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Regional · North America

US compounding rules and how they changed

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VN
v.nascimentoTL2 Moderator23 Sep 2024#1

US compounding rules and how they changed — setting out what I have, and where I think it stops being reliable.

A coverage question with the paperwork detail included, since that is what determines the answer.

Denial received, with a stated reason. My reading of the reason is that it tells me exactly what to submit next, which is the useful thing about a well-written denial.

Before I spend a week on it: is my reading of the stated criterion correct, and is there a documented precedent for this specific ground?

12 likes 22mo
JV
j.vandermolenTL3Regular25 Sep 2024#2

Picking up the opening post: that is the part I would want checked first.

Prior authorisation, step therapy, and exclusion of weight-management indications from coverage are common access barriers. The denial letter tells you which barrier you are facing.

1 like 22mo
BC
b.correiaTL2 Moderator26 Sep 2024#3

United States: FDA licenses compounds. Prescribing and pharmacy practice are state-regulated. Compounds are prescription-only. Coverage is decided by individual plans, not nationally.

0 likes 22mo
BS
buffer_shiftTL1Member27 Sep 2024#4
b.correia, post #3: United States: FDA licenses compounds. Prescribing and pharmacy practice are state-regulated. Compounds are prescription-only. Coverage is decided by individual plans, not nationally. Go to post

Indigenous healthcare systems: different indigenous healthcare systems have different medication access. Pathways through tribal health systems differ from mainstream healthcare.

23 likes in reply to #3 22mo
AE
a.eriksenTL2 Moderator28 Sep 2024#5

Private insurance gaps: some people have private insurance but medication is not covered. Manufacturer assistance programmes are the main resource for cost reduction.

3 likes 22mo
RA
r.arbuthnotTL1Member29 Sep 2024#6

This follows post #3 rather than contradicting it.

Regional variation in North America: access differs substantially by US state and Canadian province. Postcode is a major determinant of access.

0 likes 22mo
CS
c.serranoTL2 Moderator30 Sep 2024#7

Worth separating two things that post #3 runs together.

Cross-border purchase: buying in the US and bringing to Canada or vice versa involves both countries' import rules. The medication is legal but crossing borders with it is regulated.

32 likes 22mo
TN
t.nardoneTL3Regular1 Oct 2024#8
c.serrano, post #7: Worth separating two things that post #3 runs together. Cross-border purchase: buying in the US and bringing to Canada or vice versa involves both countries' import rules. The medication is legal but crossing borders with it is regulated. Go to post

Thank you for the correction. I have edited my earlier post with a note rather than silently, so the thread still makes sense to read. The error was mine and it was the kind that comes from remembering a figure instead of looking it up.

16 likes in reply to #7 22mo
TV
t.verhoevenTL2 Moderator2 Oct 2024 · edited#9
r.arbuthnot, post #6: This follows post #3 rather than contradicting it. Regional variation in North America: access differs substantially by US state and Canadian province. Postcode is a major determinant of access. Go to post

Canada: Health Canada licenses compounds. Prescribing is provincial. Compounds are prescription-only. Coverage varies between public and private insurance.

1 like in reply to #6 22mo
LC
l.chevalierTL3Regular3 Oct 2024#10

Telehealth prescribing: widespread in the US and varying in quality. Models without a clinician reviewing measurements and history are not recommended by this community.

0 likes 22mo
DB
d.barrosTL2 Moderator4 Oct 2024#11

Picking up post #8: that is the part I would want checked first.

Provincial formularies in Canada are published and are the correct source for coverage information. Coverage for weight management is less common than for diabetes.

30 likes 22mo
HK
h.karlsenTL2 Moderator5 Oct 2024#12

Coming back to post #10, because the follow-up matters more than the original answer.

United States: FDA licenses compounds. Prescribing and pharmacy practice are state-regulated. Compounds are prescription-only. Coverage is decided by individual plans, not nationally.

0 likes 22mo
NV
n.vogelTL26 Oct 2024#13
MI
m.ivaturiTL2 Moderator6 Oct 2024 · edited#14
buffer_shift, post #4: Indigenous healthcare systems: different indigenous healthcare systems have different medication access. Pathways through tribal health systems differ from mainstream healthcare. Go to post

Having read the exchange above, I think I was wrong earlier in this topic and I want to say so plainly rather than quietly editing.

The correction was fair and I had been repeating something I had not checked carefully enough.

10 likes in reply to #4 22mo
SF
s.ferreiraTL2 Moderator7 Oct 2024#15

This follows post #12 rather than contradicting it.

Provincial formularies in Canada are published and are the correct source for coverage information. Coverage for weight management is less common than for diabetes.

22 likes 22mo
OC
o.cousineauTL3Regular8 Oct 2024#16

Cross-border purchase: buying in the US and bringing to Canada or vice versa involves both countries' import rules. The medication is legal but crossing borders with it is regulated.

0 likes 22mo
RM
r.mwangiTL2 Moderator9 Oct 2024#17

Regional variation in North America: access differs substantially by US state and Canadian province. Postcode is a major determinant of access.

1 like 22mo
CN
c.niemelTL3Regular10 Oct 2024#18
c.serrano, post #7: Worth separating two things that post #3 runs together. Cross-border purchase: buying in the US and bringing to Canada or vice versa involves both countries' import rules. The medication is legal but crossing borders with it is regulated. Go to post

Private insurance gaps: some people have private insurance but medication is not covered. Manufacturer assistance programmes are the main resource for cost reduction.

6 likes in reply to #7 22mo
CR
compounding_ruthTL4Pharmacist10 Oct 2024#19

Compounding pharmacies: pharmaceutical compounding of a drug not on the FDA shortage list is substantially constrained. The landscape changed when supply normalised. Current compounding availability is limited.

0 likes 22mo
ZO
z.okonkwoTL2 Moderator11 Oct 2024#20

Practical note that does not fit anywhere else. Whatever you conclude from this topic, write down what you did and when. The single most useful thing in your own records is not any individual result; it is that they are dated and consecutive.

2 likes 22mo
IB
i.beaulieuTL2 Moderator12 Oct 2024#21

Indigenous healthcare systems: different indigenous healthcare systems have different medication access. Pathways through tribal health systems differ from mainstream healthcare.

0 likes 22mo
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NLoughranTL3Regular13 Oct 2024#22

For anyone arriving from a search: the marked solution above is the direct answer, and the replies underneath it add the caveats that make it safe to use.

23 likes 21mo
MA
m.amankwahTL2 Moderator13 Oct 2024#23
s.ferreira, post #15: This follows post #12 rather than contradicting it. Provincial formularies in Canada are published and are the correct source for coverage information. Coverage for weight management is less common than for diabetes. Go to post

On post #19 — agreed on the reasoning, with one qualification.

Telehealth prescribing: widespread in the US and varying in quality. Models without a clinician reviewing measurements and history are not recommended by this community.

6 likes in reply to #15 21mo
VS
vial_slopeTL3Regular14 Oct 2024#24

post #23 answers the question as asked. The question underneath it is different.

Canada: Health Canada licenses compounds. Prescribing is provincial. Compounds are prescription-only. Coverage varies between public and private insurance.

1 like 21mo
VO
v.okonkwoTL2 Moderator15 Oct 2024#25

Compounding pharmacies: pharmaceutical compounding of a drug not on the FDA shortage list is substantially constrained. The landscape changed when supply normalised. Current compounding availability is limited.

0 likes 21mo
T
TamburelloTL2Member16 Oct 2024#26

Prior authorisation, step therapy, and exclusion of weight-management indications from coverage are common access barriers. The denial letter tells you which barrier you are facing.

31 likes 21mo
LL
l.lundgrenTL2 Moderator16 Oct 2024#27
i.beaulieu, post #21: Indigenous healthcare systems: different indigenous healthcare systems have different medication access. Pathways through tribal health systems differ from mainstream healthcare. Go to post

Worth separating two things that post #23 runs together.

Canada: Health Canada licenses compounds. Prescribing is provincial. Compounds are prescription-only. Coverage varies between public and private insurance.

10 likes in reply to #21 21mo
I
IMainwaringTL3Regular17 Oct 2024#28
s.ferreira, post #15: This follows post #12 rather than contradicting it. Provincial formularies in Canada are published and are the correct source for coverage information. Coverage for weight management is less common than for diabetes. Go to post

Telehealth prescribing: widespread in the US and varying in quality. Models without a clinician reviewing measurements and history are not recommended by this community.

3 likes in reply to #15 21mo
RM
r.molnarTL2 Moderator18 Oct 2024#29

Coming back to post #27, because the follow-up matters more than the original answer.

United States: FDA licenses compounds. Prescribing and pharmacy practice are state-regulated. Compounds are prescription-only. Coverage is decided by individual plans, not nationally.

24 likes 21mo
TS
taper_shiftTL3Regular18 Oct 2024#30
buffer_shift, post #4: Indigenous healthcare systems: different indigenous healthcare systems have different medication access. Pathways through tribal health systems differ from mainstream healthcare. Go to post

Picking up post #27: that is the part I would want checked first.

Indigenous healthcare systems: different indigenous healthcare systems have different medication access. Pathways through tribal health systems differ from mainstream healthcare.

11 likes in reply to #4 21mo