Showing posts with label HHS. Show all posts
Showing posts with label HHS. Show all posts

Wednesday, October 28, 2020

FDA Takes Actions to Help Lower U.S. Prescription Drug Prices

Read the full FDA press release:  FDA Takes Actions to Help Lower U.S. Prescription Drug Prices - FDA.gov

In summary, the U.S. Food and Drug Administration issued a final rule entitled, “Importation of Prescription Drugs,” to implement Section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The rule allows FDA-authorized programs to import certain prescription drugs from Canada under specified conditions designed to ensure that the imported drugs pose no additional risk to the public’s health and safety, as well as to provide a “significant reduction” in costs to American consumers.

View the FDA guidance document:  Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act

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California Designated Representative (wholesaler, 3PL) Training by SkillsPlus Intl Inc.
California Designated Representative (wholesaler, 3PL) Training by SkillsPlus Intl Inc.



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, August 6, 2019

HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs

Read the full news release:  HHS Announces New Action Plan to Lay Foundation for Safe Importation of Certain Prescription Drugs - HHS.gov

It's been difficult to put all the moving pieces together in a coherent manner, regarding the HHS, state-based drug importation efforts, and the DSCSA.

Here are some more pieces of the puzzle.

According to the HHS news release:

"The U.S. Department of Health and Human Services (HHS) announced today that HHS and the U.S. Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan - PDF* that outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets."

But there are 4 major questions according to this article:  HHS and FDA's drug importation action plan - FierceHealthcare:

  1. Will Canada play ball?
  2. Will states want to play ball?
  3. How will safety issues be addressed?
  4. Will congressional Republicans interfere?

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California Designated Representative Online Training Classes. Largest selection, 3 distinct Board-approved courses. Earns a Board-accepted training affidavit. For: drug/device wholesalers, 3PL, reverse distributors.
California Designated Representative Online Training Classes. Largest selection, 3 distinct Board-approved courses. Earns a Board-accepted training affidavit. For: drug/device wholesalers, 3PL, reverse distributors.

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, July 13, 2017

National Health Care Fraud Takedown Results in Charges Against Over 412 Individuals Responsible for $1.3 Billion in Fraud Losses | OPA | Department of Justice

Read the full press release:  National Health Care Fraud Takedown Results in Charges Against Over 412 Individuals Responsible for $1.3 Billion in Fraud Losses | OPA | Department of Justice:

"Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Tom Price, M.D., announced today the largest ever health care fraud enforcement action by the Medicare Fraud Strike Force, involving 412 charged defendants across 41 federal districts, including 115 doctors, nurses and other licensed medical professionals, for their alleged participation in health care fraud schemes involving approximately $1.3 billion in false billings."

'via Blog this'

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Training programs for HMDR Exemptee, and Designated Representative 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

Monday, January 23, 2017

Annual Report Of Fraud & Abuse Control Program - DME-related items

Updated January 24, 2022

The original link broke.

You might also be interested in:

---  the original post follows below  ---

Read the full report:
The Department of Health and Human Services And The Department of Justice Health Care Fraud and Abuse Control Program - Annual Report for Fiscal Year 2016 (PDF)

"The Health Insurance Portability and Accountability Act of 1996 (HIPAA) established a national Health Care Fraud and Abuse Control Program (HCFAC or the Program) under the joint direction of the Attorney General and the Secretary of the Department of Health and Human Services (HHS), acting through the Inspector General, designed to coordinate federal, state and local law enforcement activities with respect to health care fraud and abuse."

The full report contains a specific section for DME-related items.

Return Home:  The Designated Representative and Exemptee Blog

Training course for HMDR Exemptee 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, November 6, 2015

OIG targets orthotics and vents | HME News


Read the full article: In brief: OIG targets orthotics and vents, Rep. Tipton throws support behind rural providers | HME News:

"Orthotics and vents are among the HME that the Office of Inspector General plans to focus on in fiscal year 2016, according to a work plan published last week."  . . .

"In addition to orthotic braces and vents, the OIG plans to examine provider compliance with payment requirements for power mobility devices, and nebulizer machines and related drugs."

'via Blog this'

Read the "work plan" referenced above:
WORK PLAN Fiscal Year 2016 - OFFICE OF INSPECTOR GENERAL - U.S. Department of Health and Human Services (PDF)

You might also be interested in:


Return Home:  The Designated Representative and Exemptee Blog

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

Tuesday, March 11, 2014

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From SkillsPlus International Inc.