[House Report 114-39]
[From the U.S. Government Publishing Office]
114th Congress } { Rept. 114-39
HOUSE OF REPRESENTATIVES
1st Session } { Part 1
======================================================================
NOTICE ACT
_______
March 13, 2015.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Ryan of Wisconsin, from the Committee on Ways and Means, submitted
the following
R E P O R T
[To accompany H.R. 876]
[Including cost estimate of the Congressional Budget Office]
The Committee on Ways and Means, to whom was referred the
bill (H.R. 876) to amend title XVIII of the Social Security Act
to require hospitals to provide certain notifications to
individuals classified by such hospitals under observation
status rather than admitted as inpatients of such hospitals,
having considered the same, report favorably thereon with an
amendment and recommend that the bill as amended do pass.
CONTENTS
Page
I. SUMMARY AND BACKGROUND............................................2
A. Purpose and Summary................................... 2
B. Background and Need for Legislation................... 3
C. Legislative History................................... 3
II. EXPLANATION OF THE BILL...........................................3
III.VOTES OF THE COMMITTEE............................................4
IV. BUDGET EFFECTS OF THE BILL........................................4
A. Committee Estimate of Budgetary Effects............... 4
B. Statement Regarding New Budget Authority and Tax
Expenditures Budget Authority........................ 4
C. Cost Estimate Prepared by the Congressional Budget
Office............................................... 5
V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE........5
A. Committee Oversight Findings and Recommendations...... 5
B. Statement of General Performance Goals and Objectives. 6
C. Duplication of Federal Programs Information Relating
to Unfunded Mandates................................. 6
D. Disclosure of Directed Rule Makings................... 6
E. Information Relating to Unfunded Mandates............. 6
F. Congressional Earmarks, Limited Tax Benefits, and
Limited Tariff Benefits.............................. 6
VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED.............7
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Notice of Observation Treatment and
Implication for Care Eligibility Act'' or the ``NOTICE Act''.
SEC. 2. MEDICARE REQUIREMENT FOR HOSPITAL NOTIFICATIONS OF OBSERVATION
STATUS.
Section 1866(a)(1) of the Social Security Act (42 U.S.C.
1395cc(a)(1)) is amended--
(1) in subparagraph (V), by striking at the end ``and'';
(2) in the first subparagraph (W), by striking at the end the
period and inserting a comma;
(3) in the second subparagraph (W)--
(A) by redesignating such subparagraph as
subparagraph (X); and
(B) by striking at the end the period and inserting
``, and''; and
(4) by inserting after such subparagraph (X) the following
new subparagraph:
``(Y) beginning 12 months after the date of the enactment of
this subparagraph, in the case of a hospital or critical access
hospital, with respect to each individual who receives
observation services as an outpatient at such hospital or
critical access hospital for more than 24 hours, to provide to
such individual not later than 36 hours after the time such
individual begins receiving such services (or, if sooner, upon
release)--
``(i) such oral explanation of the written
notification described in clause (ii), and such
documentation of the provision of such explanation, as
the Secretary determines to be appropriate;
``(ii) a written notification (as specified by the
Secretary pursuant to rulemaking and containing such
language as the Secretary prescribes consistent with
this paragraph) which--
``(I) explains the status of the individual
as an outpatient receiving observation services
and not as an inpatient of the hospital or
critical access hospital and the reasons for
such status of such individual;
``(II) explains the implications of such
status on services furnished by the hospital or
critical access hospital (including services
furnished on an inpatient basis), such as
implications for cost-sharing requirements
under this title and for subsequent eligibility
for coverage under this title for services
furnished by a skilled nursing facility;
``(III) includes such additional information
as the Secretary determines appropriate;
``(IV) either--
``(aa) is signed by such individual
or a person acting on such individual's
behalf to acknowledge receipt of such
notification; or
``(bb) if such individual or person
refuses to provide the signature
described in item (aa), is signed by
the staff member of the hospital or
critical access hospital who presented
the written notification and includes
the name and title of such staff
member, a certification that the
notification was presented, and the
date and time the notification was
presented; and
``(V) is written and formatted using plain
language and is made available in appropriate
languages as determined by the Secretary.''.
I. SUMMARY AND BACKGROUND
A. Purpose and Summary
The bill, H.R. 876, as ordered reported by the Committee on
Ways and Means on February 26, 2015, is legislation to provide
certainty to beneficiaries regarding their status as an
outpatient under observation (or any similar status) and not as
an inpatient. The Notice of Observation Treatment and
Implication for Care Eligibility Act (NOTICE Act) contains
bipartisan policies, promoted by Ways and Means Committee
members, that include the:
Explanation for the reason for beneficiary's
classification as outpatient or inpatient
Clarification on the implications of that
outpatient status for beneficiaries on eligibility for
Medicare coverage of items and services as well as
cost-sharing requirements
Name and title of the hospital staff who
gave an oral notification and its date and time
Requirement that the clarification be signed
by the patient, if the notification is written, to
acknowledge receipt, or if patient refuses to sign, the
written notification is signed by the staff of the
hospital who presented it
B. Background and the Need for Legislation
On February 11, 2015, Representative Lloyd Doggett (D-TX),
and Representative Todd Young (R-IN), introduced H.R. 876,
which requires hospitals to provide certain notification to
individuals classified by such hospitals under observation
status rather than admitted as inpatients of such hospitals.
The NOTICE Act provides certainty to beneficiaries with
regard to their classification as an inpatient or outpatient.
Without the NOTICE Act, beneficiaries could be subject to costs
they did not foresee due to their classification as either an
outpatient under observation or an inpatient. By clarifying a
beneficiary's status as either an outpatient under observation
(or any similar status) or as an inpatient, the NOTICE Act will
provide beneficiaries with accurate, real-time information with
respect to their classification, the services and benefits
available to them, and the respective cost-sharing requirements
they are subject to.
C. Legislative History
Background
H.R. 876 was introduced on February 11, 2015, and was
referred to the Committee on Ways and Means, in addition to the
Committee on Energy and Commerce. The bill was subsequently
referred to the Subcommittee on Health.
Committee Action
The Committee on Ways and Means marked up the bill on
February 26, 2015, and with a quorum present, ordered the bill
favorably reported.
Committee Markups
On February 26, 2015, the Committee on Ways and Means held
a markup of H.R. 876, ``NOTICE Act'', which was favorably
reported to the House of Representatives by voice vote.
II. EXPLANATION OF THE BILL
PRESENT LAW
Current statute does not include requirements for
beneficiary notification regarding their patient status.
REASONS FOR CHANGE
The Committee believes it is necessary to provide notice to
beneficiaries regarding their status as either outpatient (or
any similar status) or inpatient. In order to ensure the
transparency, it is necessary for hospitals to notify patients
of their status in order to prevent unanticipated cost sharing
for services rendered.
The Committee believes that proper prior notification to
patients will allow for the transmission of appropriate
information to increase awareness of cost sharing requirements
for services rendered. Ultimately, prior notification will
allow patients to better anticipate their costs, create
heightened clarity in the Medicare program, and reduce
uncertainty to hospitals.
EXPLANATION OF PROVISION
The provision would require documentation, as the Secretary
determines to be appropriate, to be provided to patients
explaining the status of the patient as an outpatient receiving
observation services and not as an inpatient of the hospital or
critical access hospital (CAHs). Further, hospitals and CAHs
must provide the reasons for such determination in order to
increase the transparency to patients regarding his/her status
within the Medicare program.
EFFECTIVE DATE
The provision becomes effective 12 months after the date of
enactment.
III. VOTES OF THE COMMITTEE
In compliance with clause 3(b) of rule XIII of the Rules of
the House of Representatives, the following statements are made
concerning the votes of the Committee on Ways and Means in its
consideration of the bill, H.R. 876.
The bill, H.R. 876, to amend title XVII of the Social
Security Act to require hospitals to provide certain
notifications to individuals classified by such hospitals under
observation status rather than admitted as inpatients of such
hospitals was ordered favorably reported with an amendment in
the nature of a substitute to the House of Representatives by
voice vote (with a quorum present).
VOTES ON AMENDMENTS
The amendment in the nature of a substitute was agreed to
favorably by voice vote.
IV. BUDGET EFFECTS OF THE BILL
A. Committee Estimate of Budgetary Effects
In compliance with clause 3(d) of rule XIII of the Rules of
the House of Representatives, the following statement is made
concerning the effects on the budget of the revenue provisions
of the bill, H.R. 876 as reported: The Committee agrees with
the estimates prepared by the Congressional Budget Office
(CBO), which are included below.
B. Statement Regarding New Budget Authority and Tax Expenditures Budget
Authority
The bill as reported is in compliance with clause 3(c)(2)
of rule XIII of the Rules of the House of Representatives.
Further, the bill involves no new or increased tax expenditures
and no new budget authority.
C. Cost Estimate Prepared by the Congressional Budget Office
In compliance with clause 3(c)(3) of rule XIII of the Rules
of the House of Representatives, requiring a cost estimate
prepared by the CBO, the following statement by CBO is
provided.
U.S. Congress,
Congressional Budget Office,
Washington, DC, March 11, 2015.
Hon. Paul Ryan,
Chairman, Committee on Ways and Means,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 876, the Notice of
Observation Treatment and Implication for Care Eligibility Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Erica Socker.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
H.R. 876--Notice of Observation Treatment and Implication for Care
Eligibility Act
H.R. 876 would require hospitals to notify Medicare
beneficiaries receiving observation services for more than 24
hours of their status as an outpatient under observation. The
written notification must explain that, because the beneficiary
is receiving outpatient--rather than inpatient--services:
The beneficiary will be subject to cost-
sharing requirements that apply to outpatient services,
and
The beneficiary's outpatient stay will not
count toward the three-day inpatient stay required for
a beneficiary to be eligible for Medicare coverage of
subsequent skilled nursing facility services.
Enacting H.R. 876 could affect direct spending; therefore,
pay-as-you-go procedures apply. However, CBO estimates that the
bill would not have significant budgetary effects over the
2015-2025 period.
H.R. 876 contains no intergovernmental mandates as defined
in the Unfunded Mandates Reform Act and would not affect the
budgets of state, local, or tribal governments.
The CBO staff contact for this estimate is Erica Socker.
The estimate was approved by Holly Harvey, Deputy Assistant
Director for Budget Analysis.
V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE OF
REPRESENTATIVES
A. Committee Oversight Findings and Recommendations
With respect to clause 3(c)(1) of rule XIII of the Rules of
the House of Representatives (relating to oversight findings),
the Committee concluded that it was appropriate and timely to
enact the sections included in the bill, as reported.
On May 20, 2014, the Subcommittee on Health held a hearing
on current hospital issues in the Medicare program. During this
hearing, the Subcommittee heard testimony from experts on the
classification of patients as inpatient or outpatient and the
resulting implication of patient cost sharing.
The Committee believes this legislation is necessary to
ensure that patients are made aware of their status as
outpatients (or any similar status) or as inpatients. This
legislation is needed to ensure that patients are aware of
their status in order to properly inform his/her cost-sharing
status with regard to such classification.
B. Statement of General Performance Goals and Objectives
With respect to clause 3(c)(4) of rule XIII of the Rules of
the House of Representatives, the Committee advises that the
bill contains no measure that authorizes new or additional
funding compared with the current law baseline, so no statement
of general performance goals and objectives for which any
measure authorizes funding is required.
C. Duplication of Federal Programs
In compliance with Sec. 3(g)(2) of H. Res. 5 (114th
Congress), the Committee states that no provision of the bill
establishes or reauthorizes: (1) a program of the Federal
Government known to be duplicative of another Federal program,
(2) a program included in any report from the Government
Accountability Office to Congress pursuant to section 21 of
Public Law 111-139, or (3) a program related to a program
identified in the most recent Catalog of Federal Domestic
Assistance, published pursuant to the Federal Program
Information Act (Public Law 95-220, as amended by Public Law
98-169).
D. Disclosure of Directed Rule Makings
In compliance with Sec. 3(i) of H. Res. 5 (114th Congress),
the Committee estimates that H.R. 876 specifically directs the
Secretary to complete rule-making on the change requiring
changes in CMS policy regarding the notice to patients.
E. Information Relating to Unfunded Mandates
This information is provided in accordance with section 423
of the Unfunded Mandates Act of 1995 (Pub. L. No. 104-4).
The bill does not impose a Federal mandate on the private
sector. H.R. 876 does not impose a Federal intergovernmental
mandate on State, local, or tribal governments.
F. Congressional Earmarks, Limited Tax Benefits, and Limited Tariff
Benefits
With respect to clause 9 of rule XXI of the Rules of the
House of Representatives, the Committee has carefully reviewed
the provisions of the bill, and states that the provisions of
the bill do not contain any congressional earmarks, limited tax
benefits, or limited tariff benefits within the meaning of the
rule.
VI. Changes in Existing Law Made by the Bill, as Reported
With respect to clause 3(e) of rule XIII of the rules of
the House of Representatives, H.R. 876 makes the following
changes to current law.
Changes in Existing Law Proposed by the Bill, as Reported
In compliance with clause 3(e)(1)(B) of rule XIII of the
Rules of the House of Representatives, changes in existing law
proposed by the bill, as reported, are shown as follows (new
matter is printed in italic and existing law in which no change
is proposed is shown in roman):
SOCIAL SECURITY ACT
* * * * * * *
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
Part E--Miscellaneous Provisions
* * * * * * *
agreements with providers of services; enrollment processes
Sec. 1866. (a)(1) Any provider of services (except a fund
designated for purposes of section 1814(g) and section 1835(e))
shall be qualified to participate under this title and shall be
eligible for payments under this title if it files with the
Secretary an agreement--
(A)(i) not to charge, except as provided in paragraph
(2), any individual or any other person for items or
services for which such individual is entitled to have
payment made under this title (or for which he would be
so entitled if such provider of services had complied
with the procedural and other requirements under or
pursuant to this title or for which such provider is
paid pursuant to the provisions of section 1814(e)),
and (ii) not to impose any charge that is prohibited
under section 1902(n)(3),
(B) not to charge any individual or any other person
for items or services for which such individual is not
entitled to have payment made under this title because
payment for expenses incurred for such items or
services may not be made by reason of the provisions of
paragraph (1) or (9) of section 1862(a), but only if
(i) such individual was without fault in incurring such
expenses and (ii) the Secretary's determination that
such payment may not be made for such items and
services was made after the third year following the
year in which notice of such payment was sent to such
individual; except that the Secretary may reduce such
three-year period to not less than one year if he finds
such reduction is consistent with the objectives of
this title,
(C) to make adequate provision for return (or other
disposition, in accordance with regulations) of any
moneys incorrectly collected from such individual or
other person,
(D) to promptly notify the Secretary of its
employment of an individual who, at any time during the
year preceding such employment, was employed in a
managerial, accounting, auditing, or similar capacity
(as determined by the Secretary by regulation) by an
agency or organization which serves as a fiscal
intermediary or carrier (for purposes of part A or part
B, or both, of this title) with respect to the
provider,
(E) to release data with respect to patients of such
provider upon request to an organization having a
contract with the Secretary under part B of title XI as
may be necessary (i) to allow such organization to
carry out its functions under such contract, or (ii) to
allow such organization to carry out similar review
functions under any contract the organization may have
with a private or public agency paying for health care
in the same area with respect to patients who authorize
release of such data for such purposes,
(F)(i) in the case of hospitals which provide
inpatient hospital services for which payment may be
made under subsection (b), (c), or (d) of section 1886,
to maintain an agreement with a professional standards
review organization (if there is such an organization
in existence in the area in which the hospital is
located) or with a quality improvement organization
which has a contract with the Secretary under part B of
title XI for the area in which the hospital is located,
under which the organization will perform functions
under that part with respect to the review of the
validity of diagnostic information provided by such
hospital, the completeness, adequacy, and quality of
care provided, the appropriateness of admissions and
discharges, and the appropriateness of care provided
for which additional payments are sought under section
1886(d)(5), with respect to inpatient hospital services
for which payment may be made under part A of this
title (and for purposes of payment under this title,
the cost of such agreement to the hospital shall be
considered a cost incurred by such hospital in
providing inpatient services under part A, and (I)
shall be paid directly by the Secretary to such
organization on behalf of such hospital in accordance
with a rate per review established by the Secretary,
(II) shall be transferred from the Federal Hospital
Insurance Trust Fund, without regard to amounts
appropriated in advance in appropriation Acts, in the
same manner as transfers are made for payment for
services provided directly to beneficiaries, and (III)
shall not be less in the aggregate for a fiscal year
than the aggregate amount expended in fiscal year 1988
for direct and administrative costs (adjusted for
inflation and for any direct or administrative costs
incurred as a result of review functions added with
respect to a subsequent fiscal year) of such reviews),
(ii) in the case of hospitals, critical access
hospitals, skilled nursing facilities, and home health
agencies, to maintain an agreement with a quality
improvement organization (which has a contract with the
Secretary under part B of title XI for the area in
which the hospital, facility, or agency is located) to
perform the functions described in paragraph (3)(A),
(G) in the case of hospitals which provide inpatient
hospital services for which payment may be made under
subsection (b) or (d) of section 1886, not to charge
any individual or any other person for inpatient
hospital services for which such individual would be
entitled to have payment made under part A but for a
denial or reduction of payments under section
1886(f)(2),
(H)(i) in the case of hospitals which provide
services for which payment may be made under this title
and in the case of critical access hospitals which
provide critical access hospital services, to have all
items and services (other than physicians' services as
defined in regulations for purposes of section
1862(a)(14), and other than services described by
section 1861(s)(2)(K), certified nurse-midwife
services, qualified psychologist services, and services
of a certified registered nurse anesthetist) (I) that
are furnished to an individual who is a patient of the
hospital, and (II) for which the individual is entitled
to have payment made under this title, furnished by the
hospital or otherwise under arrangements (as defined in
section 1861(w)(1)) made by the hospital,
(ii) in the case of skilled nursing facilities which
provide covered skilled nursing facility services--
(I) that are furnished to an individual who
is a resident of the skilled nursing facility
during a period in which the resident is
provided covered post-hospital extended care
services (or, for services described in section
1861(s)(2)(D), that are furnished to such an
individual without regard to such period), and
(II) for which the individual is entitled to
have payment made under this title,
to have items and services (other than services
described in section 1888(e)(2)(A)(ii)) furnished by
the skilled nursing facility or otherwise under
arrangements (as defined in section 1861(w)(1)) made by
the skilled nursing facility,
(I) in the case of a hospital or critical access
hospital--
(i) to adopt and enforce a policy to ensure
compliance with the requirements of section
1867 and to meet the requirements of such
section,
(ii) to maintain medical and other records
related to individuals transferred to or from
the hospital for a period of five years from
the date of the transfer, and
(iii) to maintain a list of physicians who
are on call for duty after the initial
examination to provide treatment necessary to
stabilize an individual with an emergency
medical condition,
(J) in the case of hospitals which provide inpatient
hospital services for which payment may be made under
this title, to be a participating provider of medical
care under any health plan contracted for under section
1079 or 1086 of title 10, or under section 613 of title
38, United States Code, in accordance with admission
practices, payment methodology, and amounts as
prescribed under joint regulations issued by the
Secretary and by the Secretaries of Defense and
Transportation, in implementation of sections 1079 and
1086 of title 10, United States Code,
(K) not to charge any individual or any other person
for items or services for which payment under this
title is denied under section 1154(a)(2) by reason of a
determination under section 1154(a)(1)(B),
(L) in the case of hospitals which provide inpatient
hospital services for which payment may be made under
this title, to be a participating provider of medical
care under section 603 of title 38, United States Code,
in accordance with such admission practices, and such
payment methodology and amounts, as are prescribed
under joint regulations issued by the Secretary and by
the Secretary of Veterans Affairs in implementation of
such section,
(M) in the case of hospitals, to provide to each
individual who is entitled to benefits under part A (or
to a person acting on the individual's behalf), at or
about the time of the individual's admission as an
inpatient to the hospital, a written statement
(containing such language as the Secretary prescribes
consistent with this paragraph) which explains--
(i) the individual's rights to benefits for
inpatient hospital services and for post-
hospital services under this title,
(ii) the circumstances under which such an
individual will and will not be liable for
charges for continued stay in the hospital,
(iii) the individual's right to appeal
denials of benefits for continued inpatient
hospital services, including the practical
steps to initiate such an appeal, and
(iv) the individual's liability for payment
for services if such a denial of benefits is
upheld on appeal,--and which provides such
additional information as the Secretary may
specify,
(N) in the case of hospitals and critical access
hospitals--
(i) to make available to its patients the
directory or directories of participating
physicians (published under section 1842(h)(4))
for the area served by the hospital or critical
access hospital,
(ii) if hospital personnel (including staff
of any emergency or outpatient department)
refer a patient to a nonparticipating physician
for further medical care on an outpatient
basis, the personnel must inform the patient
that the physician is a nonparticipating
physician and, whenever practicable, must
identify at least one qualified participating
physician who is listed in such a directory and
from whom the patient may receive the necessary
services,
(iii) to post conspicuously in any emergency
department a sign (in a form specified by the
Secretary) specifying rights of individuals
under section 1867 with respect to examination
and treatment for emergency medical conditions
and women in labor, and
(iv) to post conspicuously (in a form
specified by the Secretary) information
indicating whether or not the hospital
participates in the medicaid program under a
State plan approved under title XIX,
(O) to accept as payment in full for services that
are covered under this title and are furnished to any
individual enrolled with a Medicare+Choice organization
under part C, with a PACE provider under section 1894
or 1934, or with an eligible organization with a risk-
sharing contract under section 1876, under section
1876(i)(2)(A) (as in effect before February 1, 1985),
under section 402(a) of the Social Security Amendments
of 1967, or under section 222(a) of the Social Security
Amendments of 1972, which does not have a contract (or,
in the case of a PACE provider, contract or other
agreement) establishing payment amounts for services
furnished to members of the organization or PACE
program eligible individuals enrolled with the PACE
provider, the amounts that would be made as a payment
in full under this title (less any payments under
sections 1886(d)(11) and 1886(h)(3)(D)) if the
individuals were not so enrolled,
(P) in the case of home health agencies which provide
home health services to individuals entitled to
benefits under this title who require catheters,
catheter supplies, ostomy bags, and supplies related to
ostomy car (described in section 1861(m)(5)), to offer
to furnish such supplies to such an individual as part
of their furnishing of home health services,
(Q) in the case of hospitals, skilled nursing
facilities, home health agencies, and hospice programs,
to comply with the requirement of subsection (f)
(relating to maintaining written policies and
procedures respecting advance directives),
(R) to contract only with a health care clearinghouse
(as defined in section 1171) that meets each standard
and implementation specification adopted or established
under part C of title XI on or after the date on which
the health care clearinghouse is required to comply
with the standard or specification,
(S) in the case of a hospital that has a financial
interest (as specified by the Secretary in regulations)
in an entity to which individuals are referred as
described in section 1861(ee)(2)(H)(ii), or in which
such an entity has such a financial interest, or in
which another entity has such a financial interest
(directly or indirectly) with such hospital and such an
entity, to maintain and disclose to the Secretary (in a
form and manner specified by the Secretary) information
on--
(i) the nature of such financial interest,
(ii) the number of individuals who were
discharged from the hospital and who were
identified as requiring home health services,
and
(iii) the percentage of such individuals who
received such services from such provider (or
another such provider),
(T) in the case of hospitals and critical access
hospitals, to furnish to the Secretary such data as the
Secretary determines appropriate pursuant to
subparagraph (E) of section 1886(d)(12) to carry out
such section,
(U) in the case of hospitals which furnish inpatient
hospital services for which payment may be made under
this title, to be a participating provider of medical
care both--
(i) under the contract health services
program funded by the Indian Health Service and
operated by the Indian Health Service, an
Indian tribe, or tribal organization (as those
terms are defined in section 4 of the Indian
Health Care Improvement Act), with respect to
items and services that are covered under such
program and furnished to an individual eligible
for such items and services under such program;
and
(ii) under any program funded by the Indian
Health Service and operated by an urban Indian
organization with respect to the purchase of
items and services for an eligible urban Indian
(as those terms are defined in such section 4),
in accordance with regulations promulgated by the
Secretary regarding admission practices, payment
methodology, and rates of payment (including the
acceptance of no more than such payment rate as payment
in full for such items and services,
(V) in the case of hospitals that are not otherwise
subject to the Occupational Safety and Health Act of
1970 (or a State occupational safety and health plan
that is approved under 18(b) of such Act), to comply
with the Bloodborne Pathogens standard under section
1910.1030 of title 29 of the Code of Federal
Regulations (or as subsequently redesignated), [and]
(W) in the case of a hospital described in
section 1886(d)(1)(B)(v), to report quality
data to the Secretary in accordance with
subsection (k)[.],
[(W)] (X) maintain and, upon request of the
Secretary, provide access to documentation
relating to written orders or requests for
payment for durable medical equipment,
certifications for home health services, or
referrals for other items or services written
or ordered by the provider under this title, as
specified by the Secretary[.], and
(Y) beginning 12 months after the date of the
enactment of this subparagraph, in the case of a
hospital or critical access hospital, with respect to
each individual who receives observation services as an
outpatient at such hospital or critical access hospital
for more than 24 hours, to provide to such individual
not later than 36 hours after the time such individual
begins receiving such services (or, if sooner, upon
release)--
(i) such oral explanation of the written
notification described in clause (ii), and such
documentation of the provision of such
explanation, as the Secretary determines to be
appropriate;
(ii) a written notification (as specified by
the Secretary pursuant to rulemaking and
containing such language as the Secretary
prescribes consistent with this paragraph)
which--
(I) explains the status of the
individual as an outpatient receiving
observation services and not as an
inpatient of the hospital or critical
access hospital and the reasons for
such status of such individual;
(II) explains the implications of
such status on services furnished by
the hospital or critical access
hospital (including services furnished
on an inpatient basis), such as
implications for cost-sharing
requirements under this title and for
subsequent eligibility for coverage
under this title for services furnished
by a skilled nursing facility;
(III) includes such additional
information as the Secretary determines
appropriate;
(IV) either--
(aa) is signed by such
individual or a person acting
on such individual's behalf to
acknowledge receipt of such
notification; or
(bb) if such individual or
person refuses to provide the
signature described in item
(aa), is signed by the staff
member of the hospital or
critical access hospital who
presented the written
notification and includes the
name and title of such staff
member, a certification that
the notification was presented,
and the date and time the
notification was presented; and
(V) is written and formatted using
plain language and is made available in
appropriate languages as determined by
the Secretary.
In the case of a hospital which has an agreement in effect with
an organization described in subparagraph (F), which
organization's contract with the Secretary under part B of
title XI is terminated on or after October 1, 1984, the
hospital shall not be determined to be out of compliance with
the requirement of such subparagraph during the six month
period beginning on the date of the termination of that
contract.
(2)(A) A provider of services may charge such individual or
other person (i) the amount of any deduction or coinsurance
amount imposed pursuant to section 1813(a)(1), (a)(3), or
(a)(4), section 1833(b), or section 1861(y)(3) with respect to
such items and services (not in excess of the amount
customarily charged for such items and services by such
provider), and (ii) an amount equal to 20 per centum of the
reasonable charges for such items and services (not in excess
of 20 per centum of the amount customarily charged for such
items and services by such provider) for which payment is made
under part B or which are durable medical equipment furnished
as home health services (but in the case of items and services
furnished to individuals with end-stage renal disease, an
amount equal to 20 percent of the estimated amounts for such
items and services calculated on the basis established by the
Secretary). In the case of items and services described in
section 1833(c), clause (ii) of the preceding sentence shall be
applied by substituting for 20 percent the proportion which is
appropriate under such section. A provider of services may not
impose a charge under clause (ii) of the first sentence of this
subparagraph with respect to items and services described in
section 1861(s)(10)(A) and with respect to clinical diagnostic
laboratory tests for which payment is made under part B.
Notwithstanding the first sentence of this subparagraph, a home
health agency may charge such an individual or person, with
respect to covered items subject to payment under section
1834(a), the amount of any deduction imposed under section
1833(b) and 20 percent of the payment basis described in
section 1834(a)(1)(B). In the case of items and services for
which payment is made under part B under the prospective
payment system established under section 1833(t), clause (ii)
of the first sentence shall be applied by substituting for 20
percent of the reasonable charge, the applicable copayment
amount established under section 1833(t)(5). In the case of
services described in section 1833(a)(8) or section 1833(a)(9)
for which payment is made under part B under section 1834(k),
clause (ii) of the first sentence shall be applied by
substituting for 20 percent of the reasonable charge for such
services 20 percent of the lesser of the actual charge or the
applicable fee schedule amount (as defined in such section) for
such services.
(B) Where a provider of services has furnished, at the
request of such individual, items or services which are in
excess of or more expensive than the items or services with
respect to which payment may be made under this title, such
provider of services may also charge such individual or other
person for such more expensive items or services to the extent
that the amount customarily charged by it for the items or
services furnished at such request exceeds the amount
customarily charged by it for the items or services with
respect to which payment may be made under this title.
(C) A provider of services may in accordance with its
customary practice also appropriately charge any such
individual for any whole blood (or equivalent quantities of
packed red blood cells, as defined under regulations) furnished
him with respect to which a deductible is imposed under section
1813(a)(2), except that (i) any excess of such charge over the
cost to such provider for the blood (or equivalent quantities
of packed red blood cells, as so defined) shall be deducted
from any payment to such provider under this title, (ii) no
such charge may be imposed for the cost of administration of
such blood (or equivalent quantities of packed red blood cells,
as so defined), and (iii) such charge may not be made to the
extent such blood (or equivalent quantities of packed red blood
cells, as so defined) has been replaced on behalf of such
individual or arrangements have been made for its replacement
on his behalf. For purposes of subparagraph (C), whole blood
(or equivalent quantities of packed red blood cells, as so
defined) furnished an individual shall be deemed replaced when
the provider of services is given one pint of blood for each
pint of blood (or equivalent quantities of packed red blood
cells, as so defined) furnished such individual with respect to
which a deduction is imposed under section 1813(a)(2).
(D) Where a provider of services customarily furnishes items
or services which are in excess of or more expensive than the
items or services with respect to which payment may be made
under this title, such provider, notwithstanding the preceding
provisions of this paragraph, may not, under the authority of
section 1866(a)(2)(B)(ii), charge any individual or other
person any amount for such items or services in excess of the
amount of the payment which may otherwise be made for such
items or services under this title if the admitting physician
has a direct or indirect financial interest in such provider.
(3)(A) Under the agreement required under paragraph
(1)(F)(ii), the quality improvement organization must perform
functions (other than those covered under an agreement under
paragraph (1)(F)(i)) under the third sentence of section
1154(a)(4)(A) and under section 1154(a)(14) with respect to
services, furnished by the hospital, critical access hospital,
facility, or agency involved, for which payment may be made
under this title.
(B) For purposes of payment under this title, the cost of
such an agreement to the hospital, critical access hospital,
facility, or agency shall be considered a cost incurred by such
hospital, critical access hospital, facility, or agency in
providing covered services under this title and shall be paid
directly by the Secretary to the quality improvement
organization on behalf of such hospital, critical access
hospital, facility, or agency in accordance with a schedule
established by the Secretary.
(C) Such payments--
(i) shall be transferred in appropriate proportions
from the Federal Hospital Insurance Trust Fund and from
the Federal Supplementary Medical Insurance Trust Fund,
without regard to amounts appropriated in advance in
appropriation Acts, in the same manner as transfers are
made for payment for services provided directly to
beneficiaries, and
(ii) shall not be less in the aggregate for a fiscal
year--
(I) in the case of hospitals, than the amount
specified in paragraph (1)(F)(i)(III), and
(II) in the case of facilities, critical
access hospitals, and agencies, than the
amounts the Secretary determines to be
sufficient to cover the costs of such
organizations' conducting the activities
described in subparagraph (A) with respect to
such facilities, critical access hospitals, or
agencies under part B of title XI.
(b)(1) A provider of services may terminate an agreement with
the Secretary under this section at such time and upon such
notice to the Secretary and the public as may be provided in
regulations, except that notice of more than six months shall
not be required.
(2) The Secretary may refuse to enter into an agreement under
this section or, upon such reasonable notice to the provider
and the public as may be specified in regulations, may refuse
to renew or may terminate such an agreement after the
Secretary--
(A) has determined that the provider fails to comply
substantially with the provisions of the agreement,
with the provisions of this title and regulations
thereunder, or with a corrective action required under
section 1886(f)(2)(B),
(B) has determined that the provider fails
substantially to meet the applicable provisions of
section 1861,
(C) has excluded the provider from participation in a
program under this title pursuant to section 1128 or
section 1128A, or
(D) has ascertained that the provider has been
convicted of a felony under Federal or State law for an
offense which the Secretary determines is detrimental
to the best interests of the program or program
beneficiaries.
(3) A termination of an agreement or a refusal to renew an
agreement under this subsection shall become effective on the
same date and in the same manner as an exclusion from
participation under the programs under this title becomes
effective under section 1128(c).
(4)(A) A hospital that fails to comply with the requirement
of subsection (a)(1)(V) (relating to the Bloodborne Pathogens
standard) is subject to a civil money penalty in an amount
described in subparagraph (B), but is not subject to
termination of an agreement under this section.
(B) The amount referred to in subparagraph (A) is an amount
that is similar to the amount of civil penalties that may be
imposed under section 17 of the Occupational Safety and Health
Act of 1970 for a violation of the Bloodborne Pathogens
standard referred to in subsection (a)(1)(U) by a hospital that
is subject to the provisions of such Act.
(C) A civil money penalty under this paragraph shall be
imposed and collected in the same manner as civil money
penalties under subsection (a) of section 1128A are imposed and
collected under that section.
(c)(1) Where the Secretary has terminated or has refused to
renew an agreement under this title with a provider of
services, such provider may not file another agreement under
this title unless the Secretary finds that the reason for the
termination or nonrenewal has been removed and that there is
reasonable assurance that it will not recur.
(2) Where the Secretary has terminated or has refused to
renew an agreement under this title with a provider of
services, the Secretary shall promptly notify each State agency
which administers or supervises the administration of a State
plan approved under title XIX of such termination or
nonrenewal.
(d) If the Secretary finds that there is a substantial
failure to make timely review in accordance with section
1861(k) of long-stay cases in a hospital, he may, in lieu of
terminating his agreement with such hospital, decide that, with
respect to any individual admitted to such hospital after a
subsequent date specified by him, no payment shall be made
under this title for inpatient hospital services (including
inpatient psychiatric hospital services) after the 20th day of
a continuous period of such services. Such decision may be made
effective only after such notice to the hospital and to the
public, as may be prescribed by regulations, and its
effectiveness shall terminate when the Secretary finds that the
reason therefor has been removed and that there is reasonable
assurance that it will not recur. The Secretary shall not make
any such decision except after reasonable notice and
opportunity for hearing to the institution or agency affected
thereby.
(e) For purposes of this section, the term ``provider of
services'' shall include--
(1) a clinic, rehabilitation agency, or public health
agency if, in the case of a clinic or rehabilitation
agency, such clinic or agency meets the requirements of
section 1861(p)(4)(A) (or meets the requirements of
such section through the operation of subsection (g) or
(ll)(2) of section 1861), or if, in the case of a
public health agency, such agency meets the
requirements of section 1861(p)(4)(B) (or meets the
requirements of such section through the operation of
subsection (g) or (ll)(2) of section 1861), but only
with respect to the furnishing of outpatient physical
therapy services (as therein defined), (through the
operation of section 1861(g)) with respect to the
furnishing of outpatient occupational therapy services,
or (through the operation of section 1861(ll)(2)) with
respect to the furnishing of outpatient speech-language
pathology; and
(2) a community mental health center (as defined in
section 1861(ff)(3)(B)), but only with respect to the
furnishing of partial hospitalization services (as
described in section 1861(ff)(1)).
(f)(1) For purposes of subsection (a)(1)(Q) and sections
1819(c)(2)(E), 1833(s), 1855(i), 1876(c)(8), and 1891(a)(6),
the requirement of this subsection is that a provider of
services, Medicare+Choice organization, or prepaid or eligible
organization (as the case may be) maintain written policies and
procedures with respect to all adult individuals receiving
medical care by or through the provider or organization--
(A) to provide written information to each such
individual concerning--
(i) an individual's rights under State law
(whether statutory or as recognized by the
courts of the State) to make decisions
concerning such medical care, including the
right to accept or refuse medical or surgical
treatment and the right to formulate advance
directives (as defined in paragraph (3)), and
(ii) the written policies of the provider or
organization respecting the implementation of
such rights;
(B) to document in a prominent part of the
individual's current medical record whether or not the
individual has executed an advance directive;
(C) not to condition the provision of care or
otherwise discriminate against an individual based on
whether or not the individual has executed an advance
directive;
(D) to ensure compliance with requirements of State
law (whether statutory or as recognized by the courts
of the State) respecting advance directives at
facilities of the provider or organization; and
(E) to provide (individually or with others) for
education for staff and the community on issues
concerning advance directives.
Subparagraph (C) shall not be construed as requiring the
provision of care which conflicts with an advance directive.
(2) The written information described in paragraph (1)(A)
shall be provided to an adult individual--
(A) in the case of a hospital, at the time of the
individual's admission as an inpatient,
(B) in the case of a skilled nursing facility, at the
time of the individual's admission as a resident,
(C) in the case of a home health agency, in advance
of the individual coming under the care of the agency,
(D) in the case of a hospice program, at the time of
initial receipt of hospice care by the individual from
the program, and
(E) in the case of an eligible organization (as
defined in section 1876(b)) or an organization provided
payments under section 1833(a)(1)(A) or a
Medicare+Choice organization, at the time of enrollment
of the individual with the organization.
(3) In this subsection, the term ``advance directive'' means
a written instruction, such as a living will or durable power
of attorney for health care, recognized under State law
(whether statutory or as recognized by the courts of the State)
and relating to the provision of such care when the individual
is incapacitated.
(4) For construction relating to this subsection, see section
7 of the Assisted Suicide Funding Restriction Act of 1997
(relating to clarification respecting assisted suicide,
euthanasia, and mercy killing).
(g) Except as permitted under subsection (a)(2), any person
who knowingly and willfully presents, or causes to be
presented, a bill or request for payment inconsistent with an
arrangement under subsection (a)(1)(H) or in violation of the
requirement for such an arrangement, is subject to a civil
money penalty of not to exceed $2,000. The provisions of
section 1128A (other than subsections (a) and (b)) shall apply
to a civil money penalty under the previous sentence in the
same manner as such provisions apply to a penalty or proceeding
under section 1128A(a).
(h)(1)(A) Except as provided in paragraph (2), an institution
or agency dissatisfied with a determination by the Secretary
that it is not a provider of services or with a determination
described in subsection (b)(2) shall be entitled to a hearing
thereon by the Secretary (after reasonable notice) to the same
extent as is provided in section 205(b), and to judicial review
of the Secretary's final decision after such hearing as is
provided in section 205(g), except that, in so applying such
sections and in applying section 205(l) thereto, any reference
therein to the Commissioner of Social Security or the Social
Security Administration shall be considered a reference to the
Secretary or the Department of Health and Human Services,
respectively.
(B) An institution or agency described in subparagraph (A)
that has filed for a hearing under subparagraph (A) shall have
expedited access to judicial review under this subparagraph in
the same manner as providers of services, suppliers, and
individuals entitled to benefits under part A or enrolled under
part B, or both, may obtain expedited access to judicial review
under the process established under section 1869(b)(2). Nothing
in this subparagraph shall be construed to affect the
application of any remedy imposed under section 1819 during the
pendency of an appeal under this subparagraph.
(C)(i) The Secretary shall develop and implement a process to
expedite proceedings under this subsection in which--
(I) the remedy of termination of participation has
been imposed;
(II) a remedy described in clause (i) or (iii) of
section 1819(h)(2)(B) has been imposed, but only if
such remedy has been imposed on an immediate basis; or
(III) a determination has been made as to a finding
of substandard quality of care that results in the loss
of approval of a skilled nursing facility's nurse aide
training program.
(ii) Under such process under clause (i), priority shall be
provided in cases of termination described in clause (i)(I).
(iii) Nothing in this subparagraph shall be construed to
affect the application of any remedy imposed under section 1819
during the pendency of an appeal under this subparagraph.
(2) An institution or agency is not entitled to separate
notice and opportunity for a hearing under both section 1128
and this section with respect to a determination or
determinations based on the same underlying facts and issues.
(i)(1) If the Secretary determines that a psychiatric
hospital which has an agreement in effect under this section no
longer meets the requirements for a psychiatric hospital under
this title and further finds that the hospital's deficiencies--
(A) immediately jeopardize the health and safety of
its patients, the Secretary shall terminate such
agreement; or
(B) do not immediately jeopardize the health and
safety of its patients, the Secretary may terminate
such agreement, or provide that no payment will be made
under this title with respect to any individual
admitted to such hospital after the effective date of
the finding, or both.
(2) If a psychiatric hospital, found to have deficiencies
described in paragraph (1)(B), has not complied with the
requirements of this title--
(A) within 3 months after the date the hospital is
found to be out of compliance with such requirements,
the Secretary shall provide that no payment will be
made under this title with respect to any individual
admitted to such hospital after the end of such 3-month
period, or
(B) within 6 months after the date the hospital is
found to be out of compliance with such requirements,
no payment may be made under this title with respect to
any individual in the hospital until the Secretary
finds that the hospital is in compliance with the
requirements of this title.
(j) Enrollment Process for Providers of Services and
Suppliers.--
(1) Enrollment process.--
(A) In general.--The Secretary shall
establish by regulation a process for the
enrollment of providers of services and
suppliers under this title. Such process shall
include screening of providers and suppliers in
accordance with paragraph (2), a provisional
period of enhanced oversight in accordance with
paragraph (3), disclosure requirements in
accordance with paragraph (4), the imposition
of temporary enrollment moratoria in accordance
with paragraph (5), and the establishment of
compliance programs in accordance with
paragraph (6).
(B) Deadlines.--The Secretary shall establish
by regulation procedures under which there are
deadlines for actions on applications for
enrollment (and, if applicable, renewal of
enrollment). The Secretary shall monitor the
performance of medicare administrative
contractors in meeting the deadlines
established under this subparagraph.
(C) Consultation before changing provider
enrollment forms.--The Secretary shall consult
with providers of services and suppliers before
making changes in the provider enrollment forms
required of such providers and suppliers to be
eligible to submit claims for which payment may
be made under this title.
(2) Provider screening.--
(A) Procedures.--Not later than 180 days
after the date of enactment of this paragraph,
the Secretary, in consultation with the
Inspector General of the Department of Health
and Human Services, shall establish procedures
under which screening is conducted with respect
to providers of medical or other items or
services and suppliers under the program under
this title, the Medicaid program under title
XIX, and the CHIP program under title XXI.
(B) Level of screening.--The Secretary shall
determine the level of screening conducted
under this paragraph according to the risk of
fraud, waste, and abuse, as determined by the
Secretary, with respect to the category of
provider of medical or other items or services
or supplier. Such screening--
(i) shall include a licensure check,
which may include such checks across
States; and
(ii) may, as the Secretary determines
appropriate based on the risk of fraud,
waste, and abuse described in the
preceding sentence, include--
(I) a criminal background
check;
(II) fingerprinting;
(III) unscheduled and
unannounced site visits,
including preenrollment site
visits;
(IV) database checks
(including such checks across
States); and
(V) such other screening as
the Secretary determines
appropriate.
(C) Application fees.--
(i) Institutional providers.--Except
as provided in clause (ii), the
Secretary shall impose a fee on each
institutional provider of medical or
other items or services or supplier
(such as a hospital or skilled nursing
facility) with respect to which
screening is conducted under this
paragraph in an amount equal to--
(I) for 2010, $500; and
(II) for 2011 and each
subsequent year, the amount
determined under this clause
for the preceding year,
adjusted by the percentage
change in the consumer price
index for all urban consumers
(all items; United States city
average) for the 12-month
period ending with June of the
previous year.
(ii) Hardship exception; waiver for
certain medicaid providers.--The
Secretary may, on a case-by-case basis,
exempt a provider of medical or other
items or services or supplier from the
imposition of an application fee under
this subparagraph if the Secretary
determines that the imposition of the
application fee would result in a
hardship. The Secretary may waive the
application fee under this subparagraph
for providers enrolled in a State
Medicaid program for whom the State
demonstrates that imposition of the fee
would impede beneficiary access to
care.
(iii) Use of funds.--Amounts
collected as a result of the imposition
of a fee under this subparagraph shall
be used by the Secretary for program
integrity efforts, including to cover
the costs of conducting screening under
this paragraph and to carry out this
subsection and section 1128J.
(D) Application and enforcement.--
(i) New providers of services and
suppliers.--The screening under this
paragraph shall apply, in the case of a
provider of medical or other items or
services or supplier who is not
enrolled in the program under this
title, title XIX, or title XXI as of
the date of enactment of this
paragraph, on or after the date that is
1 year after such date of enactment.
(ii) Current providers of services
and suppliers.--The screening under
this paragraph shall apply, in the case
of a provider of medical or other items
or services or supplier who is enrolled
in the program under this title, title
XIX, or title XXI as of such date of
enactment, on or after the date that is
2 years after such date of enactment.
(iii) Revalidation of enrollment.--
Effective beginning on the date that is
180 days after such date of enactment,
the screening under this paragraph
shall apply with respect to the
revalidation of enrollment of a
provider of medical or other items or
services or supplier in the program
under this title, title XIX, or title
XXI.
(iv) Limitation on enrollment and
revalidation of enrollment.--In no case
may a provider of medical or other
items or services or supplier who has
not been screened under this paragraph
be initially enrolled or reenrolled in
the program under this title, title
XIX, or title XXI on or after the date
that is 3 years after such date of
enactment.
(E) Use of information from the department of
treasury concerning tax debts.--In reviewing
the application of a provider of services or
supplier to enroll or reenroll under the
program under this title, the Secretary shall
take into account the information supplied by
the Secretary of the Treasury pursuant to
section 6103(l)(22) of the Internal Revenue
Code of 1986, in determining whether to deny
such application or to apply enhanced oversight
to such provider of services or supplier
pursuant to paragraph (3) if the Secretary
determines such provider of services or
supplier owes such a debt.
(F) Expedited rulemaking.--The Secretary may
promulgate an interim final rule to carry out
this paragraph.
(3) Provisional period of enhanced oversight for new
providers of services and suppliers.--
(A) In general.--The Secretary shall
establish procedures to provide for a
provisional period of not less than 30 days and
not more than 1 year during which new providers
of medical or other items or services and
suppliers, as the Secretary determines
appropriate, including categories of providers
or suppliers, would be subject to enhanced
oversight, such as prepayment review and
payment caps, under the program under this
title, the Medicaid program under title XIX.
and the CHIP program under title XXI.
(B) Implementation.--The Secretary may
establish by program instruction or otherwise
the procedures under this paragraph.
(4) 90-day period of enhanced oversight for initial
claims of dme suppliers.--For periods beginning after
January 1, 2011, if the Secretary determines that there
is a significant risk of fraudulent activity among
suppliers of durable medical equipment, in the case of
a supplier of durable medical equipment who is within a
category or geographic area under title XVIII
identified pursuant to such determination and who is
initially enrolling under such title, the Secretary
shall, notwithstanding sections 1816(c), 1842(c), and
1869(a)(2), withhold payment under such title with
respect to durable medical equipment furnished by such
supplier during the 90-day period beginning on the date
of the first submission of a claim under such title for
durable medical equipment furnished by such supplier.
(5) Increased disclosure requirements.--
(A) Disclosure.--A provider of medical or
other items or services or supplier who submits
an application for enrollment or revalidation
of enrollment in the program under this title,
title XIX, or title XXI on or after the date
that is 1 year after the date of enactment of
this paragraph shall disclose (in a form and
manner and at such time as determined by the
Secretary) any current or previous affiliation
(directly or indirectly) with a provider of
medical or other items or services or supplier
that has uncollected debt, has been or is
subject to a payment suspension under a Federal
health care program (as defined in section
1128B(f)), has been excluded from participation
under the program under this title, the
Medicaid program under title XIX, or the CHIP
program under title XXI, or has had its billing
privileges denied or revoked.
(B) Authority to deny enrollment.--If the
Secretary determines that such previous
affiliation poses an undue risk of fraud,
waste, or abuse, the Secretary may deny such
application. Such a denial shall be subject to
appeal in accordance with paragraph (7).
(6) Authority to adjust payments of providers of
services and suppliers with the same tax identification
number for medicare obligations.--
(A) In general.--Notwithstanding any other
provision of this title, in the case of an
applicable provider of services or supplier,
the Secretary may make any necessary
adjustments to payments to the applicable
provider of services or supplier under the
program under this title in order to satisfy
any amount described in subparagraph (B)(ii)
due from such obligated provider of services or
supplier.
(B) Definitions.--In this paragraph:
(i) In general.--The term
``applicable provider of services or
supplier'' means a provider of services
or supplier that has the same taxpayer
identification number assigned under
section 6109 of the Internal Revenue
Code of 1986 as is assigned to the
obligated provider of services or
supplier under such section, regardless
of whether the applicable provider of
services or supplier is assigned a
different billing number or national
provider identification number under
the program under this title than is
assigned to the obligated provider of
services or supplier.
(ii) Obligated provider of services
or supplier.--The term ``obligated
provider of services or supplier''
means a provider of services or
supplier that owes an amount that is
more than the amount required to be
paid under the program under this title
(as determined by the Secretary).
(7) Temporary moratorium on enrollment of new
providers.--
(A) In general.--The Secretary may impose a
temporary moratorium on the enrollment of new
providers of services and suppliers, including
categories of providers of services and
suppliers, in the program under this title,
under the Medicaid program under title XIX, or
under the CHIP program under title XXI if the
Secretary determines such moratorium is
necessary to prevent or combat fraud, waste, or
abuse under either such program.
(B) Limitation on review.--There shall be no
judicial review under section 1869, section
1878, or otherwise, of a temporary moratorium
imposed under subparagraph (A).
(8) Compliance programs.--
(A) In general.--On or after the date of
implementation determined by the Secretary
under subparagraph (C), a provider of medical
or other items or services or supplier within a
particular industry sector or category shall,
as a condition of enrollment in the program
under this title, title XIX, or title XXI,
establish a compliance program that contains
the core elements established under
subparagraph (B) with respect to that provider
or supplier and industry or category.
(B) Establishment of core elements.--The
Secretary, in consultation with the Inspector
General of the Department of Health and Human
Services, shall establish core elements for a
compliance program under subparagraph (A) for
providers or suppliers within a particular
industry or category.
(C) Timeline for implementation.--The
Secretary shall determine the timeline for the
establishment of the core elements under
subparagraph (B) and the date of the
implementation of subparagraph (A) for
providers or suppliers within a particular
industry or category. The Secretary shall, in
determining such date of implementation,
consider the extent to which the adoption of
compliance programs by a provider of medical or
other items or services or supplier is
widespread in a particular industry sector or
with respect to a particular provider or
supplier category.
(8) Hearing rights in cases of denial or non-
renewal.--A provider of services or supplier whose
application to enroll (or, if applicable, to renew
enrollment) under this title is denied may have a
hearing and judicial review of such denial under the
procedures that apply under subsection (h)(1)(A) to a
provider of services that is dissatisfied with a
determination by the Secretary.
(k) Quality Reporting by Cancer Hospitals.--
(1) In general.--For purposes of fiscal year 2014 and
each subsequent fiscal year, a hospital described in
section 1886(d)(1)(B)(v) shall submit data to the
Secretary in accordance with paragraph (2) with respect
to such a fiscal year.
(2) Submission of quality data.--For fiscal year 2014
and each subsequent fiscal year, each hospital
described in such section shall submit to the Secretary
data on quality measures specified under paragraph (3).
Such data shall be submitted in a form and manner, and
at a time, specified by the Secretary for purposes of
this subparagraph.
(3) Quality measures.--
(A) In general.--Subject to subparagraph (B),
any measure specified by the Secretary under
this paragraph must have been endorsed by the
entity with a contract under section 1890(a).
(B) Exception.--In the case of a specified
area or medical topic determined appropriate by
the Secretary for which a feasible and
practical measure has not been endorsed by the
entity with a contract under section 1890(a),
the Secretary may specify a measure that is not
so endorsed as long as due consideration is
given to measures that have been endorsed or
adopted by a consensus organization identified
by the Secretary.
(C) Time frame.--Not later than October 1,
2012, the Secretary shall publish the measures
selected under this paragraph that will be
applicable with respect to fiscal year 2014.
(4) Public availability of data submitted.--The
Secretary shall establish procedures for making data
submitted under paragraph (4) available to the public.
Such procedures shall ensure that a hospital described
in section 1886(d)(1)(B)(v) has the opportunity to
review the data that is to be made public with respect
to the hospital prior to such data being made public.
The Secretary shall report quality measures of process,
structure, outcome, patients' perspective on care,
efficiency, and costs of care that relate to services
furnished in such hospitals on the Internet website of
the Centers for Medicare & Medicaid Services.
* * * * * * *
Text of Existing Law Amended or Repealed by the Bill, as Reported
In compliance with clause 3(e)(1)(A) of rule XIII of the
Rules of the House of Representatives, the text of each section
proposed to be amended or repealed by the bill, as reported, is
shown below:
SOCIAL SECURITY ACT
* * * * * * *
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
Part E--Miscellaneous Provisions
* * * * * * *
agreements with providers of services; enrollment processes
Sec. 1866. (a)(1) Any provider of services (except a fund
designated for purposes of section 1814(g) and section 1835(e))
shall be qualified to participate under this title and shall be
eligible for payments under this title if it files with the
Secretary an agreement--
(A)(i) not to charge, except as provided in paragraph
(2), any individual or any other person for items or
services for which such individual is entitled to have
payment made under this title (or for which he would be
so entitled if such provider of services had complied
with the procedural and other requirements under or
pursuant to this title or for which such provider is
paid pursuant to the provisions of section 1814(e)),
and (ii) not to impose any charge that is prohibited
under section 1902(n)(3),
(B) not to charge any individual or any other person
for items or services for which such individual is not
entitled to have payment made under this title because
payment for expenses incurred for such items or
services may not be made by reason of the provisions of
paragraph (1) or (9) of section 1862(a), but only if
(i) such individual was without fault in incurring such
expenses and (ii) the Secretary's determination that
such payment may not be made for such items and
services was made after the third year following the
year in which notice of such payment was sent to such
individual; except that the Secretary may reduce such
three-year period to not less than one year if he finds
such reduction is consistent with the objectives of
this title,
(C) to make adequate provision for return (or other
disposition, in accordance with regulations) of any
moneys incorrectly collected from such individual or
other person,
(D) to promptly notify the Secretary of its
employment of an individual who, at any time during the
year preceding such employment, was employed in a
managerial, accounting, auditing, or similar capacity
(as determined by the Secretary by regulation) by an
agency or organization which serves as a fiscal
intermediary or carrier (for purposes of part A or part
B, or both, of this title) with respect to the
provider,
(E) to release data with respect to patients of such
provider upon request to an organization having a
contract with the Secretary under part B of title XI as
may be necessary (i) to allow such organization to
carry out its functions under such contract, or (ii) to
allow such organization to carry out similar review
functions under any contract the organization may have
with a private or public agency paying for health care
in the same area with respect to patients who authorize
release of such data for such purposes,
(F)(i) in the case of hospitals which provide
inpatient hospital services for which payment may be
made under subsection (b), (c), or (d) of section 1886,
to maintain an agreement with a professional standards
review organization (if there is such an organization
in existence in the area in which the hospital is
located) or with a quality improvement organization
which has a contract with the Secretary under part B of
title XI for the area in which the hospital is located,
under which the organization will perform functions
under that part with respect to the review of the
validity of diagnostic information provided by such
hospital, the completeness, adequacy, and quality of
care provided, the appropriateness of admissions and
discharges, and the appropriateness of care provided
for which additional payments are sought under section
1886(d)(5), with respect to inpatient hospital services
for which payment may be made under part A of this
title (and for purposes of payment under this title,
the cost of such agreement to the hospital shall be
considered a cost incurred by such hospital in
providing inpatient services under part A, and (I)
shall be paid directly by the Secretary to such
organization on behalf of such hospital in accordance
with a rate per review established by the Secretary,
(II) shall be transferred from the Federal Hospital
Insurance Trust Fund, without regard to amounts
appropriated in advance in appropriation Acts, in the
same manner as transfers are made for payment for
services provided directly to beneficiaries, and (III)
shall not be less in the aggregate for a fiscal year
than the aggregate amount expended in fiscal year 1988
for direct and administrative costs (adjusted for
inflation and for any direct or administrative costs
incurred as a result of review functions added with
respect to a subsequent fiscal year) of such reviews),
(ii) in the case of hospitals, critical access
hospitals, skilled nursing facilities, and home health
agencies, to maintain an agreement with a quality
improvement organization (which has a contract with the
Secretary under part B of title XI for the area in
which the hospital, facility, or agency is located) to
perform the functions described in paragraph (3)(A),
(G) in the case of hospitals which provide inpatient
hospital services for which payment may be made under
subsection (b) or (d) of section 1886, not to charge
any individual or any other person for inpatient
hospital services for which such individual would be
entitled to have payment made under part A but for a
denial or reduction of payments under section
1886(f)(2),
(H)(i) in the case of hospitals which provide
services for which payment may be made under this title
and in the case of critical access hospitals which
provide critical access hospital services, to have all
items and services (other than physicians' services as
defined in regulations for purposes of section
1862(a)(14), and other than services described by
section 1861(s)(2)(K), certified nurse-midwife
services, qualified psychologist services, and services
of a certified registered nurse anesthetist) (I) that
are furnished to an individual who is a patient of the
hospital, and (II) for which the individual is entitled
to have payment made under this title, furnished by the
hospital or otherwise under arrangements (as defined in
section 1861(w)(1)) made by the hospital,
(ii) in the case of skilled nursing facilities which
provide covered skilled nursing facility services--
(I) that are furnished to an individual who
is a resident of the skilled nursing facility
during a period in which the resident is
provided covered post-hospital extended care
services (or, for services described in section
1861(s)(2)(D), that are furnished to such an
individual without regard to such period), and
(II) for which the individual is entitled to
have payment made under this title,
to have items and services (other than services
described in section 1888(e)(2)(A)(ii)) furnished by
the skilled nursing facility or otherwise under
arrangements (as defined in section 1861(w)(1)) made by
the skilled nursing facility,
(I) in the case of a hospital or critical access
hospital--
(i) to adopt and enforce a policy to ensure
compliance with the requirements of section
1867 and to meet the requirements of such
section,
(ii) to maintain medical and other records
related to individuals transferred to or from
the hospital for a period of five years from
the date of the transfer, and
(iii) to maintain a list of physicians who
are on call for duty after the initial
examination to provide treatment necessary to
stabilize an individual with an emergency
medical condition,
(J) in the case of hospitals which provide inpatient
hospital services for which payment may be made under
this title, to be a participating provider of medical
care under any health plan contracted for under section
1079 or 1086 of title 10, or under section 613 of title
38, United States Code, in accordance with admission
practices, payment methodology, and amounts as
prescribed under joint regulations issued by the
Secretary and by the Secretaries of Defense and
Transportation, in implementation of sections 1079 and
1086 of title 10, United States Code,
(K) not to charge any individual or any other person
for items or services for which payment under this
title is denied under section 1154(a)(2) by reason of a
determination under section 1154(a)(1)(B),
(L) in the case of hospitals which provide inpatient
hospital services for which payment may be made under
this title, to be a participating provider of medical
care under section 603 of title 38, United States Code,
in accordance with such admission practices, and such
payment methodology and amounts, as are prescribed
under joint regulations issued by the Secretary and by
the Secretary of Veterans Affairs in implementation of
such section,
(M) in the case of hospitals, to provide to each
individual who is entitled to benefits under part A (or
to a person acting on the individual's behalf), at or
about the time of the individual's admission as an
inpatient to the hospital, a written statement
(containing such language as the Secretary prescribes
consistent with this paragraph) which explains--
(i) the individual's rights to benefits for
inpatient hospital services and for post-
hospital services under this title,
(ii) the circumstances under which such an
individual will and will not be liable for
charges for continued stay in the hospital,
(iii) the individual's right to appeal
denials of benefits for continued inpatient
hospital services, including the practical
steps to initiate such an appeal, and
(iv) the individual's liability for payment
for services if such a denial of benefits is
upheld on appeal,--and which provides such
additional information as the Secretary may
specify,
(N) in the case of hospitals and critical access
hospitals--
(i) to make available to its patients the
directory or directories of participating
physicians (published under section 1842(h)(4))
for the area served by the hospital or critical
access hospital,
(ii) if hospital personnel (including staff
of any emergency or outpatient department)
refer a patient to a nonparticipating physician
for further medical care on an outpatient
basis, the personnel must inform the patient
that the physician is a nonparticipating
physician and, whenever practicable, must
identify at least one qualified participating
physician who is listed in such a directory and
from whom the patient may receive the necessary
services,
(iii) to post conspicuously in any emergency
department a sign (in a form specified by the
Secretary) specifying rights of individuals
under section 1867 with respect to examination
and treatment for emergency medical conditions
and women in labor, and
(iv) to post conspicuously (in a form
specified by the Secretary) information
indicating whether or not the hospital
participates in the medicaid program under a
State plan approved under title XIX,
(O) to accept as payment in full for services that
are covered under this title and are furnished to any
individual enrolled with a Medicare+Choice organization
under part C, with a PACE provider under section 1894
or 1934, or with an eligible organization with a risk-
sharing contract under section 1876, under section
1876(i)(2)(A) (as in effect before February 1, 1985),
under section 402(a) of the Social Security Amendments
of 1967, or under section 222(a) of the Social Security
Amendments of 1972, which does not have a contract (or,
in the case of a PACE provider, contract or other
agreement) establishing payment amounts for services
furnished to members of the organization or PACE
program eligible individuals enrolled with the PACE
provider, the amounts that would be made as a payment
in full under this title (less any payments under
sections 1886(d)(11) and 1886(h)(3)(D)) if the
individuals were not so enrolled,
(P) in the case of home health agencies which provide
home health services to individuals entitled to
benefits under this title who require catheters,
catheter supplies, ostomy bags, and supplies related to
ostomy car (described in section 1861(m)(5)), to offer
to furnish such supplies to such an individual as part
of their furnishing of home health services,
(Q) in the case of hospitals, skilled nursing
facilities, home health agencies, and hospice programs,
to comply with the requirement of subsection (f)
(relating to maintaining written policies and
procedures respecting advance directives),
(R) to contract only with a health care clearinghouse
(as defined in section 1171) that meets each standard
and implementation specification adopted or established
under part C of title XI on or after the date on which
the health care clearinghouse is required to comply
with the standard or specification,
(S) in the case of a hospital that has a financial
interest (as specified by the Secretary in regulations)
in an entity to which individuals are referred as
described in section 1861(ee)(2)(H)(ii), or in which
such an entity has such a financial interest, or in
which another entity has such a financial interest
(directly or indirectly) with such hospital and such an
entity, to maintain and disclose to the Secretary (in a
form and manner specified by the Secretary) information
on--
(i) the nature of such financial interest,
(ii) the number of individuals who were
discharged from the hospital and who were
identified as requiring home health services,
and
(iii) the percentage of such individuals who
received such services from such provider (or
another such provider),
(T) in the case of hospitals and critical access
hospitals, to furnish to the Secretary such data as the
Secretary determines appropriate pursuant to
subparagraph (E) of section 1886(d)(12) to carry out
such section,
(U) in the case of hospitals which furnish inpatient
hospital services for which payment may be made under
this title, to be a participating provider of medical
care both--
(i) under the contract health services
program funded by the Indian Health Service and
operated by the Indian Health Service, an
Indian tribe, or tribal organization (as those
terms are defined in section 4 of the Indian
Health Care Improvement Act), with respect to
items and services that are covered under such
program and furnished to an individual eligible
for such items and services under such program;
and
(ii) under any program funded by the Indian
Health Service and operated by an urban Indian
organization with respect to the purchase of
items and services for an eligible urban Indian
(as those terms are defined in such section 4),
in accordance with regulations promulgated by the
Secretary regarding admission practices, payment
methodology, and rates of payment (including the
acceptance of no more than such payment rate as payment
in full for such items and services,
(V) in the case of hospitals that are not otherwise
subject to the Occupational Safety and Health Act of
1970 (or a State occupational safety and health plan
that is approved under 18(b) of such Act), to comply
with the Bloodborne Pathogens standard under section
1910.1030 of title 29 of the Code of Federal
Regulations (or as subsequently redesignated), and
(W) in the case of a hospital described in
section 1886(d)(1)(B)(v), to report quality
data to the Secretary in accordance with
subsection (k).
(W) maintain and, upon request of the
Secretary, provide access to documentation
relating to written orders or requests for
payment for durable medical equipment,
certifications for home health services, or
referrals for other items or services written
or ordered by the provider under this title, as
specified by the Secretary.
In the case of a hospital which has an agreement in effect with
an organization described in subparagraph (F), which
organization's contract with the Secretary under part B of
title XI is terminated on or after October 1, 1984, the
hospital shall not be determined to be out of compliance with
the requirement of such subparagraph during the six month
period beginning on the date of the termination of that
contract.
(2)(A) A provider of services may charge such individual or
other person (i) the amount of any deduction or coinsurance
amount imposed pursuant to section 1813(a)(1), (a)(3), or
(a)(4), section 1833(b), or section 1861(y)(3) with respect to
such items and services (not in excess of the amount
customarily charged for such items and services by such
provider), and (ii) an amount equal to 20 per centum of the
reasonable charges for such items and services (not in excess
of 20 per centum of the amount customarily charged for such
items and services by such provider) for which payment is made
under part B or which are durable medical equipment furnished
as home health services (but in the case of items and services
furnished to individuals with end-stage renal disease, an
amount equal to 20 percent of the estimated amounts for such
items and services calculated on the basis established by the
Secretary). In the case of items and services described in
section 1833(c), clause (ii) of the preceding sentence shall be
applied by substituting for 20 percent the proportion which is
appropriate under such section. A provider of services may not
impose a charge under clause (ii) of the first sentence of this
subparagraph with respect to items and services described in
section 1861(s)(10)(A) and with respect to clinical diagnostic
laboratory tests for which payment is made under part B.
Notwithstanding the first sentence of this subparagraph, a home
health agency may charge such an individual or person, with
respect to covered items subject to payment under section
1834(a), the amount of any deduction imposed under section
1833(b) and 20 percent of the payment basis described in
section 1834(a)(1)(B). In the case of items and services for
which payment is made under part B under the prospective
payment system established under section 1833(t), clause (ii)
of the first sentence shall be applied by substituting for 20
percent of the reasonable charge, the applicable copayment
amount established under section 1833(t)(5). In the case of
services described in section 1833(a)(8) or section 1833(a)(9)
for which payment is made under part B under section 1834(k),
clause (ii) of the first sentence shall be applied by
substituting for 20 percent of the reasonable charge for such
services 20 percent of the lesser of the actual charge or the
applicable fee schedule amount (as defined in such section) for
such services.
(B) Where a provider of services has furnished, at the
request of such individual, items or services which are in
excess of or more expensive than the items or services with
respect to which payment may be made under this title, such
provider of services may also charge such individual or other
person for such more expensive items or services to the extent
that the amount customarily charged by it for the items or
services furnished at such request exceeds the amount
customarily charged by it for the items or services with
respect to which payment may be made under this title.
(C) A provider of services may in accordance with its
customary practice also appropriately charge any such
individual for any whole blood (or equivalent quantities of
packed red blood cells, as defined under regulations) furnished
him with respect to which a deductible is imposed under section
1813(a)(2), except that (i) any excess of such charge over the
cost to such provider for the blood (or equivalent quantities
of packed red blood cells, as so defined) shall be deducted
from any payment to such provider under this title, (ii) no
such charge may be imposed for the cost of administration of
such blood (or equivalent quantities of packed red blood cells,
as so defined), and (iii) such charge may not be made to the
extent such blood (or equivalent quantities of packed red blood
cells, as so defined) has been replaced on behalf of such
individual or arrangements have been made for its replacement
on his behalf. For purposes of subparagraph (C), whole blood
(or equivalent quantities of packed red blood cells, as so
defined) furnished an individual shall be deemed replaced when
the provider of services is given one pint of blood for each
pint of blood (or equivalent quantities of packed red blood
cells, as so defined) furnished such individual with respect to
which a deduction is imposed under section 1813(a)(2).
(D) Where a provider of services customarily furnishes items
or services which are in excess of or more expensive than the
items or services with respect to which payment may be made
under this title, such provider, notwithstanding the preceding
provisions of this paragraph, may not, under the authority of
section 1866(a)(2)(B)(ii), charge any individual or other
person any amount for such items or services in excess of the
amount of the payment which may otherwise be made for such
items or services under this title if the admitting physician
has a direct or indirect financial interest in such provider.
(3)(A) Under the agreement required under paragraph
(1)(F)(ii), the quality improvement organization must perform
functions (other than those covered under an agreement under
paragraph (1)(F)(i)) under the third sentence of section
1154(a)(4)(A) and under section 1154(a)(14) with respect to
services, furnished by the hospital, critical access hospital,
facility, or agency involved, for which payment may be made
under this title.
(B) For purposes of payment under this title, the cost of
such an agreement to the hospital, critical access hospital,
facility, or agency shall be considered a cost incurred by such
hospital, critical access hospital, facility, or agency in
providing covered services under this title and shall be paid
directly by the Secretary to the quality improvement
organization on behalf of such hospital, critical access
hospital, facility, or agency in accordance with a schedule
established by the Secretary.
(C) Such payments--
(i) shall be transferred in appropriate proportions
from the Federal Hospital Insurance Trust Fund and from
the Federal Supplementary Medical Insurance Trust Fund,
without regard to amounts appropriated in advance in
appropriation Acts, in the same manner as transfers are
made for payment for services provided directly to
beneficiaries, and
(ii) shall not be less in the aggregate for a fiscal
year--
(I) in the case of hospitals, than the amount
specified in paragraph (1)(F)(i)(III), and
(II) in the case of facilities, critical
access hospitals, and agencies, than the
amounts the Secretary determines to be
sufficient to cover the costs of such
organizations' conducting the activities
described in subparagraph (A) with respect to
such facilities, critical access hospitals, or
agencies under part B of title XI.
(b)(1) A provider of services may terminate an agreement with
the Secretary under this section at such time and upon such
notice to the Secretary and the public as may be provided in
regulations, except that notice of more than six months shall
not be required.
(2) The Secretary may refuse to enter into an agreement under
this section or, upon such reasonable notice to the provider
and the public as may be specified in regulations, may refuse
to renew or may terminate such an agreement after the
Secretary--
(A) has determined that the provider fails to comply
substantially with the provisions of the agreement,
with the provisions of this title and regulations
thereunder, or with a corrective action required under
section 1886(f)(2)(B),
(B) has determined that the provider fails
substantially to meet the applicable provisions of
section 1861,
(C) has excluded the provider from participation in a
program under this title pursuant to section 1128 or
section 1128A, or
(D) has ascertained that the provider has been
convicted of a felony under Federal or State law for an
offense which the Secretary determines is detrimental
to the best interests of the program or program
beneficiaries.
(3) A termination of an agreement or a refusal to renew an
agreement under this subsection shall become effective on the
same date and in the same manner as an exclusion from
participation under the programs under this title becomes
effective under section 1128(c).
(4)(A) A hospital that fails to comply with the requirement
of subsection (a)(1)(V) (relating to the Bloodborne Pathogens
standard) is subject to a civil money penalty in an amount
described in subparagraph (B), but is not subject to
termination of an agreement under this section.
(B) The amount referred to in subparagraph (A) is an amount
that is similar to the amount of civil penalties that may be
imposed under section 17 of the Occupational Safety and Health
Act of 1970 for a violation of the Bloodborne Pathogens
standard referred to in subsection (a)(1)(U) by a hospital that
is subject to the provisions of such Act.
(C) A civil money penalty under this paragraph shall be
imposed and collected in the same manner as civil money
penalties under subsection (a) of section 1128A are imposed and
collected under that section.
(c)(1) Where the Secretary has terminated or has refused to
renew an agreement under this title with a provider of
services, such provider may not file another agreement under
this title unless the Secretary finds that the reason for the
termination or nonrenewal has been removed and that there is
reasonable assurance that it will not recur.
(2) Where the Secretary has terminated or has refused to
renew an agreement under this title with a provider of
services, the Secretary shall promptly notify each State agency
which administers or supervises the administration of a State
plan approved under title XIX of such termination or
nonrenewal.
(d) If the Secretary finds that there is a substantial
failure to make timely review in accordance with section
1861(k) of long-stay cases in a hospital, he may, in lieu of
terminating his agreement with such hospital, decide that, with
respect to any individual admitted to such hospital after a
subsequent date specified by him, no payment shall be made
under this title for inpatient hospital services (including
inpatient psychiatric hospital services) after the 20th day of
a continuous period of such services. Such decision may be made
effective only after such notice to the hospital and to the
public, as may be prescribed by regulations, and its
effectiveness shall terminate when the Secretary finds that the
reason therefor has been removed and that there is reasonable
assurance that it will not recur. The Secretary shall not make
any such decision except after reasonable notice and
opportunity for hearing to the institution or agency affected
thereby.
(e) For purposes of this section, the term ``provider of
services'' shall include--
(1) a clinic, rehabilitation agency, or public health
agency if, in the case of a clinic or rehabilitation
agency, such clinic or agency meets the requirements of
section 1861(p)(4)(A) (or meets the requirements of
such section through the operation of subsection (g) or
(ll)(2) of section 1861), or if, in the case of a
public health agency, such agency meets the
requirements of section 1861(p)(4)(B) (or meets the
requirements of such section through the operation of
subsection (g) or (ll)(2) of section 1861), but only
with respect to the furnishing of outpatient physical
therapy services (as therein defined), (through the
operation of section 1861(g)) with respect to the
furnishing of outpatient occupational therapy services,
or (through the operation of section 1861(ll)(2)) with
respect to the furnishing of outpatient speech-language
pathology; and
(2) a community mental health center (as defined in
section 1861(ff)(3)(B)), but only with respect to the
furnishing of partial hospitalization services (as
described in section 1861(ff)(1)).
(f)(1) For purposes of subsection (a)(1)(Q) and sections
1819(c)(2)(E), 1833(s), 1855(i), 1876(c)(8), and 1891(a)(6),
the requirement of this subsection is that a provider of
services, Medicare+Choice organization, or prepaid or eligible
organization (as the case may be) maintain written policies and
procedures with respect to all adult individuals receiving
medical care by or through the provider or organization--
(A) to provide written information to each such
individual concerning--
(i) an individual's rights under State law
(whether statutory or as recognized by the
courts of the State) to make decisions
concerning such medical care, including the
right to accept or refuse medical or surgical
treatment and the right to formulate advance
directives (as defined in paragraph (3)), and
(ii) the written policies of the provider or
organization respecting the implementation of
such rights;
(B) to document in a prominent part of the
individual's current medical record whether or not the
individual has executed an advance directive;
(C) not to condition the provision of care or
otherwise discriminate against an individual based on
whether or not the individual has executed an advance
directive;
(D) to ensure compliance with requirements of State
law (whether statutory or as recognized by the courts
of the State) respecting advance directives at
facilities of the provider or organization; and
(E) to provide (individually or with others) for
education for staff and the community on issues
concerning advance directives.
Subparagraph (C) shall not be construed as requiring the
provision of care which conflicts with an advance directive.
(2) The written information described in paragraph (1)(A)
shall be provided to an adult individual--
(A) in the case of a hospital, at the time of the
individual's admission as an inpatient,
(B) in the case of a skilled nursing facility, at the
time of the individual's admission as a resident,
(C) in the case of a home health agency, in advance
of the individual coming under the care of the agency,
(D) in the case of a hospice program, at the time of
initial receipt of hospice care by the individual from
the program, and
(E) in the case of an eligible organization (as
defined in section 1876(b)) or an organization provided
payments under section 1833(a)(1)(A) or a
Medicare+Choice organization, at the time of enrollment
of the individual with the organization.
(3) In this subsection, the term ``advance directive'' means
a written instruction, such as a living will or durable power
of attorney for health care, recognized under State law
(whether statutory or as recognized by the courts of the State)
and relating to the provision of such care when the individual
is incapacitated.
(4) For construction relating to this subsection, see section
7 of the Assisted Suicide Funding Restriction Act of 1997
(relating to clarification respecting assisted suicide,
euthanasia, and mercy killing).
(g) Except as permitted under subsection (a)(2), any person
who knowingly and willfully presents, or causes to be
presented, a bill or request for payment inconsistent with an
arrangement under subsection (a)(1)(H) or in violation of the
requirement for such an arrangement, is subject to a civil
money penalty of not to exceed $2,000. The provisions of
section 1128A (other than subsections (a) and (b)) shall apply
to a civil money penalty under the previous sentence in the
same manner as such provisions apply to a penalty or proceeding
under section 1128A(a).
(h)(1)(A) Except as provided in paragraph (2), an institution
or agency dissatisfied with a determination by the Secretary
that it is not a provider of services or with a determination
described in subsection (b)(2) shall be entitled to a hearing
thereon by the Secretary (after reasonable notice) to the same
extent as is provided in section 205(b), and to judicial review
of the Secretary's final decision after such hearing as is
provided in section 205(g), except that, in so applying such
sections and in applying section 205(l) thereto, any reference
therein to the Commissioner of Social Security or the Social
Security Administration shall be considered a reference to the
Secretary or the Department of Health and Human Services,
respectively.
(B) An institution or agency described in subparagraph (A)
that has filed for a hearing under subparagraph (A) shall have
expedited access to judicial review under this subparagraph in
the same manner as providers of services, suppliers, and
individuals entitled to benefits under part A or enrolled under
part B, or both, may obtain expedited access to judicial review
under the process established under section 1869(b)(2). Nothing
in this subparagraph shall be construed to affect the
application of any remedy imposed under section 1819 during the
pendency of an appeal under this subparagraph.
(C)(i) The Secretary shall develop and implement a process to
expedite proceedings under this subsection in which--
(I) the remedy of termination of participation has
been imposed;
(II) a remedy described in clause (i) or (iii) of
section 1819(h)(2)(B) has been imposed, but only if
such remedy has been imposed on an immediate basis; or
(III) a determination has been made as to a finding
of substandard quality of care that results in the loss
of approval of a skilled nursing facility's nurse aide
training program.
(ii) Under such process under clause (i), priority shall be
provided in cases of termination described in clause (i)(I).
(iii) Nothing in this subparagraph shall be construed to
affect the application of any remedy imposed under section 1819
during the pendency of an appeal under this subparagraph.
(2) An institution or agency is not entitled to separate
notice and opportunity for a hearing under both section 1128
and this section with respect to a determination or
determinations based on the same underlying facts and issues.
(i)(1) If the Secretary determines that a psychiatric
hospital which has an agreement in effect under this section no
longer meets the requirements for a psychiatric hospital under
this title and further finds that the hospital's deficiencies--
(A) immediately jeopardize the health and safety of
its patients, the Secretary shall terminate such
agreement; or
(B) do not immediately jeopardize the health and
safety of its patients, the Secretary may terminate
such agreement, or provide that no payment will be made
under this title with respect to any individual
admitted to such hospital after the effective date of
the finding, or both.
(2) If a psychiatric hospital, found to have deficiencies
described in paragraph (1)(B), has not complied with the
requirements of this title--
(A) within 3 months after the date the hospital is
found to be out of compliance with such requirements,
the Secretary shall provide that no payment will be
made under this title with respect to any individual
admitted to such hospital after the end of such 3-month
period, or
(B) within 6 months after the date the hospital is
found to be out of compliance with such requirements,
no payment may be made under this title with respect to
any individual in the hospital until the Secretary
finds that the hospital is in compliance with the
requirements of this title.
(j) Enrollment Process for Providers of Services and
Suppliers.--
(1) Enrollment process.--
(A) In general.--The Secretary shall
establish by regulation a process for the
enrollment of providers of services and
suppliers under this title. Such process shall
include screening of providers and suppliers in
accordance with paragraph (2), a provisional
period of enhanced oversight in accordance with
paragraph (3), disclosure requirements in
accordance with paragraph (4), the imposition
of temporary enrollment moratoria in accordance
with paragraph (5), and the establishment of
compliance programs in accordance with
paragraph (6).
(B) Deadlines.--The Secretary shall establish
by regulation procedures under which there are
deadlines for actions on applications for
enrollment (and, if applicable, renewal of
enrollment). The Secretary shall monitor the
performance of medicare administrative
contractors in meeting the deadlines
established under this subparagraph.
(C) Consultation before changing provider
enrollment forms.--The Secretary shall consult
with providers of services and suppliers before
making changes in the provider enrollment forms
required of such providers and suppliers to be
eligible to submit claims for which payment may
be made under this title.
(2) Provider screening.--
(A) Procedures.--Not later than 180 days
after the date of enactment of this paragraph,
the Secretary, in consultation with the
Inspector General of the Department of Health
and Human Services, shall establish procedures
under which screening is conducted with respect
to providers of medical or other items or
services and suppliers under the program under
this title, the Medicaid program under title
XIX, and the CHIP program under title XXI.
(B) Level of screening.--The Secretary shall
determine the level of screening conducted
under this paragraph according to the risk of
fraud, waste, and abuse, as determined by the
Secretary, with respect to the category of
provider of medical or other items or services
or supplier. Such screening--
(i) shall include a licensure check,
which may include such checks across
States; and
(ii) may, as the Secretary determines
appropriate based on the risk of fraud,
waste, and abuse described in the
preceding sentence, include--
(I) a criminal background
check;
(II) fingerprinting;
(III) unscheduled and
unannounced site visits,
including preenrollment site
visits;
(IV) database checks
(including such checks across
States); and
(V) such other screening as
the Secretary determines
appropriate.
(C) Application fees.--
(i) Institutional providers.--Except
as provided in clause (ii), the
Secretary shall impose a fee on each
institutional provider of medical or
other items or services or supplier
(such as a hospital or skilled nursing
facility) with respect to which
screening is conducted under this
paragraph in an amount equal to--
(I) for 2010, $500; and
(II) for 2011 and each
subsequent year, the amount
determined under this clause
for the preceding year,
adjusted by the percentage
change in the consumer price
index for all urban consumers
(all items; United States city
average) for the 12-month
period ending with June of the
previous year.
(ii) Hardship exception; waiver for
certain medicaid providers.--The
Secretary may, on a case-by-case basis,
exempt a provider of medical or other
items or services or supplier from the
imposition of an application fee under
this subparagraph if the Secretary
determines that the imposition of the
application fee would result in a
hardship. The Secretary may waive the
application fee under this subparagraph
for providers enrolled in a State
Medicaid program for whom the State
demonstrates that imposition of the fee
would impede beneficiary access to
care.
(iii) Use of funds.--Amounts
collected as a result of the imposition
of a fee under this subparagraph shall
be used by the Secretary for program
integrity efforts, including to cover
the costs of conducting screening under
this paragraph and to carry out this
subsection and section 1128J.
(D) Application and enforcement.--
(i) New providers of services and
suppliers.--The screening under this
paragraph shall apply, in the case of a
provider of medical or other items or
services or supplier who is not
enrolled in the program under this
title, title XIX, or title XXI as of
the date of enactment of this
paragraph, on or after the date that is
1 year after such date of enactment.
(ii) Current providers of services
and suppliers.--The screening under
this paragraph shall apply, in the case
of a provider of medical or other items
or services or supplier who is enrolled
in the program under this title, title
XIX, or title XXI as of such date of
enactment, on or after the date that is
2 years after such date of enactment.
(iii) Revalidation of enrollment.--
Effective beginning on the date that is
180 days after such date of enactment,
the screening under this paragraph
shall apply with respect to the
revalidation of enrollment of a
provider of medical or other items or
services or supplier in the program
under this title, title XIX, or title
XXI.
(iv) Limitation on enrollment and
revalidation of enrollment.--In no case
may a provider of medical or other
items or services or supplier who has
not been screened under this paragraph
be initially enrolled or reenrolled in
the program under this title, title
XIX, or title XXI on or after the date
that is 3 years after such date of
enactment.
(E) Use of information from the department of
treasury concerning tax debts.--In reviewing
the application of a provider of services or
supplier to enroll or reenroll under the
program under this title, the Secretary shall
take into account the information supplied by
the Secretary of the Treasury pursuant to
section 6103(l)(22) of the Internal Revenue
Code of 1986, in determining whether to deny
such application or to apply enhanced oversight
to such provider of services or supplier
pursuant to paragraph (3) if the Secretary
determines such provider of services or
supplier owes such a debt.
(F) Expedited rulemaking.--The Secretary may
promulgate an interim final rule to carry out
this paragraph.
(3) Provisional period of enhanced oversight for new
providers of services and suppliers.--
(A) In general.--The Secretary shall
establish procedures to provide for a
provisional period of not less than 30 days and
not more than 1 year during which new providers
of medical or other items or services and
suppliers, as the Secretary determines
appropriate, including categories of providers
or suppliers, would be subject to enhanced
oversight, such as prepayment review and
payment caps, under the program under this
title, the Medicaid program under title XIX.
and the CHIP program under title XXI.
(B) Implementation.--The Secretary may
establish by program instruction or otherwise
the procedures under this paragraph.
(4) 90-day period of enhanced oversight for initial
claims of dme suppliers.--For periods beginning after
January 1, 2011, if the Secretary determines that there
is a significant risk of fraudulent activity among
suppliers of durable medical equipment, in the case of
a supplier of durable medical equipment who is within a
category or geographic area under title XVIII
identified pursuant to such determination and who is
initially enrolling under such title, the Secretary
shall, notwithstanding sections 1816(c), 1842(c), and
1869(a)(2), withhold payment under such title with
respect to durable medical equipment furnished by such
supplier during the 90-day period beginning on the date
of the first submission of a claim under such title for
durable medical equipment furnished by such supplier.
(5) Increased disclosure requirements.--
(A) Disclosure.--A provider of medical or
other items or services or supplier who submits
an application for enrollment or revalidation
of enrollment in the program under this title,
title XIX, or title XXI on or after the date
that is 1 year after the date of enactment of
this paragraph shall disclose (in a form and
manner and at such time as determined by the
Secretary) any current or previous affiliation
(directly or indirectly) with a provider of
medical or other items or services or supplier
that has uncollected debt, has been or is
subject to a payment suspension under a Federal
health care program (as defined in section
1128B(f)), has been excluded from participation
under the program under this title, the
Medicaid program under title XIX, or the CHIP
program under title XXI, or has had its billing
privileges denied or revoked.
(B) Authority to deny enrollment.--If the
Secretary determines that such previous
affiliation poses an undue risk of fraud,
waste, or abuse, the Secretary may deny such
application. Such a denial shall be subject to
appeal in accordance with paragraph (7).
(6) Authority to adjust payments of providers of
services and suppliers with the same tax identification
number for medicare obligations.--
(A) In general.--Notwithstanding any other
provision of this title, in the case of an
applicable provider of services or supplier,
the Secretary may make any necessary
adjustments to payments to the applicable
provider of services or supplier under the
program under this title in order to satisfy
any amount described in subparagraph (B)(ii)
due from such obligated provider of services or
supplier.
(B) Definitions.--In this paragraph:
(i) In general.--The term
``applicable provider of services or
supplier'' means a provider of services
or supplier that has the same taxpayer
identification number assigned under
section 6109 of the Internal Revenue
Code of 1986 as is assigned to the
obligated provider of services or
supplier under such section, regardless
of whether the applicable provider of
services or supplier is assigned a
different billing number or national
provider identification number under
the program under this title than is
assigned to the obligated provider of
services or supplier.
(ii) Obligated provider of services
or supplier.--The term ``obligated
provider of services or supplier''
means a provider of services or
supplier that owes an amount that is
more than the amount required to be
paid under the program under this title
(as determined by the Secretary).
(7) Temporary moratorium on enrollment of new
providers.--
(A) In general.--The Secretary may impose a
temporary moratorium on the enrollment of new
providers of services and suppliers, including
categories of providers of services and
suppliers, in the program under this title,
under the Medicaid program under title XIX, or
under the CHIP program under title XXI if the
Secretary determines such moratorium is
necessary to prevent or combat fraud, waste, or
abuse under either such program.
(B) Limitation on review.--There shall be no
judicial review under section 1869, section
1878, or otherwise, of a temporary moratorium
imposed under subparagraph (A).
(8) Compliance programs.--
(A) In general.--On or after the date of
implementation determined by the Secretary
under subparagraph (C), a provider of medical
or other items or services or supplier within a
particular industry sector or category shall,
as a condition of enrollment in the program
under this title, title XIX, or title XXI,
establish a compliance program that contains
the core elements established under
subparagraph (B) with respect to that provider
or supplier and industry or category.
(B) Establishment of core elements.--The
Secretary, in consultation with the Inspector
General of the Department of Health and Human
Services, shall establish core elements for a
compliance program under subparagraph (A) for
providers or suppliers within a particular
industry or category.
(C) Timeline for implementation.--The
Secretary shall determine the timeline for the
establishment of the core elements under
subparagraph (B) and the date of the
implementation of subparagraph (A) for
providers or suppliers within a particular
industry or category. The Secretary shall, in
determining such date of implementation,
consider the extent to which the adoption of
compliance programs by a provider of medical or
other items or services or supplier is
widespread in a particular industry sector or
with respect to a particular provider or
supplier category.
(8) Hearing rights in cases of denial or non-
renewal.--A provider of services or supplier whose
application to enroll (or, if applicable, to renew
enrollment) under this title is denied may have a
hearing and judicial review of such denial under the
procedures that apply under subsection (h)(1)(A) to a
provider of services that is dissatisfied with a
determination by the Secretary.
(k) Quality Reporting by Cancer Hospitals.--
(1) In general.--For purposes of fiscal year 2014 and
each subsequent fiscal year, a hospital described in
section 1886(d)(1)(B)(v) shall submit data to the
Secretary in accordance with paragraph (2) with respect
to such a fiscal year.
(2) Submission of quality data.--For fiscal year 2014
and each subsequent fiscal year, each hospital
described in such section shall submit to the Secretary
data on quality measures specified under paragraph (3).
Such data shall be submitted in a form and manner, and
at a time, specified by the Secretary for purposes of
this subparagraph.
(3) Quality measures.--
(A) In general.--Subject to subparagraph (B),
any measure specified by the Secretary under
this paragraph must have been endorsed by the
entity with a contract under section 1890(a).
(B) Exception.--In the case of a specified
area or medical topic determined appropriate by
the Secretary for which a feasible and
practical measure has not been endorsed by the
entity with a contract under section 1890(a),
the Secretary may specify a measure that is not
so endorsed as long as due consideration is
given to measures that have been endorsed or
adopted by a consensus organization identified
by the Secretary.
(C) Time frame.--Not later than October 1,
2012, the Secretary shall publish the measures
selected under this paragraph that will be
applicable with respect to fiscal year 2014.
(4) Public availability of data submitted.--The
Secretary shall establish procedures for making data
submitted under paragraph (4) available to the public.
Such procedures shall ensure that a hospital described
in section 1886(d)(1)(B)(v) has the opportunity to
review the data that is to be made public with respect
to the hospital prior to such data being made public.
The Secretary shall report quality measures of process,
structure, outcome, patients' perspective on care,
efficiency, and costs of care that relate to services
furnished in such hospitals on the Internet website of
the Centers for Medicare & Medicaid Services.
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