https://www.fincen.gov/boi

Time for Change

As of January 1, 2024, DIR fees are taken at the point of sale.  You may be asking, how can a pharmacy dispense these medications with little or no profit?  The pharmacy can get most of these fees refunded but it requires an active Medication Adherence (Sync) Program.  The pharmacy needs to move patients, no matter who the payer is, to a single dispensing action per patient, per month.  The goal is 70% of patients on a medication adherence program.  There are many benefits once this threshold is reached. 

• • Inventory is managed better and ordering is just in time
  • Man-hours are saved because the pharmacy schedules staff on fill and calling days
  • Manage the pharmacy’s EQuiPP Scores and ensure scores, at a minimum, are above the state and PSAO averages
  • Interventions, vaccines, ACE/ARBs for hypertension and diabetic patients, patients moving from BEER-listed drugs, and more.
  • Completing all Medication Therapy Management (MTMs)

This entire program is found in the Pharmacy Compliance Program, Chapter 8, Medication Adherence Program.

Enforcement

• DEA Announces Settlement with Morris & Dickson Co., LLC – Forfeiture of $19 Million

Pharmacies must challenge and document opioid physician-ordered dispensing to patients. The drug wholesaler must monitor the opioid orders of every pharmacy and when the pharmacy's opioid orders exceed the norm, the wholesaler must investigate and/or cancel their opioid orders.

New and Updated Policies

• Pharmacy
  • Patient Intake - Pharmaceuticals
• Immunizations
  • Vaccine Storage
• Non-Sterile Compounding
  • Administering, Cleaning and Sanitizing
  • Bulk Chemicals and Compounds
  • Compliant Handling
  • Component Selection Requirements
  • Compounding Process
  • Compounding Staff Pharmacist
  • Containment Supplemental Engineering Controls
  • Creating Compounding Records
  • Creating Master Formulation Records
  • Deactivating, Decontaminating, Cleaning and Disinfecting
  • Disposal
  • Drug Compounding Facilities
  • Equipment
  • Establishing a BUD for a CNSP
  • Evaluation of Complaints
  • Labeling, Packaging, Transport and Disposal
  • Labeling USP 795 Section 9
  • List of Hazardous Drugs
  • Nonsterile Compounding
  • Patient Intake – Pharmaceuticals
  • Performance Improvement
  • Personnel Training and Evaluation
  • Personal Protection Equipment
  • Pharmacist-In-Charge
  • Quality Assurance Testing
  • Receipt
  • Respiratory Protection
  • Responsibilities of Personnel Handling Hazardous Drugs
  • Storage
  • Transport
• OSHA
  • Bloodborne Pathogens and Hazard Communications
• Pharmacy
  • Patient Intake – Pharmaceuticals

New and Updated Forms & Support Documents

• Non-Sterile Compounding
  • Hazardous Drug Acknowledgement Statement (New)
  • Measuring Equipment Use Log (New)
• Pharmacy
  • Certification of Pharmacy Compliance and Credentialing
• DEMPOS
  
  • DPD Glucose Monitors & Supplies
  • DPD Mechanical In-exsufflation Devices
  • DPD Tracheostomy Care supplies
  • DPD Nebulizer Medications
  • DPD Nebulizers & Supplies
  • DPD Speech Generating Devices
  • DPD Cervical Traction Devices
  • DPD Cold Therapy
  • DPD Bowel Management Devices
  • DPD Vacuum Erection Devices
  • DPD Intravenous Immune Globulin
  • DPD Intrapulmonary Percussive Ventilation System
  • DPD Infrared Heating Pad Systems
  • DPD Heating Pads and Heat Lamps
  • DPD Oral Antiemetic Drugs
  •  

Note: 100% of the Non-Sterile Compounding Programs comply with USP <795>, USP <800>, USP Compendium, and ACHC/PCAB Standards.

Meet our Staff- Allyson Hess

Meet Allyson, she has been with the company for almost 3 years.  She is a dedicated and customer-focused Business Broker and is on a mission to streamline the sales process for both business owners and buyers. With a passion for simplifying the complexities of business ownership transfers, Ally approaches each transaction with meticulous attention to detail and exceptional organizational skills.

She's a bubbly go-getter who runs on caffeine and has a genuine love for finding the perfect fit for people. Whether it's a recommendation, a specific product, a service, or an entire business, Ally's enthusiasm shines through in her commitment to delivering exceptional results. Ally's goal is not just to facilitate transactions but to ensure that both buyers and sellers feel confident and satisfied throughout the  entire process.

When away from work she is looking for adventures and craft projects with her family and friends. When not chasing her 3-year-old daughter, Khalia, around you can catch Ally outdoors, soaking up the sunshine, cruising around on buggies, whipping up some Instagram-worthy recipes, or getting her hands dirty with DIY crafting, every moment is an opportunity for fun and creativity. Sports, swimming, and spontaneous adventures? Count her in! She says “Life's too short for dull moments, so let's dive in headfirst and make some unforgettable memories.”

Our recently engaged friend is also knee-deep in renovating an old farmhouse. She says “It's a project filled with challenges and triumphs, but I wouldn't have it any other way.”  So here's to embracing the chaos and turning dreams into reality, one coffee-fueled adventure at a time!