[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1845 Enrolled Bill (ENR)]
H.R.1845
One Hundred Twelfth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and twelve
An Act
To provide a demonstration project providing Medicare coverage 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 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 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.
(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 demonstration
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 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 (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
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 demonstration
project on access for Medicare beneficiaries to items and
services needed for the in-home administration of intravenous
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 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.
(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 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 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 conditional
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 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 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:
``(aa) 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.
``(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 communications with
the individual, representative, or plan involved.
``(dd) 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.
``(ee) The website shall permit the individual,
representative, or plan to download a statement of
reimbursement amounts (in this clause referred to
as a `statement 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 conditional amount.--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.
``(IV) Resolution of discrepancies.--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.
``(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 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.
``(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 technology.--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 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''.
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 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.
``(B) Annual computation of threshold.--
``(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-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.
``(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, 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.
``(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 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--
``(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 noncompliance 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 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.''.
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 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.''.
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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.