California Exemptee Training – for home medical device retailers

California Exemptee Training – SkillsPlus International Inc.

About Our Class:

  1. This course is $525 per student.
  2. This course is accepted by the California Department of Public Health – Food and Drug Branch.
  3. This is a web class. After completing registration, check your email for the URL for the class and the enrollment key. If you do not see the email after 10 minutes, check your SPAM or JUNK mail folder.
  4. Students review pre-recorded presentations covering the required content for certification.
  5. Following each presentation the student takes the final exam. Students may review the content of any section as many times as they want. Students may take the exam for each section as many times as needed to get a passing score (85%). Students get instant feedback on test performance.
  6. When you pass all the topic exams, click on the appropriate link at the bottom of the page, to request the documentation appropriate for the agency the student is applying to.
  7. Training Certificates for Exemptees are sent to the address provided at the end of the course via FedEx Express Service every Monday morning, unless a different schedule is indicated in the web room entry page. Oftentimes we send out certificates on a daily basis.
  8. The class is $525 per student when registered through Cvent, a secure online booking service. There are no additional fees unless you choose to add FedEx Overnight Delivery, or lose or misplace your certificates and need reprints.

Objectives:

The applicant must demonstrate knowledge and understanding of:

  1. Dangerous drugs and devices
  2. Distribution of controlled substances
  3. USP Storage conditions
  4. The safe storage and handling of home medical devices
  5. Quality Control Systems
  6. Prescription terminology

Go to DREprof.com: The Designated Representative and Exemptee Training Website

At Least 2.5 Million Home Health Patients Using Medical Equipment Vulnerable to Natural Disasters – HomeHealthCareNews

““Health care trends suggest that 2.5 million number is just going to continue to grow as more people opt to age in place,” Marriele Mango, lead author of the study and resilient power fellowship program associate for Clean Energy Group, told HHCN. “In the end, energy security just isn’t there for them in the way that it is in a nursing home, assisted living home or a hospital.”

In the event of a natural disaster, lack of energy security can be fatal.”

Read the full source article:  At Least 2.5 Million Home Health Patients Using Medical Equipment Vulnerable to Natural Disasters – HomeHealthCareNews.com

You might also be interested in:   FDA – Hurricane Checklist – Medical Devices


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Budget neutrality dampens certain oxygen reimbursement | HME News

Budget neutrality dampens certain oxygen reimbursement | HME News

“These additional cuts for home oxygen therapy are certain to impact providers and patients in rural and other non-CBA areas,” stated AAHomecare in a bulletin. “Since CMS has repeatedly made it clear that they do not believe they have the statutory authority to address the budget neutrality offset, the HME community needs to make this a priority for advocacy efforts in the 116th Congress.”

Read the source article: Budget neutrality dampens certain oxygen reimbursement | HME News


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Medicare Accounts for 16% of HME Spending — HME Business

“Another data point shows just how greatly Medicare’s importance as a revenue driver for HME has dropped. In addition to Medicare’s 16 percent share, Medicaid accounted for 15 percent of HME spending, and all other sources, such as private payer and retail sales, represented 68 percent of HME spending.”

Read The Full Source: Medicare Accounts for 16% of HME Spending — HME Business


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Training program for California HMDR Exemptee license applicants

Training program for California HMDR Exemptee license applicants

The Shift of Medical Devices to a Home Setting – PR Newswire

“One of the major changes in the medical device sector is the continuously growing emphasis on home health care through wearable device and remote monitoring devices. Technology now allows patients a much more flexible approach to therapy, one that does not diminish their life styles as previously. A recent research report by Meticulous Research estimates that the global home medical devices market is expected to reach $48.47 billion by 2022 with a CAGR of 7.8% over the period of 2016 to 2022.”

Read the full article:  Source: The Shift of Medical Devices to a Home Setting – PR Newswire


Go to DREprof.com: The Designated Representative and Exemptee Training Website

HMDR Exemptee Training

Certification class for HMDR Exemptee license applicants

National Medicare Fraud Takedown Results in Charges Against 243 Individuals for Approximately $712 Million in False Billing | OPA | Department of Justice

Be smart, be aware, be careful

“In Los Angeles, eight defendants were charged for their roles in schemes to defraud Medicare of approximately $66 million.  In one case, a doctor is charged with causing almost $23 million in losses to Medicare through his own fraudulent billing and referrals for DME, including over 1000 expensive power wheelchairs and home health services that were not medically necessary and often not provided.”

Read the full announcement – Source: National Medicare Fraud Takedown Results in Charges Against 243 Individuals for Approximately $712 Million in False Billing | OPA | Department of Justice


Go to DREprof.com: The Designated Representative and Exemptee Training Website

Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce

Assorted drug capsules and tabletsHDMA’s 2014-15 Factbook updates member financial, operational performance.

The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was looking like in 2013 just as the Drug Supply Chain Security Act was passed; presumably, the report from a year from now will show how ready the industry was for the Jan. 1, 2015, deadline coming up for reporting transaction information to customers and FDA, per DSCSA requirements. ”

Learn more details, read the full article: via Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce.


Go to DREprof.com: The Designated Representative and Exemptee Training Website

FDA Law Blog: FDA Speaks at Annual HDMA Track-and-Trace Conference

Workers in a warehouse“Throughout the conference, manufacturers, distributors, and other members of the drug supply chain expressed concern over the current lack of guidance from FDA regarding compliance with federal product tracing laws with only 49 days until the DSCSA is set to begin to take effect.

Dr. Connie Jung, Acting Associate Director for Policy and Communications for the Office of Drug Security, Integrity, and Recalls in FDA’s Center for Drug Evaluation and Research, Office of Compliance, once again spoke at the conference and attempted to address some of their concerns.”

Read the full report-out: via FDA Law Blog: FDA Speaks at Annual HDMA Track-and-Trace Conference.


Go to DREprof.com: The Designated Representative and Exemptee Training Website