File Documentation: Key to OIG Compliance
By Sheila Press, Attorney, MBA  The subject of this article is file documentation
and compliance with the OIG (Office of the Inspector General)
Compliance Guidance for the Durable Medical Equipment, Prosthetics,
Orthotics, and Supply Industry.
First published in June 1999, this document provides both
general and specific guidance as to various internal antifraud and
abuse controls that suppliers can implement on a voluntary basis.
Moreover, it identifies and discusses numerous compliance risk
areas that, according to the OIG, are particularly susceptible to
fraud and abuse by durable medical equipment, prosthetics,
orthotics and medical supply (DMEPOS) suppliers.
At the time of publication, then-Inspector June Gibbs Brown
stated, "The purpose of the guidance is to help suppliers
self-regulate, self-report, and prevent healthcare fraud. The
voluntary adoption and implementation of the guidance will serve to
promote ethical and lawful conduct and further the fundamental
mission of all suppliers, which is to provide quality items,
service, and care to patients."
Thus, the major difference between complying with HIPAA and
complying with the OIG's Guidelines is that the former is a law
requiring compliance, while the latter are voluntary guidelines.
Nevertheless, the penalties for failure to follow the Guidelines
can be severe: there are civil and criminal penalties for fraud and
abuse. Furthermore, if file documentation is found to be incomplete
during an audit, the government can require repayment of money paid
on the audited claims as well as prepayment reviews and expanded
audits.
In examining whether file documentation is complete, the maxim
to remember is: If it's not documented, it did not happen. Here are
suggested guidelines:
1. Patient Information: You should maintain an
accurate record of your patient's name, address, telephone number,
employer, and insurance information. It is advisable to make copies
of the patient's insurance cards as well as to verify coverage and
which insurance is primary/secondary.
2. Prescription: This document should, at a
minimum, contain the patient's name, date signed, an appropriate
signature, and a generic description of the service/device ordered.
Check your Medicare Supplier Manual for additional detailed
requirements for prescriptions. Also, in certain cases, a purchase
order or written authorization from a payer may suffice.
3. Clinician's Notes: There should be a dated,
signed, informative, legible note for each patient encounter. Some
other hints: When a new device is ordered, the clinician should
evaluate the patient and indicate the treatment plan. Where
appropriate, note the specific componentry to be used. For a
lower-limb prosthetic patient, indicate the patient's current and
expected functional level and how it was determined.
For certain Medicare benefits such as replacement sockets and
custom lower-limb orthotics, you must document certain medical
criteria. If billing for repairs, adjustments, and/or time, the
materials used and the time spent should be noted in the file. At
the time of delivery, note how well the device fit and functioned
as well as whether the patient received wearing instructions and/or
educational materials and any follow up to be performed. The SOAP
format may be helpful. The SOAP format is:
Subjective: what does the patient say;
Objective: what do you observe;
Assessment: what is the problem or issue with this patient
at this visit; and
Plan: what is your treatment plan to address this problem
or issue.
4. Release of Information: This form gives you
the patient's permission to use his/her treatment information for
billing purposes. See box 12 of the CMS 1500 Form. After April 14,
2003, the HIPAA Consent Form can replace the release form.
5. Assignment of Benefits: This form serves as
the patient's permission to his/her insurance carrier to pay the
provider rather than the patient. It is fraudulent to check box 12
of the CMS 1500 form if you do not have a signed assignment form in
your file.
6. Delivery Acknowledgment: Your file should
contain the patient's signed, dated form acknowledging receipt of
the device/service and noting specifically what the patient
received.
Complete and accurate file documentation is a continuing
challenge. You and your staff need to be attentive to details in
coverage criteria and to be knowledgeable about applicable Medicare
Medical Policy and file documentation requirements. It is important
to meet the challenge of complete and accurate file documentation
challenge head-on in order to safeguard your revenue.
Often, the OIG's Guidelines are given "lip service" by O&P
professionals, but compliance itself is rather haphazard. Many
practitioners believe that they are in compliance when they are
not. Often, "People don't know what they don't know." A fully
implemented, ongoing compliance program, which meets the seven
required elements of the OIG's Guidelines and which includes
policies, procedures, training, and internal auditing, is the best
tool to achieve compliance and to protect both the professional and
financial aspects of your business. Sheila M. Press, Attorney, MBA, can be contacted at 480.767.9477; e-mail: spress@hccsolutions.com; www.hccsolutions.com 
Table Of Contents - February 2003
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