02/13/2014     Paul Kesselman, DPM

Stark Laws and Diabetic Shoe Certification (Benjamin M. Schaffer, DPM)

My classmate and colleague asks several questions
which are actually quite more complicated then
they appear. First off, the issue of Stark and
signing off on a podiatric diagnosis are two
separate issues, which apparently h/she is
confusing as are other MD/DO and DPMs.

The Stark issue is one that I would defer to an
attorney to provide a formal legal response. In
lieu of that, I have personally spoken with
several health care attorneys who are well versed
in Stark and I can provide you with a brief
explanation. In most cases, as long you are
personally providing services to your own patient
in your own office there should be no Stark
violation.

Your office providing shoes to a patient, is no
different than the MD/DO performing in office
laboratory work, chest x-rays, ECG, etc. in
his/her own office. It is also no different than
you performing x-rays, and other diagnostic tests
in your own office to your own patients. The key
here is that your office is actually performing
these services and they are not purchased and
performed by another entity who comes to your
office. Those are far more complicated issues
which do not apply to shoes and DME you are
providing.

For the sake of completeness, I am including this
last statement so as to avoid any confusion. While
these other services may also be Stark exempt,
those do require a comprehensive in depth review
by a health care attorney to insure they are
exempt. Also remind the internist that h/she in
not providing a prescription or order for
anything. The issue of payment (whether direct or
indirect) is something you may also need to
address.

Stark also would not apply to the MD/DO signing a
certification form, your notes or providing any
prescription they are providing to their patients
which is then going to be peformed and billed out
by another party which the MD/DO/DPM (or their
immediate family member) has no ownership or
vested interest.

The DMEPOS Supplier Manual is also replete with
references to when the supplier is the prescribing
physician, which you may provide to the internist.
An example the internist may be familiar with is
pulmonologists who provide CPAP units to their
patients. While this is not the issue for the
MD/DO you are referring to, it is almost identical
to what your situation is. The difference here is
that of course the pulmonologist doesn't need
someone else to sign off on his notes or require a
certification form. Nevertheless, the internist
may be able to identify and more comfortable with
this somewhat parallel situation.

As to the second issue of signing off on a
podiatric diagnosis, this is actually a bit more
complicated, but has nothing to do with Stark. I
can sympathize with the MD/DO as this whole issue
of requiring the MD/DO to sign off on an exam
which they did not perform, is problematic and
understandable. It is inconsistent with 21st
Century Medicine. The MD/DO often feels they are
placed on the "firing line" and liable for a
diagnosis which they cannot (or did not) make and
for which they may have sent the patient to you in
the first place. One should be sympathetic to this
situation yet at the same time be prepared to
challenge this opinion. The HELLP act is certainly
a long term solution, which should be supported
but will not solve your current situation.

You might try a one on one conversation with the
MD and explain the above issues to them and
provide them with a formal legal opinion (which
they can understand). I also explain to my MD/DO
colleagues that their initialing my notes and
providing the certification form is required by
Medicare. It is similar if not identical to
initialing and dating a blood test, x-ray or MRI
report they have received which was performed by
another entity.

The MD/DO may have no specialty knowledge of how
that test was performed nor how to read the test
itself (e.g. an internist may not know how to read
an MRI) but they could understand the implications
of the radiologists interpretation).

The internist/endocrinoligist is merely
acknowledging the performance of the exam for
their records and acting accordingly. That is they
are referring the patient back to you for action
(med/sx or DME tx) which they are not performing
and for which they have no responsibility.

Simultaneously, there could be legal implications
for them should the patient not receive the
required materials you wish to provide (e.g.
ulcer, limb loss, etc.). That is their inaction
could also be problematic. This is certainly for
many MD/DOs a delicate situation, nevertheless it
must be dealt with and often its the DPM who is
best suited to discuss this directly with the
MD/DO.

Lastly, get your patients involved. I provide all
the paper work to my patients (including a medical
records release form). Your patient (and their
family) is actually your greatest asset.

Paul Kesselman, DPM, Woodside, NY,
drkesselmandpm1@hotmail.com

Other messages in this thread:

---

02/14/2014    Josh White, DPM, CPed

Stark Laws and Diabetic Shoe Certification (Benjamin M. Schaffer, DPM)

The following is excerpted from notification
entitled, Therapeutic Shoes for Diabetics –
Physician Documentation Requirements.

It’s intended to describe to physicians their
requirements, as participants in Medicare, how
they must respond to documentation requests from
suppliers:

"Suppliers may ask you to provide the medical
documentation described above on a routine basis
in order to assure that Medicare will pay for
these items and that your patient will not be held
financially liable .Providing this documentation
is in compliance with the HIPAA Privacy Rule. No
specific authorization is required from your
patient .Also note that you may not charge the
supplier or the beneficiary to provide this
information. Please cooperate with the supplier so
that they can provide the therapeutic shoes and
inserts that are needed by your patient.

Sincerely,

Paul J. Hughes, M.D.
Medical Director, DME MAC, Jurisdiction A

Robert D. Hoover, Jr., MD, MPH, FACP Medical
Director, DME MAC, Jurisdiction C

Adrian M. Oleck, M.D.
Medical Director, DME MAC, Jurisdiction B

Richard W. Whitten, MD, MBA, FACP
Medical Director, DME MAC, Jurisdiction D”

A link to the complete letter can be found at:
https://www.noridianmedicare.com/dme/news/docs/200
9/01_jan/dear_physician_therapeutic_shoes.html

Specifics regarding who is qualified to be a
prescriber of therapeutic shoes, a supplier and a
certifying physician are spelled out by:

Local Coverage Article for Therapeutic Shoes for
Persons with Diabetes - Policy Article – Effective
November 2013 (A37076)

https://www.noridianmedicare.com/dme/coverage/docs
/lcds/current/therapeutic_shoes_for_persons_with_d
iabetes.htm

"The Certifying Physician is defined as a doctor
of medicine (M.D.) or a doctor of osteopathy
(D.O.) who is responsible for diagnosing and
treating the beneficiary’s diabetic systemic
condition through a comprehensive plan of care.
The certifying physician may not be a podiatrist,
physician assistant, nurse practitioner, or
clinical nurse specialist.

The Prescribing Physician is the person who
actually writes the order for the therapeutic
shoe, modifications and inserts. This physician
must be knowledgeable in the fitting of diabetic
shoes and inserts. The prescribing physician may
be a podiatrist, M.D., D.O., physician assistant,
nurse practitioner, or clinical nurse specialist.
The prescribing physician may be the supplier
(i.e., the one who furnishes the footwear).

The Supplier is the person or entity that actually
furnishes the shoe, modification, and/or insert to
the beneficiary and that bills Medicare. The
supplier may be a podiatrist, pedorthist,
orthotist, prosthetist or other qualified
individual. The Prescribing Physician may be the
supplier. The Certifying Physician may only be the
supplier if the certifying physician is practicing
in a defined rural area or a defined health
professional shortage area.”

Also included are the requirements by certifying
physicians to respond to requests for certifying
documentation:

The certifying physician has certified that
indications (1, the beneficiary has diabetes
mellitus) and (2, the certifying physician has
documented in the beneficiary's medical record one
or more of the qualifying conditions) are met and
that he/she is treating the beneficiary under a
comprehensive plan of care for his/her diabetes
and that the beneficiary needs diabetic shoes. For
claims with dates of service on or after
01/01/2011, the certifying physician must:
Have an in-person visit with the beneficiary
during which diabetes management is addressed
within 6 months prior to delivery of the
shoes/inserts; and Sign the certification
statement (refer to the Documentation Requirements
section of the related Local Coverage
Determination) on or after the date of the in-
person visit and within 3 months prior to delivery
of the shoes/inserts.

Clearly it is appropriate for DPMs to both
prescribe and dispense therapeutic shoes for
qualifying patients at risk for ulceration, with
diabetes. The MD is required by Medicare to
provide requested documentation and as a Medicare
participant is not permitted to allow concerns
about Stark violation to prevent his/her providing
requested documentation.

Josh White, DPM, CPed, President/Founder SafeStep,
joshwhite@safestep.net