Compilation of the Social Security Laws

AGREEMENTS WITH PROVIDERS OF SERVICES; ENROLLMENT PROCESSES[589]

Sec. 1866. [42 U.S.C. 1395cc] (a)(1)[590] 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[591] 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[592] (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[593], or under section 613 of title 38[594], 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 chapter 17[595] 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) 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[596], or under section 222(a) of the Social Security Amendments
of 1972[597], 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)[598],

(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[599],

(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),

(W)[600] 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),

(X)[601] 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.

(Y)[602] 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[603] 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[604] 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).

(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(g)), 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(g)), 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;

(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)); and

(3)[605] opioid treatment programs (as defined in paragraph
(2) of section 1861(jjj)), but
only with respect to the furnishing of opioid use disorder treatment
services (as defined in paragraph (1) of such section).

(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)[606].

(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) 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.

(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 (5), the imposition of temporary
enrollment moratoria in accordance with paragraph (7), and the establishment
of compliance programs in accordance with paragraph (9).[607]

(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) Individual
providers.—

(I) for 2010,
$200; 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.

(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 past-due 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; nonpayment.—

(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).

(C)Nonpayment.—

(i) In general.—No payment may be made under this title or under a program described
in subparagraph (A) with respect to an item or service described in
clause (ii) furnished on or after October 1, 2017.

(ii) Item or service described.—An item or service described in this clause is an item or service
furnished—

(I) within a geographic area with respect
to which a temporary moratorium imposed under subparagraph (A) is
in effect; and

(II) by a provider of services or supplier
that meets the requirements of clause (iii).

(ii) Requirements.—For purposes of clause (ii), the requirements of this clause
are that a provider of services or supplier—

(I) enrolls under this title on or after
the effective date of such temporary moratorium; and

(II) is within a category of providers
of services and suppliers (as described in subparagraph (A)) subject
to such temporary moratorium.

(iv) Prohibition on charges for
specified items or services.—In no case
shall a provider of services or supplier described in clause (ii)(II)
charge an individual or other person for an item or service described
in clause (ii) furnished on or after October 1, 2017, to an individual
entitled to benefits under part A or enrolled under part B or an individual
under a program specified in subparagraph (A).[608]

(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.

(9)[609] 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.

(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.