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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
Other messages in this thread:
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
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