FDA Clean Manufacturing Act - Evolution of HIPAA

April 22, 2003

Joseph,

HIPAA is a 1996 act of Congress regarding privacy and security in the HMO setting and in electronic transactions. It's finally getting under way. Mainly a lot of federal and state agencies along with private sector HMOs had to agree about a lot of things and also encrypted software had to be written and implemented. The laws are so broad that implementation has already taken seven long years, and the whole process is still evolving. The government websites make this sound very idealistic. It is not. It is industry driven. All information runs seamlessly between federal, state and industry computers utilizing a single shared encrypted software.

Keep reading about it and try to find industry insiders who are working on this and dealing with the day to day headaches. I'm helping a few such people with their research and implementation. This is one of the most Big Brother-ish pieces of government work I've ever seen. There are some potential headaches for any small manufacturer (not an ISO-9000 company) who wants to engage in any business to clinics or practitioners or even to the natural products industry. These issues are still in the developmental stages and may never come to pass.

The current danger is more for the patient than for the practitioner. There will be a lot of sharing of patient information to anyone who can access the encrypted software without the patient's consent or after their initial consent. Many members of Congress understood that HIPAA was supposed to prevent exactly this. Instead HIPAA implementation actually streamlines the flow of patient information. Sadly the patient will be unable to stop the flow once their initial consent has been given. And of course to get any treatment at all from their insurance, they will have to give consent. Check out this report:

from the April 15, 2003 edition - http://www.csmonitor.com/2003/0415/p09s01-coop.html

Medical privacy takes a hit with new ruleBy Sue A. BlevinsWASHINGTON - "As of Monday, a new federal medical-privacy rule gives data-processing companies, insurers, doctors, hospitals, certain researchers, and others legal permission to share citizens' personal health information - including genetic information - without individuals' consent ......"

As far as you, Joseph, go with compounding and encapsulating formulas, you have not much FDA oversight. You do not label nor market your formulas. Right? Remember. Do not present your herbal prescriptions as medicine. Present them as food, i. e. nutritional supplements. Do not make a claim to treat a condition that can be defined or identified by the FDA. For instance, do not present a treatment for diabetes but rather a treatment (if you must call it that) for Shang Xiao, Zhong Xiao or Xia Xiao.

This whole HIPAA implementation is very fluid right now and is becoming a field day for the FDA. Joseph, the site you discovered for the Supply Side East conference is sponsored by the multinational corporations that control the supplement industry including Roche Pharmaceutical (maker of the world's vitamin E), Watson Foods, Indena International, and others of that ilk. They do not have your interests at heart, but they might indirectly protect you by protecting their own interests. Also there is no teleconferencing with the FDA and industry members, but rather a teleforum. You pay $49 to simply listen on the phone and follow along on your computer.

Emmanuel Segmen

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acugrpaz

Monday, April 21, 2003 3:56 PM

FDA Clean Manufacturing Act

All,Recently I was at a symposium attending Marilyn Allen's latest HIPAA lecture. During the lecture she said in an aside that the latest rule change by the FDA regarding dietary supplement [herbal] manufacturing practices proposes a serious danger to the herbal clinician. On the surface, the rule change seems to be a good thing as it aims to ensure labeling accuracy and safety in an industry where any problem gets trumpeted to the heavens. What Marilyn Allen claimed was that somebody supposedly in the know told her that the law change will mean that anyone who makes up a formula in their office and sells it to a patient will technically be a manufacturer and thus subject to the same rules as herbal companies. That is, we will have to have clean rooms, assaying equipment, tons of paperwork and documentation, etc., etc. and God knows what all.I do not know if this is true. After spending a lot of time on the net searching for the truth about this, I have come up empty-handed. I wonder if anyone out there in cyber-land is able to shed any light on this. I did find some articles on the subject, but they did not get to the nitty-gritty about whether I as a small herbal clinician will be subject to the same rules as herb companies. By the way, I did discover that anyone who wishes to electronically attend the meeting to be held on May 4 from 5-7pm in Washington regarding this proposed rule change may do so by either logging onto www.supplysideshow.com/fda or by calling 1-800-454-5760 to register for teleconferencing.Joseph Garner

April 22, 2003

Emmanuel,

I agree - but I don't know if you are entirely correct about consent.

You have to offer a copy of your NPP (Notice of Privacy Practices) that

will notify your patients that their PHI (Protected Health Information),

can / will be used for TPO (Treatment, Payment, or Operations) HIPAA.

The patient then signs a notice that you gave the patient your NPP,

which is kept in the chart record. If the patient refuses to sign, you

note that still keep it in the chart. This isn't a release or

authorization, it only acknowledges the patient received (or refused to

receive) the NPP. I see the HIPAA act as eliminating the need to obtain

a consent to release medical information.... which I'm sure everyone can

see the danger of.

However, each state has it's own laws that also deal with medical

information, which may be tougher than HIPAA. You have to use the

tougher of the two... so a state may make a law requiring a release to

be signed to authorize release of information. How does it go? For each

problem there's an equal and opposite government program?

Oh - there were some 'seasoned' acupuncturists at the seminar who

thought they could get out of this mess... good luck... unless you're a

cash only business - payment times for non-electronically filed claims

are going to skyrocket, forcing most insurance providers to become HIPAA

compliant.

Geoff

> __________

>

> Mon, 21 Apr 2003 23:09:49 -0700

> Re: FDA Clean Manufacturing Act - Evolution of HIPAA

.....>

> The current danger is more for the patient than for the

> practitioner. There will be a lot of sharing of patient

> information to anyone who can access the encrypted software

> without the patient's consent or after their initial consent.

> Many members of Congress understood that HIPAA was supposed

> to prevent exactly this. Instead HIPAA implementation

> actually streamlines the flow of patient information. Sadly

> the patient will be unable to stop the flow once their

> initial consent has been given. And of course to get any

> treatment at all from their insurance, they will have to give

> consent. Check out this report:

> from the April 15, 2003 edition -

> http://www.csmonitor.com/2003/0415/p09s01-coop.html

April 22, 2003

Oh - there were some 'seasoned' acupuncturists at the seminar who thought they could get out of this mess... good luck... unless you're a cash only business - payment times for non-electronically filed claims are going to skyrocket, forcing most insurance providers to become HIPAA compliant.GeoffThanks for your comments, Geoff. I concur with your comments about consent and most especially about being knowledgeable of your own state's laws.

My comments partly derived from my part time work with a local lawyer and my association with a Univ. of Texas computer security administrator. My perspective is colored by how HIPAA impacts government and private bureaucracies as well as private citizens. Insurance providers are most assuredly HIPAA registered, compliant and pretty much in charge of their destiny. They will be very happy to not pay you for a myriad of reasons or lack of compliance.

I also agree with you that learning to electronically file claims will pretty much be your destiny ... unless, as you say, you carry out a cash only business.

From working in the legal sphere, your risks have to do with obtaining payment, not so much with HIPAA legal actions. Insurance companies, and to a lesser degree manufacturers, are much more at risk for HIPAA legal actions. Your job with HIPAA is to get paid. I don't see so much the risks that Joseph was concerned about from the FDA ... though they could exist if you marketed yourself intensely.

Regarding the relationship between FDA and HIPAA: the former is our government, the latter is a law enacted by Congress. What HIPAA does is create a single encrypted software that allows federal, state and private agency computers to communicate. This is at bottom what is revolutionary about all this. This is like breaking the sound barrier or going to the moon or genetically altering a species. Before this event it was hard for two agencies in our federal government to agree on any thing or even share a common language. For those who've worked in govt. you know this to be true. Now HIPAA forces or creates a common electronic language onto agencies throughout the federal and state governments as well as private agencies. This is a revolution. This is what fascinates me was well as horrifies me.

I really don't know what it means in the long term for practitioners like yourself. But if I were you, I would learn to communicate electronically with the powers that be. I would also look for ways to bolster the cash-only side of your business. Your patients should learn to pay out of pocket for your "value-added" benefits. This is how my successful MD friends make a living.

Emmanuel Segmen