[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2599 Introduced in House (IH)]
<DOC>
115th CONGRESS
1st Session
H. R. 2599
To amend title XVIII of the Social Security Act to refine how Medicare
pays for orthotics and prosthetics and to improve beneficiary
experience and outcomes with orthotic and prosthetic care, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 23, 2017
Mr. Thompson of Pennsylvania (for himself and Mr. Thompson of
California) introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committee on
Ways and Means, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to refine how Medicare
pays for orthotics and prosthetics and to improve beneficiary
experience and outcomes with orthotic and prosthetic care, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Medicare Orthotics
and Prosthetics Improvement Act of 2017''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Modification of requirements applicable under Medicare to the
designation of accreditation organizations
for suppliers of orthotics and prosthetics.
Sec. 3. Application of existing accreditation and licensure
requirements to certain prosthetics and
custom-fabricated or custom-fitted
orthotics.
Sec. 4. Eligibility for Medicare payment for orthotics and prosthetics
based on supplier qualifications and
complexity of care.
Sec. 5. Orthotist's and prosthetist's clinical notes as part of the
patient's medical record.
Sec. 6. Distinguishing orthotists and prosthetists from suppliers of
durable medical equipment and supplies.
Sec. 7. Clarification about minimal self-adjustment for off-the-shelf
orthotics.
Sec. 8. Regulations.
SEC. 2. MODIFICATION OF REQUIREMENTS APPLICABLE UNDER MEDICARE TO THE
DESIGNATION OF ACCREDITATION ORGANIZATIONS FOR SUPPLIERS
OF ORTHOTICS AND PROSTHETICS.
(a) In General.--Section 1834(a)(20)(B) of the Social Security Act
(42 U.S.C. 1395m(a)(20)(B)) is amended--
(1) by striking ``organizations.--Not later than'' and
inserting: ``organizations.--
``(i) In general.--Subject to clause (ii),
not later than''; and
(2) by adding after clause (i), as added by paragraph (1),
the following new clauses:
``(ii) Special requirements for
accreditation of suppliers of orthotics and
prosthetics.--For purposes of applying quality
standards under subparagraph (A) for suppliers
(other than suppliers described in clause
(iii)) of items and services described in
subparagraph (D)(ii), the Secretary shall
designate and approve independent accreditation
organizations under clause (i) only if such
organizations are Boards or programs described
in subsection (h)(1)(F)(iv). Not later than
January 1, 2018, the Secretary shall ensure
that at least one, and ideally multiple,
independent accreditation organizations are
designated and approved in accordance with this
clause.
``(iii) Exception.--Suppliers described in
this clause are physicians, occupational
therapists, or physical therapists who are
licensed or otherwise regulated by the State in
which they are practicing and who receive
payment under this title, including regulations
promulgated pursuant to this subsection.''.
(b) Effective Date.--Each organization must satisfy the requirement
of section 1834(a)(20)(B)(ii), as added by subsection (a)(2), not later
than January 1, 2018, regardless of whether the organization is
designated or approved as an independent accreditation organization
before, on, or after the date of the enactment of this Act.
SEC. 3. APPLICATION OF EXISTING ACCREDITATION AND LICENSURE
REQUIREMENTS TO CERTAIN PROSTHETICS AND CUSTOM-FABRICATED
OR CUSTOM-FITTED ORTHOTICS.
(a) In General.--Section 1834(h)(1)(F) of the Social Security Act
(42 U.S.C. 1395m(h)(1)(F)) is amended--
(1) in the heading, by inserting ``or custom-fitted'' after
``custom-fabricated'';
(2) in clause (i), in the matter preceding subclause (I),
by striking ``an item of custom-fabricated orthotics described
in clause (ii) or for an item of prosthetics unless such item
is'' and inserting ``an item of orthotics or prosthetics,
including an item of custom-fabricated orthotics described in
clause (ii), unless such item is'';
(3) in clause (ii)(II), in the first sentence, by striking
``a list of items to which this subparagraph applies'' and
inserting ``a list of items for purposes of clause (i)'';
(4) in clause (iii)(III), by striking ``to provide or
manage the provision of prosthetics and custom-designed or -
fabricated orthotics'' and inserting ``to provide or manage the
provision of orthotics and prosthetics (and custom-designed or
-fabricated orthotics, in the case of an item described in
clause (ii))''; and
(5) by adding at the end the following new clause:
``(v) Exemption of off-the-shelf orthotics
included in a competitive acquisition
program.--This subparagraph shall not apply to
an item of orthotics described in paragraph
(2)(C) of section 1847(a) furnished on or after
January 1, 2018, that is included in a
competitive acquisition area under such
section.''.
(b) Effective Date.--The amendments made by subsection (a) shall
apply to orthotics and prosthetics furnished on or after January 1,
2018.
SEC. 4. ELIGIBILITY FOR MEDICARE PAYMENT FOR ORTHOTICS AND PROSTHETICS
BASED ON SUPPLIER QUALIFICATIONS AND COMPLEXITY OF CARE.
Section 1834(h) of the Social Security Act (42 U.S.C. 1395m(h)) is
amended--
(1) in paragraph (1)(F)(iii), in the matter preceding
subclause (I), by striking ``other individual who'' and
inserting ``other individual who, with respect to the provision
of orthotics and prosthetics furnished on or after January 1,
2018, and subject to paragraph (5)(A), satisfies all applicable
criteria of the provider qualification designation for such
orthotic or prosthetic, and who'';
(2) in paragraph (1)(F)(iv), by inserting before the period
the following: ``and, with respect to the provision of
orthotics and prosthetics furnished on or after January 1,
2018, and subject to paragraph (5)(A), satisfies all applicable
criteria of the provider qualification designation for such
orthotic or prosthetic''; and
(3) by adding at the end the following new paragraph:
``(5) Eligibility for payment based on supplier
qualifications and complexity of care.--
``(A) Considerations for eligibility for
payments.--
``(i) In general.--In applying clauses
(iii) and (iv) of paragraph (1)(F) for purposes
of determining whether payment may be made
under this subsection for orthotics and
prosthetics furnished on or after January 1,
2018, the Secretary shall take into account the
complexity of the respective item and, subject
to clauses (ii), (iii), and (iv), the
qualifications of the individual or entity
furnishing and fabricating such respective item
in accordance with this paragraph.
``(ii) Individuals and entities exempted
from supplier qualification criteria.--With
respect to the provision of orthotics or
prosthetics, any criteria for supplier
qualifications shall not apply to physicians,
occupational therapists, or physical therapists
who are licensed or otherwise regulated by the
State in which they are practicing and who
receive payment under this title, including
regulations promulgated pursuant to this
subsection, for the provision of orthotics and
prosthetics.
``(iii) Suppliers medicare-eligible prior
to january 1, 2018, exempted.--In the case of a
qualified supplier who is eligible to receive
payment under this title before January 1,
2018, with respect to the provision of
orthotics and prosthetics, any new criteria for
provider qualifications established after such
date shall not apply to such supplier, for the
furnishing or fabrication of such an item.
``(iv) Modifications.--The Secretary shall,
in consultation with the Boards and programs
described in paragraph (1)(F)(iv), periodically
review the criteria for supplier qualifications
and may implement by regulation any
modifications to such criteria, as determined
appropriate in accordance with such
consultation. Any such modifications shall take
effect no earlier than January 1, 2018.
``(B) Assignment of billing codes.--For purposes of
subparagraph (A), the Secretary, in consultation with
representatives of the fields of occupational therapy,
physical therapy, orthotics, and prosthetics, shall
utilize and incorporate the set of L-codes listed, as
of the date of enactment of this paragraph, in the
Centers for Medicare & Medicaid Services document
entitled `Transmittal 656' (CMS Pub. 100-04, Change
Request 3959, August 19, 2005). Transmittal 656 shall
be the controlling source of category, product, and
code assignments for the orthotics and prosthetics
care, using the supplier qualification designation for
each HCPCS code as stated in such document. In the case
that Transmittal 656 is updated, reissued, or replaced
by a subsequent document, the preceding sentence shall
be applied with respect to the most recent update,
reissuance, or replacement of such document.''.
SEC. 5. ORTHOTIST'S AND PROSTHETIST'S CLINICAL NOTES AS PART OF THE
PATIENT'S MEDICAL RECORD.
Section 1834(h) of the Social Security Act (42 U.S.C. 1395m(h)), as
amended by section 4, is amended by adding at the end the following new
paragraph:
``(6) Documentation created by orthotists and
prosthetists.--With respect to claims filed after the date of
the enactment of the Medicare Orthotics and Prosthetics
Improvement Act of 2017, for purposes of determining the
reasonableness, medical necessity, and functional level
(applicable to prosthetics) of orthotics and prosthetics,
documentation created by an orthotist or prosthetist shall be
considered part of the patient's medical record and, consistent
with the treatment of orthotic and prosthetic patient care
delivery stated in the health care professional exception
provided in clause (ii) of subsection (a)(20)(F), shall be
considered along with documentation created by other health
professionals, including physicians, nurse practitioners,
occupational therapists, and physical therapists.''.
SEC. 6. DISTINGUISHING ORTHOTISTS AND PROSTHETISTS FROM SUPPLIERS OF
DURABLE MEDICAL EQUIPMENT AND SUPPLIES.
(a) Requirements for Suppliers of Medical Equipment and Supplies.--
Section 1834(j)(5) of the Social Security Act (42 U.S.C. 1395m(j)(5))
is amended by striking subparagraph (C).
(b) Requirements for Orthotists and Prosthetists.--
(1) In general.--Section 1834 of the Social Security Act
(42 U.S.C. 1395m) is amended by adding at the end the following
new subsection:
``(v) Requirements for Orthotists and Prosthetists.--
``(1) Issuance and renewal of supplier number.--
``(A) Payment.--
``(i) In general.--No payment may be made
under this part to an orthotic or prosthetic
supplier unless such orthotic or prosthetic
supplier obtains (and renews at such intervals
as the Secretary may require) a supplier
number.
``(ii) Clarification regarding providers
under part a.--Nothing in clause (i) shall
prohibit a provider otherwise permitted to
receive payment for orthotics and prosthetics
under part A from continuing to receive payment
under such part without interruption.
``(B) Standards for possessing a supplier number.--
An orthotic or prosthetic supplier may only obtain a
supplier number if the supplier meets standards
prescribed by the Secretary that include requirements
that the orthotic or prosthetic supplier (and, where
applicable, the orthotist or prosthetist)--
``(i) licensure or accreditation--
``(I) complies with all applicable
State and Federal licensure and
regulatory requirements; or
``(II) acquires accreditation from
the American Board for Certification in
Orthotics, Prosthetics and Pedorthics,
Inc. (ABC) or the Board of
Certification/Accreditation,
International (BOC), or other
accreditation entity that the Secretary
determines has standards that are
essentially equivalent to the standards
of such Boards;
``(ii) maintains a physical facility on an
appropriate site;
``(iii) has proof of appropriate liability
insurance; and
``(iv) meets such other requirements as the
Secretary shall specify.
``(C) Prohibition against multiple supplier
numbers.--The Secretary may not issue more than one
supplier number to any orthotic or prosthetic supplier
unless the Secretary finds that the issuance of more
than one number is appropriate to identify other
entities under the ownership or control of the orthotic
or prosthetic supplier.
``(2) Order for orthotics or prosthetics.--
``(A) Information provided by orthotists and
prosthetists on detailed written orders for orthotics
and prosthetics.--An orthotist or prosthetist may
distribute to physicians, or to an individual enrolled
under this part, a detailed written order for orthotics
or prosthetics (as defined in paragraph (5)) for
commercial purposes that contains the following
information:
``(i) The identification of--
``(I) the orthotic or prosthetic
supplier; and
``(II) the individual to whom the
orthotics or prosthetics are furnished.
``(ii) The identification of the treating
physician, including the name, address, and
telephone number of the physician.
``(iii) A description of the orthotics or
prosthetics ordered.
``(iv) Any billing code identifying the
orthotics or prosthetics.
``(v) Diagnosis codes, a description of the
individual's medical and functional condition,
and information about the need for the
orthotics or prosthetics.
``(B) Information on coding and descriptors of
components provided.--If an orthotist or prosthetist
distributes a detailed written order for orthotics or
prosthetics described in subparagraph (A), the
orthotist or prosthetist shall also list on the order
the HCPCS codes and summary descriptors of the items
and services being recommended prior to submission of
the order to the treating physician for approval.
``(C) Signature by treating physician.--A detailed
written order for orthotics or prosthetics described in
subparagraph (A) shall be signed by the treating
physician.
``(3) Limitation on individual liability.--Except as
provided in paragraph (4), if an orthotist or prosthetist--
``(A) furnishes an orthosis or prosthesis to an
individual for which no payment may be made under this
part; or
``(B) subject to section 1879, furnishes an
orthosis or prosthesis to an individual for which
payment is denied under section 1862(a)(1),
any expenses incurred for the orthosis or prosthesis furnished
to an individual by the orthotist or prosthetist not on an
assigned basis shall be the responsibility of such orthotist or
prosthetist. The individual shall have no financial
responsibility for such expenses and the orthotist or
prosthetist shall refund on a timely basis to the individual
(and shall be liable to the individual for) any amounts
collected from the individual for such items and services. The
provisions of subsection (a)(18) shall apply to refunds
required under the previous sentence in the same manner as such
provisions apply to refunds under such subsection.
``(4) Individual liability.--If an orthotist or prosthetist
furnishes an orthosis or prosthesis to an individual for which
payment is denied in advance under subsection (a)(15), expenses
incurred for such orthosis or prosthesis furnished to the
individual by the orthotist or prosthetist shall be the
responsibility of the individual.
``(5) Definitions.--In this subsection:
``(A) Detailed written order for orthotics or
prosthetics.--
``(i) In general.--The term `detailed
written order for orthotics or prosthetics'
means a form or other document prepared by an
orthotist or prosthetist and signed by the
physician (as defined by section 1861(r)) that
contains information required by the Secretary
to be submitted to show that an orthosis or
prosthesis is reasonable and necessary for the
treatment of an illness or injury or to improve
the functioning of a malformed body member.
``(ii) Clarification.--The detailed written
work order for orthotics or prosthetic shall
not be considered alone for purposes of
determining the reasonableness, medical
necessity, and functional level (applicable to
prosthetics) of prosthetic devices and
orthotics.
``(B) Orthotics and prosthetics.--The term
`orthotics and prosthetics' has the meaning given that
term in section 1834(h)(4)(C).
``(C) Orthotist or prosthetist.--The term
`orthotist or prosthetist' means an individual who is
specifically trained and educated in the provision of,
and patient care management related to, prosthetics and
custom-fabricated or custom-fit orthotics, and--
``(i) in the case of a State that provides
for the licensing of orthotists and
prosthetists, is licensed by the State in which
the orthotics or prosthetics were supplied; or
``(ii) in the case of a State that does not
provide for the licensing of orthotists and
prosthetists, is certified by the American
Board of Certification in Orthotics,
Prosthetics and Pedorthics, Inc. or by the
Board of Certification/Accreditation,
International, or is certified and approved by
an entity that the Secretary determines has
certification and approval standards that are
essentially equivalent to the certification and
approval standards of such Boards.''.
(2) Impact on dmepos benefit.--The amendment made by
paragraph (1)--
(A) shall not be construed to create a separate
benefit category under title XVIII of the Social
Security Act for orthotic and prosthetic devices; but
(B) shall be construed as differentiating the
manner in which orthotic and prosthetic devices and
services are provided in contrast to other durable
medical equipment and supplies services covered under
such title.
(c) Definition of Orthotics and Prosthetics Synonymous With
Orthoses and Prostheses.--Section 1834(h)(4)(C) of the Social Security
Act (42 U.S.C. 1395m(h)(4)(C)) is amended by inserting ``(which may
also be referred to without distinction as `orthoses and prostheses')''
after ``the term `orthotics and prosthetics'''.
(d) Limitation of Competitive Acquisition for Off-the-Shelf
Orthotics.--Section 1847(a)(7)(A)(i) of the Social Security Act (42
U.S.C. 1395w-3(a)(7)(A)(i)) is amended--
(1) by inserting ``, orthotist or prosthetist (as defined
in section 1834(v)(5)(C)),'' after ``by a physician'';
(2) by inserting ``, orthotist's or prosthetist's,'' after
``to the physician's''; and
(3) by inserting ``, orthotist's or prosthetist's,'' after
``of the physician's''.
(e) Effective Date.--The amendments made by this section shall take
effect on the date of enactment of this Act, and apply to items and
services furnished on or after such date.
SEC. 7. CLARIFICATION ABOUT MINIMAL SELF-ADJUSTMENT FOR OFF-THE-SHELF
ORTHOTICS.
(a) In General.--Section 1847(a)(2)(C) of the Social Security Act
(42 U.S.C. 1395w-3(a)(2)(C)) is amended--
(1) by inserting ``furnished to a patient'' after ``section
1861(s)(9)'';
(2) by inserting ``by that patient (and not by any other
person)'' after ``minimal self-adjustment''; and
(3) by striking ``to fit to the individual'' and inserting
``to fit to that patient''.
(b) Inclusion in Medical and Other Health Services.--Section
1861(s)(9) of the Social Security Act (42 U.S.C. 1395x(s)(9)) is
amended--
(1) by striking ``leg, arm'' and inserting ``(A) leg,
arm'';
(2) in subparagraph (A), as added by paragraph (1), by
striking the semicolon at the end and inserting ``; and''; and
(3) by adding the following new subparagraph:
``(B) off-the-shelf orthotics (as defined in section
1847(a)(2)(C)).''.
(c) Effective Date.--The amendments made by this section shall take
effect on April 1, 2007, and apply to items and services furnished on
or after such date.
SEC. 8. REGULATIONS.
The Secretary shall promulgate--
(1) not later than 1 year after the enactment of this Act,
final regulations to implement the provisions of, and
amendments made by, this Act; and
(2) not later than 120 days after the enactment of this
Act, final regulations to implement the provisions of, and
amendments made by, section 427 of the Medicare, Medicaid, and
SCHIP Benefits Improvement and Protections Act of 2000, as
enacted into law by section 1(a)(6) of Public Law 106-554.
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