IIB 
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 Representa-
tives of the United States of America in Congress assembled, 
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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 INFU-
SION THERAPY 
SEC. 101. HOME INFUSION THERAPY SERVICES TEM-
PORARY TRANSITIONAL PAYMENT. 
(a) IN GENERAL.—Section 1834(u) of the Social Se-
curity Act (42 U.S.C. 1395m(u)) is amended, by adding 
at the end the following new paragraph: 
‘‘(7) HOME INFUSION THERAPY SERVICES TEM-
PORARY TRANSITIONAL PAYMENT.— 
‘‘(A) TEMPORARY
TRANSITIONAL
PAY-
MENT.— 
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‘‘(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 ther-
apy services temporary transitional pay-
ment under this part to an eligible home 
infusion supplier (as defined in subpara-
graph (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 transi-
tional home infusion drugs (as defined in 
clause (iii)). 
‘‘(ii) PERIOD
SPECIFIED.—For pur-
poses of clause (i), the period specified in 
this clause is the period beginning on Jan-
uary 1, 2019, and ending on the day be-
fore 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 in-
fusion drug’ has the meaning given to the 
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term ‘home infusion drug’ under section 
1861(iii)(3)(C)), except that clause (ii) of 
such section shall not apply if a drug de-
scribed in such clause is identified in 
clauses (i), (ii), (iii) or (iv) of subpara-
graph (C) as of the date of the enactment 
of this paragraph. 
‘‘(B) PAYMENT METHODOLOGY.—For pur-
poses of this paragraph, the Secretary shall es-
tablish 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 cat-
egories 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 
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each infusion drug administration calendar 
day in the individual’s home for drugs as-
signed 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 De-
termination on External Infusion Pumps 
(LCD number L33794) and billed with the 
following HCPCS codes (as identified as of 
July 1, 2017, and as subsequently modi-
fied 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 de-
termination and billed with the following 
HCPCS codes (as identified as of July 1, 
2017, and as subsequently modified by the 
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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 de-
termination 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 OTHER-
WISE INCLUDED.—With respect to drugs 
that are not included in payment category 
1, 2, or 3 under clause (i), (ii), or (iii), re-
spectively, the Secretary shall assign to the 
most appropriate of such categories, as de-
termined by the Secretary, drugs which 
are— 
‘‘(I) covered under such local cov-
erage determination and billed under 
HCPCS codes J7799 or J7999 (as 
identified as of July 1, 2017, and as 
subsequently modified by the Sec-
retary); or 
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‘‘(II) billed under any code that 
is implemented after the date of the 
enactment of this paragraph and in-
cluded in such local coverage deter-
mination or included in subregulatory 
guidance as a home infusion drug de-
scribed in subparagraph (A)(i). 
‘‘(D) PAYMENT AMOUNTS.— 
‘‘(i) IN
GENERAL.—Under the pay-
ment methodology, the Secretary shall pay 
eligible home infusion suppliers, with re-
spect 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 with-
out application of the geographic adjust-
ment under subsection (e) of such section. 
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‘‘(ii) PAYMENT
AMOUNT
FOR
CAT-
EGORY 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 subse-
quently modified by the Secretary). 
‘‘(iii) PAYMENT
AMOUNT
FOR
CAT-
EGORY 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 subse-
quently modified by the Secretary). 
‘‘(iv) PAYMENT
AMOUNT
FOR
CAT-
EGORY 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 
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identified as of July 1, 2017, and as subse-
quently 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 eligi-
ble home infusion supplier, to payment to 
such supplier for an infusion drug adminis-
tration calendar day in the individual’s 
home shall refer to payment only for the 
date on which professional services (as de-
scribed 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 adminis-
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tration calendar day in an individual’s 
home, furnishes to such individual transi-
tional home infusion drugs which are not 
all assigned to the same payment category 
under subparagraph (C), payment to such 
supplier for such infusion drug administra-
tion 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 fur-
nished to such individual during such cal-
endar day, for which the highest payment 
would be made under this paragraph. 
‘‘(F) ELIGIBLE
HOME
INFUSION
SUP-
PLIERS.—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 admin-
istered. 
‘‘(G) IMPLEMENTATION.—Notwithstanding 
any other provision of law, the Secretary may 
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implement this paragraph by program instruc-
tion 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 pe-
riod 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 infu-
sion 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 Medi-
care Part B Improvement Act of 2017 is on or 
before September 30, 2017, for the period be-
ginning on October 1, 2017, and ending on De-
cember 31, 2020; and 
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