[Federal Register Volume 82, Number 8 (Thursday, January 12, 2017)]
[Proposed Rules]
[Pages 3678-3694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00425]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 424
[CMS-6012-P]
RIN 0938-AR84
Medicare Program; Establishment of Special Payment Provisions and
Requirements for Qualified Practitioners and Qualified Suppliers of
Prosthetics and Custom-Fabricated Orthotics
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would specify the qualifications needed for
qualified practitioners to furnish and fabricate, and qualified
suppliers to fabricate prosthetics and custom-fabricated orthotics;
accreditation requirements that qualified suppliers must meet in order
to bill for prosthetics and custom-fabricated orthotics; requirements
that an organization must meet in order to accredit qualified suppliers
to bill for prosthetics and custom-fabricated orthotics; and a
timeframe by which qualified practitioners and qualified suppliers must
meet the applicable licensure, certification, and accreditation
requirements. In addition, this rule would remove the current exemption
from accreditation and quality standards for certain practitioners and
suppliers.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on March 13, 2017.
[[Page 3679]]
ADDRESSES: In commenting, please refer to file code CMS-6012-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-6012-P, P.O. Box 8013,
Baltimore, MD 21244-8013.
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 to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-6012-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments ONLY to the following addresses prior to
the close of the comment period:
a. For delivery in Washington, DC-- Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey 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.)
b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: John Spiegel, (410) 786-1909.
SUPPLEMENTARY INFORMATION: 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 comments received before the close of the comment period on
the following Web site as soon as possible after they have been
received: http://www.regulations.gov.
Follow the search instructions on that Web site to view public
comments.
Comments received timely will also 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
A. General Overview
Medicare services are furnished by two types of entities, providers
and suppliers. The term ``provider of services'' is defined in sections
1861(u) and 1866(e) of the Social Security Act (the Act). Based on the
statute definition of ``provider of services'' in sections 1861(u) and
1866(e) of the Act we define and use the term ``provider'' in our
regulations. At Sec. 400.202, the term ``provider'' is defined as a
hospital, a critical access hospital (CAH), a skilled nursing facility
(SNF), a comprehensive outpatient rehabilitation facility (CORF), a
home health agency (HHA), or a hospice that has in effect an agreement
to participate in Medicare, or a clinic, a rehabilitation agency, or a
public health agency that has in effect a similar agreement but only to
furnish outpatient physical therapy or speech pathology services, or a
community mental health center that has in effect a similar agreement
but only to furnish partial hospitalization services.
The term supplier is defined in section 1861(d) of the Act.
Supplier is defined as a physician or other practitioner, facility or
an entity other than a provider of services that furnishes items or
services under Medicare. A supplier that furnishes durable medical
equipment, prosthetics, orthotics, and supplies (DMEPOS) is one
category of supplier. Section 424.57(a) of our regulations defines a
DMEPOS supplier as an entity or individual, including a physician or
Part A provider, that sells or rents covered DMEPOS items to Medicare
beneficiaries that meets the DMEPOS supplier standards. Other supplier
categories may include, for example, physicians, nurse practitioners,
and physical therapists. If a supplier, such as a physician, nurse
practitioners, or physical therapist, also furnishes DMEPOS to a
patient and bills for those items, then the supplier is also considered
to be a DMEPOS supplier and must be screened and enrolled in Medicare
as a DMEPOS supplier, meeting all standards and requirements applicable
to DMEPOS suppliers in order to be enrolled in and bill Medicare.
Section 1861(n) of the Act defines ``durable medical equipment.''
See https://www.ssa.gov/OP_Home/ssact/title18/1861.htm. Also, the term
DME is included in the definition of ``medical and other health
services'' in section 1861(s)(6) of the Act, see https://www.ssa.gov/OP_Home/ssact/title18/1861.htm and also included in the definition of
medical equipment and supplies in section 1834(j)(5) of the Act. See
https://www.ssa.gov/OP_Home/ssact/title18/1834.htm. Furthermore, the
term is defined in Sec. 414.202 as equipment furnished by a supplier
or a HHA that--
Can withstand repeated use;
Effective for items classified as DME after January 1,
2002 has an expected life of at least 3 years;
Is primarily and customarily used to serve a medical
purpose;
Generally, is not useful to an individual in the absence
of an illness or injury; and
Is for use in the home.
Prosthetics and orthotics which are defined under section
1861(s)(9) of the Act as leg, arm, back, and neck braces and artificial
legs, arms, and eyes, including replacements if required because of a
change in the patient's physical condition, are included under the
coverage definition under section 1861(s)(9) of the Act. We are using
this definition of prosthetics and orthotics for the purposes of this
proposed rule. They are also described in the Medicare Benefit Policy
Manual (100-02), Chapter 15, Section 130 that specifies that these
appliances are covered under Part B when furnished incident to
physicians' services or on a physician's order.
[[Page 3680]]
B. Legislative History
1. Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act
of 2000 (BIPA)
Section 427 of the Medicare, Medicaid and SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) added
section 1834(h)(1)(F) of the Act, which states that no payment shall be
made for custom-fabricated orthotics or for an item of prosthetics
unless furnished by a qualified practitioner and fabricated by a
qualified practitioner or a qualified supplier at a facility that meets
criteria the Secretary determines appropriate. Section 1834(h)(1)(F) of
the Act describes custom-fabricated orthotics as individually
fabricated for the patient over a positive model of the patient and
also requires education, training, and experience to custom-fabricate.
A qualified practitioner is defined by BIPA as a physician or other
individual who is a qualified physical therapist or a qualified
occupational therapist; or is licensed in orthotics or prosthetics, in
the cases where the state provides such licensing; or, in states where
the state does not provide such licensing, is specifically trained and
educated to provide or manage the provision of prosthetics and custom-
designed or fabricated orthotics and is certified by the American Board
for Certification in Orthotics, Prosthetics and Pedorthics (ABC) or the
Board for Orthotist/Prosthetist Certification International,
Incorporated (BOC); or is credentialed and approved by a program that
the Secretary determines has training and education standards that are
necessary to provide such prosthetics and orthotics.
A qualified supplier is defined by BIPA as any entity that is
accredited by the ABC or the BOC or is accredited and approved by a
program that the Secretary determines has accreditation and approval
standards that are essentially equivalent to those of such Boards.
The Congress directed the Secretary to implement section 427 of
BIPA no later than 1 year after the date of the enactment using a
negotiated rulemaking process. The negotiated rulemaking committee (the
Committee) on Special Payment Provisions for Prosthetics and Certain
Custom-Fabricated Orthotics was established following the requirements
set forth by the Federal Advisory Committee Act (FACA). The Committee
held nine meetings from October 2002 to July 2003 and failed to reach a
consensus on the rulemaking. Given the continued need to address
payment provisions for prosthetics and certain custom-fabricated
orthotics, we are proposing policies and inviting public comment on our
proposals as described section II. of this proposed rule.
2. Medicare Prescription Drug, Improvement, and Modernization Act of
2003 (MMA)
Section 302(a)(1) of the Medicare Prescription Drug, Improvement,
and Modernization Act of 2003 (MMA) (Pub. L. 108-173) added a new
paragraph (20) to section 1834(a) of the Act requiring the Secretary to
establish and implement DMEPOS quality standards that suppliers must
meet in order to furnish and bill for covered items and services
described in new section 1834(a)(20)(D) of the Act, which includes
prosthetics and orthotics. The new paragraph (20) also required the
Secretary to designate and approve one or more independent
accreditation organizations to apply the quality standards. In
addition, the new section 1834(a)(20) of the Act required that to
obtain or retain a Medicare Part B billing number DMEPOS suppliers must
be accredited by one of the approved accreditation organizations.
The DMEPOS quality standards were posted on our Web site at
www.cms.gov/medicareprovidersupenroll as required by section
1834(a)(20)(E) of the Act. On May 1, 2006, we published a proposed rule
(71 FR 25654) and a subsequent final rule on August 18, 2006 (71 FR
48354) that specified the criteria that all approved accreditation
organizations must meet, set forth in Sec. 424.58. In December 2006,
we approved 11 accreditation organizations. As a result of a merger of
two of the accreditation organizations, there are now 10 accreditation
organizations.
All DMEPOS suppliers must meet the quality standards. The quality
standards required by section 1834(a)(20) of the Act are used by the
approved accrediting organizations as the basis for their accrediting
decisions.
3. Medicare Improvement for Patients and Providers Act of 2008 (MIPPA)
Section 154(b) of the Medicare Improvement for Patients and
Providers Act of 2008 (MIPPA) (Pub. L. 110-275 amended section
1834(a)(20) of the Act by adding a new subparagraph (F) to require
DMEPOS suppliers furnishing covered items and services, directly or as
a subcontractor for another entity, to have submitted to the Secretary
evidence of being accredited as meeting the applicable quality
standards on or after October 1, 2009. Section 1834 (a)(20)(F)(ii) of
the Act provided the Secretary the authority to exempt ``eligible
professionals'' and such ``other persons'' from the quality standards
and accreditation requirement unless the Secretary determined that the
standards are designed specifically to be applied to such eligible
professionals and other persons or if the Secretary determined that
licensing, accreditation or other mandatory quality requirements apply
to such eligible professionals and other persons. Eligible
professionals are defined at section 1848(k)(3)(B) of the Act as a
physician, physician assistant, nurse practitioner, clinical nurse
specialist, certified registered nurse anesthetist, certified nurse-
midwife, clinical social worker, clinical psychologist, physical or
occupational therapist or a qualified speech-language pathologist.
Section 1834(a)(20)(F)(ii) of the Act specifically refers to orthotists
and prosthetists as examples of ``other persons.'' Since orthotists and
prosthetists specifically were mentioned in the statute, we believe
that the Congress intended for those persons to be exempt unless there
were standards designed specifically to be applied to such eligible
professionals and other persons.
To date there have not been accreditation or quality requirements
designed specifically to be applied to such eligible professionals and
thus as a result, all eligible professionals and other persons,
including orthotists and prosthetists, that furnish, fabricate, and
bill for prosthetics and certain custom-fabricated orthotic items are
currently exempt from the quality standards and the accreditation
requirement.
II. Provisions of the Proposed Regulations
This proposed rule would implement certain provisions of section
1834(h)(1)(F) of the Act. It would establish the qualifications and
requirements that must be met in order to be considered a qualified
practitioner or a qualified supplier. This proposed rule would also
amend the special payment rules for items furnished by DMEPOS suppliers
set forth at Sec. 424.57 and the accreditation organization
requirements in Sec. 424.58. Only qualified practitioners who furnish
or fabricate prosthetics and custom-fabricated orthotics and qualified
suppliers that fabricate or bill for prosthetics and custom-fabricated
orthotics would be subject to these requirements.
Specifically, we are proposing the following:
Removing the exemption from quality standards and
accreditation that is currently in place in accordance with section
1834(a)(20) of the Act for certain practitioners and suppliers who
furnish
[[Page 3681]]
or fabricate prosthetics and custom-fabricated orthotics.
Revising Sec. 424.57 to include a definition of custom-
fabricated orthotics as an item as listed in section 1861(s)(9) of the
Act that must be individually made for a specific patient, constructed
using one of the positive model techniques listed in Sec. 424.57(a).
Revising Sec. 424.57(a) to include a definition of
positive model of the patient as a particular type of custom
fabrication in which one of the following modeling techniques is used:
++ Molded to the patient model as a negative impression of the
patient's body part and a positive model rectification are constructed.
++ Computer Aided Design-Computer Aided Manufacturing (CAD-CAM)
system.
++ Direct formed model.
Defining ``qualified supplier'' as a DMEPOS supplier that
is accredited in accordance with the section 1834(a)(20) of the Act.
Defining ``qualified practitioner'' as an eligible
professional or other person that meets the education, training,
licensure, and certification requirements of the section
1834(h)(1)(F)of the Act.
Specifying training, licensure, and certification
requirements that qualified practitioners must meet in order to furnish
or fabricate prosthetics and custom-fabricated orthotics.
Requiring that claims for prosthetics and custom-
fabricated orthotics that are submitted by qualified suppliers or by
beneficiaries must have been furnished by a qualified practitioner and
fabricated by a qualified practitioner or a qualified supplier as
defined in this proposed rule. Suppliers that do not meet these
requirements are at risk of revocation of their Medicare enrollment.
Defining the requirements that must be met by
organizations that are designated and approved by CMS to accredit
suppliers that bill for prosthetics and custom-fabricated orthotics.
Define ``fabrication facility'' and specify the
requirements that a facility must meet in order for qualified
practitioners and qualified suppliers to be able to fabricate
prosthetics and custom-fabricated orthotics that can be paid for by
Medicare.
Separately, in this proposed rule we also--
Describe our intent to modify the DMEPOS quality standards
to reflect the provisions of this rule, including the effective date
for meeting the revised quality standards; and
Provide the list of services and supplies subject to the
requirements of this rule (www.cms.gov/medicareprovidersupenroll).
We provide a link to the list of items and describe our intent to
revise the quality standards as information only. We are not soliciting
comments on the content of or the process for updating the quality
standards, which will be addressed through the regulatory process we
reference in section II.A.6.a. of this proposed rule. Nor are we
soliciting comment on the content of or process for updating the list
of items and supplies, which is described in section II.B. of this
proposed rule. Comments on those matters will be considered outside the
scope of this rule.
A. Updating of Accreditation and Certification Requirements
1. Removing the MIPPA Exemptions for DMEPOS Suppliers and Certain
Eligible Professionals and Other Persons Who Furnish or Fabricate
Prosthetics and Custom-Fabricated Orthotics
Consistent with the provisions of the Act, including those
provisions added by BIPA, MMA, and MIPPA, we have put in place a
framework for accreditation of suppliers that fabricate DMEPOS and bill
for DMEPOS services. However, qualified practitioners and qualified
suppliers are currently exempt from having to meet the quality
standards or to be accredited as suppliers in order to be able to bill
Medicare for prosthetics and custom-fabricated orthotics. We are
removing the exemptions in order to implement the provisions of section
1834(a)(20) of the Act.
As noted previously, section 1834(a)(20)(F)(ii) of the Act provided
the Secretary the authority to exempt ``eligible professionals'' (as
defined in section 1848(k)(3)(B) of the Act) and such ``other persons''
from the quality standards and accreditation requirement unless the
Secretary determined that the standards are designed specifically to be
applied to such eligible professionals and other persons or if the
Secretary determined that licensing, accreditation or other mandatory
quality requirements apply to such eligible professionals and other
persons. The Secretary did not determine that there were standards
designed specifically to be applied to such eligible professionals and
other persons and the Secretary did not determine that licensing,
accreditation or other mandatory quality requirements apply to such
eligible professionals and other persons. Therefore, we issued a fact
sheet on our Web site announcing the exemption at www.cms.gov/medicareprovidersupenroll.
Through this proposed rule, we are now designing standards
specifically to apply to such eligible professionals and other persons.
We believe that it is imperative to have both licensure and
certification requirements for all qualified practitioners (eligible
professionals and other persons who furnish or fabricate prosthetics
and custom-fabricated orthotics) and to have accreditation requirements
for all qualified suppliers (DMEPOS suppliers that fabricate or bill
for prosthetics and custom-fabricated orthotics that are subject to the
requirements of this proposed rule). Moreover, we believe that the
provisions in section 1834(a)(20) of the Act were enacted to achieve
that objective.
Therefore, in order to ensure that only those who are qualified to
do so can furnish, fabricate, and bill for the prosthetics and custom-
fabricated orthotics addressed by this proposed rule, we would remove
the exemption from having to meet the quality standards and the
exemption from having to be accredited that currently exist for
eligible professionals and other persons that furnish, fabricate or
bill for prosthetics and custom-fabricated orthotics.
2. Definition and Accreditation Requirements for Qualified Suppliers
Consistent with the provisions in section 1834(h)(1)(F) of the Act,
which require that no payment will be made unless those furnishing
prosthetics and custom-fabricated orthotics are qualified to do so, we
are proposing to define qualified supplier, inSec. 424.57(a), as an
entity that is--
Enrolled in Medicare as a DMEPOS supplier; and
Accredited by one of the CMS-approved accreditation
organizations that meets the proposed requirements that an organization
must meet to accredit qualified suppliers of prosthetics and custom-
fabricated orthotics in Sec. 424.58(c) (described in section II.A.5.
of this proposed rule).
In our existing regulations at Sec. 424.57(c)(22), we require
DMEPOS suppliers to be accredited by a CMS-approved accrediting
organization to receive and retain a supplier billing number. We also
state that the accreditation must indicate the specific products and
services for which the DMEPOS supplier is accredited in order for the
supplier to receive payment. To implement the statutory requirements
regarding accreditation requirements for eligible professionals and
other persons who want to furnish and bill for prosthetics and custom-
fabricated
[[Page 3682]]
orthotics, we would revise Sec. 424.57(c)(22) by--
Redesignating the existing text as paragraph (c)(22)(i).
We would also make clarifying, technical, and conforming changes. We
note that changes would not modify the intent of this provision. We
also note that this requirement would still be applicable to all DMEPOS
suppliers.
Adding a new paragraph (c)(22)(ii) to state the additional
accreditation requirements for DMEPOS suppliers that would be
fabricating and billing for prosthetics and custom-fabricated
orthotics. In order to be a qualified supplier, the DMEPOS supplier
must be accredited by a CMS-approved accreditation organization for
prosthetics and custom-fabricated orthotics as described in Sec.
424.58(c). The accreditation must indicate the specific products and
services for which the DMEPOS supplier is accredited in order for the
qualified supplier (as defined in Sec. 424.57(a)) to receive payment
for the specific prosthetics and custom-fabricated orthotics. We are
also proposing that as part of compliance with the ongoing
accreditation process, qualified suppliers must notify the AO of any
change in conditions, practices, or operations that were relied upon by
the AO at the time of accreditation. This would include, but not be
limited to, a requirement for notifying the AO of any changes in
personnel, including changes in status or qualifications of employees
of the qualified supplier or of any personnel utilized by the qualified
supplier via contract or other business relationship. This requirement
is included to ensure that qualified suppliers, once accredited,
continue to meet all of the accreditation and other supplier standards.
(See section II.A.5. of this proposed rule for more detailed
information regarding our proposed requirements for accrediting
organizations.)
Section 1834(h)(1)(F) of the Act requires, in part, that no payment
can be made for prosthetics or custom-fabricated orthotics unless the
item is fabricated by a qualified practitioner or a qualified supplier
at a facility that meets such criteria as the Secretary determines
appropriate. Therefore, we are proposing to define and establish the
criteria that such a facility must meet. We are proposing to define
``fabrication facility'' to distinguish this facility type from others
referenced in our regulations. In Sec. 424.57(a), we would define a
fabrication facility as a physical structure that--
Meets the requirements in Sec. 424.57(d)(4); and
Is utilized by a qualified practitioner or a qualified
supplier to fabricate prosthetics or custom-fabricated orthotics.
In Sec. 424.57(d)(4), based on input from other government
agencies and contractors that are involved in ensuring that prosthetics
and custom-fabricated orthotics are furnished, fabricated and paid for
properly, we would specify that the fabrication facility at which
qualified suppliers and qualified practitioners fabricate prosthetics
and custom-fabricated orthotics, as defined in Sec. 424.57(a), must
meet all of the following requirements:
Be located within the United States or one of its
territories.
Be a business that is organized, established and licensed
under applicable state and federal laws.
Have a process for maintenance and production of
fabrication records including the following:
++ Job/work orders.
++ Record tracking systems.
++ Real time recordkeeping, for example, ensuring that records are
updated as the fabrication takes place.
++ Secure storage of records with electronic and hard copy back-up.
Have a quality assurance process to identify non-standard
production outcomes, and improve fabrication outcomes.
Have a periodic review and employee demonstration of
fabrication/safety/communication/operations competencies with
corrective action plans for staff that do not meet the minimal
standards.
Have full time appropriately credentialed staff member(s)
who are (qualified practitioners or qualified suppliers) onsite to
fabricate and to supervise fabrication.
Have a laboratory area with appropriate safety equipment
(for example, flammable material storage, gloves, safety glasses, and
proper ventilation).
Have a separate waiting area and chairs with armrests, as
necessary.
Have patient care and fitting rooms with appropriate
levels of privacy and sanitation. Patient fitting and care areas should
be separate from the fabrication area.
Have disinfecting supplies, gloves, masks, and plastic for
containing contaminated materials.
Have a fabrication facility information system, paper or
digital, that can track the production, list component part number (and
serial number if available) and quantity, and that is linked to patient
information and be Health Insurance Portability and Accountability Act
compliant. Such a system must allow facility staff and management,
including those fabricating, to identify any parts that could be
recalled at a later date.
Have parallel bars, a full-length mirror, and other
appropriate assessment tools.
Have a process that mandates following precautions to
handle used patient devices that are contaminated.
Have repair and disinfecting areas clearly labeled.
Have the ability to handle all potentially hazardous
materials in facility properly.
Have an emergency management plan and a safety management
plan.
Have policy for detecting/reporting counterfeit supplies.
Have the proper tools, equipment, and computers commonly
used in the fabrication of particular items and typically associated
with the particular technical approach (negative impression/positive
model, CAD-CAM, or direct formed), as applicable. These tools and
equipment would include, but are not limited to the following:
++ Computers with appropriate graphics/modeling capacity and
technology.
++ Band saw.
++ Disc sander.
++ Sanding paper.
++ Flexible shaft sander.
++ Lathe.
++ Drill press.
++ Sewing machine.
++ Grinding equipment.
++ Paint-spraying equipment.
++ Welding equipment.
++ Alignment jig.
++ Ovens capable of heating plastics for molding.
++ Computer controlled milling machine.
++ Lockable storage areas for raw materials and finished devices.
++ Air compressor.
We note that these requirements would apply even if the fabrication
facility is the same location as that of the DMEPOS supplier.
We intend to require that AO's cannot accredit a qualified supplier
or renew the accreditation of a qualified supplier unless the qualified
supplier uses a fabrication facility that meets these criteria. We are
seeking comment on the definition of a fabrication facility and its
requirements.
3. Definition of Qualified Practitioner
We are also proposing to define qualified practitioner in Sec.
424.57(a). Our proposal would permit certain eligible professionals and
other persons who are not enrolled as an accredited DMEPOS supplier to
become a qualified
[[Page 3683]]
practitioner to furnish or fabricate prosthetic and custom-fabricated
services and supplies that are billed to Medicare if the eligible
professional or other person meets the training, licensure, and
certification requirements in proposed Sec. 424.57(d)(3).
a. Specific Eligible Professionals and Other Persons
In Sec. 424.57(a), we would identify and define the types of
eligible professionals and other persons who can become qualified
practitioners, and therefore, in accordance with the BIPA provisions,
furnish or fabricate prosthetics and custom-fabricated orthotics.
Specifically, we propose to identify and to add definitions for the
following practitioners: (1) Occupational therapist; (2) ocularist; (3)
orthotist; (4) pedorthist; (5) physical therapist; (6) physician; and
(7) prosthetist.
Occupational Therapist. Our current regulations at Sec.
484.4 specify in detail the personnel qualifications for an
occupational therapist. We are proposing to define an occupational
therapist as an individual who meets the requirements in Sec. 484.4.
We are specifically requesting comments on these proposed
qualifications for an occupational therapist to furnish/fabricate
prosthetics and custom-fabricated orthotics.
Ocularist. The American Society of Ocularists defines an
ocularist as a trained technician skilled in the arts of fitting,
shaping, and painting ocular prostheses. We note, as indicated by the
National Examining Board of Ocularists, that in addition to creating
ocular prostheses, the ocularist typically shows the patient how to
handle and care for the prosthesis, and provides long-term care through
periodic examinations. We are proposing to define an ocularist as a
trained technician skilled in the arts of fitting, shaping, and
painting ocular prostheses who is certified by the American Board for
Certification in Orthotics, Prosthetics and Pedorthics (ABC), the Board
for Orthotist/Prosthetist Certification International, Incorporated
(BOC) or the National Examining Board of Ocularists. We are
specifically requesting comments on these proposed qualifications for
an ocularist to furnish/fabricate prosthetics and custom-fabricated
orthotics.
Orthotist. Our current regulations in Sec. 485.70(d)
specify the following personnel qualifications for an orthotist:
++ Be licensed by all states in which practicing, if applicable.
++ Have successfully completed a training program in orthotics that
is jointly recognized by the American Council on Education and the
American Board for Certification in Orthotics and Prosthetics.
++ Be eligible to take that Board's certification examination in
orthotics.
We are proposing to define an orthotist as an individual who meets
the personnel qualifications in Sec. 485.70(d). We are specifically
requesting comments on these proposed qualifications for an orthotist
to furnish or fabricate prosthetics and custom-fabricated orthotics.
Pedorthist. The Pedorthic Footcare Association defines a
pedorthist as a specialist in using footwear--which includes shoes,
shoe modifications, foot orthoses and other pedorthic devices--to solve
problems in, or related to, the foot and lower limb. We are proposing
to define pedorthist in this manner. We are specifically requesting
comments on these proposed qualifications for a pedorthist to furnish
or fabricate prosthetics and custom-fabricated orthotics.
Physical Therapist. Our current regulations at Sec. 484.4
specify in detail the personnel qualifications for a physical
therapist. We are proposing to define a physical therapist as an
individual who meets the requirements in Sec. 484.4. We are
specifically requesting comments on these proposed qualifications for a
physical therapist to furnish or fabricate prosthetics and custom-
fabricated orthotics.
Physician. Our current regulations at Sec. 484.4 specify
the personnel qualifications for a physician. In addition to those
requirements, we propose to require that for purposes of furnishing or
fabricating prosthetics and custom-fabricated orthotics, a physician
must be specifically educated, certified or trained in the area of
prosthetics and custom-fabricated orthotics. The physician must be
knowledgeable and competent (as evidenced by education and experience)
in the assessment, furnishing, fabrication, care, and follow-up needs
of the patient as specifically delineated in the DMEPOS quality
standards (discussed in section II.A.6. of this proposed rule). We are
proposing such knowledge and competency requirements because we believe
it is only specialty physicians who are trained and experienced, and
who understand the specialized needs of the beneficiary requiring
prosthetics and custom-fabricated orthotics. We are specifically
requesting comments on these proposed additional qualifications for a
physician to furnish prosthetics and custom-fabricated orthotics.
Doctors of dental surgery or dental medicine, doctors of optometry,
psychiatrists, and chiropractors do not customarily furnish or
fabricate prosthetics and custom-fabricated orthotics. Therefore, we
have not proposed requirements for these eligible professionals or any
others who do not typically furnish or fabricate the prosthetics and
custom-fabricated orthotics that are subject to the provisions of this
proposed rule. However, any qualified practitioner who furnishes or
fabricates prosthetics or custom-fabricated orthotics and any qualified
supplier that fabricates or bills for such services must meet the
applicable requirements as specified in this rule.
Prosthetist. A prosthetist is able to provide all types
prosthetics, with the exception of facial prosthetics. Our current
regulations at Sec. 485.70(f) specify the personnel qualifications for
a prosthetist as follows:
++ Be licensed by all states in which they are practicing, if
applicable.
++ Have successfully completed a training program in prosthetics
that is jointly recognized by the American Council on Education and the
American Board for Certification in Orthotics and Prosthetics.
++ Be eligible to take that Board's certification examination in
prosthetics.
We are proposing to define a prosthetist as an individual who meets
the personnel qualifications in Sec. 485.70(f). We are specifically
requesting comments on these proposed qualifications for a prosthetist
to furnish or fabricate prosthetics and custom-fabricated orthotics.
b. Training, Licensure, and Certification Requirements for Qualified
Practitioners
In addition to defining the types of professionals that would be
eligible to furnish and fabricate prosthetics and custom-fabricated
orthotics, we are proposing certain licensure, training, and
certification requirements that these practitioners must meet to be
qualified practitioners who furnish or fabricate prosthetics or custom-
fabricated orthotics that are billed to Medicare by qualified
suppliers. Furnishing and fabricating prosthetics and custom-fabricated
orthotics for Medicare beneficiaries, who need these items and
services, is multifaceted and complex. We have proposed a framework of
requirements designed to ensure that eligible professionals possess the
skills and training to furnish and fabricate these items and services.
It is important that the qualified practitioners who furnish and
fabricate these items meet the requirements specified in this proposed
rule.
Therefore, in proposed Sec. 424.57(d)(3), we would specify that an
eligible professional or other person who wants
[[Page 3684]]
to be a qualified practitioner who furnishes or fabricates prosthetics
or custom-fabricated orthotics must meet either of the following
licensure and certification requirements:
++ Licensed in orthotics, pedorthics or prosthetics by the state.
++ In states that do not provide licenses for orthotics, pedorthics
or prosthetics, must be both of the following:
--Specifically, trained and educated to provide and manage the
provision of pedorthics, prosthetics, and orthotics.
--Certified by the one of the following:
+++ ABC.
+++ BOC.
+++ A Secretary-approved organization that has standards equivalent
to the ABC or BOC.
We believe these proposed requirements would ensure that the
specialized needs of Medicare beneficiaries who require prosthetics and
custom-fabricated orthotics are met. We are specifically seeking
comment on these requirements and, in particular, we are very
interested in comments regarding standards by which we should determine
that qualified practitioners are specifically trained and educated to
provide and manage the provision of pedorthics, prosthetics, and
orthotics. For example, we solicit feedback on any relevant metrics,
data sources or methods and processes to gauge competencies. We would
appreciate comments on whether a qualified practitioner who is also a
qualified supplier that is enrolled in Medicare as a DMEPOS supplier
should be required to obtain certification from ABC or BOC in addition
to meeting the qualified suppler requirements in this proposed rule.
We also clarify that, to the extent that a qualified supplier does
not fabricate a prosthetic or a custom-fabricated orthotic, such
prosthetic or custom-fabricated orthotic must be fabricated by a
qualified practitioner, and that it is the responsibility of the
qualified supplier to verify the practitioner's qualified status.
4. Claims for Prosthetics and Custom-Fabricated Orthotics
As stated previously, we are proposing that all DMEPOS suppliers
that bill for prosthetics and custom-fabricated orthotics must meet the
supplier standards in Sec. 424.57, the quality standards (discussed in
section II.A.6. of this proposed rule) and be accredited by one of the
CMS-approved accrediting organizations.
We have proposed in Sec. 424.535(a)(2)(iii) that we may revoke a
qualified supplier's enrollment from Medicare for billing for
prosthetics and custom-fabricated orthotics that are not furnished by a
qualified practitioner and fabricated by a qualified practitioner or a
qualified supplier at a facility that meets such criteria as the
Secretary determines appropriate. This is particularly important
because for those qualified practitioners who are not eligible to be
enrolled in Medicare or who are not permitted to opt out of Medicare,
there will be no CMS repository of information about their licensure or
certification. The qualified supplier would be responsible for ensuring
that the qualified practitioners who furnish or the qualified
practitioners and qualified suppliers who fabricate the items for which
the qualified supplier submits a bill meet the requirements of this
rule. The decision about revocation based on the authority in Sec.
424.535(a)(2)(iii) will be made based on the facts and circumstances of
the particular situation, and will not be based on a single individual
billing or miscoding mistake alone on the part of a supplier. We are
specifically seeking comment on the implementation of this requirement,
including how DMEPOS suppliers envision that they would comply with the
requirements that they can bill only for prosthetics and custom-
fabricated orthotics that have been furnished by qualified
practitioners and fabricated by qualified practitioners or qualified
suppliers at a facility that meets such criteria as the Secretary
determines appropriate.
5. Requirements for Accreditation Organizations
Section 1834(a)(20)(B) of the Act requires the Secretary to
designate and approve one or more independent accreditation
organizations to apply the quality standards required in section
1834(a)(20)(A) of the Act. In the August 18, 2006 final rule (71 FR
48354), we implemented our regulations at Sec. 424.58 that specified
the criteria that all approved accreditation organizations must meet.
In this proposed rule, we would specify requirements for any of the
CMS-approved accreditation organizations that accredit suppliers
fabricating prosthetics and custom-fabricated orthotics. In Sec.
424.58, we are proposing to redesignate paragraphs (c) through (e), as
paragraphs (d) through (f), and adding a new paragraph (c). In
paragraph (c), we would specify that any approved accreditation
organization must meet the following additional accreditation
requirements to accredit suppliers that bill for prosthetics and
custom-fabricated orthotics. In addition to meeting the current
requirements set forth under Sec. 424.58, the accreditation
organization must be one of the following:
The ABC.
The BOC.
An approved DMEPOS accreditation organization that has
standards equivalent to the ABC or BOC.
We are proposing to define ``a DMEPOS accreditation organization
that has standards equivalent to the ABC or BOC'' as one that employs
or contracts with an orthotist, prosthetist, occupational therapist, or
physical therapist who meets the qualified practitioner definition at
Sec. 424.57(a) and who is utilized for the purpose of surveying the
supplier for compliance, and has the authority to approve or deny
accreditation of qualified suppliers.
We believe that these proposed requirements are in concert with the
provisions of section 1834(h) of the Act requiring that the supplier be
accredited by the ABC, the BOC or accredited by a program that the
Secretary determines has accreditation and approval standards that are
essentially equivalent to those of such Board. We are specifically
seeking comment on the proposed definition.
6. Quality Standards Required in Section 1834(a)(20) of the Act
a. Overview of and Process for Updating the Quality Standards
The quality standards required by section 1834(a)(20) of the Act
are used by the accreditation organizations in order to determine
whether a supplier meets statutory and regulatory requirements and
therefore can be accredited. Any supplier would have to maintain these
standards in order to meet the accreditation requirements and be
approved as a qualified supplier to bill, continue to bill or fabricate
Medicare Part B prosthetics and custom-fabricated orthotics.
After issuance of the final rule, we would update the DMEPOS
quality standards to reflect the provisions contained in the final rule
resulting from this proposed rule. The revised quality standards would
include specifically the requirements that qualified practitioners must
meet to furnish and fabricate prosthetics and custom-fabricated
orthotics and that qualified suppliers must meet in order to fabricate
and bill Medicare for prosthetics and custom-fabricated orthotics. We
plan to solicit comments on the proposed updates to the quality
standards as we have done in the past,
[[Page 3685]]
and as set forth in section 1834(a)(20)(E) of the Act, by posting the
proposed updates to the quality standards on our Web site at:
www.cms.gov/medicareprovidersupenroll. The quality standards are
updated via our subregulatory process. Therefore, while we are
notifying the public of our intent to update the quality standards, we
are not, in this proposed rule, soliciting comment on the quality
standards or the process for updating these standards.
b. Effective Date for Compliance With New Quality Standards
We are proposing in Sec. 424.57(c)(22)(ii) that qualified
suppliers who bill Medicare for prosthetics and custom-fabricated
orthotics would need to meet the requirements included in the final
rule no later than 1 year after the posting date of the final quality
standards or at the time of the supplier's re-accreditation cycle,
whichever is later. For qualified practitioners, we would expect them
to meet the licensure and certification requirements proposed and
subsequently finalized via rulemaking within 1 year of publication of
the final rule. This takes into consideration the average length of
time (5.5 months) needed by a DMEPOS supplier to complete the DMEPOS
accreditation process, in addition to the time that may be needed for
an eligible professional to become a qualified practitioner and become
licensed or certified, as well as an extended period due to the
additional numbers of suppliers or individuals that may need to meet
the new requirements. We are requesting comment on the proposed
implementation schedule so that we may ensure that there is no
disruption in patient access to services or care.
If an ocularist, orthotist, prosthetist, physicians, pedorthist,
occupational therapist, physical therapist or any other eligible
professional is not furnishing or fabricating prosthetics or custom-
fabricated orthotics, then they would not need to meet the specific
prosthetics and custom-fabricated orthotics requirements in this
proposed rule. Similarly, if an enrolled DMEPOS supplier is not billing
for the prosthetics and custom-fabricated orthotics subject to the
provisions of this proposed rule, then the supplier would not need to
meet the specific prosthetics and custom-fabricated orthotics
requirements in this proposed rule.
B. List of Prosthetics and Certain Custom-Fabricated Orthotics
The requirements of section 1834(h)(1)(F) of the Act apply to all
prosthetics and certain custom-fabricated orthotics described in
section 1834(h)(1)(F)(ii) of the Act. Section 1834(h)(1)(F)(ii)(I) of
the Act, as added by section 427 of BIPA, states that an item described
in this clause is an item of custom-fabricated orthotics that requires
education, training, and experience to custom-fabricate and that is
included in a list established by the Secretary. Section
1834(h)(1)(F)(ii)(I) of the Act also specifies that an item of custom-
fabricated orthotics does not include shoes and shoe inserts.
Section 1834(h)(1)(F)(ii)(II) of the Act as added by section 427 of
BIPA states that the Secretary, in consultation with appropriate
experts in orthotics (including national organizations representing
manufacturers of the same), shall establish and update as appropriate a
list of items to which this subparagraph applies. No orthotic may be
included in such list unless the item is individually fabricated for
the patient over a positive model of the patient as defined later. On
August 19, 2005, we issued program instructions (Transmittal 656, CR
3959) implementing the list of HCPCS codes describing prosthetics and
custom-fabricated orthotics subject to the requirements of section
1834(h)(1)(F) of the Act. The list of HCPCS codes describing items
subject to the requirements of section 1834(h)(1)(F) of the Act has
been updated to reflect changes in HCPCS codes that have occurred since
2005. This list of HCPCS codes describing items subject to the
requirements of section 1834(h)(1)(F) of the Act would continue to be
updated through program instructions, as needed. The list is available
on the CMS Web site at www.cms.gov/medicareprovidersupenroll.
In keeping with the statute's intent to consult with appropriate
experts in developing the list, we not only reviewed the Committee's
recommendations, but also consulted with the following:
American Physical Therapy Association.
Medicare Pricing, Data, Analysis and Coding (PDAC)
contractor(s).
Orthotic & Prosthetic Alliance.
The American Occupational Therapy Association.
The American Orthotic & Prosthetic Association.
The U.S. Department of Veterans Affairs.
To implement this statutory provision, we propose to add the
following definitions in Sec. 424.57(a):
Positive model of the patient means a particular type of
custom fabrication in which one of the following occurs:
++ Is molded to the patient model as a negative impression taken of
the patient's body part and a positive model rectification are
constructed.
++ A Computer Aided Design-Computer Aided Manufacturing (CAD-CAM)
system, by use of digitizers, transmits surface contour data to
software that the practitioner uses to rectify or modify the model on
the computer screen. The data depicting the modified shape is
electronically transmitted to a commercial milling machine that carves
the rectified model.
++ A direct formed model is one in which the patient serves as the
positive model. The device is constructed over the model of the patient
and is then fabricated to the patient. The completed custom fabrication
is checked and all the necessary adjustments are made.
Custom-fabricated means an item that is individually made
for a specific patient. Specifically, a custom-fabricated item is a
device that is fabricated based on clinically derived and rectified
castings, tracings, measurements, and other images such as x-rays of
the body part. The fabrication may involve using calculation, templates
and components. This process requires the use of basic materials
including, but not limited to plastic, metal, leather or cloth in the
form of uncut or unshaped sheets, bars or other basic forms and
involves substantial work such as vacuum forming, cutting, bending,
molding, sewing, drilling, laminating, and finishing prior to fitting
on the patient. An item is considered custom-fabricated if it is
constructed by using one of the positive model techniques described in
the definition of positive model of the patient.
Lastly, we would specify in Sec. 424.57(d)(2) that items on the
list must be--(1) furnished by a qualified practitioner; (2) fabricated
by a qualified practitioner or a qualified supplier at a facility that
meets such criteria as the Secretary determines appropriate; and (3)
billed by a qualified supplier or, submitted as a claim by a
beneficiary.
The list would be updated through periodic program instructions to
reflect any changes. We intend to update the list as needed on the CMS
Web site at www.cms.gov/medicareprovidersupenroll. We note that the
list of services and supplies that are subject to the provisions of
this proposed rule is being provided for information only. We are not,
in this proposed rule, soliciting comments on the list.
We would continue to consult with experts in orthotics as changes
in positive model techniques occur that might impact the definition and
list of items subject to section 1834(h)(1)(F) of the Act. Any such
changes to the list of
[[Page 3686]]
items would be issued through program instructions. We would continue
to ensure that any change to the list of prosthetics and custom-
fabricated orthotics is done in concert with our established processes.
We would issue contractor instructions and a provider educational
article detailing the list of HCPCS codes for the prosthetics and
custom-fabricated orthotic items to which the requirements apply, as
well as instructions to DMEPOS suppliers regarding billing, data
collection, and systems operations following the publication of the
final rule. Any changes to the list items would also be published in
future CMS contractor instructions.
III. Collection of Information Requirements
A. Background
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-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 requires that we solicit comment 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 affected public, including automated collection
techniques.
B. ICRs Regarding DMEPOS Suppliers and Eligible Professionals Providing
Custom-Fabricated Orthotics (Sec. 424.57)
1. Accreditation for Physicians and Practitioners Enrolled as DMEPOS
Suppliers
Under Sec. 424.57(c)(22), DMEPOS suppliers that furnish, fabricate
and bill for prosthetics or custom-fabricated orthotics must meet all
accreditation requirements specified in these provisions, and be
licensed in orthotics, pedorthics, or prosthetics in the state in which
its practice is located (if the state requires such licensure). Table 1
identifies categories and approximate numbers of individuals who, as of
February 2014: (1) Are enrolled in Medicare as DMEPOS suppliers; (2)
have billed Medicare for prosthetic devices; and (3) are ABC or BOC
certified. This data is based on internal CMS statistics, though the
figures in Table 1 are merely rough estimates for purposes of this
proposed rule. These individuals have met all applicable state
licensure requirements (for example, for furnishing prosthetics).
Table 1--Prosthetics
------------------------------------------------------------------------
Number
enrolled as Number who are
Category DMEPOS ABC or BOC
suppliers certified
------------------------------------------------------------------------
Prosthetists............................ 8,000 5,000
Physicians.............................. 5,000 3,000
Physical and Occupational Therapists.... 1,000 500
Ocularists.............................. 400 200
Orthotists.............................. 1,500 800
Pedorthists............................. 900 500
-------------------------------
Total............................... 16,800 10,000
------------------------------------------------------------------------
The 10,000 physicians and practitioners in Table 1 who are enrolled
as DMEPOS suppliers and are accredited would meet the requirements of
proposed Sec. 424.57(c)(22); hence, the information collection
requirements in this proposed rule would not affect them. However, the
remaining 6,800 would need to obtain ABC or BOC accreditation in order
to bill Medicare for prosthetics.
Table 2 identifies categories and approximate numbers of
individuals who, as of February 2014: (1) Are enrolled in Medicare as
DMEPOS suppliers; (2) have billed Medicare for custom-fabricated
orthotics; and (3) are ABC or BOC certified. This data, too, is based
on internal CMS statistics. All of these persons have met the
applicable state licensure requirements (for example, for furnishing
custom-fabricated orthotics).
Table 2--Custom-Fabricated Orthotics
------------------------------------------------------------------------
Number
enrolled as Number who are
Category DMEPOS ABC or BOC
suppliers certified
------------------------------------------------------------------------
Prosthetists............................ 4,000 2,000
Physicians.............................. 3,000 1,500
Physical and Occupational Therapists.... 1,000 500
Ocularists.............................. 300 200
Orthotists.............................. 4,000 2,500
Pedorthists............................. 700 400
-------------------------------
Total............................... 13,000 7,100
------------------------------------------------------------------------
[[Page 3687]]
The 7,100 physicians and practitioners in Table 2 who are currently
enrolled as DMEPOS suppliers and are accredited would meet the
requirements of proposed Sec. 424.57(c)(22). Accordingly, the
information collection requirements in this proposed rule would not
affect them. However, the remaining 5,900 would need to obtain ABC or
BOC accreditation in order to bill Medicare for custom-fabricated
orthotics.
Although it is highly likely that some of the individuals in Tables
1 and 2 provide both prosthetics and custom-fabricated orthotics, we
have chosen to assume that the tables reflect unduplicated counts of
physicians and practitioners.
We cannot estimate the number of physicians and practitioners in
the universe of 12,700 (6,800 + 5,900) who would either decline to
obtain accreditation because of cost, other factors or inability to
meet the accreditation requirements. We believe that the overwhelming
majority of the 12,700 physicians and practitioners would elect to and
become accredited to continue to provide, bill, or both provide and
bill for these devices. We expect that a lower percentage of
physicians, physical therapists, and occupational therapists would seek
accreditation than would prosthetists, orthotists, pedorthists, and
ocularists. This is because furnishing prosthetics and custom-
fabricated orthotics traditionally constitutes a smaller portion of
their practices than is the case with the latter four practitioner
types. For purposes of this burden estimate only, and as outlined in
Table 3, we project that--(1) all prosthetists, orthotists, ocularists,
and pedorthists would pursue accreditation; and (2) 90 percent of
physicians, physical therapists, and occupational therapists would seek
accreditation. This results in a base figure of 12,250 physicians and
practitioners that is only slightly less than the 12,700-person
universe mentioned previously.
Table 3--Number of Physicians and Practitioners Seeking Accreditation
------------------------------------------------------------------------
Approximate
Category percentage of Number
universe *
------------------------------------------------------------------------
Prosthetists............................ 40.8 5,000
Physicians.............................. 25.7 3,150
Physical and Occupational Therapists.... 7.3 900
Ocularists.............................. 2.5 300
Orthotists.............................. 18.0 2,200
Pedorthists............................. 5.7 700
-------------------------------
Total............................... .............. 12,250
------------------------------------------------------------------------
* Rounded to nearest tenth.
The hour and cost burdens on these physicians and practitioners of
completing and submitting the paperwork associated with accreditation
would vary because each physician's and practitioner's specific
circumstances differ. However, we believe that an average per
physician/practitioner time burden of 10 hours is reasonable, though we
welcome comments on this estimate. This 10-hour period would include
the time involved in completing and submitting the necessary
accreditation paperwork, including obtaining any required supporting
documentation.
Many of the 12,250 physicians and practitioners are part of group
practices that have administrative personnel who handle various
paperwork functions on behalf of the group's physicians and
practitioners. It is probable that some administrative personnel would
complete and submit the physicians' and practitioners' accreditation
paperwork. However, we have no data that can help us predict the number
of instances in which this would occur. In an effort not to
underestimate the potential cost burden, we will assume for purposes of
our analysis that physicians and practitioners would complete and
submit their accreditation applications.
Table 4 identifies the mean hourly wages for the Bureau of Labor
Statistics (BLS) categories that most appropriately apply to the
physician and practitioner types mentioned previously. The data is from
May 2015, the most recent month for which information is available; see
http://www.bls.gov/oes/current/oes_nat.htm#43-0000. As there are no
specific BLS categories for ocularists and pedorthists, we will include
them within the larger category of orthotists and prosthetists.
Table 4--BLS Mean Hourly Wages Using May 2015 Data
------------------------------------------------------------------------
Hourly wage
BLS mean with fringe
BLS category hourly wage benefits and
($) overhead ($)
------------------------------------------------------------------------
Orthotists and Prosthetists *........... 33.63 67.26
Physicians and Surgeons................. 97.33 194.66
Physical Therapists..................... 41.25 ** 82.50
Occupational Therapists................. 39.27 ** 78.54
------------------------------------------------------------------------
* Includes ocularists and pedorthists.
** The average mean hourly wage for physical and occupational therapists
combined, which we will use in our analysis, is $80.52 (or ($82.50 +
$78.54)/2).
[[Page 3688]]
Table 5 identifies the total hour and cost burdens for enrolled
physicians and practitioners seeking accreditation. The cost burdens
are based on the wage estimates in Table 4.
Table 5--Total Hour and Costs Burdens for Enrolled Physicians and Practitioners Seeking Accreditation
----------------------------------------------------------------------------------------------------------------
Number of
Category physicians and Hour burden Total hour Hourly wage Total cost
practitioners per submission burden ($) burden ($)
----------------------------------------------------------------------------------------------------------------
Prosthetists.................... 5,000 10 50,000 67.26 3,363,000
Physicians...................... 3,150 10 31,500 194.66 6,131,790
Physical and Occupational 900 10 9,000 80.52 724,680
Therapists.....................
Ocularists...................... 300 10 3,000 67.26 201,780
Orthotists...................... 2,200 10 22,000 67.26 1,479,720
Pedorthists..................... 700 10 7,000 67.26 470,820
-------------------------------------------------------------------------------
Total....................... 12,250 .............. 122,500 .............. 12,371,790
----------------------------------------------------------------------------------------------------------------
Although this burden would be incurred in the first year of our
proposed requirement, 3 years is the maximum length of an OMB approval.
Therefore, we must average the totals in Table 5 over a 3-year period.
This result in the following average annual figures of: (1) 4,083
affected physicians and practitioners; (2) 40,830 ICR burden hours; and
(3) $4,123,930 in ICR burden costs.
2. Accreditation for Newly Enrolling Physicians and Practitioners
Table 6 outlines the annual number of physicians and practitioners
who, based on historical CMS data, would--(1) seek accreditation in
accordance with Sec. 424.57(c)(22); (2) enroll in Medicare as DMEPOS
suppliers; and (3) bill Medicare for prosthetics or custom-fabricated
orthotics.
Table 6--Annual Number of Physicians and Other Practitioners Seeking
Accreditation, Enrolling in Medicare as DMEPOS Suppliers, and Billing
for Prosthetics or Custom-Fabricated Orthotics
------------------------------------------------------------------------
Number of
Category enrollees
------------------------------------------------------------------------
Prosthetists............................................ 400
Physicians.............................................. 250
Physical and Occupational Therapists.................... 100
Ocularists.............................................. 40
Orthotists.............................................. 400
Pedorthists............................................. 100
---------------
Total............................................... 1,290
------------------------------------------------------------------------
Table 7 outlines the annual hour and cost burdens for newly
enrolling physicians and practitioners. The table applies the 10-hour
and BLS wage estimates mentioned previously.
Table 7--Annual Hour and Cost Burdens for Newly Enrolling Physicians and Practitioners Seeking Accreditation
----------------------------------------------------------------------------------------------------------------
Number of
Category physicians and Hour burden Total hour Hourly wage Total cost
practitioners per submission burden ($) burden ($)
----------------------------------------------------------------------------------------------------------------
Prosthetists.................... 400 10 4,000 67.26 269,040
Physicians...................... 250 10 2,500 194.66 486,650
Physical and Occupational 100 10 1,000 80.52 80,520
Therapists.....................
Ocularists...................... 40 10 400 67.26 26,904
Orthotists...................... 400 10 4,000 67.26 269,040
Pedorthists..................... 100 10 1,000 67.26 67,260
-------------------------------------------------------------------------------
Total....................... 1,290 .............. 12,900 .............. 1,199,414
----------------------------------------------------------------------------------------------------------------
3. Reporting Accreditation via the CMS-855S (Medicare Enrollment
Application: Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies (DMEPOS) Suppliers)
The CMS-855S is currently approved under OMB control number 0938-
1056. In order to account for the application information collection
requirements contained in this notice of proposed rulemaking, we will
submit a revised information collection request for OMB review and
approval.
a. Enrolled Physicians and Practitioners
Upon becoming accredited, physicians and practitioners would need
to report the accreditation to us via a CMS-855S change of information
request. We estimate that it would take physicians and practitioners 30
minutes to complete and submit this change request. Table 8 outlines
the total hour and cost burdens of this requirement.
[[Page 3689]]
Table 8--Total Hour and Cost Burdens for Enrolled Physicians and Practitioners Reporting Accreditation via CMS-
855S
----------------------------------------------------------------------------------------------------------------
Number of
Category physicians and Hour burden Total hour Hourly wage Total cost
practitioners per submission burden ($) burden ($)
----------------------------------------------------------------------------------------------------------------
Prosthetists.................... 5,000 0.5 2,500 67.26 168,150
Physicians...................... 3,150 0.5 1,575 194.66 306,590
Physical and Occupational 900 0.5 450 80.52 36,234
Therapists.....................
Ocularists...................... 300 0.5 150 67.26 10,089
Orthotists...................... 2,200 0.5 1,100 67.26 73,986
Pedorthists..................... 700 0.5 350 67.26 23,541
-------------------------------------------------------------------------------
Total....................... 12,250 .............. 6,125 .............. 618,590
----------------------------------------------------------------------------------------------------------------
Although this burden would be incurred in the first year of our
proposed requirement, we must average the totals in Table 8 over a 3-
year period. This results in: (1) 4,083 affected physicians and
practitioners; (2) 2,042 ICR burden hours; and (3) $206,197 in ICR
burden costs.
b. Newly Enrolling Physicians and Practitioners
When completing the CMS-855S initial enrollment application,
physicians and practitioners would have to furnish accreditation
information on the form. We estimate that this would take 30 minutes
per application. Table 9 outlines the total annual hour and cost
burdens.
Table 9--Total Annual Hour and Cost Burdens for Newly Enrolling Physicians and Practitioners Reporting
Accreditation via CMS-855S
----------------------------------------------------------------------------------------------------------------
Number of
Category physicians and Hour burden Total hour Hourly wage Total cost
practitioners per submission burden ($) burden ($)
----------------------------------------------------------------------------------------------------------------
Prosthetists.................... 400 0.5 200 67.26 13,452
Physicians...................... 250 0.5 125 194.66 24,333
Physical and Occupational 100 0.5 50 80.52 4,026
Therapists.....................
Ocularists...................... 40 0.5 20 67.26 1,345
Orthotists...................... 400 0.5 200 67.26 13,452
Pedorthists..................... 100 0.5 50 67.26 4,026
-------------------------------------------------------------------------------
Total....................... 1,290 .............. 645 .............. 60,634
----------------------------------------------------------------------------------------------------------------
4. Requirements for Becoming a Qualified Practitioner
Under Sec. 424.57(d)(3), all eligible professionals who wish to
become qualified practitioners, to provide prosthetics or custom-
fabricated orthotics, and who are not enrolled in Medicare as DMEPOS
suppliers (and therefore do not bill Medicare for these items) must--
Be licensed in orthotics, pedorthics, or prosthetics in
the state in which his or her practice is located if the state requires
such licensure; or
If the state does not require such licensure--
Be specifically trained and educated to provide and manage
the provision of pedorthics, prosthetics, or orthotics; and
Meet the certification requirements specified in Sec.
424.57(d)(3)(i)(B)(2).
Specifically, this section discusses the hour and cost burdens for
physicians and practitioners who are--(1) not enrolled in Medicare as
DMEPOS suppliers; (2) located in a state that does not require
licensure in orthotics, pedorthics, and prosthetics; and (3) must
obtain certification under Sec. 424.57(d)(3).
Approximately 15 states require licensure to furnish prosthetics
and custom-fabricated orthotics. However, we do not have concrete data
regarding the number of unenrolled and unlicensed individuals in the 35
other states or the territories who provide these items, for these
persons do not bill Medicare for them. For purposes of this burden
estimate, and solely to establish a rough figure on which commenters
can submit feedback to us, we project that approximately 5,000
physicians and practitioners would seek certification within the first
year following the implementation of Sec. 424.57(d)(3). We estimate
that 500 physicians and practitioners would seek certification under
Sec. 424.57(d)(3) each year thereafter.
As we lack sufficient data regarding the number of qualified
practitioners, who fall within the universe of 5,000 physicians and
practitioners, we will use the figures in Table 3 as a baseline
estimate. To illustrate, orthotists represented 18 percent of the
12,250 suppliers referenced in Table 3 (or 2,200 out of 12,250); we
project that 18 percent of the 5,000-person universe (or 900) would
consist of orthotists. We also utilized the wage estimates and the 10-
hour projection. This results in the following Year 1 hour and cost
burdens associated with Sec. 424.57(d)(3).
[[Page 3690]]
Table 10--Hour and Cost Burdens Associated With Sec. 424.57(d)(3) in Year 1
----------------------------------------------------------------------------------------------------------------
Number of
Category physicians and Hour burden Total hour Hourly wage Total cost
practitioners per submission burden ($) burden ($)
----------------------------------------------------------------------------------------------------------------
Prosthetists.................... 2,040 10 20,400 67.26 1,372,104
Physicians...................... 1,285 10 12,850 194.66 2,501,381
Physical and Occupational 365 10 3,650 80.52 293,898
Therapists.....................
Ocularists...................... 125 10 1,250 67.26 84,075
Orthotists...................... 900 10 9,000 67.26 605,340
Pedorthists..................... 285 10 2,850 67.26 191,691
-------------------------------------------------------------------------------
Total....................... 5,000 .............. 50,000 .............. 5,048,489
----------------------------------------------------------------------------------------------------------------
Table 11 reflects the annual hour and cost burdens in Year 2 and
each year thereafter. The figures are based on the 500-individual
universe.
Table 11--Annual Hour and Cost Burdens of Sec. 424.57(d)(3) in Year 2 and Subsequent Years
----------------------------------------------------------------------------------------------------------------
Number of
Category physicians and Hour burden Total hour Hourly wage Total cost
practitioners per submission burden ($) burden ($)
----------------------------------------------------------------------------------------------------------------
Prosthetists.................... 204 10 2,040 67.26 137,210
Physicians...................... 128 10 1,280 194.66 249,165
Physical and Occupational 36 10 360 80.52 28,987
Therapists.....................
Ocularists...................... 13 10 130 67.26 8,744
Orthotists...................... 90 10 900 67.26 60,534
Pedorthists..................... 29 10 290 67.26 19,505
-------------------------------------------------------------------------------
Total....................... 500 .............. 5,000 .............. 504,145
----------------------------------------------------------------------------------------------------------------
We averaged the totals in Tables 10 and 11 over a 3-year period.
This results in the following annual figures of: (1) 2,000 affected
physicians and practitioners; (2) 20,000 burden hours; and (3)
$2,018,926.
C. Final ICR Hour and Cost Burdens
We estimate the following total ICR burdens associated with our
proposed provisions in each of the first 3 years of this rule.
Table 12--Summary of Annual Information Collection Burdens
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Burden per annual Hourly labor Total labor Total cost
Regulation section(s) OMB Control No. respondents responses response burden cost ($) cost ($) ($)
(hours) (hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 424.57(c)(22)--Enrolled 0938-New.............. 12,250 12,250 10 122,250 [dagger] 4,123,930 4,123,930
seeking accreditation.
Sec. 424.57(c)(22)--Newly 0938-New.............. 1,290 1,290 10 12,290 [dagger][dagge 1,199,414 1,199,414
enrolling seeking accreditation. r]
Sec. 424.57(c)(22)--Enrolled 0938-1056............. 4,083 4,083 0.5 2,042 [dagger][dagge 206,197 206,197
reporting accreditation via 855S. r][dagger]
Sec. Sec. 424.57(c)(22)--Newly 0938-1056............. 1,290 1,290 0.5 645 [dagger][dagge 60,634 60,634
enrolling reporting accreditation r][dagger][da
via 855S. gger]
Sec. 424.57(d)(3) ***........... 0938-New.............. 2,000 2,000 10 20,000 [dagger][dagge 2,018,926 2,018,926
r][dagger][da
gger][dagger]
---------------------------------------------------- -------------------------
Total......................... ...................... 12,746 12,746 ........... 75,807 .............. 7,609,101 7,609,101
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed
the associated column from Table 1.
[dagger] See the values listed in Table 5.
[dagger][dagger] See the values listed in Table 7.
[dagger][dagger][dagger] See the values listed in Table 8.
[dagger][dagger][dagger][dagger] See the values listed in Table 9.
*** The values are based on the 3-year average of the values listed in tables 10 and 11. Three years is the maximum length of an OMB approval.
[dagger][dagger][dagger][dagger][dagger] See the values listed in Tables 10 and 11.
[[Page 3691]]
We welcome comments on all burden estimates contained in the
collection of information section of this notice of proposed
rulemaking.
If you comment on these information collection and recordkeeping
requirements, please do either of the following:
1. Submit your comments electronically as specified in the
ADDRESSES section of this proposed rule; or
2. Submit your comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, Attention: CMS Desk Officer,
(CMS-6012-P), Fax: (202) 395-6974; or Email:
[email protected].
IV. Regulatory Impact Statement
This proposed rule would implement a statutory mandate that only
individuals and suppliers qualified to do so can furnish, fabricate or
bill for prosthetics and custom fabricated orthotics. The statute was
enacted to ensure quality of care and eliminate care or services
furnished or fabricated by individuals who were not qualified to do so.
The idea inherent in the statute is not to deny necessary services but
to ensure that the individuals and suppliers furnishing or fabricating
these items are qualified to do so. As with all program changes,
whether undertaken by us or in response to statutory imperative--as is
the case with this rule--we always consider the impact of the proposed
changes on access to care. In the case of the statutory provisions
being implemented via this rule, we do not believe beneficiary access
to care will be significantly affected. This rule involves only a very
small percentage of the overall universe of physician, non-physician
practitioner, and organizational suppliers. Of those affected, we
believe that many either already comply with our proposed requirements
or would come into compliance. We acknowledge that there may be some
discontinuity of care in instances where a beneficiary seeks or has
been receiving items from an individual or supplier that does not meet
the requirements of the statute. However, we believe it will be
minimal, and the benefit in improved quality of care outweighs the
possible discontinuity. In addition, the phased in effective dates for
compliance will allow reasonable time for practitioners and suppliers
to meet the statutory and regulatory requirements thus minimizing any
disruption in access to needed services. We welcome comment on these
assumptions.
In summary, we believe that our proposed rule would, as the
Congress ostensibly intended in its enactment of section 1834(h)(1)(F)
of the Act, protect Medicare beneficiaries and the Medicare Trust Funds
by ensuring that only qualified practitioners furnish prosthetics and
custom fabricated orthotics.
We have examined the impact of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995, Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Order 12866 and 13563 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 economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
As previously stated in section III. of this proposed rule, we
estimate that 12,250 physicians and practitioners who are enrolled as
DMEPOS suppliers and who have billed Medicare for prosthetics or
custom-fabricated orthotics, but who are not accredited, would seek to
obtain accreditation under Sec. 424.57(c)(22) in order to continue
billing for such items. Though accreditation figures vary by
accreditation organization and by supplier type, we project (based on
internal statistics and our review of the range of accreditation fees
charged by various accreditation organizations) that the average annual
cost for a physician or practitioner to obtain and remain accredited
under Sec. 424.57(c)(22) would be roughly $1,500; this represents the
fee charged by the applicable accreditation organization. (This is
predicated on a triennial accreditation cycle, with the accreditation
costs being incurred incrementally over the 3-year period.) This
results in an annual cost to these individuals of $18,375,000 (12,250 x
$1,500). In combining this cost with the ICR costs of this proposed
rule (as shown in section III. of this proposed rule), we determine
that in no year would the total costs of this proposed rule exceed $100
million. Therefore, this is not a major 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 organization and small governmental
jurisdictions. Most entities and most other providers and suppliers are
small entities, either by nonprofit status or by having revenues of
$7.5 million to $38.5 million in any 1 year. Individuals and states are
not included in the definition of a small entity. We are not preparing
an analysis for the RFA because we have determined, and the Secretary
certifies, that this proposed rule would not have a significant
economic impact on a substantial number of small entities for two
reasons. First, the number of affected parties represents only an
extremely small percentage of the universe of over 1.5 million
individual and organizational medical providers nationwide. Second, we
do not believe an annual cost of $1,500 combined with the occasional
submission of paperwork (as described in section III. of this proposed
rule) would have a significant economic impact on these suppliers and
practitioners. We believe these costs would be less than 3 percent of
the supplier's or practitioner's revenue, as defined by HHS for
significant impact.
In addition, section 1102(b) of the 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 603 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 for Medicare payment regulations 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
proposed rule would 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 also
requires that agencies assess anticipates costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation, as the
anticipated annual spending is $30 million. In 2016, that threshold is
approximately $146 million. This proposed rule would have no
consequential effect on state, local or tribal governments or on the
private sector.
Executive Order 13132 establishes certain requirements that an
agency
[[Page 3692]]
must meet when it promulgates a proposed rule (and subsequent final
rule) that imposes substantial direct requirement cost on state and
local governments, preempts state law, or otherwise has Federalism
implications. Since this rule does not impose any costs on state or
local governments, the requirements of Executive Order 13132 are not
applicable.
There were several uncertainties associated with our proposed
projections. First, we could not determine precisely the number of
DMEPOS suppliers who would choose not to pursue accreditation or be
unable to become accredited. Second, we had no data on which to base
our 5,000-person and 500-person estimates in Tables 10 and 11. As such,
these estimates are merely designed to solicit comment on the number of
individuals who would be affected by Sec. 424.57(d)(3). Third, we
welcome comment on our estimation of $1,500 as the annual cost for a
qualified supplier to obtain and remain accredited in accordance our
proposals. Fourth, as we lack sufficient data to estimate any potential
burden on fabricating facilities, we request comments regarding the
types of possible burden and, if there are any, the costs involved.
We note that by limiting payment to the circumstances described in
this rule, our regulations would likely reduce the provision of and
billing for these items to instances consistent with the statute. We
believe, however, that this would enhance the quality of services and
items by ensuring that unqualified entities and individuals are not
furnishing such goods, while simultaneously having no real effect on
how prices are set for them.
In accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by the Office of Management and Budget.
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, 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.
List of Subjects for 42 CFR Part 424
Emergency medical services, Health facilities, Health professions,
Medicare.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR part 424 as set forth
below:
PART 424--CONDITIONS FOR MEDICARE PAYMENT
0
1. The authority citation for part 424 continues to read as follows:
Authority: Sections 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
0
2. Section 424.57 is amended as follows:
0
a. In paragraph (a) by adding the definition of ``Custom-fabricated
orthotics,'' Fabrication facility'', ``Occupational therapist'',
``Ocularist'', ``Orthotist'', ``Pedorthist'', ``Physical therapist'',
``Physician'', ``Positive model of the patient'', ``Prosthetics'',
``Prosthetist'', ``Qualified practitioner'', and ``Qualified supplier''
in alphabetical order and in the definition of ``DMEPOS supplier'' by
removing the reference ``paragraphs (c) and (d) of this section'' and
adding in its place the reference ``paragraphs (c) and (h) of this
section''.
0
b. Revising paragraph (c)(22);
0
c. In paragraph (c)(26) removing the reference ``paragraph (d) of this
section'' and adding in its place the reference ``paragraph (h) of this
section'';
0
d. Redesignating paragraph (d) as paragraph (h) and adding a new
paragraph (d);
0
e. In newly designated paragraph (h)(1)(i) and (ii), removing the
reference ``paragraph (d)(15) of this section'' and adding in its place
the reference ``paragraph (h)(15) of this section''.
0
f. In newly designated paragraphs (h)(1)(i), (ii), (h)(4)(ii)(B),
(h)(5)(iii) introductory text, (h)(12), and (h)(15)(ii), removing the
reference ``paragraph (d)'' of this section and adding in its place the
reference ``paragraph (h)'' of this section.
0
g. In newly designated paragraphs (h)(2)(i), (ii), and (iii) removing
the reference ``paragraph (d)(3) of this section'' and adding in its
place the reference ``paragraph (h)(3) of this section''.
0
h. In newly designated paragraphs (h)(3)(i), removing the references
``paragraph (d)(2) of this section'' and adding in its place the
reference ``paragraph (h)(2)'' and removing the reference ``paragraph
(d)(3)(ii) of this section'' and adding in its place the reference
``paragraph (h)(3)(ii) of this section''.
0
i. In newly designated paragraph (h)(15)(ii), removing the reference
``paragraph (d)(15)(i) of this section'' and adding in its place
``paragraph (h)(15)(i) of this section''.
The revisions and additions read as follows:
Sec. 424.57 Special payment rules for items furnished by DMEPOS
suppliers and issuance of DMEPOS supplier billing privileges.
(a) * * *
Custom-fabricated orthotic means an item as listed in section
1861(s)(9) of the Act that meets all of the following:
(i) Is individually made for a specific patient.
(ii) Is constructed using one of the positive model techniques (as
defined in this paragraph).
(iii) Is made based on clinically derived and rectified castings,
tracings, measurements, and other images (such as x-rays) of the body
part and may involve the use of calculations, templates, and
components.
(iv) Is made using basic materials including, but not limited to
the following:
(A) Plastic.
(B) Metal.
(C) Leather or cloth in the form of uncut or unshaped sheets or
bars.
(D) Other basic forms and involves substantial work such as the
following:
(1) Vacuum forming.
(2) Cutting.
(3) Bending.
(4) Molding.
(5) Sewing.
(6) Drilling.
(7) Laminating.
* * * * *
Fabrication facility means the physical structure that--
(1) Meets the requirements in paragraph (d)(4) of this section; and
(2) Must be used by a qualified practitioner or a qualified
supplier to fabricate prosthetics or custom-fabricated orthotics that
are billed to and paid for by Medicare.
* * * * *
Occupational therapist means an individual who meets the personnel
qualifications for an occupational therapist as specified in Sec.
484.4 of this chapter.
Ocularist means a trained technician skilled in the arts of
fitting, shaping, and painting ocular prostheses who is certified by
the National Examining Board of Ocularist.
Orthotist means an individual who meets the personnel
qualifications for an orthotist as specified in Sec. 485.70(d) of this
chapter.
Pedorthist means an individual with specific training in footwear
which includes other pedorthic devices to solve problems in, or related
to, the foot.
* * * * *
Physical therapist means an individual who meets the personnel
qualifications for a physical therapist as specified in Sec. 484.4 of
this chapter.
[[Page 3693]]
Physician means an individual who meets the personnel
qualifications for a physician as specified in Sec. 484.4 of this
chapter.
Positive model of the patient means a particular type of custom
fabrication in which one of the following modeling techniques is used:
(i) Molded to the patient model as a negative impression of the
patient's body part and a positive model rectification are constructed.
(ii) Computer Aided Design-Computer Aided Manufacturing (CAD-CAM)
system.
(iii) Direct formed model.
Prosthetics means an item as described in section 1861(s)(9) of the
Act.
Prosthetist means an individual who meets the personnel
qualifications for a prosthetist as specified in Sec. 485.70(f) of
this chapter.
Qualified practitioner means one of the following eligible
professionals or other persons defined in paragraph (a) of this section
who meets the prosthetic and custom-fabricated orthotic requirements
specified in paragraph (d)(3) of this section:
(i) Occupational therapist.
(ii) Ocularist.
(iii) Orthotist.
(iv) Pedorthist.
(v) Physical therapist.
(vi) Physician.
(vii) Prosthetist.
Qualified supplier means a DMEPOS supplier as defined in paragraph
(a) of this section that is accredited by a CMS-approved accreditation
organization to fabricate prosthetics and custom-fabricated orthotics
as described in Sec. 424.58(c).
* * * * *
(c) * * *
(22)(i) DMEPOS supplier requirements. A DMEPOS supplier must be
accredited by a CMS-approved accreditation organization in order to
receive and retain a supplier billing number and to enroll in Medicare.
The accreditation must indicate the specific products and services for
which the DMEPOS supplier is accredited in order for the DMEPOS
supplier to receive payment for those specific products and services.
(ii) Requirements for DMEPOS suppliers fabricating or billing
prosthetics and custom-fabricated orthotics. Effective 1 year after the
posting of the final revised quality standards or the next
revalidation, whichever is later, a DMEPOS supplier fabricating or
billing for prosthetics or any of the custom-fabricated orthotics
identified on the list described in paragraph (d)(2) of this section
must do all of the following:
(A) Meet the requirements specified in paragraph (c)(22)(i) of this
section.
(B) Be accredited by a CMS-approved accreditation organization for
orthotics and prosthetics as described in Sec. 424.58(c). The
accreditation must indicate the specific products and services for
which the DMEPOS supplier is accredited in order for the qualified
supplier (as defined in Sec. 424.57(a)) to receive payment for the
prosthetics and specific custom-fabricated orthotics.
(C) Notify the AO of any change in conditions, practices, or
operations that were relied upon by the AO at the time of
accreditation. This would include, but not be limited to, a requirement
for notifying the AO of any changes in personnel, including changes in
status or qualifications of employees of the qualified supplier or of
any personnel utilized by the qualified supplier via contract or other
business relationship. This requirement is included to ensure that
qualified suppliers, once accredited, continue to meet all of the
accreditation and other supplier standards.
* * * * *
(d) Additional standards for qualified suppliers fabricating or
billing for prosthetics or custom-fabricated orthotics, or qualified
practitioners furnishing or fabricating prosthetics and custom-
fabricated orthotics.
(1) General rule. CMS makes payment for a bill or claim for a
prosthetic or custom-fabricated orthotic identified on the list in
paragraph (d)(2) of this section and meets all of the following:
(i) Furnished by a qualified practitioner.
(ii) Fabricated by a qualified practitioner or qualified supplier
at a fabrication facility as defined in paragraph (a) of this section.
(iii)(A) Billed by a qualified supplier; or
(B) Submitted as a claim by a Medicare beneficiary.
(2) List of prosthetics and custom-fabricated orthotics subject to
the additional standards. CMS maintains a list of prosthetics and
custom-fabricated orthotics subject to the requirements in this
section. The list is--
(i) Updated as necessary; and
(ii) Posted on the CMS Web site.
(3) Training, licensure, and certification requirements for
qualified practitioners. (i) A qualified practitioner who is not
enrolled in Medicare as a DMEPOS supplier must meet either of the
following licensure and certification requirements:
(A) Licensed in orthotics, pedorthics or prosthetics by all States
in which they practice.
(B) In States that do not provide licenses for orthotics,
pedorthics or prosthetics a qualified practitioner must be--
(1) Specifically trained and educated to provide and manage the
provision of pedorthics, prosthetics, and orthotics; and
(2) Certified by any of the following:
(i) ABC.
(ii) BOC.
(iii) A Secretary-approved organization that has standards
equivalent to the ABC or BOC.
(ii) Qualified practitioners must meet the licensure, training,
education and certification requirements specified in this section
within 1 year of publication of the final rule.
(4) Fabrication facility requirements. A fabrication facility at
which qualified suppliers and qualified practitioners fabricate
prosthetics and custom-fabricated orthotics, as defined in Sec.
424.57(a), must meet all of the following requirements:
(i) Be located within the United States or one of its territories.
(ii) Be a business that is organized, established and licensed
under applicable state and federal laws.
(iii) Have a process for maintenance and production of fabrication
records including the following:
(A) Job/work orders.
(B) Record tracking systems.
(C) Real time recordkeeping, for example, ensuring that records are
updated as the fabrication takes place.
(iv) Have a quality assurance process to identify non-standard
production outcomes, and improve fabrication outcomes.
(v) Have a periodic review and employee demonstration of
fabrication/safety/communication/operations competencies with
corrective action plans for staff that do not meet the minimal
standards.
(vi) Have full time appropriately credentialed staff member(s) who
are (qualified practitioners or qualified suppliers) onsite to
fabricate and to supervise fabrication.
(vii) Have a laboratory area with appropriate safety equipment (for
example, flammable material storage, gloves, safety glasses, proper
ventilation).
(viii) Have a separate waiting area and chairs with armrests, as
necessary.
(ix) Have a patient care and fitting rooms with appropriate levels
of privacy and sanitation. Patient fitting and care areas should be
separate from the fabrication area.
[[Page 3694]]
(x) Have disinfecting supplies, gloves, masks, and plastic for
containing contaminated materials.
(xi) Have a fabrication facility information system, paper or
digital, that can track the production, list component part number (and
serial number if available), quantity, that is linked to patient
information and be Health Insurance Portability and Accountability Act
compliant. Such a system must allow facility staff and management,
including those fabricating, to identify any parts that could be
recalled at a later date.
(xii) Have parallel bars, a full-length mirror, and other
appropriate assessment tools.
(xiii) Have a process using precautions to handle used patient
devices that are contaminated.
(xiv) Have repair and disinfecting areas clearly labeled.
(xv) Have the ability to handle all potentially hazardous materials
in facility properly.
(xvi) Have an emergency management plan and a safety management
plan.
(xvii) Have policy for detecting/reporting counterfeit supplies.
(xviii) Have the proper tools, equipment, and computers commonly
used in the fabrication of particular items and typically associated
with the particular technical approach (negative impression/positive
model, CAD-CAM, or direct formed), as applicable: These tools and
equipment would include, but are not limited to the following
(A) Computers with appropriate graphics/modeling capacity and
technology.
(B) Band saw.
(C) Disc sander.
(D) Sanding paper.
(E) Flexible shaft sander.
(F) Lathe.
(G) Drill press.
(H) Sewing machine.
(I) Grinding equipment.
(J) Paint-spraying equipment.
(K) Welding equipment.
(L) Alignment jig.
(M) Ovens capable of heating plastics for molding.
(N) Computer controlled milling machine.
(O) Lockable storage areas for raw materials and finished devices.
(P) Air compressor.
* * * * *
0
3. Section 424.58 is amended as follows:
0
a. Revising the section heading.
0
b. Redesignating paragraphs (c) through (e) as paragraphs (d) through
(f) respectively.
0
c. Adding a new paragraph (c).
The revision and addition read as follows:
Sec. 424.58 Requirements for DMEPOS accreditation organizations.
* * * * *
(c) Additional requirements for accrediting qualified suppliers. To
accredit qualified suppliers that fabricate or bill Medicare for
prosthetics and custom-fabricated orthotics as specified in Sec.
424.57(c)(22)(ii), an independent accreditation organization must be
one of the following:
(1) American Board for Certification in Orthotics and Prosthetics,
Incorporated (ABC).
(2) Board for Orthotist/Prosthetist Certification International,
Incorporated (BOC).
(3) An organization that--
(i) Employs or contracts with an orthotist, prosthetist,
occupational therapist or physical therapist who--
(A) Meets the definition of qualified practitioner specified in
Sec. 424.57(a); and
(B) Is utilized for the purpose of surveying the supplier or
practitioner for compliance; and
(ii) Has the authority granted by CMS to approve or deny the
accreditation of qualified suppliers as defined in Sec. 424.57(a)
based on a determination that the organization has standards equivalent
to the ABC or BOC.
* * * * *
0
4. Section Sec. 424.535 is amended as follows:
0
a. Revising the section heading.
0
b. In paragraph (a)(2) introductory text by removing the phrase ``the
provider or supplier is--'' and adding in its place ``the provider or
supplier is any of the following:''.
0
c. In paragraph (a)(2)(ii) by removing the phrase ``Is debarred,
suspended, or'' and adding in its place the phrase ``Debarred,
suspended or''.
0
d. Adding paragraph (a)(2)(iii).
The revision and addition reads as follows:
Sec. 424.535 Revocation of enrollment and billing privileges in the
Medicare program.
(a) * * *
(2) * * *
(iii) A qualified supplier as defined in Sec. 424.57(a) that
submitted a claim for payment for a prosthetic or custom-fabricated
orthotic that was not--
(A) Furnished by a qualified practitioner; and
(B) Fabricated by a qualified practitioner or qualified supplier as
defined in Sec. 424.57(a) at a fabrication facility as defined in
Sec. 424.57(a).
* * * * *
Dated: December 9, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Dated: December 22, 2016.
Sylvia M. Burwell
Secretary, Department of Health and Human Services.
[FR Doc. 2017-00425 Filed 1-11-17; 8:45 am]
BILLING CODE 4120-01-P