II 
112TH CONGRESS 
2D SESSION 
H. R. 1845 
IN THE SENATE OF THE UNITED STATES 
DECEMBER 20, 2012 
Received 
AN ACT 
To provide a demonstration project providing Medicare cov-
erage for in-home administration of intravenous immune 
globulin (IVIG) and to amend title XVIII of the Social 
Security Act with respect to the application of Medicare 
secondary payer rules for certain claims. 
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. 
This Act may be cited as the ‘‘Medicare IVIG Access 
and Strengthening Medicare and Repaying Taxpayers Act 
of 2012’’. 
TITLE I—MEDICARE IVIG 
ACCESS 
SEC. 101. MEDICARE PATIENT IVIG ACCESS DEMONSTRA-
TION PROJECT. 
(a) ESTABLISHMENT.—The Secretary shall establish 
and implement a demonstration project under part B of 
title XVIII of the Social Security Act to evaluate the bene-
fits of providing payment for items and services needed 
for the in-home administration of intravenous immune 
globin for the treatment of primary immune deficiency dis-
eases. 
(b) DURATION AND SCOPE.— 
(1) DURATION.—Beginning not later than one 
year after the date of enactment of this Act, the 
Secretary shall conduct the demonstration project 
for a period of 3 years. 
(2) SCOPE.—The Secretary shall enroll not 
more than 4,000 Medicare beneficiaries who have 
been diagnosed with primary immunodeficiency dis-
ease for participation in the demonstration project. 
A Medicare beneficiary may participate in the dem-
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onstration project on a voluntary basis and may ter-
minate participation at any time. 
(c) COVERAGE.—Except as otherwise provided in this 
section, items and services for which payment may be 
made under the demonstration program shall be treated 
and covered under part B of title XVIII of the Social Se-
curity Act in the same manner as similar items and serv-
ices covered under such part. 
(d) PAYMENT.—The Secretary shall establish a per 
visit payment amount for items and services needed for 
the in-home administration of intravenous immune globin 
based on the national per visit low-utilization payment 
amount under the prospective payment system for home 
health services established under section 1895 of the So-
cial Security Act (42 U.S.C. 1395fff). 
(e) WAIVER AUTHORITY.—The Secretary may waive 
such requirements of title XVIII of the Social Security Act 
as may be necessary to carry out the demonstration 
project. 
(f) STUDY AND REPORT TO CONGRESS.— 
(1) INTERIM EVALUATION AND REPORT.—Not 
later than three years after the date of enactment of 
this Act, the Secretary shall submit to Congress a 
report that contains an interim evaluation of the im-
pact of the demonstration project on access for 
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Medicare beneficiaries to items and services needed 
for the in-home administration of intravenous im-
mune globin. 
(2) FINAL
EVALUATION
AND
REPORT.—Not 
later than one year after the date of completion of 
the demonstration project, the Secretary shall sub-
mit to Congress a report that contains the following: 
(A) A final evaluation of the impact of the 
demonstration project on access for Medicare 
beneficiaries to items and services needed for 
the in-home administration of intravenous im-
mune globin. 
(B) An analysis of the appropriateness of 
implementing a new methodology for payment 
for intravenous immune globulins in all care 
settings under part B of title XVIII of the So-
cial Security Act (42 U.S.C. 1395k et seq.). 
(C) An update to the report entitled 
‘‘Analysis of Supply, Distribution, Demand, and 
Access Issues Associated with Immune Globulin 
Intravenous (IGIV)’’, issued in February 2007 
by the Office of the Assistant Secretary for 
Planning and Evaluation of the Department of 
Health and Human Services. 
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(g) FUNDING.—There shall be made available to the 
Secretary to carry out the demonstration project not more 
than $45,000,000 from the Federal Supplementary Med-
ical Insurance Trust Fund under section 1841 of the So-
cial Security Act (42 U.S.C. 1395t). 
(h) DEFINITIONS.—In this section: 
(1) DEMONSTRATION
PROJECT.—The term 
‘‘demonstration project’’ means the demonstration 
project conducted under this section. 
(2) 
MEDICARE
BENEFICIARY.—The 
term 
‘‘Medicare beneficiary’’ means an individual who is 
enrolled for benefits under part B of title XVIII of 
the Social Security Act. 
(3) SECRETARY.—The term ‘‘Secretary’’ means 
the Secretary of Health and Human Services. 
TITLE 
II—STRENGTHENING 
MEDICARE 
SECONDARY 
PAYER RULES 
SEC. 201. DETERMINATION OF REIMBURSEMENT AMOUNT 
THROUGH CMS WEBSITE TO IMPROVE PRO-
GRAM EFFICIENCY. 
Section 1862(b)(2)(B) of the Social Security Act (42 
U.S.C. 1395y(b)(2)(B)) is amended by adding at the end 
the following new clause: 
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‘‘(vii) USE OF WEBSITE TO DETER-
MINE
FINAL
CONDITIONAL
REIMBURSE-
MENT AMOUNT.— 
‘‘(I) NOTICE TO SECRETARY OF 
EXPECTED DATE OF A SETTLEMENT, 
JUDGMENT, ETC.—In the case of a 
payment made by the Secretary pur-
suant to clause (i) for items and serv-
ices provided to the claimant, the 
claimant or applicable plan (as de-
fined in paragraph (8)(F)) may at 
any time beginning 120 days before 
the reasonably expected date of a set-
tlement, judgment, award, or other 
payment, notify the Secretary that a 
payment is reasonably expected and 
the expected date of such payment. 
‘‘(II) SECRETARIAL
PROVIDING 
ACCESS
TO
CLAIMS
INFORMATION 
THROUGH
A
WEBSITE.—The Sec-
retary shall maintain and make avail-
able to individuals to whom items and 
services are furnished under this title 
(and to authorized family or other 
representatives recognized under regu-
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lations and to an applicable plan 
which has obtained the consent of the 
individual) access to information on 
the claims for such items and services 
(including payment amounts for such 
claims), including those claims that 
relate to a potential settlement, judg-
ment, award, or other payment . Such 
access shall be provided to an indi-
vidual, representative, or plan through 
a website that requires a password to 
gain access to the information. The 
Secretary shall update the information 
on claims and payments on such 
website in as timely a manner as pos-
sible but not later than 15 days after 
the date that payment is made. Infor-
mation related to claims and pay-
ments subject to the notice under sub-
clause (I) shall be maintained and 
made available consistent with the fol-
lowing: 
‘‘(aa) The information shall 
be as complete as possible and 
shall include provider or supplier 
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this clause referred to as a ‘state-
ment of reimbursement amount’) 
on payments for claims under 
this title relating to a potential 
settlement, judgment, award, or 
other payment. 
‘‘(III) USE
OF
TIMELY
WEB 
DOWNLOAD AS BASIS FOR FINAL CON-
DITIONAL AMOUNT.—If an individual 
(or other claimant or applicable plan 
with the consent of the individual) ob-
tains a statement of reimbursement 
amount from the website during the 
protected period as defined in sub-
clause (V) and the related settlement, 
judgment, award or other payment is 
made during such period, then the 
last 
statement 
of 
reimbursement 
amount that is downloaded during 
such period and within 3 business 
days before the date of the settlement, 
judgment, award, or other payment 
shall constitute the final conditional 
amount subject to recovery under 
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clause (ii) related to such settlement, 
judgment, award, or other payment. 
‘‘(IV) RESOLUTION OF DISCREP-
ANCIES.—If the individual (or author-
ized representative) believes there is a 
discrepancy with the statement of re-
imbursement amount, the Secretary 
shall provide a timely process to re-
solve the discrepancy. Under such 
process the individual (or representa-
tive) must provide documentation ex-
plaining the discrepancy and a pro-
posal to resolve such discrepancy. 
Within 11 business days after the 
date of receipt of such documentation, 
the Secretary shall determine whether 
there is a reasonable basis to include 
or remove claims on the statement of 
reimbursement. If the Secretary does 
not make such determination within 
the 11 business-day period, then the 
proposal to resolve the discrepancy 
shall be accepted. If the Secretary de-
termines within such period that there 
is not a reasonable basis to include or 
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remove claims on the statement of re-
imbursement, the proposal shall be re-
jected. If the Secretary determines 
within such period that there is a rea-
sonable basis to conclude there is a 
discrepancy, the Secretary must re-
spond in a timely manner by agreeing 
to the proposal to resolve the discrep-
ancy or by providing documentation 
showing with good cause why the Sec-
retary is not agreeing to such pro-
posal and establishing an alternate 
discrepancy resolution. In no case 
shall the process under this subclause 
be treated as an appeals process or as 
establishing a right of appeal for a 
statement of reimbursement amount 
and there shall be no administrative 
or judicial review of the Secretary’s 
determinations under this subclause. 
‘‘(V) PROTECTED
PERIOD.—In 
subclause (III), the term ‘protected 
period’ means, with respect to a set-
tlement, judgment, award or other 
payment relating to an injury or inci-
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dent, the portion (if any) of the period 
beginning on the date of notice under 
subclause (I) with respect to such set-
tlement, judgment, award, or other 
payment that is after the end of a 
Secretarial response period beginning 
on the date of such notice to the Sec-
retary. Such Secretarial response pe-
riod shall be a period of 65 days, ex-
cept that such period may be extended 
by the Secretary for a period of an 
additional 30 days if the Secretary de-
termines that additional time is re-
quired to address claims for which 
payment has been made. Such Secre-
tarial response period shall be ex-
tended and shall not include any days 
for any part of which the Secretary 
determines (in accordance with regu-
lations) that there was a failure in the 
claims and payment posting system 
and the failure was justified due to 
exceptional circumstances (as defined 
in such regulations). Such regulations 
shall define exceptional circumstances 
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in a manner so that not more than 1 
percent of the repayment obligations 
under this subclause would qualify as 
exceptional circumstances. 
‘‘(VI) EFFECTIVE
DATE.—The 
Secretary shall promulgate final regu-
lations to carry out this clause not 
later than 9 months after the date of 
the enactment of this clause. 
‘‘(VII) WEBSITE INCLUDING SUC-
CESSOR
TECHNOLOGY.—In 
this 
clause, the term ‘website’ includes any 
successor technology. 
‘‘(viii) RIGHT OF APPEAL FOR SEC-
ONDARY PAYER DETERMINATIONS RELAT-
ING TO LIABILITY INSURANCE (INCLUDING 
SELF-INSURANCE), NO FAULT INSURANCE, 
AND WORKERS’ COMPENSATION LAWS AND 
PLANS.—The Secretary shall promulgate 
regulations establishing a right of appeal 
and appeals process, with respect to any 
determination under this subsection for a 
payment made under this title for an item 
or service for which the Secretary is seek-
ing to recover conditional payments from 
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an applicable plan (as defined in para-
graph (8)(F)) that is a primary plan under 
subsection (A)(ii), under which the applica-
ble plan involved, or an attorney, agent, or 
third party administrator on behalf of such 
plan, may appeal such determination. The 
individual furnished such an item or serv-
ice shall be notified of the plan’s intent to 
appeal such determination’’. 
SEC. 202. FISCAL EFFICIENCY AND REVENUE NEUTRALITY. 
(a) IN GENERAL.—Section 1862(b) of the Social Se-
curity Act (42 U.S.C. 1395y(b)) is amended— 
(1) in paragraph (2)(B)(ii), by striking ‘‘A pri-
mary plan’’ and inserting ‘‘Subject to paragraph (9), 
a primary plan’’; and 
(2) by adding at the end the following new 
paragraph: 
‘‘(9) EXCEPTION.— 
‘‘(A) IN GENERAL.—Clause (ii) of para-
graph (2)(B) and any reporting required by 
paragraph (8) shall not apply with respect to 
any settlement, judgment, award, or other pay-
ment by an applicable plan arising from liability 
insurance (including self-insurance) and from 
alleged physical trauma-based incidents (exclud-
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ing alleged ingestion, implantation, or exposure 
cases) constituting a total payment obligation 
to a claimant of not more than the single 
threshold amount calculated by the Secretary 
under subparagraph (B) for the year involved. 
‘‘(B) ANNUAL COMPUTATION OF THRESH-
OLD.— 
‘‘(i) IN
GENERAL.—Not later than 
November 15 before each year, the Sec-
retary shall calculate and publish a single 
threshold amount for settlements, judg-
ments, awards, or other payments for obli-
gations arising from liability insurance (in-
cluding self-insurance) and for alleged 
physical trauma-based incidents (excluding 
alleged ingestion, implantation, or exposure 
cases) subject to this section for that year. 
The annual single threshold amount for a 
year shall be set such that the estimated 
average amount to be credited to the Medi-
care trust funds of collections of condi-
tional payments from such settlements, 
judgments, awards, or other payments 
arising from liability insurance (including 
self-insurance) and for such alleged inci-
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in computing such threshold amount 
and such cost of collection. 
‘‘(C) 
EXCLUSION
OF
ONGOING
EX-
PENSES.—For purposes of this paragraph and 
with respect to a settlement, judgment, award, 
or other payment not otherwise addressed in 
clause (ii) of paragraph (2)(B) that includes on-
going responsibility for medical payments (ex-
cluding settlements, judgments, awards, or 
other payments made by a workers’ compensa-
tion law or plan or no fault insurance), the 
amount utilized for calculation of the threshold 
described in subparagraph (A) shall include 
only the cumulative value of the medical pay-
ments made under this title. 
‘‘(D) REPORT
TO
CONGRESS.—Not later 
than November 15 before each year, the Sec-
retary shall submit to the Congress a report on 
the single threshold amount for settlements, 
judgments, awards, or other payments for con-
ditional payment obligations arising from liabil-
ity insurance (including self-insurance) and al-
leged incidents described in subparagraph (A) 
for that year and on the establishment and ap-
plication of similar thresholds for such pay-
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ments for conditional payment obligations aris-
ing from worker compensation cases and from 
no fault insurance cases subject to this section 
for the year. For each such report, the Sec-
retary shall— 
‘‘(i) calculate the threshold amount by 
using the methodology applicable to certain 
liability claims described in subparagraph 
(B); and 
‘‘(ii) include a summary of the meth-
odology and data used in calculating each 
threshold amount and the amount of esti-
mated savings under this title achieved by 
the Secretary implementing each such 
threshold.’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to years beginning with 2014. 
SEC. 203. REPORTING REQUIREMENT. 
Section 1862(b)(8) of the Social Security Act (42 
U.S.C. 1395y(b)(8)) is amended— 
(1) in the first sentence of subparagraph (E)(i), 
by striking ‘‘shall be subject’’ and all that follows 
through the end of the sentence and inserting the 
following: ‘‘may be subject to a civil money penalty 
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of up to $1,000 for each day of noncompliance with 
respect to each claimant.’’; and 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(I) REGULATIONS.—Not later than 60 
days after the date of the enactment of this 
subparagraph, the Secretary shall publish a no-
tice in the Federal Register soliciting proposals, 
which will be accepted during a 60-day period, 
for the specification of practices for which sanc-
tions will and will not be imposed under sub-
paragraph (E), including not imposing sanc-
tions for good faith efforts to identify a bene-
ficiary pursuant to this paragraph under an ap-
plicable entity responsible for reporting infor-
mation. After considering the proposals so sub-
mitted, the Secretary, in consultation with the 
Attorney General, shall publish in the Federal 
Register, including a 60-day period for com-
ment, proposed specified practices for which 
such sanctions will and will not be imposed. 
After considering any public comments received 
during such period, the Secretary shall issue 
final rules specifying such practices.’’. 
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SEC. 204. USE OF SOCIAL SECURITY NUMBERS AND OTHER 
IDENTIFYING INFORMATION IN REPORTING. 
Section 1862(b)(8)(B) of the Social Security Act (42 
U.S.C. 1395y(b)(8)(B)) is amended by adding at the end 
(after and below clause (ii)) the following: 
‘‘Not later than 18 months after the date of en-
actment of this sentence, the Secretary shall 
modify the reporting requirements under this 
paragraph so that an applicable plan in com-
plying with such requirements is permitted but 
not required to access or report to the Sec-
retary beneficiary social security account num-
bers or health identification claim numbers, ex-
cept that the deadline for such modification 
shall be extended by one or more periods (speci-
fied by the Secretary) of up to 1 year each if 
the Secretary notifies the committees of juris-
diction of the House of Representatives and of 
the Senate that the prior deadline for such 
modification, without such extension, threatens 
patient privacy or the integrity of the secondary 
payer program under this subsection. Any such 
deadline extension notice shall include informa-
tion on the progress being made in imple-
menting such modification and the anticipated 
implementation date for such modification.’’. 
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SEC. 205. STATUTE OF LIMITATIONS. 
(a) IN GENERAL.—Section 1862(b)(2)(B)(iii) of the 
Social Security Act (42 U.S.C. 1395y(b)(2)(B)(iii)) is 
amended by adding at the end the following new sentence: 
‘‘An action may not be brought by the United States 
under this clause with respect to payment owed unless the 
complaint is filed not later than 3 years after the date 
of the receipt of notice of a settlement, judgment, award, 
or other payment made pursuant to paragraph (8) relating 
to such payment owed.’’. 
(b) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall apply with respect to actions brought 
and penalties sought on or after 6 months after the date 
of the enactment of this Act. 
Passed the House of Representatives December 19, 
2012. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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