Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012
PL 112-242 (H.R.1845), enacted 01/10/2013

126 STAT. 2374 
PUBLIC LAW 112–242—JAN. 10, 2013 
Public Law 112–242 
112th Congress 
An Act 
To provide a demonstration project providing Medicare coverage for in-home adminis-
tration 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 Representatives of 
the United States of America in Congress assembled, 
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 
DEMONSTRATION 
PROJECT. 
(a) ESTABLISHMENT.—The Secretary shall establish and imple-
ment a demonstration project under part B of title XVIII of the 
Social Security Act to evaluate the benefits of providing payment 
for items and services needed for the in-home administration of 
intravenous immune globin for the treatment of primary immune 
deficiency diseases. 
(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 disease for participation in the demonstra-
tion project. A Medicare beneficiary may participate in the 
demonstration project on a voluntary basis and may terminate 
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 Security Act in the same manner 
as similar items and services covered under such part. 
(d) PAYMENT.—The Secretary shall establish a per visit pay-
ment amount for items and services needed for the in-home adminis-
tration of intravenous immune globin based on the national per 
visit low-utilization payment amount under the prospective pay-
ment system for home health services established under section 
1895 of the Social Security Act (42 U.S.C. 1395fff). 
Effective date. 
Time period. 
42 USC 1395l 
note. 
Medicare IVIG 
Access and 
Strengthening 
Medicare and 
Repaying 
Taxpayers 
Act of 2012. 
42 USC 1305 
note. 
Jan. 10, 2013 
[H.R. 1845] 
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126 STAT. 2375 
PUBLIC LAW 112–242—JAN. 10, 2013 
(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 impact of the demonstration project on access 
for Medicare beneficiaries to items and services needed for 
the in-home administration of intravenous immune globin. 
(2) FINAL EVALUATION AND REPORT.—Not later than one 
year after the date of completion of the demonstration project, 
the Secretary shall submit to Congress a report that contains 
the following: 
(A) A final evaluation of the impact of the demonstra-
tion project on access for Medicare beneficiaries to items 
and services needed for the in-home administration of intra-
venous immune 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 Social Security Act (42 U.S.C. 1395k et seq.). 
(C) An update to the report entitled ‘‘Analysis of 
Supply, Distribution, Demand, and Access Issues Associ-
ated 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. 
(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 Medical Insurance Trust Fund 
under section 1841 of the Social 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 bene-
ficiary’’ 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 PROGRAM 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: 
‘‘(vii) USE OF WEBSITE TO DETERMINE FINAL CONDI-
TIONAL REIMBURSEMENT AMOUNT.— 
‘‘(I) NOTICE TO SECRETARY OF EXPECTED DATE 
OF A SETTLEMENT, JUDGMENT, ETC.—In the case 
of a payment made by the Secretary pursuant 
to clause (i) for items and services provided to 
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126 STAT. 2376 
PUBLIC LAW 112–242—JAN. 10, 2013 
the claimant, the claimant or applicable plan (as 
defined in paragraph (8)(F)) may at any time 
beginning 120 days before the reasonably expected 
date of a settlement, 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 
Secretary shall maintain and make available to 
individuals to whom items and services are fur-
nished under this title (and to authorized family 
or other representatives recognized under regula-
tions 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, judgment, award, or other payment. 
Such access shall be provided to an individual, 
representative, or plan through a website that 
requires a password to gain access to the informa-
tion. The Secretary shall update the information 
on claims and payments on such website in as 
timely a manner as possible but not later than 
15 days after the date that payment is made. 
Information related to claims and payments sub-
ject to the notice under subclause (I) shall be main-
tained and made available consistent with the fol-
lowing: 
‘‘(aa) The information shall be as complete 
as possible and shall include provider or sup-
plier name, diagnosis codes (if any), dates of 
service, and conditional payment amounts. 
‘‘(bb) The information accurately identifies 
those claims and payments that are related 
to a potential settlement, judgment, award, 
or other payment to which the provisions of 
this subsection apply. 
‘‘(cc) The website provides a method for 
the receipt of secure electronic communica-
tions with the individual, representative, or 
plan involved. 
‘‘(dd) The website provides that informa-
tion is transmitted from the website in a form 
that includes an official time and date that 
the information is transmitted. 
‘‘(ee) The website shall permit the indi-
vidual, representative, or plan to download a 
statement of reimbursement amounts (in this 
clause referred to as a ‘statement of reimburse-
ment 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 CONDITIONAL AMOUNT.—If an individual 
Deadline. 
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126 STAT. 2377 
PUBLIC LAW 112–242—JAN. 10, 2013 
(or other claimant or applicable plan with the con-
sent of the individual) obtains a statement of 
reimbursement amount from the website during 
the protected period as defined in subclause (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 con-
stitute the final conditional amount subject to 
recovery under clause (ii) related to such settle-
ment, judgment, award, or other payment. 
‘‘(IV) RESOLUTION OF DISCREPANCIES.—If the 
individual (or authorized representative) believes 
there is a discrepancy with the statement of 
reimbursement amount, the Secretary shall pro-
vide a timely process to resolve the discrepancy. 
Under such process the individual (or representa-
tive) must provide documentation explaining the 
discrepancy and a proposal to resolve such discrep-
ancy. 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 determines 
within such period that there is not a reasonable 
basis to include or remove claims on the statement 
of reimbursement, the proposal shall be rejected. 
If the Secretary determines within such period 
that there is a reasonable basis to conclude there 
is a discrepancy, the Secretary must respond in 
a timely manner by agreeing to the proposal to 
resolve the discrepancy or by providing documenta-
tion showing with good cause why the Secretary 
is not agreeing to such proposal 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 settlement, judgment, award or other payment 
relating to an injury or incident, the portion (if 
any) of the period beginning on the date of notice 
under subclause (I) with respect to such settle-
ment, 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 period shall be 
a period of 65 days, except that such period may 
Definition. 
Time period. 
Proposal. 
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126 STAT. 2378 
PUBLIC LAW 112–242—JAN. 10, 2013 
be extended by the Secretary for a period of an 
additional 30 days if the Secretary determines that 
additional time is required to address claims for 
which payment has been made. Such Secretarial 
response period shall be extended and shall not 
include any days for any part of which the Sec-
retary determines (in accordance with regulations) 
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 excep-
tional circumstances in a manner so that not more 
than 1 percent of the repayment obligations under 
this subclause would qualify as exceptional cir-
cumstances. 
‘‘(VI) EFFECTIVE
DATE.—The Secretary shall 
promulgate final regulations to carry out this 
clause not later than 9 months after the date of 
the enactment of this clause. 
‘‘(VII) WEBSITE INCLUDING SUCCESSOR TECH-
NOLOGY.—In this clause, the term ‘website’ 
includes any successor technology. 
‘‘(viii) RIGHT
OF
APPEAL
FOR
SECONDARY
PAYER 
DETERMINATIONS
RELATING
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 seeking to recover conditional pay-
ments from an applicable plan (as defined in paragraph 
(8)(F)) that is a primary plan under subsection (A)(ii), 
under which the applicable plan involved, or an 
attorney, agent, or third party administrator on behalf 
of such plan, may appeal such determination. The indi-
vidual furnished such an item or service shall be noti-
fied 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 Security Act 
(42 U.S.C. 1395y(b)) is amended— 
(1) in paragraph (2)(B)(ii), by striking ‘‘A primary 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 paragraph (2)(B) and 
any reporting required by paragraph (8) shall not apply 
with respect to any settlement, judgment, award, or other 
payment by an applicable plan arising from liability insur-
ance (including self-insurance) and from alleged physical 
trauma-based 
incidents 
(excluding 
alleged 
ingestion, 
implantation, or exposure cases) constituting a total pay-
ment 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 THRESHOLD.— 
Notification. 
Regulations. 
Definition. 
Regulations. 
Deadline. 
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126 STAT. 2379 
PUBLIC LAW 112–242—JAN. 10, 2013 
‘‘(i) IN
GENERAL.—Not later than November 15 
before each year, the Secretary shall calculate and 
publish a single threshold amount for settlements, 
judgments, awards, or other payments for obligations 
arising from liability insurance (including self-insur-
ance) 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 Medicare trust funds of collections of conditional 
payments from such settlements, judgments, awards, 
or other payments arising from liability insurance 
(including 
self-insurance) 
and 
for 
such 
alleged 
incidents subject to this section shall equal the esti-
mated cost of collection incurred by the United States 
(including payments made to contractors) for a condi-
tional 
payment 
arising 
from 
liability 
insurance 
(including 
self-insurance) 
and 
for 
such 
alleged 
incidents subject to this section for the year. At the 
time of calculating, but before publishing, the single 
threshold amount for a year, the Secretary shall 
inform, and seek review of, the Comptroller General 
of the United States with regard to such amount. 
‘‘(ii) PUBLICATION.—The Secretary shall include, as 
part of such publication for a year— 
‘‘(I) the estimated cost of collection incurred 
by the United States (including payments made 
to contractors) for a conditional payment arising 
from liability insurance (including self-insurance) 
and for such alleged incidents; and 
‘‘(II) a summary of the methodology and data 
used by the Secretary in computing such threshold 
amount and such cost of collection. 
‘‘(C) EXCLUSION OF ONGOING EXPENSES.—For purposes 
of this paragraph and with respect to a settlement, judg-
ment, award, or other payment not otherwise addressed 
in clause (ii) of paragraph (2)(B) that includes ongoing 
responsibility for medical payments (excluding settlements, 
judgments, awards, or other payments made by a workers’ 
compensation 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 payments made under this title. 
‘‘(D) REPORT TO CONGRESS.—Not later than November 
15 before each year, the Secretary shall submit to the 
Congress a report on the single threshold amount for settle-
ments, judgments, awards, or other payments for condi-
tional payment obligations arising from liability insurance 
(including self-insurance) and alleged incidents described 
in subparagraph (A) for that year and on the establishment 
and application of similar thresholds for such payments 
for conditional payment obligations arising from worker 
compensation cases and from no fault insurance cases sub-
ject to this section for the year. For each such report, 
the Secretary shall— 
Review. 
Deadlines. 
Publication. 
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126 STAT. 2380 
PUBLIC LAW 112–242—JAN. 10, 2013 
‘‘(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 methodology and 
data used in calculating each threshold amount and 
the amount of estimated 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 of up to $1,000 for each day of noncompli-
ance with respect to each claimant.’’; and 
(2) by adding at the end the following new subparagraph: 
‘‘(I) REGULATIONS.—Not later than 60 days after the 
date of the enactment of this subparagraph, the Secretary 
shall publish a notice in the Federal Register soliciting 
proposals, which will be accepted during a 60-day period, 
for the specification of practices for which sanctions will 
and will not be imposed under subparagraph (E), including 
not imposing sanctions for good faith efforts to identify 
a beneficiary pursuant to this paragraph under an 
applicable entity responsible for reporting information. 
After considering the proposals so submitted, 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.’’. 
SEC. 204. USE OF SOCIAL SECURITY NUMBERS AND OTHER IDENTI-
FYING 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 enactment 
of this sentence, the Secretary shall modify the reporting 
requirements under this paragraph so that an applicable 
plan in complying with such requirements is permitted 
but not required to access or report to the Secretary bene-
ficiary social security account numbers or health identifica-
tion claim numbers, except that the deadline for such modi-
fication shall be extended by one or more periods (specified 
by the Secretary) of up to 1 year each if the Secretary 
notifies the committees of jurisdiction of the House of Rep-
resentatives 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 exten-
sion notice shall include information on the progress being 
Deadline. 
Time period. 
Notification. 
Deadline. 
Notice. 
Federal Register, 
publications. 
Time period. 
42 USC 1395y 
note. 
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126 STAT. 2381 
PUBLIC LAW 112–242—JAN. 10, 2013 
LEGISLATIVE HISTORY—H.R. 1845: 
CONGRESSIONAL RECORD, Vol. 158 (2012): 
Dec. 19, considered and passed House. 
Dec. 21, considered and passed Senate. 
made in implementing such modification and the antici-
pated implementation date for such modification.’’. 
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. 
Approved January 10, 2013. 
Applicability. 
42 USC 1395y 
note. 
Deadline. 
Notification. 
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