"Complex Compounding" CVS Caremark

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Sparda29

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So the pharmacy I'm the SP at got just got a letter from CVS Caremark that apparently we are not authorized to bill "complex compounds" as per our provider agreement. This means compounds containing bulk powders, dissolution of capsules/tablets, etc. Letter requests that we cease and desist billing compounds with those ingredients and that we reverse the claims that we already billed, filled, and gave to the patient.

Is this the way CVS Caremark is going about in preventing pharmacies from billing compounds? I know ExpressScripts already attacked compounding pharmacies by refusing to cover bulk powders.

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How can they retroactively put that in place? You already provided the service....

I don't know. It said as per agreement dated "x/x/x". When I bill compounds to CVS, initially it rejects with ingredient 3/4/5 not covered. So I resubmit with clarification code 08 and it goes through and pays for ingredients 1/2/6.

For example, this compound I'm billing for is Lidocaine ointment 5% 50 gm, gabapentin 400 mg capsule #24, amitriptyline hcl 1.2 g, diclofenac 7.2 g, baclofen 4.8 g, QSAD ointment base 240 g.

The specific department that sent it was CVS/Caremark Compound Credentialing.
 
I don't think anyone from the PBM is going to respond on here. You should call them directly. But post on here so we know what's up.
 
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Please read the contract that spelled out what you can and cannot compound. If it's clear you are screwed. If not, you have see a lawyer.
 
Please read the contract that spelled out what you can and cannot compound. If it's clear you are screwed. If not, you have see a lawyer.

Yeah, the owner checked it and told me that they rushed through the contract to just get the place up and running and forgot to do the compounding credentialing part. It seems like even if you do it, it will be a ****ing audit nightmare and that they'll be auditing every frikkin compound. They're just gonna turn to worker's comp and auto insurance for the compound part of the business since they are very lax on auditing and pay about 60% of AWP.
 
Yeah, the owner checked it and told me that they rushed through the contract to just get the place up and running and forgot to do the compounding credentialing part. It seems like even if you do it, it will be a ****ing audit nightmare and that they'll be auditing every frikkin compound. They're just gonna turn to worker's comp and auto insurance for the compound part of the business since they are very lax on auditing and pay about 60% of AWP.

Yes, CVS Careless is implementing incredibly onerous credentialing for compounding in an effort to of course improve their bottom line. Unfortunately, there have been some NON PHARMACIST owned compound pharmacies who have charged exorbitant amounts for compounded drug products that have given our profession a bad name, and it's also given the PBMs the necessary cover to basically begin excluding insurance coverage of compounds. Patients and providers ultimately suffer.

These type of dirt bags:

http://www.cbsnews.com/news/investigation-insurance-billed-18000-for-unwanted-pain-meds/
 
Yes, CVS Careless is implementing incredibly onerous credentialing for compounding in an effort to of course improve their bottom line. Unfortunately, there have been some NON PHARMACIST owned compound pharmacies who have charged exorbitant amounts for compounded drug products that have given our profession a bad name, and it's also given the PBMs the necessary cover to basically begin excluding insurance coverage of compounds. Patients and providers ultimately suffer.

These type of dirt bags:

http://www.cbsnews.com/news/investigation-insurance-billed-18000-for-unwanted-pain-meds/

Yeah that's weird. The way the owner does it here is he sends these pre-printed labels with the compound ingredients on it to the doc with the recommended indication.
 
Yeah that's weird. The way the owner does it here is he sends these pre-printed labels with the compound ingredients on it to the doc with the recommended indication.

You know that is illegal. The order and formulation originated with you. That makes you a manufacturer. Nothing will happen until something happens and then yoiu not only have a lawsuit, you have state and federal criminal charges.
 
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You know that is illegal. The order and formulation originated with you. That makes you a manufacturer. Nothing will happen until something happens and then yoiu not only have a lawsuit, you have state and federal criminal charges.

Don't really get how it's illegal. I know this is how it's done at most compounding pharmacies. The doctor rarely formulates the compound.

It's actually not a pre-printed label. The owner drops off order sheets that have a list of compounds that we can make and what they contain with recommended indications and recommended SIGs and quantities. The order sheet includes instructions to include a copy of the patients insurance card front and back with the prescription and to attach the prescription to the order sheet and check off which compound they would like and to write the name of the compound on the prescription.
 
That Pharmacy in Dallas that was busted by CBS news no longer accepts INSURANCE.

I wonder why? LOL...It's owned by a Pharmacy Tech and her scum bag non pharmacist husband. How they still have a license is beyond me.

http://www.downinglabs.com/
 
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That Pharmacy in Dallas that was busted by CBS news no longer accepts INSURANCE.

I wonder why? LOL...It's owned by a Pharmacy Tech and her scum bag non pharmacist husband. How they still have a license is beyond me.

http://www.downinglabs.com/

I didn't get that part in the article where the patient gets a call from a company and then the doctor prescribes it. All of our patients are seen in the clinic and the compound is part of the regimen that they are prescribed.
 
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I didn't get that part in the article where the patient gets a call from a company and then the doctor prescribes it. All of our patients are seen in the clinic and the compound is part of the regimen that they are prescribed.

The doctor does not "order" the compound. The compound is not individualized for the patient. If there is an issue, you will be cited as a manufacturer and then you will fined or charged criminally for not following GMP.
 
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If the compound document sent from the pharmacy to the doc has any "suggested" drugs/products then that is probably illegal ("steering" the doc, marketing to the doc). Applies even if the doses/frequencies are left blank imho. PBMs know these compounds are big money makers and don't want their payors to drop ship if they're not cracking down on pharmacies doing these things.
 
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I didn't get that part in the article where the patient gets a call from a company and then the doctor prescribes it. All of our patients are seen in the clinic and the compound is part of the regimen that they are prescribed.
That's because that pharmacy employed telemarketers who obtain a list ( somehow) of government ( usually tricare) eligible patients and the telemarketing team uses subversive measures ( and dirty physicians sometimes too) to get these compounds filled. In some LinkedIn groups they literally advertise selling patient lists... It's disgusting.
 
Yeah, sounds illegal to be sending out menus of the compound drugs you offer.

That said, that seems like a really sucky agreement, with anything involving a chemical or dissolving a tablet being considered "complex" compounding.
 
If the compound document sent from the pharmacy to the doc has any "suggested" drugs/products then that is probably illegal ("steering" the doc, marketing to the doc). Applies even if the doses/frequencies are left blank imho. PBMs know these compounds are big money makers and don't want their payors to drop ship if they're not cracking down on pharmacies doing these things.

I know the owners often visit the doctors and take them out to dinners and whatnot. Actually, all of their pharmacies are in the same building/strip as the doctor's office.

Most of the patients never even come to the pharmacy, we deliver it for free.
 
I know the owners often visit the doctors and take them out to dinners and whatnot. Actually, all of their pharmacies are in the same building/strip as the doctor's office.

Most of the patients never even come to the pharmacy, we deliver it for free.

So what. Do you not understand why this is illegal? You can't give the formula to the doctor unless the doctor says I need topical drug X do yiou know how to make it? In effect you are drug manufacturer who has a proprietary formula you advertise to the doctors.
 
So what. Do you not understand why this is illegal? You can't give the formula to the doctor unless the doctor says I need topical drug X do yiou know how to make it? In effect you are drug manufacturer who has a proprietary formula you advertise to the doctors.

What's the difference between that and this: https://www.uscompounding.com/pain-management-compounding_5007_ct.aspx

So if we just market to the doctor informing him that we offer compounding services for these indications and these are some of the ingredients that we use, that's fine. But to give him the entire formula, that's no good?
 
What's the difference between that and this: https://www.uscompounding.com/pain-management-compounding_5007_ct.aspx

So if we just market to the doctor informing him that we offer compounding services for these indications and these are some of the ingredients that we use, that's fine. But to give him the entire formula, that's no good?

Here is the deal. It's all ok as long as you get paid and nothing goes wrong. Once something happens and a patient is injured, you are not looking at a local problem with your state board. You are looking at Federal beef. Defending an action against the full weight of the Federal government who will overcharge you with everything is not worth the risk in my opinion.
 
So we got a reply from CVS Caremark.

It seems that if we want to do "complex compounding" we need to be PCAB accredited, submit studies proving efficacy of compounds, show lab stability studies for the products, answer a 50 question questionnaire and provide documentation for each question. Pretty much a pain in the ass.
 
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Here is the deal. It's all ok as long as you get paid and nothing goes wrong. Once something happens and a patient is injured, you are not looking at a local problem with your state board. You are looking at Federal beef. Defending an action against the full weight of the Federal government who will overcharge you with everything is not worth the risk in my opinion.

It's common practice for compounding pharmacies to provide for their patient's Physicians a pre-printed form of their company's unique compound offerings. I believe that it's legal in most states. The problem may arise in if the RX is filled under insurance, as PBMs place a far greater burden on the Network provider pharmacy that may in fact not allow for the pre-printed RXs despite the fact that they may be legally capable of providing those RX forms in the state that they do business in. PBMs often require tasks/procedures that go beyond the state or federal laws.

I understand you concern regarding a compound drug interaction/reaction as well. By providing the doctor a pre-printed formula, a Pharmacy may be putting themselves at additional risk from a predatory attorney or a defense attorney for the prescribing physician who is wishing to guard his client against a full extent of liability.
 
Independent NYC pharmacies are a completely different animal. Nothing good will come out from posting here about what actually goes on there.
 
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It's common practice for compounding pharmacies to provide for their patient's Physicians a pre-printed form of their company's unique compound offerings. I believe that it's legal in most states. The problem may arise in if the RX is filled under insurance, as PBMs place a far greater burden on the Network provider pharmacy that may in fact not allow for the pre-printed RXs despite the fact that they may be legally capable of providing those RX forms in the state that they do business in. PBMs often require tasks/procedures that go beyond the state or federal laws.

I understand you concern regarding a compound drug interaction/reaction as well. By providing the doctor a pre-printed formula, a Pharmacy may be putting themselves at additional risk from a predatory attorney or a defense attorney for the prescribing physician who is wishing to guard his client against a full extent of liability.
You are marketing an unapproved drug product with no studies on safety, efficacy or stability. I'll repeat, if nothing goes wrong, you will be just fine. If something goes wrong, you will not just get sued and fined by the State Board, you will face an FDA investigation for manufacturing.
 
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I'm regularly perplexed by some of those products compounding pharmacies market. Weird pain gels that wouldn't seem effective on a pharmacological/pk basis, and downright dangerous and false claim products like bioidentical HRT. It seems like they thrive on workers comp/no fault cases and rich old people scared to get older. I completely understand caremarks point.
 
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I'm regularly perplexed by some of those products compounding pharmacies market. Weird pain gels that wouldn't seem effective on a pharmacological/pk basis, and downright dangerous and false claim products like bioidentical HRT. It seems like they thrive on workers comp/no fault cases and rich old people scared to get older. I completely understand caremarks point.

This. Modern compounding is supposed to be about making stuff that just isn't commercially available (like liquid medications that are only available as a tablet/capsule.) It's not supposed to be about making up completely new drugs without having to go through the new drug manufacturing process.
 
What's the difference between that and this: https://www.uscompounding.com/pain-management-compounding_5007_ct.aspx

So if we just market to the doctor informing him that we offer compounding services for these indications and these are some of the ingredients that we use, that's fine. But to give him the entire formula, that's no good?

It should be OK to send a document to a physician that states your pharmacy has a compounding service. BUT it would probably not be ok to send a document to a physician that had any specific drugs on it of any kind.

So, it is probably OK send a blank compounding document with unfilled blank lines under the generic categories of drug name, dose, frequency, quantity, etc.

Those dinners are probably considered promotion if your pharmacist talks with the physician about their pharmacy being able to compound any particular drugs.


TITLE 21—FOOD AND DRUGS

" (c) Advertising and promotion
A drug may be compounded under subsection (a) of this section only if the pharmacy, licensed pharmacist, or licensed physician does not advertise or promote the compounding of any particular drug, class of drug, or type of drug. The pharmacy, licensed pharmacist, or licensed physician may advertise and promote the compounding service provided by the licensed pharmacist or licensed physician."

http://www.gpo.gov/fdsys/pkg/USCODE...2010-title21-chap9-subchapV-partA-sec353a.pdf
 
Independent NYC pharmacies are a completely different animal. Nothing good will come out from posting here about what actually goes on there.

How so?
 
You are marketing an unapproved drug product with no studies on safety, efficacy or stability. I'll repeat, if nothing goes wrong, you will be just fine. If something goes wrong, you will not just get sued and fined by the State Board, you will face an FDA investigation for manufacturing.


You simply repeated what I had written with a little more detail.

But the highlighted part of your statement is false. Even if there are no adverse reactions to the product that was on a pre-printed form where a doctor simply circles the "compound recipe", if it was filed under insurance, the PBMs can go back via an audit and reclaim ALL of the payment. That can effectively bankrupt a business.
 
I'm regularly perplexed by some of those products compounding pharmacies market. Weird pain gels that wouldn't seem effective on a pharmacological/pk basis, and downright dangerous and false claim products like bioidentical HRT. It seems like they thrive on workers comp/no fault cases and rich old people scared to get older. I completely understand caremarks point.


You obviously have never worked in a compounding pharmacy or dispensed to a patient a compounded HRT that the patient themselves will tell you has improved their sex life, their restfulness and their overall wellbeing.

Are there certainly some outliers? I think that we've touched on a few here already. But in general, compounding Pharmacy is the last true bastion of Pharmacy practice.
 
You obviously have never worked in a compounding pharmacy or dispensed to a patient a compounded HRT that the patient themselves will tell you has improved their sex life, their restfulness and their overall

With respect, I am sure every chiropractor, homeopath, and psychic medium has the same story
 
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You obviously have never worked in a compounding pharmacy or dispensed to a patient a compounded HRT that the patient themselves will tell you has improved their sex life, their restfulness and their overall wellbeing.

Are there certainly some outliers? I think that we've touched on a few here already. But in general, compounding Pharmacy is the last true bastion of Pharmacy practice.
BULL FEATHERS. You are making unapproved products with no proof of efficacy. Anecdotal information is NOT scientific proof. You are doping it to make a fortune. I have done a ton of compounding especially in the 70's & 80's, but the doctor ordered the compounds, I did not advertise these formulas to the prescriber. I made powders, capsules, suppositories, topicals, even cocaine nose drops for an ENT that was about 100 years old. We had a 1 lb jar of cocaine alkaloid.
 
You obviously have never worked in a compounding pharmacy or dispensed to a patient a compounded HRT that the patient themselves will tell you has improved their sex life, their restfulness and their overall wellbeing.

Are there certainly some outliers? I think that we've touched on a few here already. But in general, compounding Pharmacy is the last true bastion of Pharmacy practice.
Ok Suzaane Somers. Keep bashing marketed HRT while selling all natural, completely safe bioidentical hormones to menopausal ladies and older men looking to a magical curw
 
BULL FEATHERS. You are making unapproved products with no proof of efficacy. Anecdotal information is NOT scientific proof. You are doping it to make a fortune. I have done a ton of compounding especially in the 70's & 80's, but the doctor ordered the compounds, I did not advertise these formulas to the prescriber. I made powders, capsules, suppositories, topicals, even cocaine nose drops for an ENT that was about 100 years old. We had a 1 lb jar of cocaine alkaloid.
There are lots of tasks and business practices that you did while I was in my Johnny jump up in the 1970s that are relics of the past; like the type writer and 40% gross margins in the pharmacy.

Compounding pharmacists craft medications specific to a patient's needs. It is truly a skill that sets our profession apart from any other profession. It is the essence of pharmacy practice. Some have abased it and I noted some examples in previous paragraphs, but outside of increasing the pharmacy's potential civil liability or 3rd party liability, you're simply unaware of the advances made in compounding.

Sad that someone who actually practiced when pharmacists were mostly respected now performs his " professional" tasks while being an easily replaceable cog in the most corrupt and criminal " healthcare" pharmacy related organization in America today. You'd better check your screen before you reply to this, it might be red...
 
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