Tuesday, December 29, 2009

CSIHME Launches New Website

This new website launched, The Committee to Save Independent Home Medical Equipment suppliers (or CSIHME), to help achieve its mission:
The Committee to Save Independent Home Medical Equipment suppliers (or CSIHME) is a non-profit business league formed by independent HME providers for the purpose of advancing the agenda, needs, and value of the independent HME provider community through focused lobbying efforts and public relations activities. In short, CSIHME wants to give a voice to the people who have committed their lives to helping others through Home Medical Equipment and supplies.
The site offers information about the group, and the efforts of its lobbyist and publicist. It also provides a method for people to help subsidize those efforts.

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Tuesday, December 15, 2009

FAQ: Designated Representative or Exemptee?

Question:

Californian poppyImage via Wikipedia


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.

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Tuesday, November 24, 2009

Refresher Training Is A Recommended Best Practice

This might sound obvious, but stop and think about it.

If you're already recognized by the Board of Pharmacy or the Department of Health Services as a Designated Representative, or Exemptee, respectively, when was the last time you took a refresher training course?

Rules and regulations can change over time. It's easy to forget things over time. Additionally, it's been heard on the street that some inspectors are asking about evidence of refresher training.

How do you stay current and up-to-date?

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Training for Designated Representative and 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

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Tuesday, November 10, 2009

How To Select Your Training Vendor

I just read this book by Linda Ireland, Domino: How Customer Experience Can Tip Everything in Your Business Toward Better Financial Performance . Her writing inspired this post.

You're probably following this blog because you need Exemptee or Designated Representative training. In California, there aren't all that many training vendors in this niche space. As you go comparison shopping, keep these Domino customer experience thoughts in mind:
  1. You want to learn about credible options. The vendor is trying to earn your business.
  2. You envision a solution and problem solved. The vendor needs to demonstrate, and allow you to experience, how they are going to best solve your needs.
  3. You want to buy products and services where you're in control, and it's convenient. The vendor wants to 'protect' you, by affirming any purchase decisions you've made.
  4. You want to experience problem solved, and needs are met. The vendor needs to stay engaged, ensuring your need was truly solved.
  5. You want to learn what else the vendor has to offer that solves your other problems or needs. The proactive vendor anticipates your future needs.
Bottomline, as you go shopping, keep your customer hat on, and monitor if your prospective vendor is acting in your best interests. Happy hunting!

In case you're interested in buying the book:


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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

The Designated Rep and Exemptee Professionals Blog
SkillsPlus Intl Info Blog

Tuesday, October 27, 2009

How About A Patient-Centered Medical Home Model?

A patient having his blood pressure taken by a...Image via Wikipedia

Interesting post on the KevinMD Medical Weblog, How the patient-centered medical home can improve our health care system.

The post is a good read, and I can see the rationale for moving toward a focus to a patient management focus model. The likely reliance upon technology certainly has potential ramifications for medical device, and home care delivery entities. So this is something worth following and watching.

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Tuesday, October 13, 2009

Medicare Fraud - Mafia - Violence

This Associated Press release, Mafia, violent criminals turn to Medicare fraud, reports: "Lured by easier money and shorter prison sentences, Mafia figures and other violent criminals are increasingly moving into Medicare fraud and spilling blood over what was once a white-collar crime."

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Tuesday, September 22, 2009

Home Health Industry To Grow In Years Ahead

According to Industry In Focus: US Home Health Care Revenues Set to Exceed $5 Billion by 2012, "The US home health care market, valued at nearly $4.5 billion in 2009, is set to experience steady growth in the years ahead, . . . sales revenues for the major home health care product segments are expected to reach $5.2 billion by 2012."

This is all driven by a burgeoning aging population, a critical need for cost-effective solutions for patients suffering from long-term chronic conditions, and the increasing use of technology to meet the needs of those receiving home-based medical care.

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Tuesday, September 8, 2009

Writing Standard Operating Procedures - Course Announced

The Board of Pharmacy and HMDR require folks to have SOPs (standard operating procedures). If you don't have any, you should. If you're writing them, or revising them, read on. I've just learned about this new course offering by SkillsPlus International Inc., Writing Procedures: Drug and Device Wholesalers and HMDR's.

Here's how the course is described:
Learn to write procedures quickly and thoroughly. Allan shares his experiences and techniques for writing procedures. This class is based on 30 years of experience writing procedures and teaching others to write them.
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Tuesday, August 18, 2009

Alert - Drug Wholesale Conviction - Don't be next

According to this US Attorney's Office press release, MIAMI PRESCRIPTION DRUG WHOLESALER CONVICTED:
A significant portion of the Serostim that Segredo distributed through these two companies originated from California-based AIDS patients who sold their Serostim supplies secured from the Medi-Cal Medicaid program

This drives home the point that it's essential to avoid non-standard and fraudulent distribution methods.

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Tuesday, July 21, 2009

CA - Forms for Drug Wholesalers and Designated Representatives

The Bear Flag of the Republic of CaliforniaImage via Wikipedia
There will be times when you need to submit new or revised forms to the CA State Board of Pharmacy. Here's a collection of forms that might be useful to drug wholesalers, and designated representatives.

Just a tip, make sure to pay attention to the requirements for when some of these forms need to be submitted. For example, changes in the designated representative in charge need to be reported within 30 days of a change.

Go to the California Board of Pharmacy - Applications and Forms Page

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Tuesday, July 14, 2009

Watch Your Back - I mean safety!

We all do some heavy lifting from time to time, so it's critical to pay attention to back safety. Here's a useful article from the NAW, Material Handling - Do's and Don'ts. The article frames the situation in this way:
Manual handling, and the twisting and turning that occur when they perform these tasks, can lead to musculoskeletal disorders (MSDs) or cumulative disorders (CTDs), such as injuries to the back, shoulder and neck. The cumulative effect of even minor injuries of this nature can become more pronounced over time.

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Thursday, July 9, 2009

Reinforce Key Regulatory Messages - Use Posters

GMP Posters. Suitable for training and quality efforts.
Drug wholesaler designated representatives and medical device exemptees often need to recruit the help of staff around them to ensure the company complies with regulatory requirements.

If you're looking to make your company's training or quality programs more robust, consider using posters to reinforce your key messages.

SkillsPlus International Inc. announces, "Poster! Posters! and More Posters!" in the release of their brand new GMP poster series, SkillsPlus International Inc. - GMP Good Manufacturing Practice and QSR Quality System Regulation - Large Posters (23" x 35"). Alternatively, you can also scan their offerings in the SkillsPlus GMP Poster Catalog. I find these posters strikingly beautiful, and convey very simple and understandable messages.

By the way, if you think these posters don't apply to your work situation, I encourage you to think twice. Many of them apply to many diverse work settings. Folks have been clamoring for more work-related posters, so it's great to see these new additions to poster offerings. Check it out!

Other GMP posters I've found on the web:
ISPE GMP Posters
Compliance Insight GMP Motivational Posters

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SkillsPlus Intl Inc. - GMP Compliance Training Experts
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Tuesday, July 7, 2009

CA HMDR FAQs

The Sumerian god Ningizzida was the patron of ...Image via Wikipedia
Updated 1/18/2013
I hate that they took down this FAQ PDF! However, it's back up in 2013, so I've re-linked it below. Here's what we offered in the spirit of FAQs, when the HMDR FAQs were down:
CA Exemptee FAQs


Here's something you might find helpful, The CA Home Medical Device Retailer (HMDR) licensing program Frequently Asked Questions (FAQs)

Here are the questions that are answered:
  1. What is an HMDR business and who needs an HMDR license from the DHS, Food and Drug Branch?
  2. Where can I get an HMDR license application and what are the fees?
  3. Are there exceptions to the kinds of facilities that are required to have an HMDR license?
  4. What is the licensing process and how long does the process take?
  5. Can I operate my HMDR business without a valid license?
  6. After my facility is inspected, how long afterwards must I wait for my facility license?
  7. If my facility fails to meet compliance standards, what happens?
  8. If I move or sell my business, can my license be transferred?
  9. What is a Temporary License, and what are the criteria for receiving one?
  10. What are dangerous or “legend” devices?
  11. I wish to dispense legend medical devices from my HMDR. Do I need a special license?
  12. How can I obtain an HMDR exemptee license?
  13. Can I obtain an exemptee license without working at a HMDR facility?
  14. What about HMDR renewal inspections? How frequently are they conducted, and what are some common violations found?
  15. How can I get a copy of the HMDR Law and/or guidance on requirements?
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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

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Tuesday, June 30, 2009

FL - Miami Dade County Medicare Fraudsters Named

City of Miami BeachImage via Wikipedia

Eight Miami-Dade County (Florida) residents have been indicted in connection with an alleged $22 million Medicare fraud scheme operated out of Miami businesses purporting to specialize in home health care services reports this Medical News Today article, Eight Miami-Area Residents Charged In $22 Million Medicare Fraud Scheme Involving Home Health Care Agencies.

There's no hiding now, as this article calls out the names of folks indicted. Furthermore:

"Health care fraud schemes in South Florida range from simple billing schemes and fly-by-night durable medical equipment providers, to more sophisticated frauds, including infusion fraud, fraud on the Medicare Advantage Program, and now fraud in the delivery of home health services," said Acting U.S. Attorney Jeffrey H. Sloman. "Today's coordinated criminal and civil action delivers an effective one-two punch to health care fraudsters: they were not only caught and criminally charged, but they are also being stripped of their illegal proceeds."
Related Posts:
Florida Cracks Down On Miami DME Fraud

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Tuesday, June 23, 2009

Florida Cracks Down On Miami DME Fraud


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The Miami Herald reports, Florida probes Miami-area medical-equipment kickbacks - Medicaid investigators are targeting fraud in Miami-Dade County, zeroing in on questionable billing for medical equipment. They report investigations of providers suspected of bilking the state healthcare program for low-income people by billing for oxygen concentrators that are not medically needed. Investigators also visited more than 120 Medicaid patients, some of whom may have received kickbacks from medical equipment suppliers for ordering their products.

Of note, investigators indicate that unnecessary billing for oxygen concentrators has been a particular problem over the past five years. According to Holly Benson, secretary for the Florida Agency for Health Care Administration, said fraudulent billing for oxygen concentrators is the latest scam ailing Medicaid, which spent $90 million on medical equipment in fiscal 2007-08. About 25 percent of that spending, funded by state and federal taxes, was in Miami-Dade.

In summary, it's especially important to have things in order if you're near Miami and billing for oxygen concentrators.

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Tuesday, June 16, 2009

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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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

The Designated Rep and Exemptee Professionals Blog
SkillsPlus Intl Info Blog

Thursday, June 11, 2009

CA Man Sentenced For Prescription Drug Diversion

Uh-0h. Don't get caught like this. Read this Department of Justice (DOJ) news release to see what I mean, California Man Sentenced For Prescription Drug Diversion.

According to the release, the Californian man was "was sentenced to 52 months of incarceration to be followed by three years of supervised release for illegally distributing large quantities of Serostim, an HIV drug, which were illegally purchased from illegitimate sources and then illegally sold to wholesale distributors in various parts of the country, using falsified paperwork."

Here's what this means to you, "The Prescription Drug Marketing Act (“PDMA”) requires wholesale distributors of prescription drugs to be licensed by the states in which they operate. Pursuant to the PDMA, the FDA enacted minimum state guidelines for state licensing of wholesale distributors of prescription drugs. The PDMA generally requires wholesale distributors of prescription drugs to provide to the recipient of the drugs a statement indicating each prior sale of the drug including the names of all parties to the transactions. This statement is generally referred to as the “Drug Pedigree.” The minimum state guidelines and the drug pedigree requirement are designed to eliminate potential risks to the public health by protecting the integrity of the drug distribution system."

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Tuesday, June 9, 2009

New Organization Announced - Committee to Save Independent HME Suppliers

This PR Newswire release announces the formation of a new organization, New Organization Formed To Save Independent Medical Equipment Suppliers.

You might be interested in this new organization, Committee to Save Independent HME Suppliers, LLC (CSI: HME), because this non-profit business league was created to respond to the growing threat that recent policy changes pose to the future of independent medical suppliers and the patients they serve.

In reading the press release, I learned that small home medical equipment suppliers account for 85% of suppliers in the Medicare Program.

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Saturday, June 6, 2009

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From SkillsPlus International Inc.