50940 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 410 

[CMS–3017–IFC] 

RIN 0938–AM74 

Medicare Program; Conditions for 

Payment of Power Mobility Devices, 

including Power Wheelchairs and 

Power-Operated Vehicles 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Interim final rule with comment 

period. 

SUMMARY: This interim final rule 

conforms our regulations to section 

302(a)(2)(E)(iv) of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (Pub. L. 108– 

173). This rule defines the term power 

mobility devices (PMDs) as power 

wheelchairs and power operated 

vehicles (POVs or scooters). It sets forth 

revised conditions for Medicare 

payment of PMDs and defines who may 

prescribe PMDs. This rule also requires 

a face-to-face examination of the 

beneficiary by the physician or treating 

practitioner and a PMD prescription and 

pertinent parts of the medical record 

that the durable medical equipment 

supplier maintains in records and 

makes available to CMS or its agents 

upon request. Finally, this rule 

discusses CMS’ policy on 

documentation that may be requested by 

CMS or its agents to support a Medicare 

claim for payment, as well as the 

elimination of the Certificate of Medical 

Necessity for PMDs. 

DATES: Effective date: These regulations 

are effective on October 25, 2005. 

Comment date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

November 25, 2005. 

ADDRESSES: In commenting, please refer 

to file code CMS–3017–IFC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.cms.hhs.gov/regulations/ 

ecomments (Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word). 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address ONLY: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3017– 

IFC, P.O. Box 8013, Baltimore, MD 

21244–1850. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By express or overnight mail. You 

may send written comments (one 

original and two copies) to the following 

address ONLY: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3017–IFC, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786– 

7195 in advance to schedule your 

arrival with one of our staff members. 

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850. 

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal Government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed). 

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by mailing 

your comments to the addresses 

provided at the end of the ‘‘Collection 

of Information Requirements’’ section in 

this document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Karen Daily, (410) 786–0189. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this rule to assist us in fully 

considering issues and developing 

policies. You can assist us by 

referencing the file code CMS–3017–IFC 

and the specific ‘‘issue identifier’’ that 

precedes the section on which you 

choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all electronic 

comments received before the close of 

the comment period on our public web 

site as soon as possible after they have 

been received. Hard copy comments 

received timely will be available for 

public inspection as they are received, 

generally beginning approximately 3 

weeks after publication of a document, 

at the headquarters of the Centers for 

Medicare & Medicaid Services, 7500 

Security Boulevard, Baltimore, 

Maryland 21244, Monday through 

Friday of each week from 8:30 a.m. to 

4 p.m. To schedule an appointment to 

view public comments, phone 1–800– 

743–3951. 

I. Background 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘BACKGROUND’’ at the 

beginning of your comments.] 

Sections 1832(a)(1) and 1861(s)(6) of 

the Act establish that the provision of 

durable medical equipment is a covered 

benefit under Part B of the Medicare 

program. Section 1834(a)(1)(A) provides 

that Medicare will pay for covered items 

defined in section 1834(a)(13) which, in 

turn, defines the term ‘‘covered item’’ to 

include durable medical equipment 

(DME) defined in section 1861(n). 

Section 1861(n) provides that DME 

includes wheelchairs, including poweroperated vehicles that may 

appropriately be used as wheelchairs, 

that are necessary based on the 

beneficiary’s medical and physical 

condition, meet safety requirements 

prescribed by the Secretary, and are 

used in the beneficiary’s home, 

including an institution used as the 

beneficiary’s home other than a hospital 

described in section 1861(e)(1) or a 

skilled nursing facility described in 

section 1819(a)(1). Section 414.202 of 

our regulations further defines DME as 

equipment that can withstand repeated 

use, is primarily and customarily used 

to serve a medical purpose, generally is 

not useful to a person in the absence of 

an illness or injury, and is appropriate 

for use in the home. We have 

interpreted the term wheelchair to 

include both power wheelchairs and 

power-operated vehicles (POVs or 

scooters), and we collectively refer to 

Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 50941 

power wheelchairs and power-operated 

vehicles as power mobility devices 

(PMDs). 

When POVs were first introduced, we 

were concerned about their stability and 

the danger they could pose to a 

Medicare beneficiary. Therefore, we 

issued a regulation (57 FR 57688) 

allowing only specialists in physical 

medicine, orthopedic surgery, 

neurology, and rheumatology to 

prescribe POVs. At that time, we 

believed that these specialists were the 

most qualified to perform the required 

evaluation to determine whether a POV 

was medically necessary and whether 

the beneficiary had the capacity to 

operate the POV safely and effectively. 

At the same time, beneficiaries were 

able to get a prescription for a power 

wheelchair without seeing a specialist. 

We did not issue a similar regulation for 

power wheelchairs because we did not 

harbor the same concerns about their 

safety. 

Our requirement that only certain 

specialists could prescribe a POV may 

have created a disincentive for qualified 

beneficiaries to obtain POVs. Many 

beneficiaries may not have realized that 

under an exception to this requirement 

set forth in § 410.38(c)(4), they could 

obtain a prescription from their 

physician if a specialist was not 

reasonably accessible. For example, if 

travel to the specialist would be more 

than one day’s round trip from the 

beneficiary’s home or if the beneficiary’s 

medical condition precluded travel to 

the nearest available specialist, we 

stated that these circumstances would 

satisfy the ‘‘not reasonably accessible’’ 

requirement. We allowed this exception 

under the current regulation because it 

addressed the needs of beneficiaries 

who lived in rural or other areas with 

limited access, or who were physically 

unable to see a specialist. 

However, since POVs were first 

introduced the technology has 

improved. For example, the POV now 

has an improved turning radius that 

gives it greater stability and makes it 

easier to use. Given that these 

technological advancements have made 

many POVs safer to use, a specialist 

assessment of the beneficiary’s capacity 

to operate a POV, while recommended, 

is no longer required. 

In addition, CMS and the Office of the 

Inspector General (OIG) have identified 

inflated and falsified billings as a 

serious problem among certain DME 

suppliers. Medicare payments for power 

wheelchairs have increased 

approximately 350 percent from 1999 to 

2003 (from $259 million in 1999 to 

approximately $1.2 billion for 2003), 

while overall Medicare program outlays 

have risen approximately 28 percent. 

In an effort to address fraud and 

abuse, Medicare contractors have 

always had the authority to review 

claims and additional documentation to 

determine if services provided were 

reasonable and necessary in accordance 

with section 1862(A)(1)(a). 

Section 302(a)(2) of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003, Pub. L. 108– 

173 (MMA), added section 

1834(a)(1)(E)(iv) to the Act, which 

provides that payment may not be made 

for a covered item consisting of a 

motorized or power wheelchair unless a 

physician (as defined in section 

1861(r)(1) of the Act), or a physician 

assistant, nurse practitioner, or clinical 

nurse specialist (as those terms are 

defined in section 1861(aa)(5) of the 

Act) has conducted a face-to-face 

examination of the beneficiary and 

written a prescription for the item. This 

regulation is intended to implement 

section 1834(a)(1)(E)(iv) of the Act. 

Payment for the history and physical 

examination will be made through the 

appropriate evaluation and management 

(E&M) code corresponding to the history 

and physical examination of the patient. 

Due to the MMA requirement that the 

physician or treating practitioner create 

a written prescription and this 

regulation’s requirement that the 

physician or treating practitioner 

prepare pertinent parts of the medical 

record for submission to the DME 

supplier, we will establish an add-on G 

Code (used in addition to an E&M code 

for the examination) to recognize the 

additional physician work and 

resources required to establish and 

document the need for the PMD. We 

believe that the typical amount of 

additional physician work and 

resources involved is equivalent to the 

physician fee schedule relative values 

established for a level 1 office visit for 

an established patient (CPT 99211). The 

payment amount for such a visit is 

$21.60; therefore, the payment amount 

for this new G code for 2005 will be 

$21.60, adjusted by the geographic area 

where the service is provided, and 

based on the physician fee schedule 

relative values for a level 1 established 

office visit (CPT 99211). This change to 

the physician fee schedule will be 

effective with this rule. 

II. Provisions of the Interim Final Rule 

[If you choose to comment on issues 

in this section, please include the 

caption ‘‘Provisions of the Interim Final 

Rule’’ at the beginning of your 

comments.] 

We are revising § 410.38(c) of our 

regulations to specify the following: 

• The definition of a ‘‘power mobility 

device (PMD)’’. We are defining PMDs 

as a subclass of wheelchairs that 

includes both power wheelchairs and 

power-operated vehicles that a 

beneficiary uses in the home. 

• The definition of a ‘‘physician’’ and 

a ‘‘treating practitioner’’. As directed by 

section 1834(a)(1)(E)(iv), we are defining 

the term ‘‘physician’’ in accordance 

with section 1861(r)(1) of the Act. We 

are defining the term ‘‘treating 

practitioner’’ to mean a physician 

assistant, nurse practitioner, and 

clinical nurse specialist, as those terms 

are defined by section 1861(aa)(5) of the 

Act. We are using the term ‘‘treating’’ to 

further explain that the practitioner 

must be the one who has conducted the 

face-to-face examination of the 

beneficiary. We believe that the removal 

of restrictions regarding who can 

prescribe POVs will increase a 

beneficiary’s access to the PMD that is 

most appropriate for the beneficiary’s 

condition. Currently, physicians (other 

than the specialists currently described 

in section 410.38) and other treating 

practitioners cannot prescribe POVs and 

are limited to prescribing power 

wheelchairs. 

• The definition of ‘‘supplier.’’ We 

are defining the term supplier for the 

purposes of this rule as a durable 

medical equipment (DME) supplier. 

• The physician or treating 

practitioner must conduct a face-to-face 

examination of the beneficiary and write 

a PMD prescription. 

• The PMD prescription must be in 

writing and signed and dated by the 

physician or treating practitioner who 

performed the face-to-face examination 

and received by the supplier within 30 

days after the face-to-face examination. 

We are defining the term ‘‘prescription’’ 

as a written order that must include the 

beneficiary’s name, the date of the faceto-face examination, the diagnoses and 

conditions that the PMD is expected to 

modify, a description of the item (for 

example, a narrative description of the 

specific type of PMD), the length of 

need, the physician or treating 

practitioner’s signature and the date the 

prescription is written. 

• A beneficiary discharged from a 

hospital does not need to have a 

separate face-to-face examination if the 

physician or treating practitioner who 

performed the face-to-face examination 

during his or her hospital stay issues the 

written prescription and supporting 

documentation for the PMD and they 

are received by the supplier within 30 

days after the date of discharge. 

50942 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 

• The face-to-face examination 

requirement does not apply when only 

accessories for PMDs are being ordered. 

• In addition to the prescription for 

the PMD, the physician or treating 

practitioner must provide to the 

supplier supporting documentation 

which will include pertinent parts of 

the medical record that clearly support 

the medical necessity for the PMD in the 

beneficiary’s home. Pertinent parts from 

the documentation of the beneficiary’s 

PMD evaluation may include the 

history, physical examination, 

diagnostic tests, summary of findings, 

diagnoses, and treatment plans. The 

physician or treating practitioner should 

select only those parts of the medical 

record that clearly demonstrate medical 

necessity for the PMD. The parts of the 

medical record selected should be 

sufficient to delineate the history of 

events that led to the request for the 

PMD; identify the mobility deficits to be 

corrected by the PMD; and document 

that other treatments do not obviate the 

need for the PMD, that the beneficiary 

lives in an environment that supports 

the use of the PMD and that the 

beneficiary or caregiver is capable of 

operating the PMD. In most cases, the 

information recorded at the face-to-face 

examination will be sufficient. 

However, there may be some cases 

where the physician or treating 

practitioner has treated a patient for an 

extended period of time and the 

information recorded at the face-to-face 

examination refers to previous notes in 

the medical record. In this instance, 

those previous notes would also be 

needed. 

An example (not all inclusive) of the 

pertinent parts of the medical record 

would be beneficiary X recently 

sustained traumatic amputation of his 

right leg below the knee and his right 

arm below the elbow as a result of an 

automobile accident. He also sustained 

significant lacerations to his left foot, 

which is extensively scarred. Prior to 

the trauma, beneficiary X had been an 

active retiree. Lacking sufficient 

ambulation to move about his home, 

patient X has used a bedside commode 

and is dependent on others to bring food 

to his bedroom. He is eager to regain 

independent mobility, and requests a 

PMD during a follow-up examination 

with his treating physician. Based on 

his knowledge of the beneficiary’s prior 

medical history and his assessment of 

the beneficiary’s current condition, 

using his clinical judgment the 

physician decides to prescribe a power 

wheelchair. The physician’s knowledge 

of the provisions of the Mobility 

Assistive Equipment (MAE) National 

Coverage Decision (NCD) (available at 

http://www.cms.hhs.gov/manuals/ 

pm_trans/R37NCD.pdf) informs his 

discussion of available options with the 

beneficiary. The physician believes that 

the beneficiary would not be able to 

safely operate a POV. The physician 

writes a prescription with the required 

information including the description of 

the device (i.e., a power wheelchair). 

The Subjective section of the 

physician’s progress note for the face-toface examination summarizes the 

history of the automobile accident, 

subsequent hospitalization and surgical 

revision and closure of the amputation 

stumps. The patient’s request of the 

device is also mentioned. In the 

Objective findings, the physician notes 

the beneficiary’s general appearance and 

the absence of the amputated arm and 

leg. The function of the remaining 

extremities is noted, including 

movement and strength in the 

remaining left arm and left leg. The 

Assessment includes the physician’s 

determination that the beneficiary 

cannot ambulate sufficiently to get 

beyond his bedroom, and that mobility 

devices other than a power wheelchair 

are not sufficient to correct the deficit, 

and the Plan indicates the prescription 

of a power wheelchair, with a notation 

that the beneficiary’s home environment 

does not prevent the appropriate use of 

the device. Believing the progress notes 

sufficiently present the rationale for 

prescription of the device, the physician 

instructs the office staff to send a copy 

of the progress notes along with the 

prescription to the supplier. 

Another example (not all inclusive) of 

the pertinent parts of the medical record 

would be beneficiary Y lives in a small 

rural town. He developed heart failure 

after a myocardial infarction earlier in 

the year, for which he had been 

transported by air to the state’s 

university medical center 75 miles 

away. His medical history also includes 

hypertension, mild osteoarthritis, and 

gastroesophageal reflux. He is treated 

medically for his cardiac condition by 

his cardiologist at the university 

medical center. He sees his primary care 

physician in town for his other medical 

conditions. The cardiologist maintains 

good contact with the primary care 

physician, routinely sharing copies of 

his test results and chart notes. Over the 

past few months, beneficiary Y has 

complained progressively of difficulty 

walking due to fatigue. The cardiologist 

is aware of this and has adjusted his 

medications accordingly and added 

home oxygen to his regimen. The 

beneficiary phones his primary care 

physician, who he last saw two months 

ago, with a request for a POV. 

Beneficiary Y’s primary physician 

schedules a home visit to examine him 

after office hours. He notes that the 

home is a one story rambler and that the 

halls and doorways are wide enough to 

allow the use of a POV. The 

beneficiary’s physical examination 

findings at rest are consistent with his 

heart failure diagnosis, but do not seem 

severe enough to prevent the beneficiary 

from walking short distances in his 

home. The physician knows from 

experience that the severity of the 

symptoms and signs of heart failure can 

vary over the course of the day and with 

exertion. The physician asks the 

beneficiary to stand and walk from the 

bedroom to the dining room, a distance 

of 20 feet. The beneficiary stops after a 

few steps, saying he needs to catch his 

breath. Patient Y continues to walk 

slowly, but manages to get to the dining 

room after about a minute. Based on his 

knowledge of the beneficiary’s prior 

medical history and his assessment of 

the beneficiary’s current condition, the 

physician decides that the beneficiary 

needs a PMD and that other mobility 

devices are not sufficient to correct his 

mobility deficits to perform mobility 

related activities of daily living in his 

home. The physician’s knowledge of the 

provisions of the Mobility Assistive 

Equipment (MAE) NCD informs his 

discussion of available options with the 

beneficiary. The physician believes that 

the patient has adequate strength and 

stability to safely operate a POV. 

The Subjective section of the 

physician’s progress note for the home 

visit briefly notes the history of cardiac 

disease, and refers to the cardiologist’s 

notes for more details. The beneficiary’s 

request for the device is also mentioned. 

In the Objective findings, the physician 

notes the beneficiary’s general 

appearance and the physical 

examination findings including the 

patient’s attempt to walk to the dining 

room. Basic information about the 

beneficiary’s home setting is also 

included. The Assessment includes the 

physician’s determination that the 

patient cannot ambulate adequately, and 

that his cardiac symptoms are worsened 

by the exertion of ambulation. The Plan 

indicates the prescription of a POV with 

a notation that the beneficiary’s home 

environment does not prevent the 

appropriate use of the device. Believing 

that the progress note alone does not 

sufficiently present the rationale for the 

prescription of the device, the physician 

instructs the office staff to send the 

prescription and additional records to 

the supplier, including copies of the 

cardiologist’s notes, echocardiogram 

Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 50943 

and cardiac stress test results, and 

arterial blood gas results. 

• Physicians, treating practitioners, 

and suppliers must comply with all 

applicable Federal laws and regulations, 

including the HIPAA Privacy Rule. Any 

physician, treating practitioner or 

supplier that is a HIPAA covered entity 

must meet the relevant HIPAA Privacy 

Rule requirements, including the 

minimum necessary standard, when 

disclosing the supporting 

documentation and requested additional 

information. The physician, treating 

practitioner or supplier that is a HIPAA 

covered entity should make sure to 

redact any materials that may be 

contained within the medical record 

that are not necessary to support the 

prescription. For example, a gynecologic 

report would not be needed in the 

records submitted for a beneficiary 

whose clinical need for a PMD is based 

solely on disability secondary to a 

stroke. 

• The supplier must obtain the 

prescription and supporting 

documentation prior to dispensing the 

PMD. 

• Upon request, suppliers must 

submit to CMS or its agents the PMD 

prescription and supporting 

documentation that they received from 

the physician or treating practitioner. 

• Upon request, suppliers must 

submit additional documentation if the 

PMD prescription and supporting 

documentation are not sufficient to 

determine that the PMD is reasonable 

and necessary. Additional 

documentation may include physician 

office records, hospital records, nursing 

home records, home health agency 

records, records from other healthcare 

professionals, and test reports. This 

documentation does not need to be 

submitted with every claim, but must be 

made available to CMS or its agent upon 

request. 

• The PMD must meet any safety 

requirements specified by CMS. 

III. Response to Comments 

Because of the large number of items 

of correspondence we normally receive 

on Federal Register documents 

published for comment, we are not able 

to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

IV. Waiver of Proposed Rulemaking 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register and invite public comment on 

the proposed rule. The notice of 

proposed rulemaking includes a 

reference to the legal authority, under 

which the rule is proposed, and the 

terms and substance of the proposed 

rule or a description of the subjects and 

issues involved. This procedure can be 

waived, however, if an agency finds 

good cause that a notice-and-comment 

procedure is impracticable, or contrary 

to the public interest, and if the agency 

incorporates a statement of this finding 

and supporting reasons in the rule 

issued. 

Since this change conforms our 

regulations to section 1834(a)(1)(E)(iv) 

of the Act, we believe it would be 

contrary to the public interest to delay 

implementing this beneficiary relief 

pending notice-and-comment 

procedure. The Congress has prohibited 

Medicare from paying for covered items 

consisting of motorized or power 

wheelchairs unless a physician (as 

defined in section 1861(r)(1)), a 

physician assistant, nurse practitioner, 

or a clinical nurse specialist (as those 

terms are defined in section 1861(aa)(5)) 

conducts a face-to-face examination of 

the beneficiary and writes a prescription 

for the item. We believe that the face-toface examination and prescription 

requirements are mandated by section 

302(a)(2)(E)(iv) of the MMA and involve 

little exercise of agency discretion. 

Therefore, we believe that notice and 

comment procedure are unnecessary 

with respect to these provisions. In 

addition, this rule removes a current 

regulatory restriction that limits POV 

prescribing to certain specialists. We 

believe that this limitation is 

inconsistent with the MMA, which 

expressly allows a physician, physician 

assistant, nurse practitioner or a clinical 

nurse specialist to prescribe a PMD, and 

we believe that removing this limitation 

will increase beneficiary access to the 

appropriate PMD for his or her medical 

condition. Moreover, because CMS and 

the OIG have concluded that fraudulent 

billing practices for PMDs have been a 

substantial problem, evidenced by an 

approximate 350 percent increase in 

billings for these devices in 1999 to 

2003, we believe that it would be 

contrary to the public interest to delay 

a regulation intended to stem the 

abusive billing practices of certain DME 

suppliers. We believe that requiring the 

physician or treating practitioner to 

submit to the DME supplier the 

prescription along with the pertinent 

parts of the medical record that 

demonstrate the medical necessity for 

the PMD, and the requirement that the 

supplier must obtain the prescription 

and supporting documentation prior to 

dispensing the PMD will address some 

of these abusive billing practices by 

restraining the billing for PMDs outside 

of bona fide patient care activity. The 

additional payment to the physician or 

treating practitioner is consistent with 

these changes. 

On May 5, 2005, CMS issued a new 

National Coverage Decision (NCD) for 

Mobility Assistive Equipment, which 

includes power mobility devices. In 

addition, in September 2005, the 

Certificate of Medical Necessity (CMN) 

for power wheelchairs and POVs will 

expire. These changes, plus the changes 

made by MMA and through this 

regulation will provide greater certainty 

in this area and assist suppliers of PMDs 

in complying with not only the 

mandates of MMA but also the new 

NCD. Specifically, new requirements for 

specific content of the written 

prescription, the submission of 

pertinent portions of the medical record, 

and the submission of additional 

supporting information, together with 

elimination of the CMN, and the 

additional payment, operationalize the 

NCD requirements and statutory 

changes in ways that will not only bring 

more certainty to all participants, but 

also greatly reduce the risk that a 

supplier will be denied payment 

through no fault of its own. Delaying 

any element of these interrelated 

changes will jeopardize the smooth 

implementation of these reforms. 

Therefore, we find good cause to 

waive the notice of proposed 

rulemaking and to issue this as an 

interim final rule. We are providing a 

90-day public comment period. 

V. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide a 30- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. In order to fairly evaluate 

whether an information collection 

should be approved by OMB, section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 (PRA) requires 

that we solicit comments on the 

following issues: 

• The need for the information 

collection and its usefulness in carrying 

out the proper functions of our agency. 

• The accuracy of our estimate of the 

information collection burden. 

• The quality, utility, and clarity of 

the information to be collected. 

• Recommendations to minimize the 

information collection burden on the 

50944 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 

affected public, including automated 

collection techniques. 

To be able to address public 

comments on these information 

collection requirements prior to the 

effective date of this rule, written 

comments and recommendations will be 

considered from the public if received 

by the individuals designated below by 

September 26, 2005. 

We are soliciting public comment on 

each of these issues for the following 

section of this document that contains 

information collection requirements: 

Section 410.38 Durable medical 

equipment: Scope and conditions. 

Certificate of Medical Necessity (CMN) 

Discussion 

The Certificate of Medical Necessity 

(CMN) was previously established to 

allow efficient adjudication of claims by 

automating the submission of certain 

information needed to make medical 

necessity determinations. CMS 

implemented a CMN requirement for 

certain items of DME under section 

1834(j)(2) of the Act and applied that 

requirement to payment claims for 

manual wheelchairs, motorized 

wheelchairs and power-operated 

vehicles (scooters) since the items were 

potentially subject to abuse by 

unscrupulous DME suppliers. The 

historical coverage criteria for these 

items were subjective and interpreted 

differently by clinicians; services that 

were not medically necessary were 

described in a manner that made those 

services appear to be medically 

necessary. The CMN was created to 

eliminate some of the subjectivity 

associated with this decision making 

process. 

Recently, a CMS contractor completed 

an analysis of the utility of each CMN 

and found in some cases a 45 percent 

rate of non-compliance of CMNs. This 

finding underscored the belief that the 

CMNs do not accurately reflect the 

contents of the physician’s medical 

record. Some portion of this noncompliance is attributed to failure to 

fully understand coverage criteria. 

With the publication of the national 

coverage determination on Mobility 

Assistive Equipment in May 2005, CMS 

provided guidance on how contractors 

are to determine whether PMDs have 

been appropriately prescribed. As a 

result, physicians, treating practitioners 

and suppliers better know how to 

properly evaluate and document a 

beneficiary’s medical condition and 

appropriately prescribe PMDs. 

Therefore, we have determined that the 

practical utility of a CMN, given the 

function-based approach to coverage, is 

questionable and for these reasons, the 

continued use of a CMN for power 

wheelchairs or power-operated vehicles 

is no longer required. 

CMS previously estimated that the 

burden associated with the completion 

and collection of the CMNs for power 

mobility devices as 38,192 hours or 

approximately 12 minutes per CMN. 

This burden estimate included the time 

required for physicians to extract data 

from the medical record, record that on 

the CMN, and forward the CMN to the 

supplier. It did not include the burden 

of the physician writing the prescription 

itself. It included the time required for 

the supplier to determine, when a 

beneficiary was seen for a PMD, 

whether a CMN had been submitted 

and, if so, whether it contained the 

necessary physician information; to 

notify the physician if additional 

information was needed; to collect and 

enter the supplier information on the 

CMN; and to store the CMN. Eliminating 

the CMN results in the elimination of 

this burden for both physicians and 

suppliers. 

Section 410.38(c)(2)(ii) states that 

Medicare Part B will pay for a power 

mobility device if the physician or 

treating practitioner writes a 

prescription, which is received by the 

supplier within 30 days after the date of 

the face-to-face examination of the 

beneficiary. The burden associated with 

writing the prescription is the time and 

effort necessary for the physician or 

treating practitioner to draft a 

prescription that contains the 

information required by this regulation. 

CMS estimates that it will take 

approximately 2 minutes for the 

physician or treating practitioner to 

prepare and submit the prescription, 

and that 187,000 PMD prescriptions will 

be submitted each year, for a total 

annual burden of 187,000 × 2 ÷ 60 = 

6,233 hours. 

Section 410.38(c)(2)(iii) requires 

physicians and treating practitioners to 

collect and submit to suppliers 

supporting documentation from the 

beneficiary’s medical records which 

demonstrates that the item being 

provided is medically necessary. This is 

in addition to writing and submitting 

the prescription to the supplier. Section 

410.38(c)(5)(i) requires a supplier to 

maintain a copy of the PMD 

prescription and supporting 

documentation to support its claim for 

payment for the prescribed PMD and to 

make this information available to CMS 

and its agents upon request. CMS 

believes that this overall physician and 

supplier burden is similar to the burden 

we previously estimated for a CMN. 

The burden includes physicians 

identifying parts of the medical record, 

having them copied, and giving them to 

the beneficiary with the prescription. In 

some instances, the physician might 

need to submit additional information at 

the request of the supplier. On the 

supplier side, the burden includes 

receiving the documentation, reviewing 

the documentation to ensure it is 

complete, and storing the 

documentation. In some instances, the 

supplier may determine that the 

medical record documentation may not 

be sufficient to meet CMS 

documentation requirements and may 

request that the physician submit more 

information such as additional chart 

notes which document medical history. 

Overall, as discussed above, we 

believe that there will be a shift in the 

burden of information collection from 

the supplier to the physician. CMS 

estimates that this combined burden 

will be no more than 10 minutes. We 

have previously estimated that 187,000 

prescriptions for these devices will be 

written yearly. This will result in an 

estimated burden of 31,167 hours 

(187,000 prescriptions × 10 minutes ÷ 

60). 

If you comment on these information 

collection and recordkeeping 

requirements, please mail copies 

directly to the following: Centers for 

Medicare & Medicaid Services, Office of 

Strategic Operations and Regulatory 

Affairs, Regulations Development 

Group, Attn.: William N. Parham, III, 

CMS–3017–IFC, Room C4–26–05, 7500 

Security Boulevard, Baltimore, MD 

21244–1850; and Office of Information 

and Regulatory Affairs, Office of 

Management and Budget, Room 10235, 

New Executive Office Building, 

Washington, DC 20503, Attn: 

Christopher Martin, CMS Desk Officer, 

CMS–3017–IFC, 

Christopher_Martin@omb.eop.gov. Fax 

(202) 395–6974. 

VI. Regulatory Impact Statement 

We have examined the impact of this 

rule as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the 

Congressional Review Act, the 

Regulatory Flexibility Act (RFA) 

(September 16, 1980, Pub. L. 96–354), 

section 1102(b) of the Social Security 

Act, the Unfunded Mandates Reform 

Act of 1995 (Pub. L. 104–4), and 

Executive Order 13132. 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 50945 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

rules with economically significant 

effects ($100 million or more in any 1 

year). The Congressional Review Act 

imposes a similar requirement, and 

provides for the Congress to review 

major rules. 

In analyzing the effects of this 

regulation, we believe that most 

physicians are already conducting a 

face-to-face examination before 

prescribing a wheelchair. Also, though 

treating practitioners are now allowed to 

prescribe PMDs, we do not believe that 

these changes will significantly alter the 

number of prescriptions for PMDs. This 

rule also removes the requirement that 

a specialist order a POV. Given that 

physicians and treating practitioners 

can now prescribe POVs, we believe as 

a result of this regulation that more 

PMD prescriptions will be for POVs, 

rather than the more expensive power 

wheelchairs. In addition, in conjunction 

with this rule, an additional payment 

will be made to physicians and treating 

practitioners for the submission of the 

written prescription and pertinent parts 

of the medical record to the DME 

supplier. Taken together, we believe 

that the impact of these changes as a 

result of this regulation will have 

minimal net impact on the Medicare 

program. 

While we believe that the net impact 

on Medicare reimbursements for PMDs 

of this rule and the recently published 

NCD will be minimal, the provisions of 

this rule will likely cause a shift in the 

composition of the PMDs reimbursed by 

Medicare. We expect that this rule will 

result in a shift in PMD prescriptions 

from power wheelchairs to POVs. We 

have no empirical basis for projecting 

shifts in market share. Nor do we have 

a basis for discriminating between the 

shift that is the result of the NCD and 

the shift that is a result of this rule. 

However, we believe that the 

Congressional decision to allow a 

broader range of physicians and treating 

practitioners to prescribe POVs will lead 

to an increased number of POV 

prescriptions. This shift could well be 

10 percent or greater. If 10 percent or 

more of the estimated 175,000 power 

wheelchair prescriptions in FY 2004 

shifted from power wheelchairs to POVs 

(with the total unchanged at 187,000 

prescriptions for both categories of 

PMDs), this would imply reduced sales 

for the former of $84 million (assuming 

an average cost of $4,800) and increased 

sales of the latter of $35M (assuming an 

average cost of $2,000). Accordingly, we 

are classifying this as an economically 

significant rule under EO 12866, and as 

a major rule under the Congressional 

Review Act. 

Under the Executive Order, we 

analyze the benefits, costs, and 

alternatives of major rules. While 

difficult to quantify, we believe that 

Medicare beneficiaries will benefit from 

the increased ability to obtain POVs. 

Beneficiaries would gain both from the 

increased utility of the less cumbersome 

devices, and from reduced cost-sharing 

(on average, $560 in decreased 

coinsurance if average costs of the 

devices were $2,000 and $4,800, 

respectively). We expect the shift in the 

composition of prescriptions to result in 

a net minimal impact on the value of 

Medicare reimbursements for PMDs. 

Since manufacturers typically produce 

both types of PMDs (other than specialty 

‘‘high end’’ manufacturers unaffected by 

this rule), we expect the net effect on 

PMD manufacturer revenue from 

Medicare reimbursement of PMDs 

should be negligible. 

There are other costs and benefits. 

Taxpayers, suppliers, and patients will 

all gain from increased accuracy in 

prescribing and increased certainty of 

proper payment. The increased burden 

on physicians and treating practitioners 

from the new analytic and 

documentation requirements will be 

offset by the new add-on payment we 

are implementing with this rule. As 

discussed in the preceding PRA 

analysis, suppliers will face decreases in 

record-keeping requirements. None of 

these other effects are economically 

substantial (for example, increased 

payments to physicians and treating 

practitioners are likely to be on the 

order of $5 million annually). As a 

result, we believe that the predominant 

effects of this rule are both positive and 

substantial, and that the benefits of this 

rule outweigh its costs. 

We do not believe that any reasonable 

alternatives exist that would alter these 

conclusions or lead to even larger 

economic benefits. The primary causes 

of these effects were the Congressional 

decisions to allow a substantial increase 

in the number and types of providers 

allowed to prescribe POVs, and to 

require a face-to-face examination. We 

are required to implement those 

statutory changes. Coupled with our 

recent national coverage decision, other 

implementing details in this rule 

(especially improved documentation for 

suppliers), and other planned reforms 

(physician and treating practitioner 

payments, improved classification of 

mobility assistive equipment, 

elimination of the CMN), we expect the 

needs of mobility-impaired beneficiaries 

to be better met, and the needs of 

suppliers to be better met, than under 

any alternative set of reforms. 

We welcome additional information 

on the likely effects of this rule, and 

suggestions for changes that would 

improve the rule. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses. For purposes of the RFA, 

small entities include small businesses, 

nonprofit organizations, and 

government agencies. Most hospitals 

and most other providers and suppliers 

are small entities, either by nonprofit 

status or by having revenues of $6 

million to $29 million in any 1 year. 

Individuals and States are not included 

in the definition of a small entity. We 

have determined that this rule will not 

have a significant economic impact on 

a substantial number of small entities. 

Furthermore, the RFA does not require 

such analysis for rules that, like this 

one, do not require a proposed rule. 

However, we appreciate that there are 

three classes of small entities that will 

face impacts and we address their 

potential concerns. Furthermore, HHS 

policy is to voluntarily analyze impacts 

on small entities if there is even a 

possibility of significant impact. The 

analysis that follows, together with the 

preceding impact analysis and other 

information in this preamble, 

constitutes an Initial Regulatory 

Flexibility Analysis. 

First, equipment manufacturers may 

be affected if substantial changes in the 

market for PMDs arise from this rule. As 

indicated previously, we expect the 

principal economic effect of this rule to 

be to shift prescriptions from one class 

of equipment, power wheelchairs, to 

another class of equipment, POVs. That 

effect will arise largely among those 

Medicare beneficiaries who can operate 

a POV and do not, therefore, require a 

power wheelchair. The manufacturing 

of these two types of equipment is 

dominated by a handful of firms. Most 

of these firms produce both types of 

vehicles and can presumably shift 

production from one line to another 

without incurring major cost. As 

indicated previously, volume increases 

likely to occur independently of this 

rule may obviate the need for any such 

shifts. Accordingly, we do not believe 

that the impact on these entities will be 

significant, nor that a substantial 

number of ‘‘small’’ entities will be 

affected. We note that there are a 

number of small firms that specialize in 

‘‘high end’’ equipment for patients with 

very severe mobility impairments who 

need highly specialized equipment or 

accessories. We believe these firms will 

be unaffected by this rule, as the 

50946 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 

segment of the market they serve would 

not be candidates for POVs. 

Second, physicians and treating 

practitioners gained a great deal of 

important new guidance through our 

recent national coverage decision. The 

newly added classes of treating 

practitioners will benefit in their ability 

to serve their patients by prescribing the 

equipment most suitable to their needs. 

Nonetheless, there is some 

inconvenience associated with more 

complex decision algorithms and the 

documentation requirements added by 

this rule. These costs do not rise to the 

level of ‘‘significant’’ within the 

standards of the RFA, but we 

nonetheless plan to ameliorate them 

through additional payment when 

PMDs are prescribed. 

Third, suppliers of durable medical 

equipment include thousands of firms, 

both large and ‘‘small’’ within the RFA 

definitions. The principal effect of this 

rule on these suppliers will be to 

increase their ability to assure that 

prescriptions are valid (in terms of 

medical necessity) before they supply 

equipment to beneficiaries, and that 

they will therefore be reimbursed for 

equipment they supply. This is a 

positive effect rather than a negative 

effect (the RFA requires consideration of 

alternatives that minimize adverse 

impacts). As previously indicated, we 

believe that there are few if any 

alternatives to this rule that would 

provide higher benefits. 

We welcome additional information 

on the problems faced by small entities, 

comments on these conclusions, and 

suggestions for changes that would 

provide even greater benefits. 

In addition, section 1102(b) of the 

Social Security Act requires us to 

prepare a regulatory impact analysis if 

a rule may have a significant impact on 

the operations of a substantial number 

of small rural hospitals. This analysis 

must conform to the provisions of 

section 604 of the RFA. For purposes of 

section 1102(b) of the Act, we define a 

small rural hospital as a hospital that is 

located outside of a Metropolitan 

Statistical Area and has fewer than 100 

beds. We are not preparing an analysis 

for section 1102(b) of the Act because 

we have determined and the Secretary 

certifies that this rule will not have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies assess anticipated costs 

and benefits before issuing any rule 

whose requirements mandate the 

expenditure in any 1 year by State, 

local, or tribal governments, in the 

aggregate, or by the private sector, of 

$100 million in 1995 dollars, adjusted 

for subsequent inflation (that threshold 

is now approximately $120 million). 

This rule contains no mandates other 

than that for documentation of 

prescriptions, and hence does not 

remotely approach that cost threshold. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

This regulation does not impose any 

costs or burden on State or local 

governments. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects in 42 CFR Part 410 

Health facilities, Health professions, 

Kidney diseases, Laboratories, 

Medicare, Reporting and recordkeeping 

requirements, Rural areas, and X-rays. 

■ For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services amends 42 CFR 

Chapter IV, as set forth below: 

PART 410 SUPPLEMENTARY 

MEDICAL INSURANCE (SMI) 

BENEFITS 

■ 1. The authority citation for part 410 

is revised to read as follows: 

Authority: Secs. 1102, 1834, and 1871 of 

the Social Security Act (42 U.S.C. 1302, 

1395m, and 1395hh). 

Subpart B—Medical and Other Health 

Services 

■ 2. Section 410.38 is amended by 

revising paragraph (c) to read as follows: 

§ 410.38 Durable medical equipment: 

Scope and conditions. 

* * * * * 

(c) Power mobility devices (PMDs). (1) 

Definitions. For the purposes of this 

paragraph (c), the following definitions 

apply: 

Physician has the same meaning as in 

section 1861(r)(1) of the Act. 

Power mobility device means a 

covered item of durable medical 

equipment that is in a class of 

wheelchairs that includes a power 

wheelchair (a four-wheeled motorized 

vehicle whose steering is operated by an 

electronic device or a joystick to control 

direction and turning) or a poweroperated vehicle (a three or fourwheeled motorized scooter that is 

operated by a tiller) that a beneficiary 

uses in the home. 

Prescription means a written order 

completed by the physician or treating 

practitioner who performed the face-toface examination and that includes, the 

beneficiary’s name, the date of the faceto-face examination, the diagnoses and 

conditions that the PMD is expected to 

modify, a description of the item (for 

example, a narrative description of the 

specific type of PMD), the length of 

need, and the physician or treating 

practitioner’s signature and the date the 

prescription was written. 

Treating practitioner means a 

physician assistant, nurse practitioner, 

or clinical nurse specialist as those 

terms are defined in section 1861(aa)(5) 

of the Act, who has conducted a faceto-face examination of the beneficiary. 

Supplier means a durable medical 

equipment (DME) supplier. 

(2) Conditions of payment. Medicare 

Part B pays for a power mobility device 

if the physician or treating practitioner, 

as defined in paragraph (c)(1) of this 

section: 

(i) Conducts a face-to-face 

examination of the beneficiary for the 

purpose of evaluating and treating the 

beneficiary for his or her medical 

condition and determining the medical 

necessity for the PMD as part of an 

appropriate overall treatment plan; 

(ii) Writes a prescription, as defined 

in paragraph (c)(1) of this section, which 

is provided to the beneficiary or 

supplier, and is received by the supplier 

within 30 days of the face-to-face 

examination. 

(iii) Provides supporting 

documentation, including pertinent 

parts of the beneficiary’s medical record 

(e.g., history, physical examination, 

diagnostic tests, summary of findings, 

diagnoses, treatment plans and/or other 

information as may be appropriate) that 

supports the medical necessity for the 

power mobility device, which is 

received by the supplier within 30 days 

after the face-to-face examination. 

(3) Exceptions. (i) Beneficiaries 

discharged from a hospital do not need 

to receive a separate face-to-face 

examination as long as the physician or 

treating practitioner who performed the 

face-to-face examination of the 

beneficiary in the hospital issues a PMD 

prescription and supporting 

documentation that is received by the 

supplier within 30 days after the date of 

discharge. 

(ii) Accessories for PMDs may be 

ordered by the physician or treating 

practitioner without conducting a faceto-face examination of the beneficiary. 

(4) Dispensing a power mobility 

device. Suppliers may not dispense a 

Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Rules and Regulations 50947 

PMD to a beneficiary until the PMD 

prescription and the supporting 

documentation have been received from 

the physician or treating practitioner 

who performed the face-to-face 

examination of the beneficiary. Such 

documents must be received within 30 

days after the date of the face-to-face 

examination. 

(5) Documentation. (i) A supplier 

must maintain the prescription and the 

supporting documentation provided by 

the physician or treating practitioner 

and make them available to CMS and its 

agents upon request. 

(ii) Upon request by CMS or its 

agents, a supplier must submit 

additional documentation to CMS or its 

agents to support and/or substantiate 

the medical necessity for the power 

mobility device. 

(6) Safety requirements. The PMD 

must meet any safety requirements 

specified by CMS. 

* * * * * 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare— 

Supplementary Medical Insurance Program) 

Dated: July 28, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: August 3, 2005. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 05–17098 Filed 8–24–05; 2:30 pm] 

BILLING CODE 4120–01–P