Shrinking - Insurance Coverage Of Some Compounded Meds

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Updated November 15, 2023

The original link broke.

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Compounding: Inspections, Recalls, and other Actions - FDA.gov

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It appears that health insurers are getting concerned about the safety and quality of compounded meds.

Compounding Problems: Anthem Restricts Coverage Of Some Compounded Meds | Pharmalot:

"More fallout from the compounding controversy. Anthem Blue Cross Blue Shield, one of the nation's largest insurers, has decided to end reimbursement of certain compounded medications as of November 1. Specifically, the insurer will not pay for compounded bulk powders or pharmaceutical adjuvants that are not approved by the FDA, according to a mailing that were sent to pharmacists."

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FDA - Pharmacy Alert - Front Range Laboratories - Testing Concerns

Updated November 18, 2024

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Compounding: Inspections, Recalls, and other Actions - FDA.gov

https://www.fda.gov/drugs/human-drug-compounding/compounding-inspections-recalls-and-other-actions

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Drug Safety and Availability > CDER Statement: FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories:

"In a recent inspection, FDA investigators observed that methods used by Front Range to assess sterility and other qualities (e.g., strength and stability) may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from Front Range are not reliable. FDA recommends that pharmacies not use this firm for sterility and other quality attributes testing at this time."

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CA Board of Pharmacy - It's Time to Complete Self-Assessments - Download Forms

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Updated March 14, 2021

Use the latest version of the forms posted on the Board's website:

CA Board of Pharmacy - Self-Assessment Forms

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The Board just sent out an email announcement informing California hospital pharmacies, hospital outpatient pharmacies, community pharmacies, compounding pharmacies, and wholesalers that they should now complete their self-assessments.  The Board expects that all self-assessments be completed in the next 30 days.

CA Board of Pharmacy - Applications and Forms:

" *Earlier this year, the board submitted to the Office of Administrative Law revised self-assessment forms that incorporated statutory and regulatory updates since 2011. This rulemaking was withdrawn from OAL, and a formal rulemaking will be initiated later this year. However, the revised (2013) forms MAY be used by a pharmacist or designated representative in charge if desired.

Current regulations require that the version(s) last approved by OAL be completed; however, the board will accept completion of either the OAL-approved versions OR the versions that were revised in 2013 (which will be the subject of a future formal rulemaking)."

Follow this link to find and download the Self-Assessment Forms

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• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
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• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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Renew Your License Early - Avoid New Computer System Disruptions - CA Board of Pharmacy

August 30, 2013 Update:

I just ran across the following updated information on the Board's website, "Does your license expire September 30, October 1, October 31, or November 1? . . . If your license renewal date falls between September 30 to November 1 (inclusive), these cashiering disruptions could affect you."

- - -

California Board of Pharmacy:

"Does your license expire August 31, September 1, September 30 or October 1?

If so, please note:

The Department of Consumer Affairs is beginning its transition to a new computer system. Phase 1 implementation begins for certain departmental agencies in mid-September 2013. During this transition, there will be temporary disruptions in cashiering and other services affecting all Department of Consumer Affairs agencies, including the Board of Pharmacy. These disruptions will prevent the update of licensing records available online. (The Board of Pharmacy will transfer to the new system in phase 2.)

If your license renewal date falls between August 31 to October 1 (inclusive), these cashiering disruptions could affect you.

Please renew your license early! Do not wait and risk delayed renewal of your license!"

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Share Your CMS Round 2 Concerns With Congress

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AAHomecare Blog: Get a Bigger BANG for the August Recess Buck:

"Resources

For tips on how to talk to Congress and be more effective in the political process, download our 10 Step Guides in the AAHomecare Grassroots Toolbox.

For details about the bidding program and the reasonable alternative, the market pricing program, go to www.aahomecare.org/advocacy.

Find your Representative and Senators’ phone numbers and email addresses in our congressional directory."


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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

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     California (earn a training completion certificate):

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• The Exemptee Institute

Senate In Recess - Didn't Vote On Track-and-Trace, Compounding Bill

Senate puts off vote for track-and-trace, compounding bill | Drug Store News:

"The Senate was expected to take up a bill designed to secure the drug supply chain and establish a list of "do not compound" medications, but left for recess Friday without voting on it.

The bill, S. 959, the Pharmaceutical Quality, Security and Accountability Act, had received some support from groups like the National Community Pharmacists Association, which supported the bill's goal of enhancing security, but expressed reservations about the compounding provision."

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CMS Proposes Capped Rental Rule for DME -- HME Business

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CMS Proposes Capped Rental Rule for DME -- HME Business:

"The Centers for Medicare and Medicaid funding have proposed a rule to rent “routinely purchased” DME items falling under the three-year minimum lifetime requirement and that have allowables of more than $150.

Under the proposed rule, Medicare would only purchase an item outright if its statistics show that the agency purchased the item 75 percent or more of the time during the period of July 1986 through June 1987. If not, those items would be reimbursed on a 13-month capped rental basis."

Follow this link to the proposed rule: Medicare Program: End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies

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• CA Designated Representative Reverse Distributor Training  
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     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

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Pharmacy Diversion Awareness Conferences by the DEA

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Updated June 4, 2024

The original link broke.

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DEA Meetings and Events

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The California Board of Pharmacy, in a recent e-mail says,

"Prescription drug abuse is at an all-time high in this country. Drug diversion continues to be a principal cause of discipline for regulators of pharmacies, pharmacists and wholesalers. The federal Drug Enforcement Administration are conducting regional one-day conferences on these topics. The board will award six hours of continuing education credit to pharmacists and pharmacy technicians who attend a full session.

There will be meetings located in San Jose on August 18 and 19 and San Diego on August 16 and 17."

Follow this link to the DEA webpage for Pharmacy Diversion Awareness Conference dates, locations, general information, and registration

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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