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Lymphedema Pump Ordering Policy Modified. Requires Physician or NPP Face-To-Face Encounter. Certificate of Medical Necessity Clarifications.

Two recent related Medicare changes for 2014 will affect Medicare providers, suppliers and beneficiaries who order, supply and use sequential pneumatic compression devices ("pumps") in the treatment of lymphedema. These recent changes concern the enforcement of the "face-to-face encounter" requirement which became effective July 1, 2013 and the implementation of ordering/referring provider edits which became effective January 6, 2014.

Face-to-Face Encounter. Section 6407 of the Affordable Care Act established a face-to-face encounter requirement for certain items of DME. The law requires that a physician must document that a physician, nurse practitioner, physician assistant or clinical nurse specialist has had a face-to-face encounter with the patient. The encounter must occur within the 6 months before the order is written for the DME. (reference http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM8304.pdf ) This is an explicit requirement for a "face-to-face" examination and determination that a pneumatic sequential device is medically required. Most physicians already do this, but the rule is to prevent ordering of a pump without actually seeing the patient and determining that the "conservative measures" have been tried for four weeks and have not helped. In the case of a DME ordered by a PA, NP or CNS, a physician (MD or DO) must document the occurrence of a face-to-face encounter by signing/co-signing and dating the pertinent portion of the medical record. CMS will accept a single confirming signature, including the date, as sufficient if there are several pertinent portions of the medical record. Enforcement of the changes has been repeatedly delayed, and implementation is being done in a piecemeal manner.

Written Order Prior to Delivery. CMS has started enforcement of the written order prior to delivery (WOPD) requirement on January 1, 2014. This puts the burden of having a written order from the ordering physician prior to delivering the ordered DME. The written order for the DME must follow the guidance in the CMS "Program Integrity Manual," Chapter 5, Section 5.2.3 (available at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internt-Only-Manuals-IOMs-Items/CMS019033.html ) and include, at a minimum;

  1. the beneficiary's name,
  2. the item of DME ordered,
  3. the prescribing practitioner's National Provider Identifier (NPI),
  4. the signature of the ordering practitioner and
  5. the date of the order.
Failure to meet any of the above requirements will result in denial of the claim.

Specified Covered Items (Partial List). The DME list of Specified Covered Items includes lymphedema pumps and appliances as follows, (the original list was at 77 FR 44798).

HCPCS
Code
Description
E0650Pneumatic compressor non-segmental home model
E0651Pneumatic compressor segmental home model without calibrated gradient pressure
E0652Pneumatic compressor segmental home model with calibrated gradient pressure
E0655Non- segmental pneumatic appliance for use with pneumatic compressor on half arm
E0656Non- segmental pneumatic appliance for use with pneumatic compressor on trunk
E0657Non- segmental pneumatic appliance for use with pneumatic compressor chest
E0660Non- segmental pneumatic appliance for use with pneumatic compressor on full leg
E0665Non- segmental pneumatic appliance for use with pneumatic compressor on full arm
E0666Non- segmental pneumatic appliance for use with pneumatic compressor on half leg
E0667Segmental pneumatic appliance for use with pneumatic compressor on full-leg
E0668Segmental pneumatic appliance for use with pneumatic compressor on full arm
E0669Segmental pneumatic appliance for use with pneumatic compressor on half leg
E0671Segmental gradient pressure pneumatic appliance full leg
E0672Segmental gradient pressure pneumatic appliance full arm
E0673Segmental gradient pressure pneumatic appliance half leg

Ordering and Referral Denial Edits. On January 6, 2014 Medicare Contractors turned on denial edits on all durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) claims from suppliers to verify that a valid physician's national provider identifier (NPI) is on the order, and deny the claim when the information is invalid. [MLN Matters Article SE1305 "Full Implementation of Edits on the Ordering/Referring Providers in Medicare Part B, DME, and Part A Home Health Agency (HHA) Claims (Change Requests 6417, 6421, 6696, and 6856)" http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/se1305.pdf ]

Certificate of Medical Necessity (CMN). In addition to the requirement for the physician to document the medical necessity for a pneumatic sequential compression device in the patient's medical record, a CMN must also be executed. Unfortunately, the current CMS-846 form (at http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/CMS846.pdf ) has not been updated since 2005, and only provides for documentation of the medical necessity for a pump to treat post-mastectomy lymphedema, malignant lymphedema or hereditary lymphedema (congenital or lymphedema praecox). There is little room on the form to note the history of other causes of lymphedema, treatment of which may require the use of the pneumatic sequential compression device. Modification of Question 3 might be used to enable a "yes" answer for secondary lymphedema from other than cancer cause corresponding to a diagnosis code 457.1. Addition of the phrase "lymphedema tarda" in Question 5 might be used to enable a "yes" response in the case of late occurring hereditary lymphedema with diagnosis code 757.0.