CMS Discontinues Use of Certificates of Medical Necessity for DME - HomeCareMag

• The best California HMDR Exemptee training certification course for home medical device retail Exemptee license applicants and their supervisors & managers. State-approved by the CDPH.

According to the article:

California Exemptee Training

"As part of its ongoing efforts to increase access to care and to reduce unnecessary administrative burden for stakeholders, the Centers for Medicare & Medicaid Services (CMS) will be discontinuing the use of Certificates of Medical Necessity (CMNs) and Durable Medical Equipment (DME) Information Forms (DIFs) for claims with dates of service on or after Jan. 1, 2023. CMS suppliers must continue to submit CMN and DIF information for claims with dates of service before Jan. 1, 2023 if it is required."

Read the full source article: CMS Discontinues Use of Certificates of Medical Necessity for DME - HomeCareMag

Read more about this change here:  Elimination of Certificates of Medical Necessity & Durable Medical Equipment Information Forms - MLN Matters (pdf)

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

California HMDR Exemptee Online Training Certification Class

• State-approved California Exemptee training for Exemptee license applicants & their managers

California HMDR Exemptee online training certification course

- for home medical device retailers​

Buy Exemptee training now!

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 accepted by the California Department of Public Health - include it in your license application.

• $525 per student. 
• Earns a course completion certificate accepted by the California Department of Public Health. Covers required topics specified in the Exemptee license application form
• Learn more and buy - no extra fees to retake quizzes

Nearly 10,000 students have taken our state license-related training programs.

Contact us:  (415) 948-5220

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

FDA Issues Two DSCSA Draft Guidances

• Board-approved California Designated Representative online training programs by SkillsPlus International Inc. | Training courses for wholesalers, 3PL, and reverse distributors.

The FDA issued 2 DSCSA draft guidances:

Date Published	Type	Title
7/05/2022	Draft Guidance	Identifying Trading Partners Under the Drug Supply Chain Security Act
7/05/2022	Draft Guidance	DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry

View the full list of Drug Supply Chain Security Act Law and Policies - FDA.gov

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

SkillsPlus International Inc. - The leader in compliance training

SkillsPlus International Inc.

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The leader in compliance training

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Mailing Address

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FRAUD ALERT: Scammers Diverting Drug Shipments from Distributors, Pharmacies

• Board-approved California Designated Representative online training courses for: 
      Wholesalers | 3PL | Reverse Distributors

Here is the full text of an email alert sent by the California State Board of Pharmacy:

"Pharmacies, hospitals, and distributors are being warned about scammers using sophisticated techniques to obtain account numbers and other sensitive information and unlawfully divert quantities of pharmaceutical goods in transit. In some cases, scammers pretended to represent the state’s board of pharmacy or employees for a particular distributor or pharmacy.

The callers requested and obtained each pharmacy’s DEA number and account purchasing information for their principal distributor. The scammers then called each distributor – pretending to be the pharmacy – and ordered between $100,000 and $300,000 worth of products. Common products ordered included a variety of HIV medications (Descovy, Triumeq, Odefsey) and Xarelto, Otezla, and Eliquis.

Once the products were delivered, the scammers called the pharmacy – pretending to be the distributor – and advised the pharmacy the order was made in error. The scammers then arranged for a courier to pick up the diverted product.

The Healthcare Distribution Alliance Pharmaceutical Cargo Security Coalition (HDAPCSC) has released a report about this problem: “Fraud Alert: Distributor/Customer Product Ordering Scheme,” Version 2 (Updated June 2022). The report discusses methods being used to divert drug shipments and tips for protecting distributors and pharmacies.

The California State Board of Pharmacy urges drug distributors and pharmacists to read the report and learn how to spot fraudulent activity and prevent drug diversion."

###

Source: 

FRAUD ALERT: Scammers Diverting Drug Shipments from Distributors, Pharmacies (an email alert sent by the California State Board of Pharmacy on June 24, 2022)

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

CPSC Warns Consumers To Stop Using Certain Bed Rails

• California HMDR Exemptee training certification course - a state-approved online class for home medical device retailer Exemptee license applicants

According to the article:

"The Consumer Product Safety Commission (CPSC) is warning consumers to stop using 285,000 adult portable bed rails from Mobility Transfer Systems and Metal Tubing USA Inc. because they create an entrapment hazard and pose a risk of serious injury or death to users.

CPSC’s warning applies to 10 models of bed rails manufactured by and sold by Mobility Transfer Systems from 1992 to 2021 and by Metal Tubing USA Inc. from 2021 and 2022. CPSC is urging consumers to immediately stop using, disassemble, and dispose of the following bed rail models: ..."

Follow the link below to view the list of models to avoid.

Read the full source article:  CPSC WARNS CONSUMERS: STOP USING BED RAILS FROM 2 MAKERS - HME Business

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

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think - JDSupra

• California Board-approved California Designated Representative online training courses for: Wholesalers | 3PL (third-party logistics providers) | Reverse Distributors

Updated May 27, 2022:

The FDA has extended the due date for comments. 

"The Agency has received a request for a 90-day extension of the comment period for the proposed rule. The request conveyed concern that the current 120-day comment period, which ends on June 6, 2022, does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule.

FDA has considered the request and is extending the comment period for the proposed rule for 90 days, until September 6, 2022. The Agency believes that a 90-day extension allows adequate time for interested persons to submit comments."  

Source: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers; Extension of Comment Period - SUPPLEMENTARY INFORMATION dated May 17, 2022 - Federal Register

---  the original post follows below  ---

According to the article:

"On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay increased the variation across wholesale and 3PL licensure that the federal Drug Supply Chain Security Act (DSCSA) intended to resolve. The proposed rules create more questions than answers and will likely require significant time and litigation before the rules are finalized." ...

"Here are some of the highlights we saw and questions we have about gaps or challenges in the proposed rules." ...

Read the full source article: The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think - JDSupra

Return Home:  The Designated Representative and Exemptee Blog

- - -

California Board-approved California Designated Representative online training courses for:

     Wholesalers | 3PL (third-party logistics providers) | Reverse Distributors

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