42 U.S.C. § 1395y : US Code - Section 1395Y: Exclusions from coverage and medicare as secondary payer

Search 42 U.S.C. § 1395y : US Code - Section 1395Y: Exclusions from coverage and medicare as secondary payer

(a) Items or services specifically excluded
Notwithstanding any other provision of this subchapter, no
payment may be made under part A or part B of this subchapter for
any expenses incurred for items or services -
(1)(A) which, except for items and services described in a
succeeding subparagraph, are not reasonable and necessary for the
diagnosis or treatment of illness or injury or to improve the
functioning of a malformed body member,
(B) in the case of items and services described in section
1395x(s)(10) of this title, which are not reasonable and
necessary for the prevention of illness,
(C) in the case of hospice care, which are not reasonable and
necessary for the palliation or management of terminal illness,
(D) in the case of clinical care items and services provided
with the concurrence of the Secretary and with respect to
research and experimentation conducted by, or under contract
with, the Medicare Payment Advisory Commission or the Secretary,
which are not reasonable and necessary to carry out the purposes
of section 1395ww(e)(6) of this title,(!1)
(E) in the case of research conducted pursuant to section 1320b-
12 of this title, which is not reasonable and necessary to carry
out the purposes of that section,
(F) in the case of screening mammography, which is performed
more frequently than is covered under section 1395m(c)(2) of this
title or which is not conducted by a facility described in
section 1395m(c)(1)(B) of this title, in the case of screening
pap smear and screening pelvic exam, which is performed more
frequently than is provided under section 1395x(nn) of this
title, and, in the case of screening for glaucoma, which is
performed more frequently than is provided under section
1395x(uu) of this title,
(G) in the case of prostate cancer screening tests (as defined
in section 1395x(oo) of this title), which are performed more
frequently than is covered under such section,
(H) in the case of colorectal cancer screening tests, which are
performed more frequently than is covered under section 1395m(d)
of this title,
(I) the frequency and duration of home health services which
are in excess of normative guidelines that the Secretary shall
establish by regulation,
(J) in the case of a drug or biological specified in section
1395w-3a(c)(6)(C) of this title for which payment is made under
part B of this subchapter that is furnished in a competitive area
under section 1395w-3b of this title, that is not furnished by an
entity under a contract under such section,
(K) in the case of an initial preventive physical examination,
which is performed not later than 6 months after the date the
individual's first coverage period begins under part B of this
subchapter,
(L) in the case of cardiovascular screening blood tests (as
defined in section 1395x(xx)(1) of this title), which are
performed more frequently than is covered under section
1395x(xx)(2) of this title, and
(M) in the case of a diabetes screening test (as defined in
section 1395x(yy)(1) of this title), which is performed more
frequently than is covered under section 1395x(yy)(3) of this
title;
(2) for which the individual furnished such items or services
has no legal obligation to pay, and which no other person (by
reason of such individual's membership in a prepayment plan or
otherwise) has a legal obligation to provide or pay for, except
in the case of Federally qualified health center services;
(3) which are paid for directly or indirectly by a governmental
entity (other than under this chapter and other than under a
health benefits or insurance plan established for employees of
such an entity), except in the case of rural health clinic
services, as defined in section 1395x(aa)(1) of this title, in
the case of Federally qualified health center services, as
defined in section 1395x(aa)(3) of this title, in the case of
services for which payment may be made under section 1395qq(e) of
this title, and in such other cases as the Secretary may specify;
(4) which are not provided within the United States (except for
inpatient hospital services furnished outside the United States
under the conditions described in section 1395f(f) of this title
and, subject to such conditions, limitations, and requirements as
are provided under or pursuant to this subchapter, physicians'
services and ambulance services furnished an individual in
conjunction with such inpatient hospital services but only for
the period during which such inpatient hospital services were
furnished);
(5) which are required as a result of war, or of an act of war,
occurring after the effective date of such individual's current
coverage under such part;
(6) which constitute personal comfort items (except, in the
case of hospice care, as is otherwise permitted under paragraph
(1)(C));
(7) where such expenses are for routine physical checkups,
eyeglasses (other than eyewear described in section 1395x(s)(8)
of this title) or eye examinations for the purpose of
prescribing, fitting, or changing eyeglasses, procedures
performed (during the course of any eye examination) to determine
the refractive state of the eyes, hearing aids or examinations
therefor, or immunizations (except as otherwise allowed under
section 1395x(s)(10) of this title and subparagraph (B), (F),
(G), (H), or (K) of paragraph (1));
(8) where such expenses are for orthopedic shoes or other
supportive devices for the feet, other than shoes furnished
pursuant to section 1395x(s)(12) of this title;
(9) where such expenses are for custodial care (except, in the
case of hospice care, as is otherwise permitted under paragraph
(1)(C));
(10) where such expenses are for cosmetic surgery or are
incurred in connection therewith, except as required for the
prompt repair of accidental injury or for improvement of the
functioning of a malformed body member;
(11) where such expenses constitute charges imposed by
immediate relatives of such individual or members of his
household;
(12) where such expenses are for services in connection with
the care, treatment, filling, removal, or replacement of teeth or
structures directly supporting teeth, except that payment may be
made under part A of this subchapter in the case of inpatient
hospital services in connection with the provision of such dental
services if the individual, because of his underlying medical
condition and clinical status or because of the severity of the
dental procedure, requires hospitalization in connection with the
provision of such services;
(13) where such expenses are for -
(A) the treatment of flat foot conditions and the
prescription of supportive devices therefor,
(B) the treatment of subluxations of the foot, or
(C) routine foot care (including the cutting or removal of
corns or calluses, the trimming of nails, and other routine
hygienic care);
(14) which are other than physicians' services (as defined in
regulations promulgated specifically for purposes of this
paragraph), services described by section 1395x(s)(2)(K) of this
title, certified nurse-midwife services, qualified psychologist
services, and services of a certified registered nurse
anesthetist, and which are furnished to an individual who is a
patient of a hospital or critical access hospital by an entity
other than the hospital or critical access hospital, unless the
services are furnished under arrangements (as defined in section
1395x(w)(1) of this title) with the entity made by the hospital
or critical access hospital;
(15)(A) which are for services of an assistant at surgery in a
cataract operation (including subsequent insertion of an
intraocular lens) unless, before the surgery is performed, the
appropriate utilization and quality control peer review
organization (under part B of subchapter XI of this chapter) or a
carrier under section 1395u of this title has approved of the use
of such an assistant in the surgical procedure based on the
existence of a complicating medical condition, or
(B) which are for services of an assistant at surgery to which
section 1395w-4(i)(2)(B) of this title applies;
(16) in the case in which funds may not be used for such items
and services under the Assisted Suicide Funding Restriction Act
of 1997 [42 U.S.C. 14401 et seq.];
(17) where the expenses are for an item or service furnished in
a competitive acquisition area (as established by the Secretary
under section 1395w-3(a) of this title) by an entity other than
an entity with which the Secretary has entered into a contract
under section 1395w-3(b) of this title for the furnishing of such
an item or service in that area, unless the Secretary finds that
the expenses were incurred in a case of urgent need, or in other
circumstances specified by the Secretary;
(18) which are covered skilled nursing facility services
described in section 1395yy(e)(2)(A)(i) of this title and which
are furnished to an individual who is a resident of a skilled
nursing facility during a period in which the resident is
provided covered post-hospital extended care services (or, for
services described in section 1395x(s)(2)(D) of this title, which
are furnished to such an individual without regard to such
period), by an entity other than the skilled nursing facility,
unless the services are furnished under arrangements (as defined
in section 1395x(w)(1) of this title) with the entity made by the
skilled nursing facility;
(19) which are for items or services which are furnished
pursuant to a private contract described in section 1395a(b) of
this title;
(20) in the case of outpatient occupational therapy services or
outpatient physical therapy services furnished as an incident to
a physician's professional services (as described in section
1395x(s)(2)(A) of this title), that do not meet the standards and
conditions (other than any licensing requirement specified by the
Secretary) under the second sentence of section 1395x(p) of this
title (or under such sentence through the operation of section
1395x(g) of this title) as such standards and conditions would
apply to such therapy services if furnished by a therapist;
(21) where such expenses are for home health services
(including medical supplies described in section 1395x(m)(5) of
this title, but excluding durable medical equipment to the extent
provided for in such section) furnished to an individual who is
under a plan of care of the home health agency if the claim for
payment for such services is not submitted by the agency; or
(22) subject to subsection (h) of this section, for which a
claim is submitted other than in an electronic form specified by
the Secretary.
Paragraph (7) shall not apply to Federally qualified health center
services described in section 1395x(aa)(3)(B) of this title. In
making a national coverage determination (as defined in paragraph
(1)(B) of section 1395ff(f) of this title) the Secretary shall
ensure consistent with subsection (l) of this section that the
public is afforded notice and opportunity to comment prior to
implementation by the Secretary of the determination; meetings of
advisory committees with respect to the determination are made on
the record; in making the determination, the Secretary has
considered applicable information (including clinical experience
and medical, technical, and scientific evidence) with respect to
the subject matter of the determination; and in the determination,
provide a clear statement of the basis for the determination
(including responses to comments received from the public), the
assumptions underlying that basis, and make available to the public
the data (other than proprietary data) considered in making the
determination.
(b) Medicare as secondary payer
(1) Requirements of group health plans
(A) Working aged under group health plans
(i) In general
A group health plan -
(I) may not take into account that an individual (or the
individual's spouse) who is covered under the plan by
virtue of the individual's current employment status with
an employer is entitled to benefits under this subchapter
under section 426(a) of this title, and
(II) shall provide that any individual age 65 or older
(and the spouse age 65 or older of any individual) who has
current employment status with an employer shall be
entitled to the same benefits under the plan under the same
conditions as any such individual (or spouse) under age 65.
(ii) Exclusion of group health plan of a small employer
Clause (i) shall not apply to a group health plan unless
the plan is a plan of, or contributed to by, an employer that
has 20 or more employees for each working day in each of 20
or more calendar weeks in the current calendar year or the
preceding calendar year.
(iii) Exception for small employers in multiemployer or
multiple employer group health plans
Clause (i) also shall not apply with respect to individuals
enrolled in a multiemployer or multiple employer group health
plan if the coverage of the individuals under the plan is by
virtue of current employment status with an employer that
does not have 20 or more individuals in current employment
status for each working day in each of 20 or more calendar
weeks in the current calendar year and the preceding calendar
year; except that the exception provided in this clause shall
only apply if the plan elects treatment under this clause.
(iv) Exception for individuals with end stage renal disease
Subparagraph (C) shall apply instead of clause (i) to an
item or service furnished in a month to an individual if for
the month the individual is, or (without regard to
entitlement under section 426 of this title) would upon
application be, entitled to benefits under section 426-1 of
this title.
(v) "Group health plan" defined
In this subparagraph, and subparagraph (C), the term "group
health plan" has the meaning given such term in section
5000(b)(1) of the Internal Revenue Code of 1986, without
regard to section 5000(d) of such Code.
(B) Disabled individuals in large group health plans
(i) In general
A large group health plan (as defined in clause (iii)) may
not take into account that an individual (or a member of the
individual's family) who is covered under the plan by virtue
of the individual's current employment status with an
employer is entitled to benefits under this subchapter under
section 426(b) of this title.
(ii) Exception for individuals with end stage renal disease
Subparagraph (C) shall apply instead of clause (i) to an
item or service furnished in a month to an individual if for
the month the individual is, or (without regard to
entitlement under section 426 of this title) would upon
application be, entitled to benefits under section 426-1 of
this title.
(iii) "Large group health plan" defined
In this subparagraph, the term "large group health plan"
has the meaning given such term in section 5000(b)(2) of the
Internal Revenue Code of 1986, without regard to section
5000(d) of such Code.
(C) Individuals with end stage renal disease
A group health plan (as defined in subparagraph (A)(v)) -
(i) may not take into account that an individual is
entitled to or eligible for benefits under this subchapter
under section 426-1 of this title during the 12-month period
which begins with the first month in which the individual
becomes entitled to benefits under part A of this subchapter
under the provisions of section 426-1 of this title, or, if
earlier, the first month in which the individual would have
been entitled to benefits under such part under the
provisions of section 426-1 of this title if the individual
had filed an application for such benefits; and
(ii) may not differentiate in the benefits it provides
between individuals having end stage renal disease and other
individuals covered by such plan on the basis of the
existence of end stage renal disease, the need for renal
dialysis, or in any other manner;
except that clause (ii) shall not prohibit a plan from paying
benefits secondary to this subchapter when an individual is
entitled to or eligible for benefits under this subchapter
under section 426-1 of this title after the end of the 12-month
period described in clause (i). Effective for items and
services furnished on or after February 1, 1991, and before
August 5, 1997,(!2) (with respect to periods beginning on or
after February 1, 1990), this subparagraph shall be applied by
substituting "18-month" for "12-month" each place it appears.
Effective for items and services furnished on or after August
5, 1997,(!2) (with respect to periods beginning on or after the
date that is 18 months prior to August 5, 1997), clauses (i)
and (ii) shall be applied by substituting "30-month" for "12-
month" each place it appears.
(D) Treatment of certain members of religious orders
In this subsection, an individual shall not be considered to
be employed, or an employee, with respect to the performance of
services as a member of a religious order which are considered
employment only by virtue of an election made by the religious
order under section 3121(r) of the Internal Revenue Code of
1986.
(E) General provisions
For purposes of this subsection:
(i) Aggregation rules
(I) All employers treated as a single employer under
subsection (a) or (b) of section 52 of the Internal Revenue
Code of 1986 shall be treated as a single employer.
(II) All employees of the members of an affiliated
service group (as defined in section 414(m) of such Code)
shall be treated as employed by a single employer.
(III) Leased employees (as defined in section 414(n)(2)
of such Code) shall be treated as employees of the person
for whom they perform services to the extent they are so
treated under section 414(n) of such Code.
In applying sections of the Internal Revenue Code of 1986
under this clause, the Secretary shall rely upon regulations
and decisions of the Secretary of the Treasury respecting
such sections.
(ii) "Current employment status" defined
An individual has "current employment status" with an
employer if the individual is an employee, is the employer,
or is associated with the employer in a business
relationship.
(iii) Treatment of self-employed persons as employers
The term "employer" includes a self-employed person.
(F) Limitation on beneficiary liability
An individual who is entitled to benefits under this
subchapter and is furnished an item or service for which such
benefits are incorrectly paid is not liable for repayment of
such benefits under this paragraph unless payment of such
benefits was made to the individual.
(2) Medicare secondary payer
(A) In general
Payment under this subchapter may not be made, except as
provided in subparagraph (B), with respect to any item or
service to the extent that -
(i) payment has been made, or can reasonably be expected to
be made, with respect to the item or service as required
under paragraph (1), or
(ii) payment has been made, or can reasonably be expected
to be made under a workmen's compensation law or plan of the
United States or a State or under an automobile or liability
insurance policy or plan (including a self-insured plan) or
under no fault insurance.
In this subsection, the term "primary plan" means a group
health plan or large group health plan, to the extent that
clause (i) applies, and a workmen's compensation law or plan,
an automobile or liability insurance policy or plan (including
a self-insured plan) or no fault insurance, to the extent that
clause (ii) applies. An entity that engages in a business,
trade, or profession shall be deemed to have a self-insured
plan if it carries its own risk (whether by a failure to obtain
insurance, or otherwise) in whole or in part.
(B) Conditional payment
(i) Authority to make conditional payment
The Secretary may make payment under this subchapter with
respect to an item or service if a primary plan described in
subparagraph (A)(ii) has not made or cannot reasonably be
expected to make payment with respect to such item or service
promptly (as determined in accordance with regulations). Any
such payment by the Secretary shall be conditioned on
reimbursement to the appropriate Trust Fund in accordance
with the succeeding provisions of this subsection.
(ii) Repayment required
A primary plan, and an entity that receives payment from a
primary plan, shall reimburse the appropriate Trust Fund for
any payment made by the Secretary under this subchapter with
respect to an item or service if it is demonstrated that such
primary plan has or had a responsibility to make payment with
respect to such item or service. A primary plan's
responsibility for such payment may be demonstrated by a
judgment, a payment conditioned upon the recipient's
compromise, waiver, or release (whether or not there is a
determination or admission of liability) of payment for items
or services included in a claim against the primary plan or
the primary plan's insured, or by other means. If
reimbursement is not made to the appropriate Trust Fund
before the expiration of the 60-day period that begins on the
date notice of, or information related to, a primary plan's
responsibility for such payment or other information is
received, the Secretary may charge interest (beginning with
the date on which the notice or other information is
received) on the amount of the reimbursement until
reimbursement is made (at a rate determined by the Secretary
in accordance with regulations of the Secretary of the
Treasury applicable to charges for late payments).
(iii) Action by United States
In order to recover payment made under this subchapter for
an item or service, the United States may bring an action
against any or all entities that are or were required or
responsible (directly, as an insurer or self-insurer, as a
third-party administrator, as an employer that sponsors or
contributes to a group health plan, or large group health
plan, or otherwise) to make payment with respect to the same
item or service (or any portion thereof) under a primary
plan. The United States may, in accordance with paragraph
(3)(A) collect double damages against any such entity. In
addition, the United States may recover under this clause
from any entity that has received payment from a primary plan
or from the proceeds of a primary plan's payment to any
entity. The United States may not recover from a third-party
administrator under this clause in cases where the third-
party administrator would not be able to recover the amount
at issue from the employer or group health plan and is not
employed by or under contract with the employer or group
health plan at the time the action for recovery is initiated
by the United States or for whom it provides administrative
services due to the insolvency or bankruptcy of the employer
or plan.
(iv) Subrogation rights
The United States shall be subrogated (to the extent of
payment made under this subchapter for such an item or
service) to any right under this subsection of an individual
or any other entity to payment with respect to such item or
service under a primary plan.
(v) Waiver of rights
The Secretary may waive (in whole or in part) the
provisions of this subparagraph in the case of an individual
claim if the Secretary determines that the waiver is in the
best interests of the program established under this
subchapter.
(vi) Claims-filing period
Notwithstanding any other time limits that may exist for
filing a claim under an employer group health plan, the
United States may seek to recover conditional payments in
accordance with this subparagraph where the request for
payment is submitted to the entity required or responsible
under this subsection to pay with respect to the item or
service (or any portion thereof) under a primary plan within
the 3-year period beginning on the date on which the item or
service was furnished.
(C) Treatment of questionnaires
The Secretary may not fail to make payment under subparagraph
(A) solely on the ground that an individual failed to complete
a questionnaire concerning the existence of a primary plan.
(3) Enforcement
(A) Private cause of action
There is established a private cause of action for damages
(which shall be in an amount double the amount otherwise
provided) in the case of a primary plan which fails to provide
for primary payment (or appropriate reimbursement) in
accordance with paragraphs (1) and (2)(A).
(B) Reference to excise tax with respect to nonconforming group
health plans
For provision imposing an excise tax with respect to
nonconforming group health plans, see section 5000 of the
Internal Revenue Code of 1986.
(C) Prohibition of financial incentives not to enroll in a
group health plan or a large group health plan
It is unlawful for an employer or other entity to offer any
financial or other incentive for an individual entitled to
benefits under this subchapter not to enroll (or to terminate
enrollment) under a group health plan or a large group health
plan which would (in the case of such enrollment) be a primary
plan (as defined in paragraph (2)(A)). Any entity that violates
the previous sentence is subject to a civil money penalty of
not to exceed $5,000 for each such violation. The provisions of
section 1320a-7a of this title (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 1320a-7a(a) of this title.
(4) Coordination of benefits
Where payment for an item or service by a primary plan is less
than the amount of the charge for such item or service and is not
payment in full, payment may be made under this subchapter
(without regard to deductibles and coinsurance under this
subchapter) for the remainder of such charge, but -
(A) payment under this subchapter may not exceed an amount
which would be payable under this subchapter for such item or
service if paragraph (2)(A) did not apply; and
(B) payment under this subchapter, when combined with the
amount payable under the primary plan, may not exceed -
(i) in the case of an item or service payment for which is
determined under this subchapter on the basis of reasonable
cost (or other cost-related basis) or under section 1395ww of
this title, the amount which would be payable under this
subchapter on such basis, and
(ii) in the case of an item or service for which payment is
authorized under this subchapter on another basis -
(I) the amount which would be payable under the primary
plan (without regard to deductibles and coinsurance under
such plan), or
(II) the reasonable charge or other amount which would be
payable under this subchapter (without regard to
deductibles and coinsurance under this subchapter),
whichever is greater.
(5) Identification of secondary payer situations
(A) Requesting matching information
(i) Commissioner of Social Security
The Commissioner of Social Security shall, not less often
than annually, transmit to the Secretary of the Treasury a
list of the names and TINs of medicare beneficiaries (as
defined in section 6103(l)(12) of the Internal Revenue Code
of 1986) and request that the Secretary disclose to the
Commissioner the information described in subparagraph (A) of
such section.
(ii) Administrator
The Administrator of the Centers for Medicare&Medicaid
Services shall request, not less often than annually, the
Commissioner of the Social Security Administration to
disclose to the Administrator the information described in
subparagraph (B) of section 6103(l)(12) of the Internal
Revenue Code of 1986.
(B) Disclosure to fiscal intermediaries and carriers
In addition to any other information provided under this
subchapter to fiscal intermediaries and carriers, the
Administrator shall disclose to such intermediaries and
carriers (or to such a single intermediary or carrier as the
Secretary may designate) the information received under
subparagraph (A) for purposes of carrying out this subsection.
(C) Contacting employers
(i) In general
With respect to each individual (in this subparagraph
referred to as an "employee") who was furnished a written
statement under section 6051 of the Internal Revenue Code of
1986 by a qualified employer (as defined in section
6103(l)(12)(E)(iii) of such Code), as disclosed under
subparagraph (B), the appropriate fiscal intermediary or
carrier shall contact the employer in order to determine
during what period the employee or employee's spouse may be
(or have been) covered under a group health plan of the
employer and the nature of the coverage that is or was
provided under the plan (including the name, address, and
identifying number of the plan).
(ii) Employer response
Within 30 days of the date of receipt of the inquiry, the
employer shall notify the intermediary or carrier making the
inquiry as to the determinations described in clause (i). An
employer (other than a Federal or other governmental entity)
who willfully or repeatedly fails to provide timely and
accurate notice in accordance with the previous sentence
shall be subject to a civil money penalty of not to exceed
$1,000 for each individual with respect to which such an
inquiry is made. The provisions of section 1320a-7a of this
title (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 1320a-7a(a) of this title.
(D) Obtaining information from beneficiaries
Before an individual applies for benefits under part A of
this subchapter or enrolls under part B of this subchapter, the
Administrator shall mail the individual a questionnaire to
obtain information on whether the individual is covered under a
primary plan and the nature of the coverage provided under the
plan, including the name, address, and identifying number of
the plan.
(6) Screening requirements for providers and suppliers
(A) In general
Notwithstanding any other provision of this subchapter, no
payment may be made for any item or service furnished under
part B of this subchapter unless the entity furnishing such
item or service completes (to the best of its knowledge and on
the basis of information obtained from the individual to whom
the item or service is furnished) the portion of the claim form
relating to the availability of other health benefit plans.
(B) Penalties
An entity that knowingly, willfully, and repeatedly fails to
complete a claim form in accordance with subparagraph (A) or
provides inaccurate information relating to the availability of
other health benefit plans on a claim form under such
subparagraph shall be subject to a civil money penalty of not
to exceed $2,000 for each such incident. The provisions of
section 1320a-7a of this title (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 1320a-7a(a) of this title.
(c) Drug products
No payment may be made under part B of this subchapter for any
expenses incurred for -
(1) a drug product -
(A) which is described in section 107(c)(3) of the Drug
Amendments of 1962,
(B) which may be dispensed only upon prescription,
(C) for which the Secretary has issued a notice of an
opportunity for a hearing under subsection (e) of section 355
of title 21 on a proposed order of the Secretary to withdraw
approval of an application for such drug product under such
section because the Secretary has determined that the drug is
less than effective for all conditions of use prescribed,
recommended, or suggested in its labeling, and
(D) for which the Secretary has not determined there is a
compelling justification for its medical need; and
(2) any other drug product -
(A) which is identical, related, or similar (as determined in
accordance with section 310.6 of title 21 of the Code of
Federal Regulations) to a drug product described in paragraph
(1), and
(B) for which the Secretary has not determined there is a
compelling justification for its medical need,
until such time as the Secretary withdraws such proposed order.
(d) Items or services provided for emergency medical conditions
For purposes of subsection (a)(1)(A) of this section, in the case
of any item or service that is required to be provided pursuant to
section 1395dd of this title to an individual who is entitled to
benefits under this subchapter, determinations as to whether the
item or service is reasonable and necessary shall be made on the
basis of the information available to the treating physician or
practitioner (including the patient's presenting symptoms or
complaint) at the time the item or service was ordered or furnished
by the physician or practitioner (and not on the patient's
principal diagnosis). When making such determinations with respect
to such an item or service, the Secretary shall not consider the
frequency with which the item or service was provided to the
patient before or after the time of the admission or visit.
(e) Item or service by excluded individual or entity or at
direction of excluded physician; limitation of liability of
beneficiaries with respect to services furnished by excluded
individuals and entities
(1) No payment may be made under this subchapter with respect to
any item or service (other than an emergency item or service, not
including items or services furnished in an emergency room of a
hospital) furnished -
(A) by an individual or entity during the period when such
individual or entity is excluded pursuant to section 1320a-7,
1320a-7a, 1320c-5 or 1395u(j)(2) of this title from participation
in the program under this subchapter; or
(B) at the medical direction or on the prescription of a
physician during the period when he is excluded pursuant to
section 1320a-7, 1320a-7a, 1320c-5 or 1395u(j)(2) of this title
from participation in the program under this subchapter and when
the person furnishing such item or service knew or had reason to
know of the exclusion (after a reasonable time period after
reasonable notice has been furnished to the person).
(2) Where an individual eligible for benefits under this
subchapter submits a claim for payment for items or services
furnished by an individual or entity excluded from participation in
the programs under this subchapter, pursuant to section 1320a-7,
1320a-7a, 1320c-5, 1320c-9 (as in effect on September 2, 1982),
1395u(j)(2), 1395y(d) (as in effect on August 18, 1987), or 1395cc
of this title, and such beneficiary did not know or have reason to
know that such individual or entity was so excluded, then, to the
extent permitted by this subchapter, and notwithstanding such
exclusion, payment shall be made for such items or services. In
each such case the Secretary shall notify the beneficiary of the
exclusion of the individual or entity furnishing the items or
services. Payment shall not be made for items or services furnished
by an excluded individual or entity to a beneficiary after a
reasonable time (as determined by the Secretary in regulations)
after the Secretary has notified the beneficiary of the exclusion
of that individual or entity.
(f) Utilization guidelines for provision of home health services
The Secretary shall establish utilization guidelines for the
determination of whether or not payment may be made, consistent
with paragraph (1)(A) of subsection (a) of this section, under part
A or part B of this subchapter for expenses incurred with respect
to the provision of home health services, and shall provide for the
implementation of such guidelines through a process of selective
postpayment coverage review by intermediaries or otherwise.
(g) Contracts with utilization and quality control peer review
organizations
The Secretary shall, in making the determinations under
paragraphs (1) and (9) of subsection (a) of this section, and for
the purposes of promoting the effective, efficient, and economical
delivery of health care services, and of promoting the quality of
services of the type for which payment may be made under this
subchapter, enter into contracts with utilization and quality
control peer review organizations pursuant to part B of subchapter
XI of this chapter.
(h) Waiver of electronic form requirement
(1) The Secretary -
(A) shall waive the application of subsection (a)(22) of this
section in cases in which -
(i) there is no method available for the submission of claims
in an electronic form; or
(ii) the entity submitting the claim is a small provider of
services or supplier; and
(B) may waive the application of such subsection in such
unusual cases as the Secretary finds appropriate.
(2) For purposes of this subsection, the term "small provider of
services or supplier" means -
(A) a provider of services with fewer than 25 full-time
equivalent employees; or
(B) a physician, practitioner, facility, or supplier (other
than provider of services) with fewer than 10 full-time
equivalent employees.
(i) Awards and contracts for original research and experimentation
of new and existing medical procedures; conditions
In order to supplement the activities of the Medicare Payment
Advisory Commission under section 1395ww(e) of this title in
assessing the safety, efficacy, and cost-effectiveness of new and
existing medical procedures, the Secretary may carry out, or award
grants or contracts for, original research and experimentation of
the type described in clause (ii) of section 1395ww(e)(6)(E) of
this title with respect to such a procedure if the Secretary finds
that -
(1) such procedure is not of sufficient commercial value to
justify research and experimentation by a commercial
organization;
(2) research and experimentation with respect to such procedure
is not of a type that may appropriately be carried out by an
institute, division, or bureau of the National Institutes of
Health; and
(3) such procedure has the potential to be more cost-effective
in the treatment of a condition than procedures currently in use
with respect to such condition.
(j) Nonvoting members and experts
(1) Any advisory committee appointed to advise the Secretary on
matters relating to the interpretation, application, or
implementation of subsection (a)(1) of this section shall assure
the full participation of a nonvoting member in the deliberations
of the advisory committee, and shall provide such nonvoting member
access to all information and data made available to voting members
of the advisory committee, other than information that -
(A) is exempt from disclosure pursuant to subsection (a) of
section 552 of title 5 by reason of subsection (b)(4) of such
section (relating to trade secrets); or
(B) the Secretary determines would present a conflict of
interest relating to such nonvoting member.
(2) If an advisory committee described in paragraph (1) organizes
into panels of experts according to types of items or services
considered by the advisory committee, any such panel of experts may
report any recommendation with respect to such items or services
directly to the Secretary without the prior approval of the
advisory committee or an executive committee thereof.
(k) Dental benefits under group health plans
(1) Subject to paragraph (2), a group health plan (as defined in
subsection (a)(1)(A)(v) (!3) of this section) providing
supplemental or secondary coverage to individuals also entitled to
services under this subchapter shall not require a medicare claims
determination under this subchapter for dental benefits
specifically excluded under subsection (a)(12) of this section as a
condition of making a claims determination for such benefits under
the group health plan.
(2) A group health plan may require a claims determination under
this subchapter in cases involving or appearing to involve
inpatient dental hospital services or dental services expressly
covered under this subchapter pursuant to actions taken by the
Secretary.
(l) National and local coverage determination process
(1) Factors and evidence used in making national coverage
determinations
The Secretary shall make available to the public the factors
considered in making national coverage determinations of whether
an item or service is reasonable and necessary. The Secretary
shall develop guidance documents to carry out this paragraph in a
manner similar to the development of guidance documents under
section 371(h) of title 21.
(2) Timeframe for decisions on requests for national coverage
determinations
In the case of a request for a national coverage determination
that -
(A) does not require a technology assessment from an outside
entity or deliberation from the Medicare Coverage Advisory
Committee, the decision on the request shall be made not later
than 6 months after the date of the request; or
(B) requires such an assessment or deliberation and in which
a clinical trial is not requested, the decision on the request
shall be made not later than 9 months after the date of the
request.
(3) Process for public comment in national coverage
determinations
(A) Period for proposed decision
Not later than the end of the 6-month period (or 9-month
period for requests described in paragraph (2)(B)) that begins
on the date a request for a national coverage determination is
made, the Secretary shall make a draft of proposed decision on
the request available to the public through the Internet
website of the Centers for Medicare&Medicaid Services or
other appropriate means.
(B) 30-day period for public comment
Beginning on the date the Secretary makes a draft of the
proposed decision available under subparagraph (A), the
Secretary shall provide a 30-day period for public comment on
such draft.
(C) 60-day period for final decision
Not later than 60 days after the conclusion of the 30-day
period referred to under subparagraph (B), the Secretary shall -

(i) make a final decision on the request;
(ii) include in such final decision summaries of the public
comments received and responses to such comments;
(iii) make available to the public the clinical evidence
and other data used in making such a decision when the
decision differs from the recommendations of the Medicare
Coverage Advisory Committee; and
(iv) in the case of a final decision under clause (i) to
grant the request for the national coverage determination,
the Secretary shall assign a temporary or permanent code
(whether existing or unclassified) and implement the coding
change.
(4) Consultation with outside experts in certain national
coverage determinations
With respect to a request for a national coverage determination
for which there is not a review by the Medicare Coverage Advisory
Committee, the Secretary shall consult with appropriate outside
clinical experts.
(5) Local coverage determination process
(A) Plan to promote consistency of coverage determinations
The Secretary shall develop a plan to evaluate new local
coverage determinations to determine which determinations
should be adopted nationally and to what extent greater
consistency can be achieved among local coverage
determinations.
(B) Consultation
The Secretary shall require the fiscal intermediaries or
carriers providing services within the same area to consult on
all new local coverage determinations within the area.
(C) Dissemination of information
The Secretary should serve as a center to disseminate
information on local coverage determinations among fiscal
intermediaries and carriers to reduce duplication of effort.
(6) National and local coverage determination defined
For purposes of this subsection -
(A) National coverage determination
The term "national coverage determination" means a
determination by the Secretary with respect to whether or not a
particular item or service is covered nationally under this
subchapter.
(B) Local coverage determination
The term "local coverage determination" has the meaning given
that in section 1395ff(f)(2)(B) of this title.
(m) Coverage of routine costs associated with certain clinical
trials of category A devices
(1) In general
In the case of an individual entitled to benefits under part A
of this subchapter, or enrolled under part B of this subchapter,
or both who participates in a category A clinical trial, the
Secretary shall not exclude under subsection (a)(1) of this
section payment for coverage of routine costs of care (as defined
by the Secretary) furnished to such individual in the trial.
(2) Category A clinical trial
For purposes of paragraph (1), a "category A clinical trial"
means a trial of a medical device if -
(A) the trial is of an experimental/investigational (category
A) medical device (as defined in regulations under section
405.201(b) of title 42, Code of Federal Regulations (as in
effect as of September 1, 2003));
(B) the trial meets criteria established by the Secretary to
ensure that the trial conforms to appropriate scientific and
ethical standards; and
(C) in the case of a trial initiated before January 1, 2010,
the device involved in the trial has been determined by the
Secretary to be intended for use in the diagnosis, monitoring,
or treatment of an immediately life-threatening disease or
condition.