IV PROVIDERS NEED TO PLUG INTO COMPLIANCE PDF Free Download
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32 | JULY/AUGUST 2022
COVER FOCUS FOLLOW THE SCIENCE
One of the fastest growing
industries in health care is IV
hydration. The low cost of
entering the space, together
with a skill set that can be
attained rapidly and inexpensively
are two of the reasons. But providers
have to be very careful not to confuse
the ease of entering the space with
the regulatory risks. They are two
very different things! One is easy; the
other isn’t.
The biggest warning sign of “risk
ignorance” is how IV hydration pro-
viders describe what they do. Here are
the three biggest “tells”:
1. “It’s just vitamins,”
2. “It’s super low risk, and the FDA
doesn’t really focus on this,” and
3. “IV infusion will absolutely cure/
fix _________________.”
Many IV hydration providers are
businesspeople with no clinical quali-
fications. They may assume that no
state or federal professional licensing
body will focus on what they do with
their business. But that’s simply not
true. The state licensing authorities
of every professional working in their
business are focused on the behavior
of that professional. And (described
below) several state and federal
authorities have already shown very
active interest in the IV hydration
industry. For these reasons, there is
no basis for the assumption that no
license equals no risk.
Physicians and medical practices
who have added IV hydration therapy
to their practices might also be sur-
prised about the level of state and
federal scrutiny. Thinking that the
space is somehow more relaxed than
what they do every day is a mistake.
And while drugs can be compounded
by licensed physicians, doing it in
office is restricted to a patient who
presents with an immediate need for
the product or because “it would not
be safe for the patient to take the
drug home for self-administration,
and it would be more convenient for
the physician to have the drug in his
or her office to administer immediate-
ly upon diagnosis, rather than asking
the physician to order the drug and
have the patient return to the health
care practitioner for administration.”
The truth is that IV hydration is full of
legal risks. And the key reason is that it
involves dependence on compounded
pharmaceutical items. IV hydration pro-
viders need to take note of things like:
1. The FDA’s job is principally to
protect the public by ensuring
that products we use are clean
and effective;
2. Products used by the IV hydra-
tion industry are produced by
compounding pharmacies, which
IV PROVIDERS
NEED TO PLUG INTO
COMPLIANCE
Providers have to be careful not to confuse the ease of
entering the space with the regulatory risks.
BY JEFFREY L. COHEN, ESQ.
JULY/AUGUST 2022 | 33
COVER FOCUS FOLLOW THE SCIENCE
are regulated to the minute detail
of how they do things (e.g., the
clothing worn by pharmacy staff,
air filtration);
3. Compounded products are not
considered to be FDA approved
and are inherently suspect by
regulatory authorities of being
insterile and/or ineffective;
4. The FDA is completely aware of
the IV hydration industry;
5. The FDA works hand-in-hand with
the state boards of pharmacy and
other agencies to investigate and
shut down dangerous situations;
6. There have been reported cases
of people almost dying from
infusion of vitamins, which have
resulted in the FDA and other
state and federal authorities
swooping in to protect the pub-
lic. Those efforts have caught
physicians, compounding phar-
macies and IV hydration provid-
ers in the regulatory net; and
7. The Federal Trade Commission
(FTC) actively suppresses all
claims of outcomes from using
compounded products (including
IV hydration).
To get an “inside view” of how
the FDA view the IV hydration (and
HRT and med spa) industry, read the
October 25, 2021 FDA Memo1 on the
topic, which:
• Reminds us of the application of
very specific regulatory require-
ments applicable to pharmacies;
• Reminds that the 503A FDC
exemption applicable to physicians
compounding in office is limited to
situations involving a valid patient-
specific prescription; and
• Discussed specific cases of
medical offices compounding in
insanitary conditions, including
those involving the infusion of IV
vitamins.
State medical boards also see the
risk. In 2020, the Federation of State
Medical Boards (2020 “White Paper
on Compounding Medications by
Physicians”)2 addressed physician
compounding and stated it should
only be done:
1. When triggered by a specific
patient need;
2. Only for one’s own patients;
3. Not in large quantities or for
retail sale;
4. Ensuring the ingredients are
necessary for treating a patient’s
medical condition (documented
in the patient medical record);
5. When the fees are not “unreason-
able” or “excessive” fees;
6. Guided by what’s in the patient’s
best interest.
In response to the regulatory envi-
ronment facing the IV hydration
industry, providers would be best
served to:
1. Appreciate that IV hydration
is viewed by state and federal
regulators like any other medical
procedure;
2. Make sure they’re fully educated
about the laws applicable to them;
3. Only use compound pharmacies
that have been fully vetted and
with well-documented historical
and ongoing regulatory compli-
ance. There is no liability protec-
tion for an IV hydration provider
simply pointing the finger at their
pharmacy supplier;
4. Understand that submitting
claims for reimbursement by any
insurer will materially increase
regulatory risks;
5. Accept that making any promises
about the outcomes of using IV
hydration is an invitation to meet
people with three letter agencies
emblazed on their wind breakers;
and
6. Work with competitors and regu-
lators to agree on workable and
science-based definitions of what
“quality” actually means for the
industry. n
1 FDA highlights concerns with compounding of drug products by medical
offices and clinics under insanitary conditions 10.25.2021 | FDA https://
www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-
compounding-drug-products-medical-offices-and-clinics-under-insanitary
2 White Paper on Compounding of Medications by Physicians 5.27.2020 | Fed-
eration of State Medical Boards https://www.fsmb.org/siteassets/advocacy/
publications/white-paper-on-physician-compounding-2020-for-posting.pdf
JEFF COHEN, ESQ.
n
Contributing author and co-founder, American
IV Association (AIVA), a national association
for owners, operators, and providers of IV
hydration therapy services offering reliable
guidance about evolving industry legal
requirements, regulations, and best practices.
n
Founder, Florida Healthcare Law Firm
n
www.floridahealthcarelawfirm.com; www.
americaniv.com
“ PHYSICIANS AND MEDICAL
PRACTICES WHO HAVE ADDED IV
HYDRATION THERAPY TO THEIR
PRACTICES MIGHT ALSO BE
SURPRISED ABOUT THE LEVEL OF
STATE AND FEDERAL SCRUTINY.”
