Apria Brings to Light New OIG Report Highlighting Concerns Surrounding CMS Competitive Bidding Program for Home Medical Equipment | Business Wire

Read the full article: Apria Brings to Light New OIG Report Highlighting Concerns Surrounding CMS Competitive Bidding Program for Home Medical Equipment | Business Wire:

"Report findings show that more than 40% of the 146 suppliers examined did not meet licensure requirements and were incorrectly awarded contracts by CMS due to database inaccuracies. An additional 14 of the examined suppliers still require further research by CMS to determine whether they have met the necessary licensure requirements. These database deficiencies and inaccuracies were attributed to complex variations in state licensure requirements and the challenges that CMS has faced in maintaining a current and accurate database."

'via Blog this'

Read the OIG report:
Department of Health and Human Services - OFFICE OF INSPECTOR GENERAL - INCOMPLETE AND INACCURATE LICENSURE DATA ALLOWED SOME SUPPLIERS IN ROUND 2 OF THE
DURABLE MEDICAL EQUIPMENT COMPETITIVE BIDDING PROGRAM THAT DID NOT HAVE REQUIRED LICENSES (pdf)

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For CA Home Medical Device Retailer (HMDR) Exemptee license applicants

CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.
The Exemptee Institute

NEW! CA Designated Representative-3PL online training certification by SkillsPlus Intl Inc.- We'll send you the 3PL training affidavit upon successful course completion.
CA Designated Representative online web-based training certification by SkillsPlus Intl Inc. - Available around-the-clock 24 x 7
FL Certified Designated Representative (CDR) online exam prep course - Lots of practice exams - Practice makes perfect!
The Designated Representative Institute

DME MACs clarify vent requirements | HME News

• Buy California HMDR Exemptee training now!
• California Exemptee Training - for HMDR (home medical device retailers). $525 per student (no extra fees to retake quizzes). State approved by the California Department of Public Health. Earns a course completion certificate suitable for your Exemptee license application. #HMDR #HME #DME #HMDRexemptee 

Updated December 24, 2020

You might also be interested in:

CMS Releases Updated Guide to Home Oxygen and Other Durable Medical Equipment Coverage - U.S. COPD Coalition

- - -  the original post follows below  - - -

Read the details: DME MACs clarify vent requirements | HME News:

"In highly anticipated clarifications on coding and coverage requirements for ventilators, the DME MACs have acknowledged that coverage for the product category isn’t quite black and white."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

California Exemptee Training - for HMDR (home medical device retailers). $525 per student (no extra fees to retake quizzes). State approved by the California Department of Public Health. Earns a course completion certificate suitable for your Exemptee license application. #HMDR #HME #DME #HMDRexemptee

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Exemptee Licensure Requirements - HMDR

• California HMDR Exemptee Training - Online Training Certification Course. $525 per student. State approved. Earns a course completion certificate.

Question:
What are the minimum qualifications to apply for an HMDR Exemptee license?

Answer:
The minimum qualifications are described in the Application For Home Medical Device Retailer Exemptee License - New and Renewal (aka HMDR Exemptee Application).

Refer to Section 6 of the application form, and the associated application instructions for Section 6 (Minimum Qualifications).

Section 6 covers the following areas:

• Education
• On-the-Job Training
• Work Experience, and 
• Training Programs.

You might also be interested in:

        

• CA HMDR Exemptee online internet-based training certification by SkillsPlus Intl Inc.

Return Home:  The Designated Representative and Exemptee Blog

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

California Board of Pharmacy Issues Licensing Guidance for 3PLs | iwla1891

• California Designated Representative 3PL Training Course - Board-approved online training program for third-party logistics providers. Earns a training affidavit to include in your license application.
         Sign-up now for California Designated 3PL training!

Read the full article: California Board of Pharmacy Issues Licensing Guidance for 3PLs | iwla1891:

"The California Board of Pharmacy issued guidance this week outlining the process for obtaining the licensing as third-party logistics providers or non-resident third-party logistics providers in the state. This requirement extends to all 3PLs that ship pharmaceuticals to or from California.

Prior to the Drug Supply Chain Security Act (DSCSA), 3PLs were required to obtain licensing as a wholesaler—now 3PLs and wholesalers are separate entities under California law." . . .

"Please see the complete guidance and visit www.pharmacy.ca.gov to access the online application."

'via Blog this'

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California Designated Representative 3PL Training Course - Board-approved online training program for third-party logistics providers. Earns a training affidavit to include in your license application.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• Wholesale Distributor & Third-Party Logistics Providers Reporting - FDA Requirement

E-Pedigree Agenda Item - CA Pharmacy Board Meeting 3-21-2012

Updated 4/19/2012 with the following:

The CA Board of Pharmacy just emailed this out:

"On behalf of the Board of Pharmacy, the Department of Consumer Affairs today added to its website the webcast of its March 21, 2012 Enforcement Committee/e-Pedigree Meeting.  At this meeting, presentations were made by FDA and multiple supply chain members.  . . .

To view the webcast of the March 21, 2012 meeting go to:
http://www.dca.ca.gov/publications/multimedia/pharm_20120321.wmv  "


Note:  I hope you've got patience with the wmv download.  I didn't have 2 hours worth of patience to wait for the download.

- - - - original post follows - - - -

According to this California Board of Pharmacy NOTICE OF MEETING AND AGENDA - Enforcement Committee and E‐Pedigree Public Meeting - March 21, 2012:

Here's what's listed under this agenda item, Discussion on the Implementation of California’s Electronic Pedigree Requirements for Prescription Medication:

a. Discussion about the Presence of Counterfeit Avastin in California Physician Offices
b. Presentation and Discussion of a Proposal for Federal Legislation by the Pharmaceutical Distribution Security Alliance
c. Presentation by Connie T. Jung, RPh, PhD, Acting Associate Director for Policy and Communications, Center for Drug Evaluation and Research, US Food and Drug Administration
d. Presentations and Questions from the Pharmaceutical Supply Chain on Their Readiness to Meet California’s Staggered E‐Pedigree Implementation Schedule 1. Kimberly Fleming, Senior Manager, Product Security, EMD Serono, Inc, 2. Robert Celeste, Director, Healthcare, GS1 US 3. Other Companies, Associations and Other Entities Wishing to Address the Committee on E‐Pedigree Issues
e. General Discussion
f. Discussion and Possible Action to Develop Regulation Requirements Specifying a Unique Identification Number for Prescription Medication Pursuant to California’s E‐Pedigree Requirements
f. Discussion and Possible Action to Develop “Grandfathering” Provisions for Non‐Pedigreed Dangerous Drugs Pursuant to section 4163.2 of the Business and Professions

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California Designated Representative Training Courses - Accepted by the California Board of Pharmacy - Earn a training affidavit to include in your license application

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• e-Pedigree - CA Board of Pharmacy Mtg 9/7/2011 (skillsplusinfo.blogspot.com)
• Don't Get Caught Without A California HMDR Exemptee (skillsplusinfo.blogspot.com)

Qualifications - Minimum Requirements - CA HMDR Exemptee License

• Buy now! California HMDR Exemptee license training course.
• California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health (Food and Drug Branch). For home medical device retailers. If you are applying for a California Exemptee license, you'll need to include proof of required training in your license application. Take this online course to earn a course completion certificate for your license application.

CA HMDR Exemptee - Minimum Qualifications

Don't get tripped up.

Many folks are interested in becoming a California Home Medical Device Retailer (HMDR Exemptee.

However, it's easy to miss that the application states some minimum requirements about who is qualified to submit an application.

According to the California Application for Home Medical Device Retailer Exemptee License - New and Renewal form, these are the minimum qualifications:

• Education: High school diploma GED or equivalent. Attach copies of any applicable certifications or licenses that you may hold.
• On-the-Job Training: Attach copies of current employer's training records listing job-specific training provided and dates completed.
• Work Experience: One or more years paid experience, attach dates, name(s) of employer(s), and addresses. Training must have been supervised by a licensed exemptee, Pharmacist-In-Charge or equivalent.
• Training Programs: Indicate by yes or no the training you have completed specific to the five topics listed. Attach copies of certificates or transcripts.

Especially watch out for the Work Experience requirement.

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--------------------------------------

California HMDR Exemptee Online Training Certification Class. Earns a course completion certificate accepted by the California Department of Public Health (Food and Drug Branch). For home medical device retailers.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Related articles

• California HMDR Exemptee - Online CBT Training (skillsplusinfo.blogspot.com)
• Don't Get Caught Without A California HMDR Exemptee (skillsplusinfo.blogspot.com)
• An E-learning Black Box Warning: Caution, This Course May Be Hazardous to Your Sanity (skillsplusinfo.blogspot.com)
• CA Home Medical Device Retailer Exemptee License Application (skillsplusinfo.blogspot.com)

CA Pharmacy - Wholesaler Surety Bond Info

Sign-up for Board-approved Designated Representative training:

• California Designated Rep Wholesaler online training course 
• California Designated Representative 3PL online training course 
• California Designated Rep Reverse Distributor online training course
  

Updated December 26, 2021

According to the California Board of Pharmacy - Instructions for Filing a Nonresident Wholesaler Application webpage, in addition to addressing other requirements, an application for a nonresident wholesaler must also include a surety bond or other equivalent means of security.

Here's how to find the forms and more information about surety bonds. I haven't provided the pdf links because it's important to me that you access the most current forms and information available. Therefore, it's best to follow this clickpath:  

• The surety bond form, standby letter of credit form and cash deposit form are now available on the board’s Web site. Look for "Surety Bond Information" and "Surety Bond - Questions and Answers."

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FAQ: Designated Representative or Exemptee?

• California Board of Pharmacy Designated Representative Training Courses | by SkillsPlus Intl Inc.  - for wholesalers, 3PL, and reverse distributors. Board Approved. 
  
• Buy Board-approved California Designated Representative training now!

Updated May 25, 2022

Unfortunately, the originally linked document is no longer available.

---  the original post follows below  ---

Question:

Am I a "Designated Representative" or "Exemptee" in the eyes of the California State Board of Pharmacy?

Answer:
Designated Representative.

According to the DESIGNATED REPRESENTATIVE* - REQUIREMENTS AND APPLICATION 17M-27 (Rev. 1/08):

Under California law, the name used to describe any individual who is in charge of any wholesale drug premises (in California or elsewhere) will change on January 1, 2006, from the former name, exemptee, to designated representative. For conventional use, the board will refer to such an individual as a designated representative throughout this application.

Return Home:  The Designated Representative and Exemptee Blog

-------------

California Board of Pharmacy Designated Representative Training Courses | by SkillsPlus Intl Inc.  - for wholesalers, 3PL, and reverse distributors. Board Approved.

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training 
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute

Pharmacy Designated Representative Training Requirements

• People also buy California Designated Representative training courses for:
        Wholesalers | 3PL | Reverse Distributors

Pharmacy Designated Representative Training Requirements

If you're new to the pharmacy world of the Designated Representative, maybe this quick introduction will help. I'm going to explain, using the California (CA) State Board of Pharmacy as the example.

According to the CA Designated Representative application form:

A designated representative is an individual who performs clerical, inventory control, housekeeping, delivery, maintenance, or similar functions related to the distribution or dispensing of dangerous drugs or dangerous devices. To work as a designated representative, you must possess and keep a current certificate as a designated representative.

There are quite a number of requirements that have to be met in order to qualify, including the following training requirements listed on the application form:

Complete a training program that, at a minimum, addresses each of the following subjects:
(A) Knowledge and understanding of California and federal law relating to the distribution of dangerous drugs and dangerous devices.
(B) Knowledge and understanding of California and federal law relating to the distribution of controlled substances.
(C) Knowledge and understanding of quality control systems.
(D) Knowledge and understanding of the United States Pharmacopoeia standards relating to the safe storage and handling of drugs.
(E) Knowledge and understanding of prescription terminology, abbreviations, dosages and format.

The trick then becomes finding a way to fulfill the training program requirement. I've posted links to training and certification service providers below.

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Training programs for California Designated Representative license applicants - Earn a training affidavit

Return Home:  The Designated Representative and Exemptee Blog

- - -

For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training  
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute