1.This Act may be cited as the
Medicare IVIG Access and Strengthening
Medicare and Repaying Taxpayers Act of 2012
.
<enum>I</enum><header>Medicare IVIG
Access</header>
<section id="H6F2C22FC329C481994E51EF93E78B718"><enum>101.</enum><header>Medicare
patient IVIG access demonstration project</header>
<subsection id="H26DBABC6632B4848B1C46A0AAA8CE8CC"><enum>(a)</enum><header>Establishment</header><text>The
Secretary shall establish and implement 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.</text>
</subsection><subsection id="H5543B1B595C0405D993C4339DCEE04F3"><enum>(b)</enum><header>Duration and
scope</header>
<paragraph id="HC70D80784B24493696861F617C91C550"><enum>(1)</enum><header>Duration</header><text>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.</text>
</paragraph><paragraph id="H38DEF57C0C82426BBB5B488402C25A40"><enum>(2)</enum><header>Scope</header><text>The
Secretary shall enroll not more than 4,000 Medicare beneficiaries who have been
diagnosed with primary immunodeficiency disease for participation in the
demonstration project. A Medicare beneficiary may participate in the
demonstration project on a voluntary basis and may terminate participation at
any time.</text>
</paragraph></subsection><subsection id="HD3762A8B9CAF472FA56F92779FCC7CFA"><enum>(c)</enum><header>Coverage</header><text display-inline="yes-display-inline">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.</text>
</subsection><subsection id="HCC490CD3A8AE420097292208E37AA3C0"><enum>(d)</enum><header>Payment</header><text display-inline="yes-display-inline">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 Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395fff">42 U.S.C.
1395fff</external-xref>).</text>
</subsection><subsection id="H5B514D7766A84DEEAA99CF586E33ADCF"><enum>(e)</enum><header>Waiver
authority</header><text>The Secretary may waive such requirements of title
XVIII of the Social Security Act as may be necessary to carry out the
demonstration project.</text>
</subsection><subsection id="HA26046EAE64946E891B945A2BE48EC45"><enum>(f)</enum><header>Study and report
to Congress</header>
<paragraph id="H6DBBE82997E04E60822D2849B1593F73"><enum>(1)</enum><header>Interim
evaluation and report</header><text>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.</text>
</paragraph><paragraph id="HEE7CD00550884C7B9336D329913163AD"><enum>(2)</enum><header>Final evaluation
and report</header><text>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:</text>
<subparagraph id="H27BD1318A9A449D189BC7C2E709F9E19"><enum>(A)</enum><text>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
immune globin.</text>
</subparagraph><subparagraph id="H48CCEECCB5C94280A53428D5D2CC6E2F"><enum>(B)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/42/1395k">42
U.S.C. 1395k et seq.</external-xref>).</text>
</subparagraph><subparagraph id="H988CFFF954BF4F6A8623121380AC1089"><enum>(C)</enum><text>An update to the
report entitled <quote>Analysis of Supply, Distribution, Demand, and Access
Issues Associated with Immune Globulin Intravenous (IGIV)</quote>, issued in
February 2007 by the Office of the Assistant Secretary for Planning and
Evaluation of the Department of Health and Human Services.</text>
</subparagraph></paragraph></subsection><subsection id="H3691B67D099347C3B47E7D561CCEA8A1"><enum>(g)</enum><header>Funding</header><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/42/1395t">42 U.S.C.
1395t</external-xref>).</text>
</subsection><subsection id="H2B922E67C8E44A1EBCCF90F538469703"><enum>(h)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="H97A8472E4ACE49FDAD823589D4D8AE17"><enum>(1)</enum><header>Demonstration
project</header><text>The term <term>demonstration project</term> means the
demonstration project conducted under this section.</text>
</paragraph><paragraph id="H777C70C566214158BCFA3A2AEBB4315F"><enum>(2)</enum><header>Medicare
beneficiary</header><text>The term <term>Medicare beneficiary</term> means an
individual who is enrolled for benefits under part B of title XVIII of the
Social Security Act.</text>
</paragraph><paragraph id="HA264BC79CF274632AD0EC84574DCFF90"><enum>(3)</enum><header>Secretary</header><text>The
term <term>Secretary</term> means the Secretary of Health and Human
Services.</text>
</paragraph></subsection></section><enum>II</enum><header>Strengthening
Medicare Secondary Payer Rules </header>
<section id="H016B12CCDEF34427AC858DE551BA6711"><enum>201.</enum><header>Determination
of reimbursement amount through CMS website to improve program
efficiency</header><text display-inline="no-display-inline">Section
1862(b)(2)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C. 1395y(b)(2)(B)</external-xref>) is
amended by adding at the end the following new clause:</text>
<quoted-block id="HB2F3E9FF950E408B9A3351665BBCE71D" style="OLC">
<clause id="H05985601A4264758B9B05176C2C8CC90"><enum>(vii)</enum><header>Use of website
to determine final conditional reimbursement amount</header>
<subclause id="H65A89D34711A42739A7C4A0C976A604C"><enum>(I)</enum><header>Notice to
Secretary of expected date of a settlement, judgment, etc</header><text display-inline="yes-display-inline">In the case of a payment made by the
Secretary pursuant to clause (i) for items and services provided to 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.</text>
</subclause><subclause id="H8E7EBB8B36364435B0170FCEB0D07996"><enum>(II)</enum><header>Secretarial
providing access to claims information through a website</header><text display-inline="yes-display-inline">The Secretary shall maintain and make
available to individuals to whom items and services are furnished under this
title (and to authorized family or other representatives recognized under
regulations 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 information. 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 subject to the notice under
subclause (I) shall be maintained and made available consistent with the
following:</text>
<item id="H59377F6E73C849CF93A721488E89AFB2"><enum>(aa)</enum><text>The
information shall be as complete as possible and shall include provider or
supplier name, diagnosis codes (if any), dates of service, and conditional
payment amounts.</text>
</item><item id="H41273BFF6D1C463BA360CDC98615DEF9"><enum>(bb)</enum><text display-inline="yes-display-inline">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.</text>
</item><item id="HB97D14388EE6439D9A238794FF619D38"><enum>(cc)</enum><text>The
website provides a method for the receipt of secure electronic communications
with the individual, representative, or plan involved.</text>
</item><item id="H39A3613CA33748F387E6B37208B1B5EA"><enum>(dd)</enum><text>The
website provides that information is transmitted from the website in a form
that includes an official time and date that the information is
transmitted.</text>
</item><item id="HD6FC66B0C7AE48948C5CE920079627CC"><enum>(ee)</enum><text display-inline="yes-display-inline">The website shall permit the individual,
representative, or plan to download a statement of reimbursement amounts (in
this clause referred to as a <quote>statement of reimbursement amount</quote>)
on payments for claims under this title relating to a potential settlement,
judgment, award, or other payment.</text>
</item></subclause><subclause id="HC156BF497EDE420BBB86051968EC8524"><enum>(III)</enum><header>Use of timely
web download as basis for final conditional amount</header><text display-inline="yes-display-inline">If
an individual (or other claimant or applicable plan with the consent 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 constitute the final conditional amount subject to recovery
under clause (ii) related to such settlement, judgment, award, or other
payment.</text>
</subclause><subclause id="H6043F2FDF1BD4FB4A223392F03530E6A"><enum>(IV)</enum><header>Resolution of
discrepancies</header><text display-inline="yes-display-inline">If the
individual (or authorized representative) believes there is a discrepancy with
the statement of reimbursement amount, the Secretary shall provide a timely
process to resolve the discrepancy. Under such process the individual (or
representative) must provide documentation explaining the discrepancy and a
proposal 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 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 documentation 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.</text>
</subclause><subclause id="HB6CE93B198D54378819211DF83F2AAA2"><enum>(V)</enum><header>Protected
period</header><text display-inline="yes-display-inline">In subclause (III),
the term <quote>protected period</quote> 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 settlement, judgment, award, or other payment that is after the
end of a Secretarial response period beginning on the date of such notice to
the Secretary. Such Secretarial response period shall be a period of 65 days,
except that such period may 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 Secretary 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 exceptional circumstances in a manner so that not more
than 1 percent of the repayment obligations under this subclause would qualify
as exceptional circumstances.</text>
</subclause><subclause id="H6C9B9178622E42539986D5519FC360AA"><enum>(VI)</enum><header>Effective
date</header><text display-inline="yes-display-inline">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.</text>
</subclause><subclause commented="no" id="H43AF24D600AC4FA09D76DF0A486E9D31"><enum>(VII)</enum><header>Website
including successor technology</header><text>In this clause, the term
<quote>website</quote> includes any successor technology.</text>
</subclause></clause><clause id="H31A4F067DDEC4B8D8E7A2CC2DF9FD8E1"><enum>(viii)</enum><header>Right of
appeal for secondary payer determinations relating to liability insurance
(including self-insurance), no fault insurance, and workers' compensation laws
and plans</header><text display-inline="yes-display-inline">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 payments 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 individual furnished such an item
or service shall be notified of the plan’s intent to appeal such
determination</text>
</clause><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="H021FC2A37FCE43E782877A0DBBE137BC"><enum>202.</enum><header>Fiscal
efficiency and revenue neutrality</header>
<subsection id="HAA9694B145F4485E820BF0FFCE46C93D"><enum>(a)</enum><header>In
general</header><text>Section 1862(b) of the Social Security Act
(<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C.
1395y(b)</external-xref>) is amended—</text>
<paragraph id="H748D1D95F5C546BC8D8424F39701769E"><enum>(1)</enum><text>in paragraph
(2)(B)(ii), by striking <quote>A primary plan</quote> and inserting
<quote>Subject to paragraph (9), a primary plan</quote>; and</text>
</paragraph><paragraph id="H42C835504BDB49448574569331085485"><enum>(2)</enum><text>by adding at the
end the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="H68A4462D41374174957D93D086B374A2" style="OLC">
<paragraph id="H97615623BD214C74BD80CD281A84AAFD"><enum>(9)</enum><header>Exception</header>
<subparagraph commented="no" id="HA481C14DF8FD4381A26F9D9AEC572938"><enum>(A)</enum><header>In
general</header><text display-inline="yes-display-inline">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 insurance (including self-insurance) and
from alleged physical trauma-based incidents (excluding 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.</text>
</subparagraph><subparagraph commented="no" id="H653E4C5629974DB1BBA08EDE9F2DD55C"><enum>(B)</enum><header>Annual
computation of threshold</header>
<clause id="HE0FB610BBF94409DAF700B78E35F307C"><enum>(i)</enum><header>In
general</header><text>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-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 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 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 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.</text>
</clause><clause id="H355EC136030F4C06A583D6EB9CC13BDF"><enum>(ii)</enum><header>Publication</header><text>The
Secretary shall include, as part of such publication for a year—</text>
<subclause commented="no" id="H3127A33E92334AD5916F275516D6E368"><enum>(I)</enum><text display-inline="yes-display-inline">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</text>
</subclause><subclause commented="no" id="H8CF39C9A43924061A61CA8570E7BBDDE"><enum>(II)</enum><text>a summary of the
methodology and data used by the Secretary in computing such threshold amount
and such cost of collection.</text>
</subclause></clause></subparagraph><subparagraph id="H71DD963EF5F244F4AB1624F2E2990F5D"><enum>(C)</enum><header>Exclusion of
ongoing expenses</header><text display-inline="yes-display-inline">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 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.</text>
</subparagraph><subparagraph id="HDE5DC7E592E34C50B7ED7BE6211829A7"><enum>(D)</enum><header>Report to
congress</header><text>Not later than November 15 before each year, the
Secretary shall submit to the Congress a report on the single threshold amount
for settlements, judgments, awards, or other payments for conditional 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 subject to this section for the year. For each such
report, the Secretary shall—</text>
<clause id="HBC75D454E7AB4A9FB3A03DFC0C0C3B15"><enum>(i)</enum><text>calculate the
threshold amount by using the methodology applicable to certain liability
claims described in subparagraph (B); and</text>
</clause><clause id="H49A071E6404A4C1593F87DB12EE94B97"><enum>(ii)</enum><text>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.</text>
</clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></subsection><subsection commented="no" id="H0F80CA6C98FD4111A1156B5792FE83C2"><enum>(b)</enum><header>Effective
date</header><text>The amendments made by subsection (a) shall apply to years
beginning with 2014.</text>
</subsection></section><section id="HDA5FD42464F24DC78C89A47D38429933"><enum>203.</enum><header>Reporting
requirement</header><text display-inline="no-display-inline">Section 1862(b)(8)
of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C. 1395y(b)(8)</external-xref>) is
amended—</text>
<paragraph id="H6BD64D020F7F4076A59E6D7B19B08E00"><enum>(1)</enum><text>in the first
sentence of subparagraph (E)(i), by striking <quote>shall be subject</quote>
and all that follows through the end of the sentence and inserting the
following: <quote>may be subject to a civil money penalty of up to $1,000 for
each day of noncompliance with respect to each claimant.</quote>; and</text>
</paragraph><paragraph id="HAA05526AF8B44A86B0C2E7D6B0697162"><enum>(2)</enum><text>by adding at the
end the following new subparagraph:</text>
<quoted-block id="H8B1E9887498F48C4A72B00DD1A769A71" style="OLC">
<subparagraph id="H0DE5E5FFE3CA4DFC9EA52B122EB5239F"><enum>(I)</enum><header>Regulations</header><text>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 comment, 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.</text>
</subparagraph><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="H13C9FA2F20984C2C89E72C272EE337DE"><enum>204.</enum><header>Use of social
security numbers and other identifying information in reporting</header><text display-inline="no-display-inline">Section 1862(b)(8)(B) of the Social Security
Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C.
1395y(b)(8)(B)</external-xref>) is amended by adding at the end (after and
below clause (ii)) the following:</text>
<quoted-block display-inline="no-display-inline" id="HEA2BAB27051248A2AE039E6A4B688C58" style="traditional">
<quoted-block-continuation-text quoted-block-continuation-text-level="subparagraph">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 beneficiary social security
account numbers or health identification claim numbers, except that the
deadline for such modification 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 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 information
on the progress being made in implementing such modification and the
anticipated implementation date for such
modification.</quoted-block-continuation-text><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section commented="no" id="H37FE4D4D21D444C3B59A9F12C9F34B67"><enum>205.</enum><header>Statute of
limitations</header>
<subsection commented="no" id="H50A278C4BDD043A6B5A977A1A2651ECE"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section
1862(b)(2)(B)(iii) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C. 1395y(b)(2)(B)(iii)</external-xref>) is
amended by adding at the end the following new sentence: <quote>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.</quote>.</text>
</subsection><subsection commented="no" id="HDA271781EEFF4FDAB6D907B420231D2A"><enum>(b)</enum><header>Effective
date</header><text>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.</text>
</subsection></section>
Passed the House of
Representatives December 19, 2012.
Karen L. Haas,
Clerk