[Federal Register: August 26, 2005 (Volume 70, Number 165)]
[Rules and Regulations]
[Page 50939-50947]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26au05-25]
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Part VII
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Part 410
Medicare Program; Conditions for Payment of Power Mobility Devices,
Including Power Wheelchairs and Power-Operated Vehicles; Interim Final
Rule
[[Page 50940]]
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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.
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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 power-operated 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
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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 Sec. 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 Sec. 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 face-to-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.
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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-to-face
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
[[Page 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-to-face 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
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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 non-compliance 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 x 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 x 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
[[Page 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
[[Page 50946]]
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.
0
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
0
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
0
2. Section 410.38 is amended by revising paragraph (c) to read as
follows:
Sec. 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 power-operated vehicle (a three or four-wheeled 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-to-face examination and
that includes, the beneficiary's name, the date of the face-to-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 face-to-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 face-to-face examination of
the beneficiary.
(4) Dispensing a power mobility device. Suppliers may not dispense
a
[[Page 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