[112th Congress Public Law 242]
[From the U.S. Government Printing Office]
[[Page 2373]]
MEDICARE IVIG ACCESS AND STRENGTHENING MEDICARE AND REPAYING TAXPAYERS
ACT OF 2012
[[Page 126 STAT. 2374]]
Public Law 112-242
112th Congress
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. <<NOTE: Jan. 10,
2013 - [H.R. 1845]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Medicare IVIG
Access and Strengthening Medicare and Repaying Taxpayers Act of 2012. 42
USC 1305 note.>>
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. <<NOTE: 42 USC 1395l note.>> 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) <<NOTE: Effective date. Time period.>> 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).
[[Page 126 STAT. 2375]]
(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
[[Page 126 STAT. 2376]]
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 <<NOTE: Deadline.>> 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
[[Page 126 STAT. 2377]]
(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 <<NOTE: Proposal.>> such process
the individual (or representative) must
provide documentation explaining the
discrepancy and a proposal to resolve
such discrepancy. Within 11 <<NOTE: Time
period.>> 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) <<NOTE: Definition.>>
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
[[Page 126 STAT. 2378]]
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) <<NOTE: Regulations. Deadline.>>
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 <<NOTE: Definition.>> 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 <<NOTE: Regulations.>> 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 <<NOTE: Notification.>> 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.--
[[Page 126 STAT. 2379]]
``(i) <<NOTE: Deadlines. Publication.>> 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 <<NOTE: Review.>> 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--
[[Page 126 STAT. 2380]]
``(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 <<NOTE: 42 USC 1395y note.>> 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 <<NOTE: Deadline. Notice. Federal Register,
publications. Time period.>> 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 <<NOTE: Deadline. Time
period. Notification.>> 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
[[Page 126 STAT. 2381]]
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 <<NOTE: Deadline. Notification.>> 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 <<NOTE: Applicability. 42 USC 1395y
note.>> 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.
LEGISLATIVE HISTORY--H.R. 1845:
---------------------------------------------------------------------------
CONGRESSIONAL RECORD, Vol. 158 (2012):
Dec. 19, considered and passed House.
Dec. 21, considered and passed Senate.
<all>