Dr.EndoIndy said:Denials are usually procedural rather than clinical, and the order that works reflects that.
Agreed, and coverage criteria are plan-specific rather than insurer-specific. Two people with the same insurer and different employers have different rules, which is why "my insurer covers it" is not transferable information.
Worth separating that from cost and coverage, which this thread keeps folding into the same question. They behave differently and the advice does not transfer.
AussieAnna said:Agreed, and the enforcement dates were staggered by category — 503A first, 503B a few weeks later — because outsourcing facilities have manufactured…
Bookmarking. The distinction being drawn above is the one nobody else makes. Taking it to my next appointment.
Dr.EndoIndy said:Denials are usually procedural rather than clinical, and the order that works reflects that.
This is where I part company with the consensus forming above. The affordability discussion here usually stops at individual tactics. At list price this class is out of reach for most of the people who would benefit, and no amount of appeal strategy changes that — it is a pricing problem wearing a paperwork costume.
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Browse GL Biochemgary_naperville said:Two pharmacies quoted me last year, one describing itself as 503A and one as 503B, and I assumed 503B just meant bigger until both stopped within…
FDA inspection results for compounding pharmacies selling compounded supply: you can look up any 503B facility's FDA inspection history on the FDA website.
Check for: Form 483 observations (violations), warning letters, and recall history. A clean inspection record is a strong indicator of quality. My pharmacy has had 0 Form 483 observations in their last 4 inspections.
This is public information. Use it. Link: fda.gov/inspections-compliance-enforcement-and-criminal-investigations