Q1: Is it true that any document that is in the patient’s chart, even if it did not originate from the treating physician, is a part of the medical record?
A1: Per Section 1833(e) of the Social Security Act, “The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports.”
Q2: Since the physician who manages the diabetes usually sends the patient to a Podiatrist for any issues of the feet, is it acceptable to use the Podiatrist’s documentation to support medical necessity?
A2: Yes, the documentation in the patient’s medical record from the Podiatrist can be used to support medical necessity. See Section 1833(e) of the Social Security Act.
Q3: I was given information by the manufacturer about the ankle gauntlet that said the ankle gauntlet helped patients with circulation problems. So, if I get medical documentation to show the patient has circulation problems will Medicare pay for the gauntlet?
A3: Please refer to LCD 11527 Ankle-Foot/Knee-Ankle-Foot Orthosis which states “Ankle-foot orthoses (AFO) described by codes L1900-L1990, L2106-L2116, L4350, L4360, and L4386 are covered for ambulatory patients with weakness or deformity of the foot and ankle, who require stabilization for medical reasons, and have the potential to benefit functionally.”
Q4: Does the ankle gauntlet meet criteria for coverage with diabetic shoes?
A4: Ankle-foot orthoses (AFO) described by codes L1900-L1990, L2106-L2116, L4350, L4360, and L4386 are covered for ambulatory patients with weakness or deformity of the foot and ankle, who require stabilization for medical reasons, and have the potential to benefit functionally. There must be documentation in the medical record that supports the need and the benefit.
Q5: If I attend training provided by the manufacturer of the therapeutic shoe and receive a certificate of completion, does this place me in the other qualified individual category as outlined in the LCD L1535? The particular type of footwear (shoes, inserts, modifications) which is necessary must be prescribed by a podiatrist or other qualified physician, knowledgeable in the fitting of diabetic shoes and inserts. The footwear must be fitted and furnished by a podiatrist, or other qualified individual such as a pedorthist, orthotist or prosthetist.
A5: Per CMS direction at this time, this is sufficient as long as there is proof that training was attended and completed.
Q6: Where is it in writing that I have to have progress notes or documentation in addition to the Certifying Statement of Physician to support medical necessity?
A6: Refer to LCD L1535 Therapeutic Shoes for Person with Diabetes and LCD L11527 AFO, Ankle Gauntlet, which both contain the following.
Section 1833(e) of the Social Security Act precludes payment to any provider of services unless "there has been furnished such information as may be necessary in order to determine the amounts due such provider" (42 U.S.C. §1395l (e)). It is expected that the patient's medical records will reflect the need for the care provided. The patient's medical records include the physician's office records, hospital records, nursing home records, home health agency records, records from other healthcare professionals and test reports. This documentation must be available to the DMERC upon request.
Region B Supplier Manual Chapter 17, Page 9 of 11
Region A Supplier Manuel Chapter 9
Documentation in the Patient Medical Records
For any DMEPOS item to be covered by Medicare, the patient's medical record must contain sufficient documentation of the patient's medical condition to substantiate the necessity for the type and quantity of items ordered, and for the frequency of use or replacement (if applicable). The information should include the patient's diagnosis and other pertinent information including, but not limited to, duration of the patient's condition, clinical course (worsening or improvement), prognosis, nature and extent of functional limitations, other therapeutic interventions and results, past experience with related items, etc. If an item requires a CMN, it is recommended that a copy of the completed CMN be kept in the patient's record. However, neither a physician's order nor a CMN nor a supplier-prepared statement nor a physician attestation by itself provides sufficient documentation of medical necessity, even though it is signed by the treating physician. There must be clinical information in the patient's medical record that supports the medical necessity for the item and substantiates the answers on the CMN (if applicable), or information on a supplier-prepared statement or physician attestation (if applicable).
Q7: I have a difficult time getting medical records from the physicians and from nursing homes. Is there a regulation that requires them to provide me with these records?
A7: Section 1842 (p)(4) of the Social Security Act states: In the case of an item or service defined in paragraph (3), (6), (8), or (9) of subsection 1861(s) ordered by a physician or a practitioner specified in subsection (b)(18)(C), but furnished by another entity, if the Secretary (or fiscal agent of the Secretary) requires the entity furnishing the item or service to provide diagnostic or other medical information in order for payment to be made to the entity, the physician or practitioner shall provide that information to the entity at the time that the item or service is ordered by the physician or practitioner.
Despite this statute, many physicians are reluctant to release medical records because of HIPAA concerns. While HIPAA requires adoption of practices to safeguard protected health information (PHI), there are exceptions for disclosure of PHI for the purposes of treatment, payment or healthcare operations. Therefore, suppliers can assure physicians that it is not a violation of HIPAA to provide a DME supplier with medical records that support the medical necessity of prescribed equipment.
Providing medical records to DME suppliers falls under the disclosure of PHI for the purposes of payment. Medicare statute requires that payment only be made for items or services that are "reasonable and necessary" and payment cannot be made or confirmed without these records. Furthermore, these records may be provided without having a Business Associate Agreement with the supplier requesting the records or a release of information from the beneficiary.
LPET