[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3178 Referred in Senate (RFS)]
<DOC>
115th CONGRESS
1st Session
H. R. 3178
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 26, 2017
Received; read twice and referred to the Committee on Finance
_______________________________________________________________________
AN ACT
To amend title XVIII of the Social Security Act to improve the delivery
of home infusion therapy and dialysis and the application of the Stark
rule under the Medicare program, 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 Part B
Improvement Act of 2017''.
(b) Table of Contents.--The table of contents of this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--IMPROVEMENTS IN PROVISION OF HOME INFUSION THERAPY
Sec. 101. Home infusion therapy services temporary transitional
payment.
Sec. 102. Extension of Medicare Patient IVIG Access Demonstration
Project.
Sec. 103. Orthotist's and prosthetist's clinical notes as part of the
patient's medical record.
TITLE II--IMPROVEMENTS IN DIALYSIS SERVICES
Sec. 201. Independent accreditation for dialysis facilities and
assurance of high quality surveys.
Sec. 202. Expanding access to home dialysis therapy.
TITLE III--IMPROVEMENTS IN APPLICATION OF STARK RULE
Sec. 301. Modernizing the application of the Stark rule under Medicare.
Sec. 302. Funds from the Medicare Improvement Fund.
TITLE I--IMPROVEMENTS IN PROVISION OF HOME INFUSION THERAPY
SEC. 101. HOME INFUSION THERAPY SERVICES TEMPORARY TRANSITIONAL
PAYMENT.
(a) In General.--Section 1834(u) of the Social Security Act (42
U.S.C. 1395m(u)) is amended, by adding at the end the following new
paragraph:
``(7) Home infusion therapy services temporary transitional
payment.--
``(A) Temporary transitional payment.--
``(i) In general.--The Secretary shall, in
accordance with the payment methodology
described in subparagraph (B) and subject to
the provisions of this paragraph, provide a
home infusion therapy services temporary
transitional payment under this part to an
eligible home infusion supplier (as defined in
subparagraph (F)) for items and services
described in subparagraphs (A) and (B) of
section 1861(iii)(2)) furnished during the
period specified in clause (ii) by such
supplier in coordination with the furnishing of
transitional home infusion drugs (as defined in
clause (iii)).
``(ii) Period specified.--For purposes of
clause (i), the period specified in this clause
is the period beginning on January 1, 2019, and
ending on the day before the date of the
implementation of the payment system under
paragraph (1)(A).
``(iii) Transitional home infusion drug
defined.--For purposes of this paragraph, the
term `transitional home infusion drug' has the
meaning given to the term `home infusion drug'
under section 1861(iii)(3)(C)), except that
clause (ii) of such section shall not apply if
a drug described in such clause is identified
in clauses (i), (ii), (iii) or (iv) of
subparagraph (C) as of the date of the
enactment of this paragraph.
``(B) Payment methodology.--For purposes of this
paragraph, the Secretary shall establish a payment
methodology, with respect to items and services
described in subparagraph (A)(i). Under such payment
methodology the Secretary shall--
``(i) create the three payment categories
described in clauses (i), (ii), and (iii) of
subparagraph (C);
``(ii) assign drugs to such categories, in
accordance with such clauses;
``(iii) assign appropriate Healthcare
Common Procedure Coding System (HCPCS) codes to
each payment category; and
``(iv) establish a single payment amount
for each such payment category, in accordance
with subparagraph (D), for each infusion drug
administration calendar day in the individual's
home for drugs assigned to such category.
``(C) Payment categories.--
``(i) Payment category 1.--The Secretary
shall create a payment category 1 and assign to
such category drugs which are covered under the
Local Coverage Determination on External
Infusion Pumps (LCD number L33794) and billed
with the following HCPCS codes (as identified
as of July 1, 2017, and as subsequently
modified by the Secretary): J0133, J0285,
J0287, J0288, J0289, J0895, J1170, J1250,
J1265, J1325, J1455, J1457, J1570, J2175,
J2260, J2270, J2274, J2278, J3010, or J3285.
``(ii) Payment category 2.--The Secretary
shall create a payment category 2 and assign to
such category drugs which are covered under
such local coverage determination and billed
with the following HCPCS codes (as identified
as of July 1, 2017, and as subsequently
modified by the Secretary): J1559 JB, J1561 JB,
J1562 JB, J1569 JB, or J1575 JB.
``(iii) Payment category 3.--The Secretary
shall create a payment category 3 and assign to
such category drugs which are covered under
such local coverage determination and billed
with the following HCPCS codes (as identified
as of July 1, 2017, and as subsequently
modified by the Secretary): J9000, J9039,
J9040, J9065, J9100, J9190, J9200, J9360, or
J9370.
``(iv) Infusion drugs not otherwise
included.--With respect to drugs that are not
included in payment category 1, 2, or 3 under
clause (i), (ii), or (iii), respectively, the
Secretary shall assign to the most appropriate
of such categories, as determined by the
Secretary, drugs which are--
``(I) covered under such local
coverage determination and billed under
HCPCS codes J7799 or J7999 (as
identified as of July 1, 2017, and as
subsequently modified by the
Secretary); or
``(II) billed under any code that
is implemented after the date of the
enactment of this paragraph and
included in such local coverage
determination or included in
subregulatory guidance as a home
infusion drug described in subparagraph
(A)(i).
``(D) Payment amounts.--
``(i) In general.--Under the payment
methodology, the Secretary shall pay eligible
home infusion suppliers, with respect to items
and services described in subparagraph (A)(i)
furnished during the period described in
subparagraph (A)(ii) by such supplier to an
individual, at amounts equal to the amounts
determined under the physician fee schedule
established under section 1848 for services
furnished during the year for codes and units
of such codes described in clauses (ii), (iii),
and (iv) with respect to drugs included in the
payment category under subparagraph (C)
specified in the respective clause, determined
without application of the geographic
adjustment under subsection (e) of such
section.
``(ii) Payment amount for category 1.--For
purposes of clause (i), the codes and units
described in this clause, with respect to drugs
included in payment category 1 described in
subparagraph (C)(i), are one unit of HCPCS code
96365 plus four units of HCPCS code 96366 (as
identified as of July 1, 2017, and as
subsequently modified by the Secretary).
``(iii) Payment amount for category 2.--For
purposes of clause (i), the codes and units
described in this clause, with respect to drugs
included in payment category 2 described in
subparagraph (C)(i), are one unit of HCPCS code
96369 plus four units of HCPCS code 96370 (as
identified as of July 1, 2017, and as
subsequently modified by the Secretary).
``(iv) Payment amount for category 3.--For
purposes of clause (i), the codes and units
described in this clause, with respect to drugs
included in payment category 3 described in
subparagraph (C)(i), are one unit of HCPCS code
96413 plus four units of HCPCS code 96415 (as
identified as of July 1, 2017, and as
subsequently modified by the Secretary).
``(E) Clarifications.--
``(i) Infusion drug administration day.--
For purposes of this subsection, a reference,
with respect to the furnishing of transitional
home infusion drugs or home infusion drugs to
an individual by an eligible home infusion
supplier, to payment to such supplier for an
infusion drug administration calendar day in
the individual's home shall refer to payment
only for the date on which professional
services (as described in section
1861(iii)(2)(A)) were furnished to administer
such drugs to such individual. For purposes of
the previous sentence, an infusion drug
administration calendar day shall include all
such drugs administered to such individual on
such day.
``(ii) Treatment of multiple drugs
administered on same infusion drug
administration day.--In the case that an
eligible home infusion supplier, with respect
to an infusion drug administration calendar day
in an individual's home, furnishes to such
individual transitional home infusion drugs
which are not all assigned to the same payment
category under subparagraph (C), payment to
such supplier for such infusion drug
administration calendar day in the individual's
home shall be a single payment equal to the
amount of payment under this paragraph for the
drug, among all such drugs so furnished to such
individual during such calendar day, for which
the highest payment would be made under this
paragraph.
``(F) Eligible home infusion suppliers.--In this
paragraph, the term `eligible home infusion supplier'
means a supplier that is enrolled under this part as a
pharmacy that provides external infusion pumps and
external infusion pump supplies and that maintains all
pharmacy licensure requirements in the State in which
the applicable infusion drugs are administered.
``(G) Implementation.--Notwithstanding any other
provision of law, the Secretary may implement this
paragraph by program instruction or otherwise.''.
(b) Conforming Amendment.--Section 1842(b)(6)(I) of the Social
Security Act (42 U.S.C. 1395u(b)(6)(I)) is amended by inserting ``or,
in the case of items and services described in clause (i) of section
1834(u)(7)(A) furnished to an individual during the period described in
clause (ii) of such section, payment shall be made to the eligible home
infusion therapy supplier'' after ``payment shall be made to the
qualified home infusion therapy supplier''.
SEC. 102. EXTENSION OF MEDICARE PATIENT IVIG ACCESS DEMONSTRATION
PROJECT.
Section 101(b) of the Medicare IVIG Access and Strengthening
Medicare and Repaying Taxpayers Act of 2012 (42 U.S.C. 1395l note) is
amended--
(1) in paragraph (1), by inserting after ``for a period of
3 years'' the following: ``and, subject to the availability of
funds under subsection (g)--
``(A) if the date of enactment of the Medicare Part
B Improvement Act of 2017 is on or before September 30,
2017, for the period beginning on October 1, 2017, and
ending on December 31, 2020; and
``(B) if the date of enactment of such Act is after
September 30, 2017, for the period beginning on the
date of enactment of such Act and ending on December
31, 2020''''; and
(2) in paragraph (2), by adding at the end the following
new sentences: ``Subject to the preceding sentence, a Medicare
beneficiary enrolled in the demonstration project on September
30, 2017, shall be automatically enrolled during the period
beginning on the date of the enactment of the Medicare Part B
Improvement Act of 2017 and ending on December 31, 2020,
without submission of another application. Chapter 35 of title
44, United States Code, shall not apply to any application form
used for a Medicare beneficiary who enrolls in the
demonstration project on or after such date of enactment.''.
SEC. 103. 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)) is
amended by adding at the end the following new paragraph:
``(5) Documentation created by orthotists and
prosthetists.--For purposes of determining the reasonableness
and medical necessity of orthotics and prosthetics,
documentation created by an orthotist or prosthetist shall be
considered part of the individual's medical record to support
documentation created by eligible professionals described in
section 1848(k)(3)(B).''.
TITLE II--IMPROVEMENTS IN DIALYSIS SERVICES
SEC. 201. INDEPENDENT ACCREDITATION FOR DIALYSIS FACILITIES AND
ASSURANCE OF HIGH QUALITY SURVEYS.
(a) Accreditation and Surveys.--
(1) In general.--Section 1865 of the Social Security Act
(42 U.S.C. 1395bb) is amended--
(A) in subsection (a)--
(i) in paragraph (1), in the matter
preceding subparagraph (A), by striking ``or
the conditions and requirements under section
1881(b)''; and
(ii) in paragraph (4), by inserting
``(including a renal dialysis facility)'' after
``facility''; and
(B) by adding at the end the following new
subsection:
``(e) With respect to an accreditation body that has received
approval from the Secretary under subsection (a)(3)(A) for
accreditation of provider entities that are required to meet the
conditions and requirements under section 1881(b), in addition to
review and oversight authorities otherwise applicable under this title,
the Secretary shall (as the Secretary determines appropriate) conduct,
with respect to such accreditation body and provider entities, any or
all of the following as frequently as is otherwise required to be
conducted under this title with respect to other accreditation bodies
or other provider entities:
``(1) Validation surveys referred to in subsection (d).
``(2) Accreditation program reviews (as defined in section
488.8(c) of title 42 of the Code of Federal Regulations, or a
successor regulation).
``(3) Performance reviews (as defined in section 488.8(a)
of title 42 of the Code of Federal Regulations, or a successor
regulation).''.
(2) Timing for acceptance of requests from accreditation
organizations.--Not later than 90 days after the date of
enactment of this Act, the Secretary of Health and Human
Services shall begin accepting requests from national
accreditation bodies for a finding described in section
1865(a)(3)(A) of the Social Security Act (42 U.S.C.
1395bb(a)(3)(A)) for purposes of accrediting provider entities
that are required to meet the conditions and requirements under
section 1881(b) of such Act (42 U.S.C. 1395rr(b)).
(b) Requirement for Timing of Surveys of New Dialysis Facilities.--
Section 1881(b)(1) of the Social Security Act (42 U.S.C. 1395rr(b)(1))
is amended by adding at the end the following new sentence: ``Beginning
180 days after the date of the enactment of this sentence, an initial
survey of a provider of services or a renal dialysis facility to
determine if the conditions and requirements under this paragraph are
met shall be initiated not later than 90 days after such date on which
both the provider enrollment form (without regard to whether such form
is submitted prior to or after such date of enactment) has been
determined by the Secretary to be complete and the provider's
enrollment status indicates approval is pending the results of such
survey.''.
SEC. 202. EXPANDING ACCESS TO HOME DIALYSIS THERAPY.
(a) Allowing Use of Telehealth for Monthly End Stage Renal Disease-
Related Visits.--
(1) In general.--Paragraph (3) of section 1881(b) of the
Social Security Act (42 U.S.C. 1395rr(b)) is amended--
(A) by redesignating subparagraphs (A) and (B) as
clauses (i) and (ii), respectively;
(B) in clause (i), as redesignated by subparagraph
(A), by striking ``under this subparagraph'' and
inserting ``under this clause'';
(C) in clause (ii), as redesignated by subparagraph
(A), by inserting ``subject to subparagraph (B),''
before ``on a comprehensive'';
(D) by striking ``With respect to'' and inserting
``(A) With respect to''; and
(E) by adding at the end the following new
subparagraph:
``(B)(i) Subject to clause (ii), an individual who is determined to
have end stage renal disease and who is receiving home dialysis may
choose to receive monthly end stage renal disease-related visits,
furnished on or after January 1, 2019, via telehealth.
``(ii) Clause (i) shall apply to an individual only if the
individual receives a face-to-face visit, without the use of
telehealth--
``(I) in the case of the initial 3 months of home dialysis
of such individual, at least monthly; and
``(II) after such initial 3 months, at least once every 3
consecutive months.''.
(2) Conforming amendment.--Paragraph (1) of such section is
amended by striking ``paragraph (3)(A)'' and inserting
``paragraph (3)(A)(i)''.
(b) Expanding Originating Sites for Telehealth To Include Renal
Dialysis Facilities and the Home for Purposes of Monthly End Stage
Renal Disease-Related Visits.--
(1) In general.--Section 1834(m) of the Social Security Act
(42 U.S.C. 1395m(m)) is amended--
(A) in paragraph (4)(C)(ii), by adding at the end
the following new subclauses:
``(IX) A renal dialysis facility,
but only for purposes of section
1881(b)(3)(B).
``(X) The home of an individual,
but only for purposes of section
1881(b)(3)(B).''; and
(B) by adding at the end the following new
paragraph:
``(5) Treatment of home dialysis monthly esrd-related
visit.--The geographic requirements described in paragraph
(4)(C)(i) shall not apply with respect to telehealth services
furnished on or after January 1, 2019, for purposes of section
1881(b)(3)(B), at an originating site described in subclause
(VI), (IX), or (X) of paragraph (4)(C)(ii)), subject to
applicable State law requirements, including State licensure
requirements.''.
(2) No facility fee if originating site for home dialysis
therapy is the home.--Section 1834(m)(2)(B) of the Social
Security (42 U.S.C. 1395m(m)(2)(B)) is amended--
(A) by redesignating clauses (i) and (ii) as
subclauses (I) and (II), respectively, and by indenting
each of such subclauses 2 ems to the right;
(B) in subclause (II), as redesignated by
subparagraph (A), by striking ``clause (i) or this
clause'' and inserting ``subclause (I) or this
subclause'';
(C) by striking ``site.--With respect to'' and
inserting ``site.--
``(i) In general.--Subject to clause (ii),
with respect to''; and
(D) by adding at the end the following new clause:
``(ii) No facility fee if originating site
for home dialysis therapy is the home.--No
facility fee shall be paid under this
subparagraph to an originating site described
in subclause (X) of paragraph (4)(C)(ii).''.
(c) Clarification Regarding Telehealth Provided to Beneficiaries.--
Section 1128A(i)(6) of the Social Security Act (42 U.S.C. 1320a-
7a(i)(6)) is amended--
(1) in subparagraph (H), by striking ``; or'' and inserting
a semicolon;
(2) in subparagraph (I), by striking the period at the end
and inserting ``; or''; and
(3) by adding at the end the following new subparagraph:
``(J) the provision of telehealth technologies on
or after January 1, 2019, to individuals with end stage
renal disease under title XVIII by a health care
provider for the purpose of furnishing of
telehealth.''.
(d) Study and Report on Further Expansion.--
(1) Study.--The Comptroller General of the United States
shall conduct a study to examine the feasibility, benefits, and
drawbacks of expanding the use of telehealth and store-and-
forward technologies under the Medicare program under title
XVIII of the Social Security Act for items and services
included in renal dialysis services, as such term is defined in
section 1881(b)(14)(B) of such Act (42 U.S.C.
1395rr(b)(14)(B)).
(2) Report.--Not later than 2 years after the date of the
enactment of this Act, the Comptroller General shall submit to
Congress a report on the results of the study conducted under
paragraph (1).
TITLE III--IMPROVEMENTS IN APPLICATION OF STARK RULE
SEC. 301. MODERNIZING THE APPLICATION OF THE STARK RULE UNDER MEDICARE.
(a) Clarification of the Writing Requirement and Signature
Requirement for Arrangements Pursuant to the Stark Rule.--
(1) Writing requirement.--Section 1877(h)(1) of the Social
Security Act (42 U.S.C. 1395nn(h)(1)) is amended by adding at
the end the following new subparagraph:
``(D) Written requirement clarified.--In the case of any
requirement pursuant to this section for a compensation
arrangement to be in writing, such requirement shall be
satisfied by such means as determined by the Secretary,
including by a collection of documents, including
contemporaneous documents evidencing the course of conduct
between the parties involved.''.
(2) Signature requirement.--Section 1877(h)(1) of the
Social Security Act (42 U.S.C. 1395nn(h)(1)), as amended by
paragraph (1), is further amended by adding at the end the
following new subparagraph:
``(E) Special rule for signature requirements.--In
the case of any requirement pursuant to this section
for a compensation arrangement to be in writing and
signed by the parties, such signature requirement shall
be met if--
``(i) not later than 90 consecutive
calendar days immediately following the date on
which the compensation arrangement became
noncompliant, the parties obtain the required
signatures; and
``(ii) the compensation arrangement
otherwise complies with all criteria of the
applicable exception.''.
(b) Indefinite Holdover for Lease Arrangements and Personal
Services Arrangements Pursuant to the Stark Rule.--Section 1877(e) of
the Social Security Act (42 U.S.C. 1395nn(e)) is amended--
(1) in paragraph (1), by adding at the end the following
new subparagraph:
``(C) Holdover lease arrangements.--In the case of
a holdover lease arrangement for the lease of office
space or equipment, which immediately follows a lease
arrangement described in subparagraph (A) for the use
of such office space or subparagraph (B) for the use of
such equipment and that expired after a term of at
least 1 year, payments made by the lessee to the lessor
pursuant to such holdover lease arrangement, if--
``(i) the lease arrangement met the
conditions of subparagraph (A) for the lease of
office space or subparagraph (B) for the use of
equipment when the arrangement expired;
``(ii) the holdover lease arrangement is on
the same terms and conditions as the
immediately preceding arrangement; and
``(iii) the holdover arrangement continues
to satisfy the conditions of subparagraph (A)
for the lease of office space or subparagraph
(B) for the use of equipment.''; and
(2) in paragraph (3), by adding at the end the following
new subparagraph:
``(C) Holdover personal service arrangement.--In
the case of a holdover personal service arrangement,
which immediately follows an arrangement described in
subparagraph (A) that expired after a term of at least
1 year, remuneration from an entity pursuant to such
holdover personal service arrangement, if--
``(i) the personal service arrangement met
the conditions of subparagraph (A) when the
arrangement expired;
``(ii) the holdover personal service
arrangement is on the same terms and conditions
as the immediately preceding arrangement; and
``(iii) the holdover arrangement continues
to satisfy the conditions of subparagraph
(A).''.
SEC. 302. FUNDS FROM THE MEDICARE IMPROVEMENT FUND.
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)) is amended by striking ``during and after fiscal year
2021, $270,000,000'' and inserting ``during and after fiscal year 2021,
$245,000,000''.
Passed the House of Representatives July 25, 2017.
Attest:
KAREN L. HAAS,
Clerk.