Monday, January 29, 2018

California HMDR Laws for 2018

California HMDR Laws for 2018

New CA Home Medical Device Retailer (HMDR) Legislation - Effective January 1, 2018


Read the full bill text:   AB 1387, Arambula. Home medical device retail facility business: licensing: inspections.

The Sherman Food, Drug, and Cosmetic Law, among other things, prohibits a person from conducting a home medical device retail facility business in the state without a valid license from the State Department of Public Health. Existing law requires the department to inspect each place of business prior to issuing a license, and further requires the department to inspect each licensee at least annually.

This bill would modify, until January 1, 2023, the requirement for the department to inspect a licensed home medical device retail facility business if it is accredited, as specified, by an accreditation organization approved by the federal Centers for Medicare and Medicaid Services. If so accredited, the bill would authorize the department to conduct an inspection only upon a complaint made to the department regarding the licensee. For a licensee that is not so accredited, the bill would continue to require the department to conduct an inspection at least annually.

Source: The legislation above is referenced on the CA HMDR Program website

Training program and certification for California Home Medical Device Retailers (HMDR) Exemptee license applicants - Earn a course completion certificate


Monday, October 31, 2016

Exemptee Refresher Training Is A Recommended Best Practice

Training for HMDR Exemptees and license applicants

Home medical device retailer (HMDR) Exemptee refresher training is a best practice.


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

If you're already recognized by the Department of Health Services as an Exemptee, 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?

You might also be interested in:
California Exemptee Certification Class - for home medical device retailers (HMDR)


Wednesday, October 19, 2016

AAHomecare Cost Study - October 2016 - American Association for Homecare

Access the report: American Association for Homecare - AAHomecare Cost Study - October 2016:

"A study from a well-established leader in healthcare economics shows that Medicare reimbursement rates for home medical equipment cover just 88% of overall costs for companies providing this service.

The study, Analysis of the Cost of Providing Durable Medical Equipment to the Medicare Population: Measuring the Impact of Competitive Bidding, raises serious concerns about the future viability of the home medical equipment industry under the current Medicare model."

'via Blog this'

You might also be interested in:
California Exemptee Certification Class for HMDR exemptee license applicants

Tuesday, October 18, 2016

HMDR Exemptee License Questions? Then Contact The CDPH HMDR Program

How To Contact The California Home Medical Device Retailer (HMDR) Program


View the full webpage:  Home Medical Device Retail Program:

Contact

Telephone Number:
(800) 495-3232

Fax Number:
(916) 650-6650

Overnight Mailing Address:
​​California Dept. of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS 7602
Sacramento, CA 95814

Regular Mailing Address:
California Dept. of Public Health
Food and Drug Branch
PO Box 997435, MS 7602
Sacramento, CA 95899-7435

FDB Email Address:
FDBinfo@cdph.ca.gov

You might also be interested in this:
California Exemptee Certification Class - for home medical device retailers (HMDR)

Monday, October 17, 2016

Where Can I Download HMDR License Application Forms?

Download HMDR License Application Forms

For California Home Medical Device Retailers (HMDR)

There is a CDPH HMDR webpage that links to the current application forms for both the firm license application(s) needed by each individual facility location where home medical devices (prescription Rx devices and non prescription devices) will be sold, leased or rented when ordered by a physician or other prescriber.

The application for the HMDR Exemptee is also linked on the webpage for firms who wish to sell prescription Rx devices such as respiratory equipment, medical oxygen and other equipment identified as dangerous or legend devices under California law.

These forms can be filled out online using the Adobe reader but must be printed out, signed and returned to the license desk to complete the license application process.

Source:
CDPH Home Medical Device Retailer (HMDR) Certificates and Licenses

You might also be interested in:
The California Exemptee Certification Class - CDPH-accepted training for home medical device retailer (HMDR) Exemptee license applicants

Thursday, October 13, 2016

What Topics Must Be Covered In An Exemptee Certification Class?

Q:  What Topics Must Be Covered In An Exemptee Certification Class?


Answer:
At a minimum, a California Exemptee certification class must cover the following topics:
  • State and Federal laws relating to the distribution of dangerous drugs and dangerous devices
  • State and Federal laws relating to the distribution of controlled substances
  • Knowledge and understanding of quality control systems
  • The United States Pharmacopoeia standards relating to the safe storage and handling of drugs
  • The safe storage and handling of home medical devices
  • Prescription terminology, abbreviations, and format

You might be interested in the following course that teaches the topics above:

Wednesday, October 12, 2016

I've Taken The Exemptee Certification Class, Now What?

Answer:
You've completed an Exemptee certification class. If you are a new Exemptee license applicant, then pay attention to the following:

  • Indicate on the application that you've completed a training class or course that covered the specified topics
  • Submit appropriate proof that you completed training. This means, don't forget to attach a copy of the completed training certificate or transcript with your application.

Source:
Application For Home Medical Device Retailer Exemptee License - New And Renewal (PDF)

You might also be interested in:
California Exemptee Certification Class - for home medical device retailers (HMDR)