More than three years after the Patient Protection and Affordable Care Act (PPACA, or the Health Reform Law) was signed into law by President Obama, the Centers for Medicare & Medicaid Services (CMS) issued its proposed rule to begin implementing Section 6407 of that law which requires beneficiaries to have a “face-to-face” encounter prior to a physician prescribing durable medical equipment (DME). The law requires physicians to document that a physician, physician assistant (PA), nurse practitioner (NP) or clinical nurse specialist (CNS) has had a face-to-face encounter with the beneficiary within six months preceding the written order for the DME, or other reasonable timetable the secretary may determine.
On July 10, 2012, CMS issued its proposed rule in the Federal Register. It was part of a larger proposed rule largely covering 2013 physician payment policy revisions. As a condition of payment for many DME items, the proposed rule will require that a physician, PA, NP or CNS has had a face-to-face encounter with the beneficiary. This encounter must be documented by the physician and communicated to the DME provider. Under the proposal, the encounter must occur no more than 90 days before the written order or 30 days after the order is written.
Comments on the proposed rule are due on September 4, 2012. CMS is likely to issue a final rule by November 1, 2012, and have an effective date for the new requirement for DME items provided on or after January 1, 2013. It is important for HME providers to understand all the requirements of the proposal, and based on the forthcoming CMS final rule, identify additional policies and procedures to implement and train staff on to ensure compliance with the new rule by January 2013.
Items Subject to the Exam Requirement
CMS is proposing four criteria that would subject DME items to the face-to-face requirement:
A. DME that currently require a written order prior to delivery as defined by CMS in its Program Integrity Manual; the PIM identifies pressure reducing pads, mattress overlays, mattresses, and beds; seat lift mechanisms; transcutaneous electrical nerve stimulation (TENS) units; power operated vehicles (POV); and power wheelchairs.
B. DME with a Medicare fee schedule ceiling of more than $1,000.
C. Items that CMS, based on recommendations from the DME MACs, believes are particularly susceptible to fraud, waste and abuse. The DME MACs recommended the following items warrant increased practitioner involvement because they are often marketed directly to beneficiaries:
• Pressure reducing pads;
• Mattress overlays, mattresses and beds;
• Seat lift mechanisms;
• TENS units;
• Automatic external defibrillators (AED);
• External infusion pumps;
• Glucose monitors;
• Wheelchairs and wheelchair accessories;
• Nebulizers;
• Negative pressure wound therapy (NPWT) pumps;
• Oxygen and oxygen equipment;
• Pneumatic compression devices;
• Positive airway pressure devices;
• Respiratory assists devices, and;
• Cervical traction devices.
D. DME CMS determines is vulnerable to fraud, waste and abuse based on reports of the HHS Office of Inspector General (OIG), Government Accountability Office (GAO) or other government oversight entities. CMS provides three such examples: pressure reducing support surfaces, home oxygen therapy, and negative pressure wound therapy.
CMS proposes a list of 164 DME HCPCS codes (see sidebar) that CMS believes will reduce the risk of fraud, waste and abuse. This list would be published and updated annually in the Federal Register and would appear on the CMS website. The list contains DME and not prosthetics and orthotics because, according to CMS, these DME items are often marketed directly to beneficiaries and the face-to-face encounter will help ensure ordering physicians are familiar with and document the beneficiary’s medical condition and that the items are reasonable and necessary.
The face-to-face requirement does not supersede any more specific regulatory requirements for face-to-face encounters such as the one for power mobility devices (PMD). PMDs are included in the list because they are already subject to a face-to-face encounter requirement with a 45-day period between the date of the face-to-face exam and the date of the written order.
Documentation of the Written Order
The proposed rule would require that, during the encounter, the physician, PA, NP or CNS conduct a needs assessment, evaluate or treat the beneficiary for the medical condition that supports the need for each covered DME ordered and document that encounter in the medical record. CMS identifies the following examples of pertinent parts of the medical record that can demonstrate the face-to-face encounter has occurred include: history, physician examination, diagnostic tests, summary of findings, diagnoses, treatment plans or other information, as appropriate.
CMS explains in its proposed rule that the face-to-face encounter should substantiate that the beneficiary’s condition justifies the need for the specific DME item. If a face-to-face encounter occurs within 90 days prior to the written order, but is not related to the condition warranting the DME item, the rule proposes to allow an additional face-to-face encounter up to 30 days after the written order to substantiate medical necessity. If the beneficiary has not had a face-to-face encounter with a physician, PA, NP, or CNS within 90 days of the written order, the same 30-day policy allowing a face-to-face encounter after the written order applies.
CMS sets forth seven minimum elements of a written order which must be documented for the order to be considered complete: beneficiary name, item of DME ordered, prescribing practitioner NPI, signature of the prescribing practitioner, date of the order, beneficiary’s diagnosis and necessary proper usage instructions, as applicable (i.e. duration of use, method of utilization and correct positioning).
The physician must also document the face-to-face encounter, regardless of whether it was performed by the physician, PA, NP, or CNS. The rule lays out the options for how this should be documented depending on who performed the actual encounter. The rule proposes that when the physician performs the encounter, the pertinent portion(s) of the beneficiary’s medical record containing sufficient information to document that the face-to-face encounter meets CMS’ requirements would be considered sufficient and valid documentation of the encounter when submitted to the DME provider and available to CMS upon request.
When the face-to-face encounter is performed by a PA, NP or CNS, the physician still must document the encounter. The rule proposes several different options for how the documentation should be handled.
Physician Attestation: The physician signs and dates an attestation stating that the PA, NP, or CNS preformed the encounter with the specified beneficiary on the specified date and evaluated the need for the specified DME item.
Physician Signs Medical Record: The physician signs or cosigns the pertinent portion of the medical record for the beneficiary for the date of the encounter, documenting that the patient was evaluated for the condition related to the DME item on that date of service.
Physician Initials History and Physical Exam: The physician initials the history and physical exam for the beneficiary for the date of the encounter to document that the patient was evaluated for the condition related to the DME item on that date of service.
Supplier Notification: The DME supplier must have access to the documentation of the face-to-face encounter and must maintain the written order and supporting documentation and make them available to CMS upon request for seven years from the date of service. The rule proposes four options on how the documentation of the face-to-face encounter should be communicated to the DME provider as follows:
A. Practitioner who wrote the order provides the documentation of the encounter directly to the DME provider.
B. Physician who completes the documentation provides it directly to the DME provider.
C. The documentation, regardless of who completes it, is provided to the DME provider through the same process as the written order for the DME item.
D. Physician provides a copy of the documentation to the beneficiary for him/her to deliver to the DME provider of his/her choice.
Physician Payment: CMS proposes a new physician billing code (a G-code) estimated at $15 to compensate physicians who document that a PA, NP or CNS practitioner performed the face-to-face encounter for the list of specified DME items. This G-code does not apply when a physician bills an evaluation and management code when the physician performs the encounter himself/herself. The G-codes may only be used when the physician documents a face-to-face encounter that is performed by a PA, NP, or CNS. Additionally, if multiple orders for DME originate from one office visit, the physician is only eligible for the G-code payment once.
HCPCS Codes and Descriptions
MATTRESSES, BEDS
E0185 Gel or gel-like pressure mattress pad
E0188 Synthetic sheepskin pad
E0189 Lamb’s wool sheepskin pad
E0194 Air fluidized bed
E0197 Air pressure pad for mattress standard length and width
E0198 Water pressure pad for mattress standard length and width
E0199 Dry pressure pad for mattress standard length and width
E0250 Hospital bed fixed height with any type of side rails, mattress
E0251 Hospital bed fixed height with any type side rails without mattress
E0255 Hospital bed variable height with any type side rails with mattress
E0256 Hospital bed variable height with any type side rails without mattress
E0260 Hospital bed semi-electric (head and foot adjustment) with any type side rails with mattress
E0261 Hospital bed semi-electric (head and foot adjustment) with any type side rails without mattress
E0265 Hospital bed total electric (head, foot and height adjustments) with any type side rails with mattress
E0266 Hospital bed total electric (head, foot and height adjustments) with any type side rails without mattress
E0290 Hospital bed fixed height without rails with mattress
E0291 Hospital bed fixed height without rail without mattress
E0292 Hospital bed variable height without rail without mattress
E0293 Hospital bed variable height without rail with mattress
E0294 Hospital bed semi-electric (head and foot adjustment) without rail with mattress
E0295 Hospital bed semi-electric (head and foot adjustment) without rail without mattress
E0296 Hospital bed total electric (head, foot and height adjustments) without rail with mattress
E0297 Hospital bed total electric (head, foot and height adjustments) without rail without mattress
E0300 Pediatric crib, hospital grade, fully enclosed
E0301 Hospital bed heavy duty extra wide, with weight capacity 350-600 lbs with any type of rail, without mattress
E0302 Hospital bed Heavy Duty extra wide, with weight capacity greater than 600 lbs with any type of rail, without mattress
E0303 Hospital bed heavy duty extra wide, with weight capacity 350-600 lbs with any type of rail, with mattress
E0304 Hospital bed heavy duty extra wide, with weight capacity greater than 600 lbs with any type of rail, with mattress
RESPIRATORY
E0424 Stationary compressed gas oxygen system rental; includes contents, regulator, nebulizer, cannula or mask and tubing
E0431 Portable gaseous oxygen system rental includes portable container, regulator, flowmeter, humidifier, cannula or mask and tubing
E0433 Portable liquid oxygen system
E0434 Portable liquid oxygen system, rental; includes portable container, supply reservoir, humidifier, flowmeter, refill adaptor, content gauge, cannula or mask, and tubing
E0439 Stationary liquid oxygen system rental, includes container, contents, regulator, flowmeter, humidifier, nebulizer, cannula or mask, and tubing
E0441 Oxygen contents, gaseous (one month supply)
E0442 Oxygen contents, liquid (one month supply)
E0443 Portable oxygen contents, gas (one month supply)
E0444 Portable oxygen contents, liquid (one month supply)
E0450 Volume control ventilator without pressure support used with invasive interface
E0457 Chest shell
E0459 Chest wrap
E0460 Negative pressure ventilator portable or stationary
E0461 Volume control ventilator without pressure support node for a noninvasive interface
E0462 Rocking bed with or without side rail
E0463 Pressure support ventilator with volume control mode used for invasive surfaces
E0464 Pressure support vent with volume control mode used for noninvasive surfaces
E0470 Respiratory assist device, bi-level pressure capability, without backup rate used non-invasive interface
E0471 Respiratory assist device, bi-level pressure capability, with backup rate for a non-invasive interface
E0472 Respiratory assist device, bi-level pressure capability, with backup rate for invasive interface
E0480 Percussor electric/pneumatic home model
E0482 Cough stimulating device, alternating positive and negative airway pressure
E0483 High frequency chest wall oscillation air pulse generator system
E0484 Oscillatory positive expiratory device, non-electric
E0570 Nebulizer with compressor
E0575 Nebulizer, ultrasonic, large volume
E0580 Nebulizer, durable, glass or autoclavable plastic, bottle type for use with regulator or flowmeter
E0585 Nebulizer with compressor and heater
E0601 Continuous airway pressure device
BLOOD GLUCOSE MONITOR
E0607 Home blood glucose monitor
SEAT LIFT MECHANISM, PATIENT LIFTS, PNEUMATIC COMPRESSORS
E0627 Seat lift mechanism incorporated lift-chair
E0628 Separate seat lift mechanism for patient owned furniture electric
E0629 Separate seat lift mechanism for patient owned furniture non-electric
E0636 Multi positional patient support system, with integrated lift, patient accessible controls
E0650 Pneumatic compressor non-segmental home model
E0651 Pneumatic compressor segmental home model without calibrated gradient pressure
E0652 Pneumatic compressor segmental home model with calibrated gradient pressure
E0655 Non-segmental pneumatic appliance for use with pneumatic compressor on half arm
E0656 Non-segmental pneumatic appliance for use with pneumatic compressor on trunk
E0657 Non-segmental pneumatic appliance for use with pneumatic compressor chest
E0660 Non-segmental pneumatic appliance for use with pneumatic compressor on full leg
E0665 Non-segmental pneumatic appliance for use with pneumatic compressor on full arm
E0666 Non- segmental pneumatic appliance for use with pneumatic compressor on half leg
E0667 Segmental pneumatic appliance for use with pneumatic compressor on full leg
E0668 Segmental pneumatic appliance for use with pneumatic compressor on full arm
E0669 Segmental pneumatic appliance for use with pneumatic compressor on half leg
E0671 Segmental gradient pressure pneumatic appliance full leg
E0672 Segmental gradient pressure pneumatic appliance full arm
E0673 Segmental gradient pressure pneumatic appliance half leg
E0675 Pneumatic compression device, high pressure, rapid inflation/deflation cycle, for arterial insufficiency
UV LIGHT THERAPY, TENS, ETC.
E0692 Ultraviolet light therapy system panel treatment 4 foot panel
E0693 Ultraviolet light therapy system panel treatment 6 foot panel
E0694 Ultraviolet multidirectional light therapy system in 6 foot cabinet
E0720 Transcutaneous electrical nerve stimulation, two lead, local stimulation
E0730 Transcutaneous electrical nerve stimulation, four or more leads, for multiple nerve stimulation
E0731 Form fitting conductive garment for delivery of TENS or NMES
E0740 Incontinence treatment system, pelvic floor stimulator, monitor, sensor, and/or trainer
E0744 Neuromuscular stimulator for scoliosis
E0745 Neuromuscular stimulator electric shock unit
E0747 Osteogenesis stimulator, electrical, non-invasive, other than spine application.
E0748 Osteogenesis stimulator, electrical, non-invasive, spinal application
E0749 Osteogenesis stimulator, electrical, surgically implanted
E0760 Osteogenesis stimulator, low intensity ultrasound, non-invasive
E0762 Transcutaneous electrical joint stimulation system including all accessories
E0764 Functional neuromuscular stimulator, transcutaneous stimulations of muscles of ambulation with computer controls
E0765 FDA approved nerve stimulator for treatment of nausea and vomiting
INFUSION PUMPS, TRACTION
E0782 Infusion pumps, implantable, non-programmable
E0783 Infusion pump, implantable, programmable
E0784 External ambulatory infusion pump
E0786 Implantable programmable infusion pump, replacement
E0840 Tract frame attach to headboard, cervical traction
E0849 Traction equipment cervical, free-standing stand/frame, pneumatic, applying traction force to other than mandible
E0850 Traction stand, free standing, cervical traction
E0855 Cervical traction equipment not requiring additional stand or frame
E0856 Cervical traction device, cervical collar with inflatable air bladder
MANUAL WHEELCHAIR ACCESSORIES
E0958 Manual wheelchair accessory, one-arm drive attachment
E0959 Manual wheelchair accessory-adapter for amputee
E0960 Manual wheelchair accessory, shoulder harness/strap
E0961 Manual wheelchair accessory wheel lock brake extension handle
E0966 Manual wheelchair accessory, headrest extension
E0967 Manual wheelchair accessory, hand rim with projections
E0968 Commode seat, wheelchair
E0969 Narrowing device wheelchair
E0971 Manual wheelchair accessory anti-tipping device
E0973 Manual wheelchair accessory, adjustable height, detachable armrest
E0974 Manual wheelchair accessory anti-rollback device
E0978 Manual wheelchair accessory positioning belt/safety belt/pelvic strap
E0980 Manual wheelchair accessory safety vest
E0981 Manual wheelchair accessory seat upholstery, replacement only
E0982 Manual wheelchair accessory, back upholstery, replacement only
E0983 Manual wheelchair accessory power add on to convert manual wheelchair to motorized wheelchair, joystick control
E0984 Manual wheelchair accessory power add on to convert manual wheelchair to motorized wheelchair, tiller control
E0985 Wheelchair accessory, seat lift mechanism
E0986 Manual wheelchair accessory, push activated power assist
E0990 Manual wheelchair accessory, elevating leg rest
E0992 Manual wheelchair accessory, elevating leg rest solid seat insert
E0994 Arm rest
E0995 Wheelchair accessory calf rest
E1002 Wheelchair accessory power seating system, tilt only
E1003 Wheelchair accessory power seating system, recline only without shear
E1004 Wheelchair accessory power seating system, recline only with mechanical shear
E1005 Wheelchair accessory power seating system, recline only with power shear
E1006 Wheelchair accessory power seating system, tilt and recline without shear
E1007 Wheelchair accessory power seating system, tilt and recline with mechanical shear
E1008 Wheelchair accessory power seating system, tilt and recline with power shear
E1010 Wheelchair accessory, addition to power seating system, power leg elevation system, including leg rest pair
E1014 Reclining back, addition to pediatric size wheelchair
E1015 Shock absorber for manual wheelchair
E1020 Residual limb support system for wheelchair
E1028 Wheelchair accessory, manual swing away, retractable or removable mounting hardware for joystick, other control interface or positioning accessory
E1029 Wheelchair accessory, ventilator tray
E1030 Wheelchair accessory, ventilator tray, gimbaled
ROLLABOUTS, TRANSPORT CHAIRS, ETC.
E1031 Rollabout chair, any and all types with castors 5 inches or greater
E1035 Multi-positional patient transfer system with integrated seat operated by care giver
E1036 Patient transfer system
E1037 Transport chair, pediatric size
E1038 Transport chair, adult size up to 300lb
E1039 Transport chair, adult size heavy duty >300lb
E1161 Manual adult size wheelchair includes tilt in space
E1227 Special height arm for wheelchair
E1228 Special back height for wheelchair
E1232 Wheelchair, pediatric size, tilt-in-space, folding, adjustable with seating system
E1233 Wheelchair, pediatric size, tilt-in-space, folding, adjustable without
E1234 Wheelchair, pediatric size, tilt-in-space, folding, adjustable without seating system
E1235 Wheelchair, pediatric size, rigid, adjustable, with seating system
E1236 Wheelchair, pediatric size, folding, adjustable, with seating system
E1237 Wheelchair, pediatric size, rigid, adjustable, without seating system
E1238 Wheelchair, pediatric size, folding, adjustable, without seating system
E1296 Special sized wheelchair seat height
E1297 Special sized wheelchair seat depth by upholstery
E1298 Special sized wheelchair seat depth and/or width by construction
E1310 Whirlpool non-portable
SPEECH GENERATING DEVICES
E2502 Speech generating devices prerecord messages between eight and 20 Minutes
E2506 Speech generating devices prerecord messages over 40 minutes
E2508 Speech generating devices message through spelling, manual type
E2510 Speech generating devices synthesized with multiple message methods
MANUAL WHEELCHAIRS
E2227 Rigid pediatric wheelchair adjustable
K0001 Standard wheelchair
K0002 Standard hemi (low seat) wheelchair
K0003 Lightweight wheelchair
K0004 High strength lightweight wheelchair
K0005 Ultra lightweight wheelchair
K0006 Heavy duty wheelchair
K0007 Extra heavy duty wheelchair
K0009 Other manual wheelchair/base
ETC.
K0606 AED garment with electronic analysis
K0730 Controlled dose inhalation drug delivery system
