Do you need to be a physician to preform IVF / surrogate births in the US?

[Modest_anteater]

Hello.

I am a pharmacist and was planning on starting my own IVF clinic with a lab to impregnate surrogate mothers with donor egg and sperm. I was unable to find any information on how this is regulated. Will I have to hire a physician to oversee operations? How about a PA or NP? I imagine embryo implantation into the uterus is the most regulated part of this procedure. Thank you for any input or hints to where I can find the framework related to regulation of IVF. I understand that the actual surgical harvesting of eggs would required a board certified surgeon.

Bonus points: Could I start a standalone IVF clinic in Mexico.

Thanks everyone and please if you are going to pass unsolicited judgement on me refrain.

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[VA Hopeful Dr]

 

[Psai]

You want us to tell you how to do something that you have no clue about and no business doing?

wtf?

 

[Mad Jack]

Deadly curious why you think some reproductive medicine board-certified OB/GYN is going to be your lackey when they could do the same thing and just cut you right out of the process. You bring literally nothing to the table.

 

[VA Hopeful Dr]

You want us to tell you how to do something that you have no clue about and no business doing?

wtf?

Deadly curious why you think some reproductive medicine board-certified OB/GYN is going to be your lackey when they could do the same thing and just cut you right out of the process. You bring literally nothing to the table.

 

[atomi]

You'd do a lot more good for everybody if you just set up an adoption agency instead.

 

[The Knife & Gun Club]

Hello.

I am a pharmacist and was planning on starting my own IVF clinic with a lab to impregnate surrogate mothers with donor egg and sperm. I was unable to find any information on how this is regulated. Will I have to hire a physician to oversee operations? How about a PA or NP? I imagine embryo implantation into the uterus is the most regulated part of this procedure. Thank you for any input or hints to where I can find the framework related to regulation of IVF. I understand that the actual surgical harvesting of eggs would required a board certified surgeon.

Bonus points: Could I start a standalone IVF clinic in Mexico.

Thanks everyone and please if you are going to pass unsolicited judgement on me refrain.

Giving you the benefit of the doubt - No this is not legal. Like at all. IVF is a medical procedure - you must be an MD/DO to perform it. Further it would be ground for malpractice (you'd get sued in ~2 seconds) for any doctor to perform IVF without completing an OBGyn Residency & Reproductive Endocrinology Fellowship. The people that do OBGyn-REI are some of the highest paid physicians in medicine to boot - you cant just hire one on a whim. In fact even in Mexico I would bet its still not legal.

Are you saying this as someone who knows and understands how to do IVF, has the capital to start a business, and just wants to know the legality? IVF is not a skill you can learn on youtube.

Edit: upon review REI salaries are around 330k/year. Not as high as I thought but still ~100k above average

 

[VA Hopeful Dr]

Giving you the benefit of the doubt -

Well there's your first mistake.

No this is not legal. Like at all. IVF is a medical procedure - you must be an MD/DO to perform it. Further it would be ground for malpractice (you'd get sued in ~2 seconds) for any doctor to perform IVF without completing an OBGyn Residency & Reproductive Endocrinology Fellowship. The people that do OBGyn-REI are some of the highest paid physicians in medicine to boot - you cant just hire one on a whim. In fact even in Mexico I would bet its still not legal.

Are you saying this as someone who knows and understands how to do IVF, has the capital to start a business, and just wants to know the legality? IVF is not a skill you can learn on youtube.

Edit: upon review REI salaries are around 330k/year. Not as high as I thought but still ~100k above average

You're half right. The other issue is that IVF is considered high complexity from a lab standpoint and getting certified and maintaining certification for high complexity labs is a huge pain.

 

[Modest_anteater]

Giving you the benefit of the doubt - No this is not legal. Like at all. IVF is a medical procedure - you must be an MD/DO to perform it. Further it would be ground for malpractice (you'd get sued in ~2 seconds) for any doctor to perform IVF without completing an OBGyn Residency & Reproductive Endocrinology Fellowship. The people that do OBGyn-REI are some of the highest paid physicians in medicine to boot - you cant just hire one on a whim. In fact even in Mexico I would bet its still not legal.

Are you saying this as someone who knows and understands how to do IVF, has the capital to start a business, and just wants to know the legality? IVF is not a skill you can learn on youtube.

Edit: upon review REI salaries are around 330k/year. Not as high as I thought but still ~100k above average

Hello. I have significant experience witnessing and helping out with IVF procedures in urban India working directly with Indian physicians. I understand the process very well. It seems like I will research the requirements in Mexico as the requirements in the US seem quite strict. Thank you for the feed back it was very useful!

 

[DocWinter]

Hello. I have significant experience witnessing and helping out with IVF procedures in urban India working directly with Indian physicians. I understand the process very well. It seems like I will research the requirements in Mexico as the requirements in the US seem quite strict. Thank you for the feed back it was very useful!

Great, once the patients get their discount gastric bands in Tijuana they can scoot over to your establishment for a nice low cost, worry free pharmacist approved embryo transfer.

 

[BigRedBeta]

HOLY ****

so my wife and I had trouble getting pregnant with our second and have seen first hand the intricacy that reproductive medicine requires. It's not that US regulations are high, it's that the process as a whole requires a ton of resources, lab processing, technical expertise in doing the fertilization, and on and on and on. The whole premise is a ****ing joke that you could do this by yourself.

@The Knife & Gun Club - for the record, although IVF is well known for being an expensive procedure, it's mainly that insurance doesn't cover it, so the cash payments are more widely broadcast (if insurance didn't cover gall bladder removal, you could imagine that even laypersons would know the price for that procedure). A good friend of mine from medical school is an REI and she told me while we were looking at IVF that costs for the procedure have largely plateaued in the mids 2000's and for the actual IVF patients they frequently are only breaking even after paying for equipment/storage and salaries of lab techs. If patients have insurance that covers in vitro, it is not uncommon for the MD's to actually lose money on the process. More money is made on the patients who end up with correctable causes of infertility that don't proceed to IVF. Of course, some REI's will offer the three rounds of IVF with a partial refund if you don't get pregnant, but you have to prepay for everything and if you get a baby the first go, then they keep your money - which financially makes a lot of sense for the REI, but could be considered predatory in some circumstances.

 

[sunshinefl]

HOLY ****

so my wife and I had trouble getting pregnant with our second and have seen first hand the intricacy that reproductive medicine requires. It's not that US regulations are high, it's that the process as a whole requires a ton of resources, lab processing, technical expertise in doing the fertilization, and on and on and on. The whole premise is a ****ing joke that you could do this by yourself.

@The Knife & Gun Club - for the record, although IVF is well known for being an expensive procedure, it's mainly that insurance doesn't cover it, so the cash payments are more widely broadcast (if insurance didn't cover gall bladder removal, you could imagine that even laypersons would know the price for that procedure). A good friend of mine from medical school is an REI and she told me while we were looking at IVF that costs for the procedure have largely plateaued in the mids 2000's and for the actual IVF patients they frequently are only breaking even after paying for equipment/storage and salaries of lab techs. If patients have insurance, it is not uncommon for the MD's to actually lose money on the process. More money is made on the patients who end up with correctable causes of infertility that don't proceed to IVF. Of course, some REI's will offer the three rounds of IVF with a partial refund if you don't get pregnant, but you have to prepay for everything and if you get a baby the first go, then they keep your money - which financially makes a lot of sense, but could be considered predatory in some circumstances.

I can kind of understand saying that you usually have success given 3 cycles, and offer a 3 cycle/1 pregnancy package.

 

[The Knife & Gun Club]

Well there's your first mistake.



You're half right. The other issue is that IVF is considered high complexity from a lab standpoint and getting certified and maintaining certification for high complexity labs is a huge pain.

HOLY ****

so my wife and I had trouble getting pregnant with our second and have seen first hand the intricacy that reproductive medicine requires. It's not that US regulations are high, it's that the process as a whole requires a ton of resources, lab processing, technical expertise in doing the fertilization, and on and on and on. The whole premise is a ****ing joke that you could do this by yourself.

@The Knife & Gun Club - for the record, although IVF is well known for being an expensive procedure, it's mainly that insurance doesn't cover it, so the cash payments are more widely broadcast (if insurance didn't cover gall bladder removal, you could imagine that even laypersons would know the price for that procedure). A good friend of mine from medical school is an REI and she told me while we were looking at IVF that costs for the procedure have largely plateaued in the mids 2000's and for the actual IVF patients they frequently are only breaking even after paying for equipment/storage and salaries of lab techs. If patients have insurance, it is not uncommon for the MD's to actually lose money on the process. More money is made on the patients who end up with correctable causes of infertility that don't proceed to IVF. Of course, some REI's will offer the three rounds of IVF with a partial refund if you don't get pregnant, but you have to prepay for everything and if you get a baby the first go, then they keep your money - which financially makes a lot of sense, but could be considered predatory in some circumstances.

Thanks for the additional info! Im obviously by no means an expert on the subject....Just have a girlfriend who does REI research.

 

[Goro]

You'd do a lot more good for everybody if you just set up an adoption agency instead.

If I could "like' this post a million times, I would do so!

 

[BigRedBeta]

I can kind of understand saying that you usually have success given 3 cycles, and offer a 3 cycle/1 pregnancy package.

Yeah, it's just hard to be comfortable when someone asks you for a check with $65000+ written on it.

My wife who did all the research into this said there was some study that showed patient's who participated in such a package had a higher live birth rate than those who didn't. It's interesting and one of the possible correlations is that the REI works harder to get you pregnant whether consciously or subconsciously, because they already have your money.

 

[VA Hopeful Dr]

Yeah, it's just hard to be comfortable when someone asks you for a check with $65000+ written on it.

My wife who did all the research into this said there was some study that showed patient's who participated in such a package had a higher live birth rate than those who didn't. It's interesting and one of the possible correlations is that the REI works harder to get you pregnant whether consciously or subconsciously, because they already have your money.

We did laser acupuncture with ours and the theory was that just lying there for a few extra minutes might make some kind of difference. Relaxing maybe?

 

[IMreshopeful]

Hello. I have significant experience witnessing and helping out with IVF procedures in urban India working directly with Indian physicians. I understand the process very well. It seems like I will research the requirements in Mexico as the requirements in the US seem quite strict. Thank you for the feed back it was very useful!

So you’re going to try and do something which was probably illegal to do in India (practice as a non-physician a procedure which physicians can only do), let alone the United States. Just because the doctors there are super unethical and corrupt AF doesn't mean it was a good thing to do there (speaking from experience having had to deal with them).

Good luck in jail

 

[libertyyne]

Giving you the benefit of the doubt - No this is not legal. Like at all. IVF is a medical procedure - you must be an MD/DO to perform it. Further it would be ground for malpractice (you'd get sued in ~2 seconds) for any doctor to perform IVF without completing an OBGyn Residency & Reproductive Endocrinology Fellowship. The people that do OBGyn-REI are some of the highest paid physicians in medicine to boot - you cant just hire one on a whim. In fact even in Mexico I would bet its still not legal.

Are you saying this as someone who knows and understands how to do IVF, has the capital to start a business, and just wants to know the legality? IVF is not a skill you can learn on youtube.

Edit: upon review REI salaries are around 330k/year. Not as high as I thought but still ~100k above average

ground for malpractice? I think you are confusing being credentialed for doing something with legally being able to do something. I know of a few cases where physicians not trained in plastics were performing plastics procedures for many years. Heck I have even seen FM docs who just practice OBGYN and are credentialed to do C-sections all day at hospitals. I dont believe there are regulations besides the requirements to obtain a license. Shady , yes. Difficuly getting malpractice coverage, probably. not illegal or grounds for a lawsuit until you do something bad tho, even then usually the laws are written with decisions made by someone with similar training.

 

[The Knife & Gun Club]

ground for malpractice? I think you are confusing being credentialed for doing something with legally being able to do something. I know of a few cases where physicians not trained in plastics were performing plastics procedures for many years. Heck I have even seen FM docs who just practice OBGYN and are credentialed to do C-sections all day at hospitals. I dont believe there are regulations besides the requirements to obtain a license. Shady , yes. Difficuly getting malpractice coverage, probably. not illegal or grounds for a lawsuit until you do something bad tho, even then usually the laws are written with decisions made by someone with similar training.

Bolded is actually exactly what I was trying to say. That even if it’s not illegal, one could easily be sued almost instantly (given how common “bad” outcomes are) for practicing far outside their scope of practice

 

[BigRedBeta]

We did laser acupuncture with ours and the theory was that just lying there for a few extra minutes might make some kind of difference. Relaxing maybe?

I tried to post a good Dr. Evil "prepare the laser" photo, but apparently I'm not smart enough to get it to work


MOD EDIT: Here you go, Just helping a fellow intensivist out. - group_theory

 

[deleted103644]

ground for malpractice? I think you are confusing being credentialed for doing something with legally being able to do something. I know of a few cases where physicians not trained in plastics were performing plastics procedures for many years. Heck I have even seen FM docs who just practice OBGYN and are credentialed to do C-sections all day at hospitals. I dont believe there are regulations besides the requirements to obtain a license. Shady , yes. Difficuly getting malpractice coverage, probably. not illegal or grounds for a lawsuit until you do something bad tho, even then usually the laws are written with decisions made by someone with similar training.

Requirement to get a license, yes, a medical license.

Which the OP does not have.

 

[libertyyne]

Requirement to get a license, yes, a medical license.

Which the OP does not have.

If you read the thread it is clearly talking about OP getting a non credentialed IVF credentialed physician to help them set up the business. So it is referencing that, obviously OP does not have a license.

 

[Raney Schauer]

Bonus points: Could I start a standalone IVF clinic in Mexico.

You can go to Mexican prison then.

 

[Raney Schauer]

If this was legit it wouldn't be here.

 

[CherryRedDracul]

OP, what are you going to offer the reproductive endocrinologist in terms of skillset? Why does he/she need you? That's a principle question you will have to answer.