Friday, December 7, 2018

Where To Find The Florida CDR Application Form

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Question:

Where can I get the Florida Certified Designated Representative (CDR) application form?


Answer:
  • then scroll down the page and click the button labeled, "Apply using a printable application."

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Thursday, December 6, 2018

OIG report catches $34m in CMS overpayments to med device suppliers over 3 years - MassDevice

Read the full article:  OIG report catches $34m in CMS overpayments to med device suppliers over 3 years - MassDevice

"The U.S. Dept. of Health and Human Services’ Office of the Inspector General recently published a report claiming that the Centers for Medicare and Medicaid Services overpaid medical device suppliers by $34 million"

Read the OIG report:
Medicare Improperly Paid Suppliers for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Provided to Beneficiaries During Inpatient Stays (PDF)

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)
California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Wednesday, December 5, 2018

What Is the Value of Your DME Business? - HomeCareMag.com

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Read the full article:  What Is the Value of Your DME Business? - HomeCareMag.com


"Common threads among DME company owner valuation statements include: “All DMEs sell for two times annual revenue,” or “My DME should be worth the sum of all of the monies I invested into the company,” or “I wouldn’t consider selling my DME for less than 10 times annual profits.” Those who make these statements are in for a rude awakening when they attempt to sell their company or engage a skilled health care valuation professional."


Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)
California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Thursday, November 22, 2018

Industry Calls for Changes to FDA’s DSCSA Product Identifier Guidance - RAPS.org

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Read the full article:  Industry Calls for Changes to FDA’s DSCSA Product Identifier Guidance - RAPS.org

"The biggest change industry is calling for is for FDA to allow manufacturers to use the GS1 Global Trade Identification Number (GTIN), which typically contains the National Drug Code (NDC) number along with other information, in the human-readable portion of the product identifier in place of the NDC. This request is echoed by the Biotechnology Innovation Organization (BIO), the Association for Accessible Medicines, the Healthcare Distribution Alliance, Bristol-Myers Squibb, Shire and GS1 itself.

In its comments, the BIO also asks FDA to revise the guidance to allow manufacturers more flexibility when it comes to ordering the human-readable portion of the product identifier."

You might also be interested in:
ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy
California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Wednesday, November 21, 2018

Nonresident medical device sellers operating in CA may face fines with few options for compliance - DOTmed

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Read the full editorial by Robert J. Kerwin:  Nonresident medical device sellers operating in CA may face fines with few options for compliance - DOTmed


"In California, the Board of Pharmacy, which regulates matters pertaining to wholesaling of medical devices, is requiring sellers of medical devices who do not reside in California (“nonresident wholesalers”) to have a wholesalers’ license from their home state or else be subjected to a fine for conducting business in California without an appropriate license. This, despite the fact that many states do not issue medical device wholesalers’ licenses." 


Return Home:  The Designated Representative and Exemptee Blog

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Designated Representative Training Courses - wholesalers, 3PL, reverse distributors (California & Florida)
Designated Representative Training Courses - wholesalers, 3PL, reverse distributors (California & Florida)


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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

You Snooze, You Lose: How Insurers Dodge The Costs Of Popular Sleep Apnea Devices - NPR

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Read the full article:   You Snooze, You Lose: How Insurers Dodge The Costs Of Popular Sleep Apnea Devices - NPR

"Medicare, the government insurance program for seniors and the disabled, began requiring CPAP "compliance" after a boom in demand. Between 2001 and 2009, Medicare payments for individual sleep studies almost quadrupled to $235 million. Many of those studies led to a CPAP prescription. Under Medicare rules, patients must use the CPAP for four hours a night for at least 70 percent of the nights in any 30-day period within three months of getting the device. Medicare requires doctors to document the adherence and effectiveness of the therapy."

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Saturday, November 17, 2018

Survey: Turnover on the rise among hourly workers - Drug Store News

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Read the full article:

Survey: Turnover on the rise among hourly workers - Drug Store News

Key excerpts from the article: 
Respondents cited “better opportunities/promotions” as the No. 1 reason for departures in the retail industry, followed by more money and a desire for a more hours. When asked what retailers will be looking to do to curb turnover moving forward, “training” and “career pathing” were cited as the top focus areas, followed by “better communications on the employee value proposition” and “changes to compensation packages.”  
“To retain top employees, employers need to lay out clear career paths, offer training and pay competitive wages. It’s critical that employees feel nurtured and that they feel part of the organization instead of just having a job.”

Maintaining business continuity and regulatory compliance are top priorities in the HMDR niche. It's wise to consider the items mentioned in the article above.

Additionally, it's not unusual for some businesses to manage with just one HMDR Exemptee, or keep the bare minimum of licensed HMDR Exemptees on staff.  However, these companies can run into a situation that can affect the company's business financial health. In the event the company loses a licensed Exemptee (for example, the Exemptee quits and cross-coverage by another licensed Exemptee isn't possible), then the business operation could get into trouble with regulatory agencies, or just as bad, must suspend operation (until a licensed Exemptee can be on premise).

It's a difficult scenario, to be left scrambling, trying to find, hire, and get a new employee properly licensed as an Exemptee.  Therefore, consider the risks, and keep just the "right" number of licensed HMDR Exemptees.

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)
California HMDR Exemptee Training Certification Course for Home Medical Device Retailers (accepted by the California Department of Public Health - Food and Drug Branch)


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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Tuesday, November 13, 2018

Who Can You Call? - Ask A Board Inspector

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Read the full notice:  Got a question? Ask an Inspector - California Board of Pharmacy

"The board can be contacted via email, fax or telephone with questions pertaining to pharmacy law and regulations. On Tuesdays and Thursdays, a board inspector will be available to answer telephone inquiries. 
Note: The board’s inspectors and staff cannot provide you with legal advice, but they will assist you by identifying any statutory or regulatory sections that may pertain to your questions. Should you need legal advice, you are advised to contact a lawyer."

Return Home:  The Designated Representative and Exemptee Blog

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Designated Representative Training Courses - California and Florida
Designated Representative Training Courses - California (wholesaler, 3PL, reverse distributor) - Florida CDR Exam Prep Course


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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Friday, November 9, 2018

AmerisourceBergen's compounding site still on ice despite beefed-up oversight - BioPharma Dive

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Read the full article:

AmerisourceBergen's compounding site still on ice despite beefed-up oversight - BioPharma Dive

"PharMEDium, a drug compounder and subsidiary of AmerisourceBergen, received a series of Form 483s over the last year as regulators observed issues at several of its manufacturing plants. Some of the more common issues included failing to have procedures that adequately protect against contamination or ensure quality control."

Return Home:  The Designated Representative and Exemptee Blog

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Root Cause Analysis and Deviation Investigation Report Writing - An online self-study FDA cGMP training
Root Cause Analysis and Deviation Investigation Report Writing - An online self-study FDA cGMP training course


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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Monday, October 29, 2018

Amazon to sell exclusive brand of consumer medical devices - Becker's Hospital Review

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Read the full article: 

Amazon to sell exclusive brand of consumer medical devices - Becker's Hospital Review

"Amazon, through a partnership with health brand consultancy Arcadia Group, will sell an exclusive new brand of consumer-focused medical devices, including blood pressure cuffs and glucose monitors" . . . 
"Arcadia Group said it had created a brand of at-home medical devices for Amazon, called Choice. It will be sold exclusively on the e-commerce giant's website."

Return Home:  The Designated Representative and Exemptee Blog

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California Home Medical Device Retailer - HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)
California Home Medical Device Retailer - HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Thursday, October 25, 2018

FDA Publishes DSCSA-Related Guidance on Verification Systems

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According to this newly published FDA guidance:

Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry (PDF)

"Certain trading partners (manufacturers, wholesale distributors, dispensers, and repackagers) are required to have verification systems in place" . . .

Background  

Section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added by the Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54), established requirements to facilitate the tracing and verification of certain prescription drug products through the U.S. pharmaceutical distribution supply chain.

FDA is issuing this guidance to describe FDA’s interpretation of the requirements of section 582 of the FD&C Act regarding verification systems. This guidance provides recommendations for a robust verification system for the determination, quarantine, and investigation of suspect products, as well as the quarantine, notification, and disposition of illegitimate products.

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy
California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) - Approved by the California State Board of Pharmacy

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Monday, October 22, 2018

California Designated Representative - Continuing Education

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Read the full article:  California Designated Representative - Ongoing Training (on Tumblr)

"One self-assessment question is, ”Are training and experience provided to all employees to assure all personnel comply with all licensing requirements? (CCR 1780[f][4])”  This question suggests that ongoing training is expected.   
One form of training could be taking one of our courses as a form of refresher training."

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy)
California Designated Representative Training Courses (approved by the California State Board of Pharmacy)


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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Friday, October 19, 2018

Medtrade Fall 2018 - New Product Pavilion Winners

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Read the full article:   Medtrade wrap-up: Winning products, winning event and one big winner
"Medtrade attendees selected Caire’s FreeStyle Comfort portable oxygen concentrator as this year’s gold winner in the New Product Pavilion. 
Abely’s portable electric recliner, the Abelift, took home silver; and 3B Medical’s CPAP hose cleaner, the Lumin Bullet, took home bronze."

Return Home:  The Designated Representative and Exemptee Blog

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California HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)
California HMDR Exemptee Training Certification Course (approved by the California Department of Public Health - Food and Drug Branch)


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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Thursday, October 11, 2018

Supply Chain Considerations During Hurricanes - Logistics for the Life Sciences

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Read the full article:  Supply Chain Considerations During Hurricanes - Logistics for the Life Sciences

"As Hurricane Michael hits the Florida Panhandle, it again reminds us to assess potential locations and routes at risk, and to initiate efforts to minimize disruption."  . . . 
"In this article, Jim Monkmeyer, President of Transportation at DHL Supply Chain, comments on content from the recent Resilience 360 report, “Hurricane Peak Season: What to Expect in 2018.”"

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):
California Designated Representative Training for 3PL (approved by the California State Board of Pharmacy)
California Designated Representative Training for 3PL (approved by the California State Board of Pharmacy)

Tuesday, October 9, 2018

FDA Raises Questions on McKesson’s Ability to Detect Illegitimate Products - RAPS.org

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Read the full news article:   FDA Raises Questions on McKesson’s Ability to Detect Illegitimate Products - RAPS.org
"“Transaction data for prescription drug purchases from the firm show that lot/batch numbers are not captured/retained; as such the firm does not have sufficient processes in place to determine and notify, within 24 hours, all the immediate trading partners that the firm had reason to believe may have received illegitimate product,” the 483 says."

Read the FDA Form 483:   McKesson Corporation, San Francisco, CA. Form 483 issued 07/03/2018 (PDF)

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy)
California Designated Representative Training Courses (approved by the California State Board of Pharmacy)

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Friday, October 5, 2018

ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

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Read the full article:   ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

According to the article, the FDA released the following guidances:
  1. Product Identifiers Under the Drug Supply Chain Security Act- Questions and Answers Guidance for Industry (PDF)
  2. Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF)
  3. Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy (PDF)

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses (approved by the California State Board of Pharmacy)
California Designated Representative Training Courses (approved by the California State Board of Pharmacy) - Earn a training affidavit

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Thursday, October 4, 2018

Hundreds of Florida's Life Science Leaders to Convene at BioFlorida Annual Conference - BioFlorida.com

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Read the full press release:  Hundreds of Florida's Life Science Leaders to Convene at BioFlorida Annual Conference - Annual Conference Showcases Advancements & Drives Growth of the Life Sciences Industry in Florida - BioFlorida.com

"Hundreds of Florida's executives, scientists, researchers, investors, legislators, and service providers from the biopharmaceutical, medical device, and healthIT industry will gather October 14-16 at The Westin Fort Lauderdale Beach Resort to hear from experts on recent industry trends, connect with investors and potential partners, and celebrate Florida innovation and achievements-all to continue the growth of the industry in the state."

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Tuesday, October 2, 2018

AmerisourceBergen to pay $625M in drug distribution settlement - Modern Healthcare

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Read the full article:  Modern Healthcare - AmerisourceBergen to pay $625M in drug distribution settlement

"In order to avoid the Food and Drug Administration's regulatory oversight, AmerisourceBergen did not register Medical Initiatives as a repackager or manufacturer with the agency, records show. Instead, the group portrayed Medical Initiatives as a state-regulated pharmacy, exploiting an exemption to the FDA registration requirement that is reserved for legitimate pharmacies, not for manufacturers or repackagers, authorities said."

Return Home:  The Designated Representative and Exemptee Blog

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California Designated Representative Training Courses - accepted by the California State Board of Pharmacy
California Designated Representative Training Courses - accepted by the California State Board of Pharmacy


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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Thursday, September 6, 2018

Designated Representative Training Courses - A collection of links

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A Useful Link Collection - Designated Representative Training Courses

Every once in awhile, it's helpful to put related links together in a collection.  I've put this collection together for Designated Representative license applicants.


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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Friday, August 3, 2018

US subpoenas AmerisourceBergen over opioid products - CNBC

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Read the full article:  US subpoenas AmerisourceBergen over opioid products - CNBC (click this link)

"AmerisourceBergen, which is among the defendants, is one of the largest drug distributors in the country. AmerisourceBergen and rivals Cardinal Health and McKesson control 85 percent of the U.S. prescription drug market.  The subpoena came from the U.S. Attorneys Office for the Southern District of Florida."

This topic is related to the opioid epidemic and reporting suspicious orders of controlled substances.

Return Home:  The Designated Representative and Exemptee Blog

California Designated Representative training courses accepted by the California State Board of Pharmacy. For wholesalers, 3PL, and reverse distributors.  Earn a training affidavit.

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Tuesday, July 24, 2018

Building a New Drug Wholesaler Compensation Model: What Happens as Brand Inflation Slows? - Drug Channels

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Read the full article:  Building a New Drug Wholesaler Compensation Model: What Happens as Brand Inflation Slows? - Drug Channels

" . . . what this could mean for the Big Three drug wholesalers --- AmerisourceBergen, Cardinal Health, and McKesson. I explain some of the problems that arise when wholesalers are compensated based on a brand-name drug’s list price. I then suggest an alternative approach that would reshape wholesalers’ economics. It appears that even the wholesalers’ trade association supports some sort of new model."


Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Saturday, July 21, 2018

Wholesalers, are you ready for an inspection? - California State Board of Pharmacy

Wholesalers, are you ready for an inspection? - A newsletter article by the California State Board of Pharmacy (The Script - July 2018 Page 12 - click this link)

SkillsPlus International Inc.'s California Designated Representative training courses are accepted by the California State Board of Pharmacy - Learn more and buy!

"Be prepared. Whether the Board is conducting an inspection related to a complaint or a request is made for a routine inspection, having important records readily retrievable will help expedite the process. The Board recommends wholesalers' Designated Representatives and Designated Representatives-In-Charge become aware of the location of the following records. Maintaining these records in a centralized area may help when a board inspector arrives at your front door."


California Designated Representative Training Courses
Here's a list of the major categories of records:

  • Policies and Procedures
  • Records
  • Controlled Substances
  • Training Records
  • Licenses and Registrations
  • Miscellaneous Reports

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Friday, June 29, 2018

Most Medicare Claims for Replacement PAP Device Supplies Didn't Comply With Medicare Requirements - OIG

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California HMDR Exemptee Training Certification:

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Read the full June 2018 report:

Most Medicare Claims for Replacement Positive Airway Pressure Device Supplies Did Not Comply With Medicare Requirements - DHS OIG (PDF - click this link)

"Most Medicare claims that DME suppliers submitted for replacement PAP device supplies did not comply with Medicare requirements. Of the 110 claims in our sample, 24 complied with Medicare requirements; however, 86 claims with payments totaling $13,414 did not. On the basis of our sample results, we estimated that Medicare made overpayments of almost $631.3 million for replacement PAP device supply claims that did not meet Medicare requirements."

The CMS expressed interest in educating health care providers on avoiding Medicare billing errors.

Return Home:  The Designated Representative and Exemptee Blog


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Training for HMDR Exemptee license applicants - Earn a course completion certificate - Accepted by the California Dept of Public Health (CDPH)


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

     California (earn a training affidavit):
     Florida:

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

     California (earn a training completion certificate):

Tuesday, June 12, 2018

AAH reports drop in suppliers ... | HME News

California HMDR Exemptee Training
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California HMDR Exemptee Training Certification:

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Read the full article:   In brief: AAH reports drop in suppliers, Trustees report shaky finances | HME News:

"The states with the biggest reductions in the number of unique traditional DME suppliers from November 2010 to January 2018 are Florida (52%), California (45%), Illinois (42%) and Texas (39%)."

'via Blog this'

Return Home:  The Designated Representative and Exemptee Blog

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

     California (earn a training affidavit):

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

     California (earn a training completion certificate):

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