[House Report 118-691]
[From the U.S. Government Publishing Office]
118th Congress } { Rept. 118-691
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
======================================================================
SENIORS' ACCESS TO CRITICAL MEDICATIONS ACT OF 2024
_______
September 19, 2024.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mrs. Rodgers of Washington, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany H.R. 5526]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 5526) to amend title XVIII of the Social
Security Act to clarify the application of the in-office
ancillary services exception to the physician self-referral
prohibition for drugs furnished under the Medicare program,
having considered the same, reports favorably thereon with
amendments and recommends that the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 3
Background and Need for Legislation.............................. 3
Committee Action................................................. 4
Committee Votes.................................................. 4
Oversight Findings and Recommendations........................... 6
New Budget Authority, Entitlement Authority, and Tax Expenditures 6
Congressional Budget Office Estimate............................. 6
Federal Mandates Statement....................................... 6
Statement of General Performance Goals and Objectives............ 6
Duplication of Federal Programs.................................. 6
Related Committee and Subcommittee Hearings...................... 6
Committee Cost Estimate.......................................... 7
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 7
Advisory Committee Statement..................................... 7
Applicability to Legislative Branch.............................. 7
Section-by-Section Analysis of the Legislation................... 7
Changes in Existing Law Made by the Bill, as Reported............ 8
Minority, Additional, or Dissenting Views........................
Exchange of Letters with Additional Committees of Referral....... 95
The amendments are as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Seniors' Access to Critical
Medications Act of 2024''.
SEC. 2. CLARIFYING THE APPLICATION OF THE IN-OFFICE ANCILLARY SERVICES
EXCEPTION TO THE PHYSICIAN SELF-REFERRAL
PROHIBITION FOR COVERED OUTPATIENT DRUGS FURNISHED
UNDER THE MEDICARE PROGRAM.
(a) In General.--Section 1877(b)(2) of the Social Security Act (42
U.S.C. 1395nn(b)(2)) is amended by adding at the end the following new
sentence: ``With respect to services described in subsection (h)(6)(J)
consisting of covered part D drugs (as defined in section 1860D-2(e))
furnished to an individual during the period beginning on January 1,
2025, and ending on December 31, 2029, such drugs shall be treated as
having been furnished in accordance with subparagraph (A)(ii) if such
drugs are picked up in a building described in subclause (I) or (II) of
such subparagraph by such individual, or a family member or caregiver
on behalf of such individual, or delivered to such individual by a
mail, delivery, or courier service, but only if, during the 1-year
period ending on the date such drugs were so furnished, such individual
had a face-to-face encounter with the prescriber of such drugs (not
including any such encounter conducted via telehealth), and only if
such individual has an ongoing on preexisting relationship with such
prescriber.''.
(b) Report.--Not later than 3 years after the date of the enactment
of this Act, the Secretary of Health and Human Services shall submit to
Congress a report that contains--
(1) the number of individuals who were furnished drugs in a
manner that would constitute a violation of section 1877 of the
Social Security Act (42 U.S.C. 1395nn) but for the amendment
made by subsection (a);
(2) an analysis of the change in expenditures under title
XVIII of such Act (42 U.S.C. 1395 et seq.) attributable to such
amendment;
(3) a description of which drugs were furnished in a manner
described in paragraph (1); and
(4) such amendment's impact on prices for such drugs.
SEC. 3. MEDICARE COVERAGE OF EXTERNAL INFUSION PUMPS AND NON-SELF-
ADMINISTRABLE HOME INFUSION DRUGS.
Section 1861(n) of the Social Security Act (42 U.S.C. 1395x(n)) is
amended by adding at the end the following new sentence: ``Beginning
with the first calendar quarter beginning on or after the date that is
one year after the date of the enactment of the `Seniors' Access to
Critical Medications Act of 2024', an external infusion pump and
associated home infusion drug (as defined in subsection (iii)(3)(C)) or
other associated supplies that do not meet the appropriate for use in
the home requirement applied to the definition of durable medical
equipment under section 414.202 of title 42, Code of Federal
Regulations (or any successor to such regulation) shall be treated as
meeting such requirement if each of the following criteria is
satisfied:
``(1) The prescribing information approved by the Food and
Drug Administration for the home infusion drug associated with
the pump instructs that the drug should be administered by or
under the supervision of a health care professional.
``(2) A qualified home infusion therapy supplier (as defined
in subsection (iii)(3)(D)) administers or supervises the
administration of the drug or biological in a safe and
effective manner in the patient's home (as defined in
subsection (iii)(3)(B)).
``(3) The prescribing information described in paragraph (1)
instructs that the drug should be infused at least 12 times per
year--
``(A) intravenously or subcutaneously; or
``(B) at infusion rates that the Secretary determines
would require the use of an external infusion pump.''.
SEC. 4. MEDICARE IMPROVEMENT FUND.
Section 1898(b)(1) of the Social Security Act (42 U.S.C.
1395iii(b)(1)) is amended by striking ``$0'' and inserting
``$114,000,000''.
Amend the title so as to read:
A bill to amend title XVIII of the Social Security Act to
clarify the application of the in-office ancillary services
exception to the physician self-referral prohibition for
covered outpatient drugs furnished under the Medicare program,
and to provide coverage of external infusion pumps and non-
self-administrable home infusion drugs under such program.
Purpose and Summary
H.R. 5526, the Seniors' Access to Critical Medications Act
of 2024, would amend the physician self-referral law to permit
Medicare patients to receive prescription drugs via caregivers
picking up drugs on the patient's behalf or via mail or
couriers delivering the drug to the patient in instances when a
provider prescribes a drug to be dispensed by a pharmacy that
falls under the self-referral law's definition of an in-office
ancillary service. Current law prohibits such arrangements for
Medicare beneficiaries.
Background and Need for Legislation
Enacted in 1989, the physician self-referral law (also
colloquially referred to as the Stark Law) prohibit physicians
from making referrals for certain ``designated health
services'' paid for by Medicare to entities with which the
physicians or their immediate family members have a financial
relationship. The law was passed to address fraud and abuse
from inappropriate prescribing practices by physicians, where
physicians prescribe or refer follow-up services to themselves
so that they can financially benefit from the subsequent
referral. While referrals and follow-ups are a key part of a
patient's care, the misalignment of financial incentives that
can encourage physicians to overprescribe services for their
own financial gain are wasteful and harmful to patients. The
self-referral law is designed to protect both patients and the
integrity of the Medicare program. The law is critical in
protecting Medicare beneficiaries by ensuring that financial
considerations do not influence patient care, and that provider
decisions are made on the basis of clinical criteria.
However, the self-referral law includes a limited number of
narrow exceptions. For instance, the self-referral law creates
limited carve-outs for specific physician services that are
furnished by another physician who is member of the referring
physician's group practice or under the supervision of another
physician who is a member of the referring physician's group
practice. This ensures that providers within a same practice
are not prohibited from collaborating together. One notable
service included in this ``in-office ancillary services
exception'' are pharmacy services for outpatient prescription
drugs. Under the exception, a physician may prescribe a drug to
a pharmacy located in the same building as the provider's,
allowing for physicians to coordinate dosages for treatments
and suppose case management for patients utilizing their
services.
Of note, the implementing regulations for the in-office
ancillary services exception limits the application of these
services at 42 CFR 411.355 by stating that the exception shall
only apply ``where an item is dispensed to a patient'', thus
precluding the ability for drugs to be dispensed indirectly to
a patient through either a caregiver picking up the drug on the
patient's behalf or being mailed to a patient by the pharmacy.
During the COVID-19 Public Health Emergency, the Centers
for Medicare & Medicaid Services (CMS) provided a limited
waiver from the Stark Law by waiving the ``location
requirement'' of the in-office ancillary services exception.
This allowed for physicians to mail prescriptions to patients
alongside the newly established telehealth authorities, as a
means to keep patients out of physician offices and hospitals
during the pandemic. Patients benefited from the enhanced
flexibility that allowed them to better maintain access to care
and regular uptake of their prescribed medications.
With the expiration of the waivers and the Public Health
Emergency, H.R. 5526 would renew the ability for patients to
have medications indirectly dispensed to them under the
physician self-referral law, either through caregiver picking
up the drug on the individual's behalf or by receiving the drug
through a mail courier, for an additional five years.
Committee Action
On October 19, 2023, the Subcommittee on Health held a
hearing on H.R. 5526. The title of the hearing was ``What's the
Prognosis?: Examining Medicare Proposals to Improve Patient
Access to Care & Minimize Red Tape for Doctors.'' The
Subcommittee received testimony from:
Meena Seshamani, MD, PhD, Director, Center
for Medicare, Centers for Medicare & Medicaid Services;
Leslie Gordon, MPP, Director, Health Care,
GAO;
Paul Masi, MPP, Executive Director, Medicare
Payment Advisory Commission;
Steven Furr, MD, FAAFP, President-Elect,
American Academy of Family Physicians;
Debra Patt, MD, PhD, MBA, Executive Vice
President, Texas Oncology;
Joe Albanese, MPP, Senior Policy Analyst,
Paragon Health Institute; and,
Matthew Fiedler, PhD, Joseph A. Pechman
Senior Fellow in Economic Studies, Brookings Schaeffer
Initiative on Health Policy, The Brookings Institution.
On March 12, 2024, the Subcommittee on Health met in open
markup session and forwarded H.R. 5526, to the full Committee
by a recorded vote of 19 yeas and 6 nays.
On June 12, 2024, the full Committee on Energy and Commerce
met in open markup session and ordered H.R. 5526, as amended,
favorably reported to the House by a recorded vote of 41 yeas
and 0 nays.
Committee Votes
Clause 3(b) of rule XIII requires the Committee to list the
record votes on the motion to report legislation and amendments
thereto. The following reflects the record votes taken during
the Committee consideration:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Oversight Findings and Recommendations
Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of
rule XIII, the Committee held a hearing and made findings that
are reflected in this report.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to clause 3(c)(2) of rule XIII, the Committee
finds that H.R. 5526 would result in no new or increased budget
authority, entitlement authority, or tax expenditures or
revenues.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII, at the time this
report was filed, the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974 was not available.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to amend
the physician self-referral law to permit Medicare patients to
receive prescription drugs under certain circumstances.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 5526 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
Related Committee and Subcommittee Hearings
Pursuant to clause 3(c)(6) of rule XIII, the following
hearing was used to develop or consider H.R. 5526:
On October 19, 2023, the Subcommittee on
Health held a hearing on H.R. 5526. The title of the
hearing was ``What's the Prognosis?: Examining Medicare
Proposals to Improve Patient Access to Care & Minimize
Red Tape for Doctors.'' The Subcommittee received
testimony from:
Meena Seshamani, MD, PhD,
Director, Center for Medicare, Centers for
Medicare & Medicaid Services;
Leslie Gordon, MPP, Director,
Health Care, GAO;
Paul Masi, MPP, Executive
Director, Medicare Payment Advisory Commission;
Steven Furr, MD, FAAFP,
President-Elect, American Academy of Family
Physicians;
Debra Patt, MD, PhD, MBA,
Executive Vice President, Texas Oncology;
Joe Albanese, MPP, Senior Policy
Analyst, Paragon Health Institute; and,
Matthew Fiedler, PhD, Joseph A.
Pechman Senior Fellow in Economic Studies,
Brookings Schaeffer Initiative on Health
Policy, The Brookings Institution.
Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974. At the time this report was
filed, the estimate was not available.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 5526 contains no earmarks, limited
tax benefits, or limited tariff benefits.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 provides that the Act may be cited as the
``Seniors' Access to Critical Medications Act of 2024''.
Section 2. Clarifying the application of the in-office ancillary
services exception to the physician self-referral prohibition
for covered outpatient drugs furnished under the Medicaid
program
Section 2 clarifies that the existing exception, which
allows for physicians to refer prescriptions to pharmacies that
currently meet the in-office ancillary services exception,
shall permit caregivers or mail couriers to deliver outpatient
drugs to the patient. This section further clarifies that such
flexibility shall only be provided to patients that have been
seen by their physician in-person within the past year and to
patients that have an ongoing pre-existing relationship with
their physicians. The policy would begin on January 1, 2025,
and end on December 31, 2029.
Section 3. Medicare coverage of external infusion pumps and non-self-
administrable home infusion drugs
Section 3 clarifies further coverage of certain home
infusion drugs and external infusion pumps by Medicare.
Section 4. Medicare Improvement Fund
Section 4 increases the Medicare Improvement Fund's total
value to $114 million.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
SOCIAL SECURITY ACT
* * * * * * *
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
Part E--Miscellaneous Provisions
definitions of services, institutions, etc.
Sec. 1861. For purposes of this title--
Spell of Illness
(a) The term ``spell of illness'' with respect to any
individual means a period of consecutive days--
(1) beginning with the first day (not included in a
previous spell of illness) (A) on which such individual
is furnished inpatient hospital services, inpatient
critical access hospital services or extended care
services, and (B) which occurs in a month for which he
is entitled to benefits under part A, and
(2) ending with the close of the first period of 60
consecutive days thereafter on each of which he is
neither an inpatient of a hospital or critical access
hospital nor an inpatient of a facility described in
section 1819(a)(1) or subsection (y)(1).
Inpatient Hospital Services
(b) The term ``inpatient hospital services'' means the
following items and services furnished to an inpatient of a
hospital and (except as provided in paragraph (3)) by the
hospital--
(1) bed and board;
(2) such nursing services and other related services,
such use of hospital facilities, and such medical
social services as are ordinarily furnished by the
hospital for the care and treatment of inpatients, and
such drugs, biologicals, supplies, appliances, and
equipment, for use in the hospital, as are ordinarily
furnished by such hospital for the care and treatment
of inpatients; and
(3) such other diagnostic or therapeutic items or
services, furnished by the hospital or by others under
arrangements with them made by the hospital, as are
ordinarily furnished to inpatients either by such
hospital or by others under such arrangements;
excluding, however--
(4) medical or surgical services provided by a
physician, resident, or intern, services described by
subsection (s)(2)(K), certified nurse-midwife services,
qualified psychologist services, and services of a
certified registered nurse anesthetist; and
(5) the services of a private-duty nurse or other
private-duty attendant.
Paragraph (4) shall not apply to services provided in a
hospital by--
(6) an intern or a resident-in-training under a
teaching program approved by the Council on Medical
Education of the American Medical Association or, in
the case of an osteopathic hospital, approved by the
Committee on Hospitals of the Bureau of Professional
Education of the American Osteopathic Association, or,
in the case of services in a hospital or osteopathic
hospital by an intern or resident-in-training in the
field of dentistry, approved by the Council on Dental
Education of the American Dental Association, or in the
case of services in a hospital or osteopathic hospital
by an intern or resident-in-training in the field of
podiatry, approved by the Council on Podiatric Medical
Education of the American Podiatric Medical
Association; or
(7) a physician where the hospital has a teaching
program approved as specified in paragraph (6), if (A)
the hospital elects to receive any payment due under
this title for reasonable costs of such services, and
(B) all physicians in such hospital agree not to bill
charges for professional services rendered in such
hospital to individuals covered under the insurance
program established by this title.
Inpatient Psychiatric Hospital Services
(c) The term ``inpatient psychiatric hospital services''
means inpatient hospital services furnished to an inpatient of
a psychiatric hospital.
Supplier
(d) The term ``supplier'' means, unless the context otherwise
requires, a physician or other practitioner, a facility, or
other entity (other than a provider of services) that furnishes
items or services under this title.
Hospital
(e) The term ``hospital'' (except for purposes of sections
1814(d), 1814(f), and 1835(b), subsection (a)(2) of this
section, paragraph (7) of this subsection, and subsection (i)
of this section) means an institution which--
(1) is primarily engaged in providing, by or under
the supervision of physicians, to inpatients (A)
diagnostic services and therapeutic services for
medical diagnosis, treatment, and care of injured,
disabled, or sick persons, or (B) rehabilitation
services for the rehabilitation of injured, disabled,
or sick persons;
(2) maintains clinical records on all patients;
(3) has bylaws in effect with respect to its staff of
physicians;
(4) has a requirement that every patient with respect
to whom payment may be made under this title must be
under the care of a physician, except that a patient
receiving qualified psychologist services (as defined
in subsection (ii)) may be under the care of a clinical
psychologist with respect to such services to the
extent permitted under State law;
(5) provides 24-hour nursing service rendered or
supervised by a registered professional nurse, and has
a licensed practical nurse or registered professional
nurse on duty at all times; except that until January
1, 1979, the Secretary is authorized to waive the
requirement of this paragraph for any one-year period
with respect to any institution, insofar as such
requirement relates to the provision of twenty-four-
hour nursing service rendered or supervised by a
registered professional nurse (except that in any event
a registered professional nurse must be present on the
premises to render or supervise the nursing service
provided, during at least the regular daytime shift),
where immediately preceding such one-year period he
finds that--
(A) such institution is located in a rural
area and the supply of hospital services in
such area is not sufficient to meet the needs
of individuals residing therein,
(B) the failure of such institution to
qualify as a hospital would seriously reduce
the availability of such services to such
individuals, and
(C) such institution has made and continues
to make a good faith effort to comply with this
paragraph, but such compliance is impeded by
the lack of qualified nursing personnel in such
area;
(6)(A) has in effect a hospital utilization review
plan which meets the requirements of subsection (k) and
(B) has in place a discharge planning process that
meets the requirements of subsection (ee);
(7) in the case of an institution in any State in
which State or applicable local law provides for the
licensing of hospitals, (A) is licensed pursuant to
such law or (B) is approved, by the agency of such
State or locality responsible for licensing hospitals,
as meeting the standards established for such
licensing;
(8) has in effect an overall plan and budget that
meets the requirements of subsection (z); and
(9) meets such other requirements as the Secretary
finds necessary in the interest of the health and
safety of individuals who are furnished services in the
institution.
For purposes of subsection (a)(2), such term includes any
institution which meets the requirements of paragraph (1) of
this subsection. For purposes of sections 1814(d) and 1835(b)
(including determination of whether an individual received
inpatient hospital services or diagnostic services for purposes
of such sections), section 1814(f)(2), and subsection (i) of
this section, such term includes any institution which (i)
meets the requirements of paragraphs (5) and (7) of this
subsection, (ii) is not primarily engaged in providing the
services described in section 1861(j)(1)(A) and (iii) is
primarily engaged in providing, by or under the supervision of
individuals referred to in paragraph (1) of section 1861(r), to
inpatients diagnostic services and therapeutic services for
medical diagnosis, treatment, and care of injured, disabled, or
sick persons, or rehabilitation services for the rehabilitation
of injured, disabled, or sick persons. For purposes of section
1814(f)(1), such term includes an institution which (i) is a
hospital for purposes of sections 1814(d), 1814(f)(2), and
1835(b) and (ii) is accredited by a national accreditation body
recognized by the Secretary under section 1865(a), or is
accredited by or approved by a program of the country in which
such institution is located if the Secretary finds the
accreditation or comparable approval standards of such program
to be essentially equivalent to those of such a national
accreditation body.. Notwithstanding the preceding provisions
of this subsection, such term shall not, except for purposes of
subsection (a)(2), include any institution which is primarily
for the care and treatment of mental diseases unless it is a
psychiatric hospital (as defined in subsection (f)). The term
``hospital'' also includes a religious nonmedical health care
institution (as defined in subsection (ss)(1)), but only with
respect to items and services ordinarily furnished by such
institution to inpatients, and payment may be made with respect
to services provided by or in such an institution only to such
extent and under such conditions, limitations, and requirements
(in addition to or in lieu of the conditions, limitations, and
requirements otherwise applicable) as may be provided in
regulations consistent with section 1821. For provisions
deeming certain requirements of this subsection to be met in
the case of accredited institutions, see section 1865. The term
``hospital'' also includes a facility of fifty beds or less
which is located in an area determined by the Secretary to meet
the definition relating to a rural area described in
subparagraph (A) of paragraph (5) of this subsection and which
meets the other requirements of this subsection, except that--
(A) with respect to the requirements for nursing
services applicable after December 31, 1978, such
requirements shall provide for temporary waiver of the
requirements, for such period as the Secretary deems
appropriate, where (i) the facility's failure to fully
comply with the requirements is attributable to a
temporary shortage of qualified nursing personnel in
the area in which the facility is located, (ii) a
registered professional nurse is present on the
premises to render or supervise the nursing service
provided during at least the regular daytime shift, and
(iii) the Secretary determines that the employment of
such nursing personnel as are available to the facility
during such temporary period will not adversely affect
the health and safety of patients;
(B) with respect to the health and safety
requirements promulgated under paragraph (9), such
requirements shall be applied by the Secretary to a
facility herein defined in such manner as to assure
that personnel requirements take into account the
availability of technical personnel and the educational
opportunities for technical personnel in the area in
which such facility is located, and the scope of
services rendered by such facility; and the Secretary,
by regulations, shall provide for the continued
participation of such a facility where such personnel
requirements are not fully met, for such period as the
Secretary determines that (i) the facility is making
good faith efforts to fully comply with the personnel
requirements, (ii) the employment by the facility of
such personnel as are available to the facility will
not adversely affect the health and safety of patients,
and (iii) if the Secretary has determined that because
of the facility's waiver under this subparagraph the
facility should limit its scope of services in order
not to adversely affect the health and safety of the
facility's patients, the facility is so limiting the
scope of services it provides; and
(C) with respect to the fire and safety requirements
promulgated under paragraph (9), the Secretary (i) may
waive, for such period as he deems appropriate,
specific provisions of such requirements which if
rigidly applied would result in unreasonable hardship
for such a facility and which, if not applied, would
not jeopardize the health and safety of patients, and
(ii) may accept a facility's compliance with all
applicable State codes relating to fire and safety in
lieu of compliance with the fire and safety
requirements promulgated under paragraph (9), if he
determines that such State has in effect fire and
safety codes, imposed by State law, which adequately
protect patients.
The term ``hospital'' does not include, unless the context
otherwise requires, a critical access hospital (as defined in
section 1861(mm)(1)) or a rural emergency hospital (as defined
in subsection (kkk)(2)).
Psychiatric Hospital
(f) The term ``psychiatric hospital'' means an institution
which--
(1) is primarily engaged in providing, by or under
the supervision of a physician, psychiatric services
for the diagnosis and treatment of mentally ill
persons;
(2) satisfies the requirements of paragraphs (3)
through (9) of subsection (e);
(3) maintains clinical records on all patients and
maintains such records as the Secretary finds to be
necessary to determine the degree and intensity of the
treatment provided to individuals entitled to hospital
insurance benefits under part A; and
(4) meets such staffing requirements as the Secretary
finds necessary for the institution to carry out an
active program of treatment for individuals who are
furnished services in the institution.
In the case of an institution which satisfies paragraphs (1)
and (2) of the preceding sentence and which contains a distinct
part which also satisfies paragraphs (3) and (4) of such
sentence, such distinct part shall be considered to be a
``psychiatric hospital''.
Outpatient Occupational Therapy Services
(g) The term ``outpatient occupational therapy services'' has
the meaning given the term ``outpatient physical therapy
services'' in subsection (p), except that ``occupational''
shall be substituted for ``physical'' each place it appears
therein.
Extended Care Services
(h) The term ``extended care services'' means the following
items and services furnished to an inpatient of a skilled
nursing facility and (except as provided in paragraphs (3), (6)
and (7)) by such skilled nursing facility--
(1) nursing care provided by or under the supervision
of a registered professional nurse;
(2) bed and board in connection with the furnishing
of such nursing care;
(3) physical or occupational therapy or speech-
language pathology services furnished by the skilled
nursing facility or by others under arrangements with
them made by the facility;
(4) medical social services;
(5) such drugs, biologicals, supplies, appliances,
and equipment, furnished for use in the skilled nursing
facility, as are ordinarily furnished by such facility
for the care and treatment of inpatients;
(6) medical services provided by an intern or
resident-in- training of a hospital with which the
facility has in effect a transfer agreement (meeting
the requirements of subsection (l)), under a teaching
program of such hospital approved as provided in the
last sentence of subsection (b), and other diagnostic
or therapeutic services provided by a hospital with
which the facility has such an agreement in effect; and
(7) such other services necessary to the health of
the patients as are generally provided by skilled
nursing facilities, or by others under arrangements
with them made by the facility;
excluding, however, any item or service if it would not be
included under subsection (b) if furnished to an inpatient of a
hospital.
Post-Hospital Extended Care Services
(i) The term ``post-hospital extended care services'' means
extended care services furnished an individual after transfer
from a hospital in which he was an inpatient for not less than
3 consecutive days before his discharge from the hospital in
connection with such transfer. For purposes of the preceding
sentence, items and services shall be deemed to have been
furnished to an individual after transfer from a hospital, and
he shall be deemed to have been an inpatient in the hospital
immediately before transfer therefrom, if he is admitted to the
skilled nursing facility (A) within 30 days after discharge
from such hospital, or (B) within such time as it would be
medically appropriate to begin an active course of treatment,
in the case of an individual whose condition is such that
skilled nursing facility care would not be medically
appropriate within 30 days after discharge from a hospital; and
an individual shall be deemed not to have been discharged from
a skilled nursing facility if, within 30 days after discharge
therefrom, he is admitted to such facility or any other skilled
nursing facility.
Skilled Nursing Facility
(j) The term ``skilled nursing facility'' has the meaning
given such term in section 1819(a).
Utilization Review
(k) A utilization review plan of a hospital or skilled
nursing facility shall be considered sufficient if it is
applicable to services furnished by the institution to
individuals entitled to insurance benefits under this title and
if it provides--
(1) for the review, on a sample or other basis, of
admissions to the institution, the duration of stays
therein, and the professional services (including drugs
and biologicals) furnished, (A) with respect to the
medical necessity of the services, and (B) for the
purpose of promoting the most efficient use of
available health facilities and services;
(2) for such review to be made by either (A) a staff
committee of the institution composed of two or more
physicians (of which at least two must be physicians
described in subsection (r)(1) of this section), with
or without participation of other professional
personnel, or (B) a group outside the institution which
is similarly composed and (i) which is established by
the local medical society and some or all of the
hospitals and skilled nursing facilities in the
locality, or (ii) if (and for as long as) there has not
been established such a group which serves such
institution, which is established in such other manner
as may be approved by the Secretary;
(3) for such review, in each case of inpatient
hospital services or extended care services furnished
to such an individual during a continuous period of
extended duration, as of such days of such period
(which may differ for different classes of cases) as
may be specified in regulations, with such review to be
made as promptly as possible, after each day so
specified, and in no event later than one week
following such day; and
(4) for prompt notification to the institution, the
individual, and his attending physician of any finding
(made after opportunity for consultation to such
attending physician) by the physician members of such
committee or group that any further stay in the
institution is not medically necessary.
The review committee must be composed as provided in clause (B)
of paragraph (2) rather than as provided in clause (A) of such
paragraph in the case of any hospital or skilled nursing
facility where, because of the small size of the institution,
or (in the case of a skilled nursing facility) because of lack
of an organized medical staff, or for such other reason or
reasons as may be included in regulations, it is impracticable
for the institution to have a properly functioning staff
committee for the purposes of this subsection. If the Secretary
determines that the utilization review procedures established
pursuant to title XIX are superior in their effectiveness to
the procedures required under this section, he may, to the
extent that he deems it appropriate, require for purposes of
this title that the procedures established pursuant to title
XIX be utilized instead of the procedures required by this
section.
Agreements for Transfer Between Skilled Nursing Facilities and
Hospitals
(l) A hospital and a skilled nursing facility shall be
considered to have a transfer agreement in effect if, by reason
of a written agreement between them or (in case the two
institutions are under common control) by reason of a written
undertaking by the person or body which controls them, there is
reasonable assurance that--
(1) transfer of patients will be effected between the
hospital and the skilled nursing facility whenever such
transfer is medically appropriate as determined by the
attending physician; and
(2) there will be interchange of medical and other
information necessary or useful in the care and
treatment of individuals transferred between the
institutions, or in determining whether such
individuals can be adequately cared for otherwise than
in either of such institutions.
Any skilled nursing facility which does not have such an
agreement in effect, but which is found by a State agency (of
the State in which such facility is situated) with which an
agreement under section 1864 is in effect (or, in the case of a
State in which no such agency has an agreement under section
1864, by the Secretary) to have attempted in good faith to
enter into such an agreement with a hospital sufficiently close
to the facility to make feasible the transfer between them of
patients and the information referred to in paragraph (2),
shall be considered to have such an agreement in effect if and
for so long as such agency (or the Secretary, as the case may
be) finds that to do so is in the public interest and essential
to assuring extended care services for persons in the community
who are eligible for payments with respect to such services
under this title.
Home Health Services
(m) The term ``home health services'' means the following
items and services furnished to an individual, who is under the
care of a physician, a nurse practitioner or a clinical nurse
specialist (as those terms are defined in subsection (aa)(5)),
or a physician assistant (as defined in subsection (aa)(5)), by
a home health agency or by others under arrangements with them
made by such agency, under a plan (for furnishing such items
and services to such individual) established and periodically
reviewed by a physician, a nurse practitioner, a clinical nurse
specialist, or a physician assistant, which items and services
are, except as provided in paragraph (7), provided on a
visiting basis in a place of residence used as such
individual's home--
(1) part-time or intermittent nursing care provided
by or under the supervision of a registered
professional nurse;
(2) physical or occupational therapy or speech-
language pathology services;
(3) medical social services under the direction of a
physician, a nurse practitioner, a clinical nurse
specialist, or a physician assistant;
(4) to the extent permitted in regulations, part-time
or intermittent services of a home health aide who has
successfully completed a training program approved by
the Secretary;
(5) medical supplies (including catheters, catheter
supplies, ostomy bags, and supplies related to ostomy
care, and a covered osteoporosis drug (as defined in
subsection (kk)), but excluding other drugs and
biologicals) and durable medical equipment and
applicable disposable devices (as defined in section
1834(s)(2)) while under such a plan;
(6) in the case of a home health agency which is
affiliated or under common control with a hospital,
medical services provided by an intern or resident-in-
training of such hospital, under a teaching program of
such hospital approved as provided in the last sentence
of subsection (b); and
(7) any of the foregoing items and services which are
provided on an outpatient basis, under arrangements
made by the home health agency, at a hospital or
skilled nursing facility, or at a rehabilitation center
which meets such standards as may be prescribed in
regulations, and--
(A) the furnishing of which involves the use
of equipment of such a nature that the items
and services cannot readily be made available
to the individual in such place of residence,
or
(B) which are furnished at such facility
while he is there to receive any such item or
service described in clause (A),
but not including transportation of the individual in
connection with any such item or service;
excluding, however, any item or service if it would not be
included under subsection (b) if furnished to an inpatient of a
hospital and home infusion therapy (as defined in subsection
(iii)(i)). For purposes of paragraphs (1) and (4), the term
``part-time or intermittent services'' means skilled nursing
and home health aide services furnished any number of days per
week as long as they are furnished (combined) less than 8 hours
each day and 28 or fewer hours each week (or, subject to review
on a case-by-case basis as to the need for care, less than 8
hours each day and 35 or fewer hours per week). For purposes of
sections 1814(a)(2)(C) and 1835(a)(2)(A), ``intermittent''
means skilled nursing care that is either provided or needed on
fewer than 7 days each week, or less than 8 hours of each day
for periods of 21 days or less (with extensions in exceptional
circumstances when the need for additional care is finite and
predictable).
Durable Medical Equipment
(n) The term ``durable medical equipment'' includes iron
lungs, oxygen tents, hospital beds, and wheelchairs (which may
include a power-operated vehicle that may be appropriately used
as a wheelchair, but only where the use of such a vehicle is
determined to be necessary on the basis of the individual's
medical and physical condition and the vehicle meets such
safety requirements as the Secretary may prescribe) used in the
patient's home (including an institution used as his home other
than an institution that meets the requirements of subsection
(e)(1) of this section or section 1819(a)(1)), whether
furnished on a rental basis or purchased, and includes blood-
testing strips and blood glucose monitors for individuals with
diabetes without regard to whether the individual has Type I or
Type II diabetes or to the individual's use of insulin (as
determined under standards established by the Secretary in
consultation with the appropriate organizations) and eye
tracking and gaze interaction accessories for speech generating
devices furnished to individuals with a demonstrated medical
need for such accessories; except that such term does not
include such equipment furnished by a supplier who has used,
for the demonstration and use of specific equipment, an
individual who has not met such minimum training standards as
the Secretary may establish with respect to the demonstration
and use of such specific equipment. With respect to a seat-lift
chair, such term includes only the seat-lift mechanism and does
not include the chair. Beginning with the first calendar
quarter beginning on or after the date that is one year after
the date of the enactment of the ``Seniors' Access to Critical
Medications Act of 2024'', an external infusion pump and
associated home infusion drug (as defined in subsection
(iii)(3)(C)) or other associated supplies that do not meet the
appropriate for use in the home requirement applied to the
definition of durable medical equipment under section 414.202
of title 42, Code of Federal Regulations (or any successor to
such regulation) shall be treated as meeting such requirement
if each of the following criteria is satisfied:
(1) The prescribing information approved by the Food
and Drug Administration for the home infusion drug
associated with the pump instructs that the drug should
be administered by or under the supervision of a health
care professional.
(2) A qualified home infusion therapy supplier (as
defined in subsection (iii)(3)(D)) administers or
supervises the administration of the drug or biological
in a safe and effective manner in the patient's home
(as defined in subsection (iii)(3)(B)).
(3) The prescribing information described in
paragraph (1) instructs that the drug should be infused
at least 12 times per year--
(A) intravenously or subcutaneously; or
(B) at infusion rates that the Secretary
determines would require the use of an external
infusion pump.
Home Health Agency
(o) The term ``home health agency'' means a public agency or
private organization, or a subdivision of such an agency or
organization, which--
(1) is primarily engaged in providing skilled nursing
services and other therapeutic services;
(2) has policies, established by a group of
professional personnel (associated with the agency or
organization), including one or more physicians, nurse
practitioners or clinical nurse specialists (as those
terms are defined in subsection (aa)(5)), certified
nurse-midwives (as defined in subsection (gg)), or
physician, nurse practitioner, clinical nurse
specialist, certified nurse-midwife, physician
assistant, assistants (as defined in subsection
(aa)(5)) and one or more registered professional
nurses, to govern the services (referred to in
paragraph (1)) which it provides, and provides for
supervision of such services by a physician, nurse
practitioner, clinical nurse specialist, certified
nurse-midwife, physician assistant, or registered
professional nurse;
(3) maintains clinical records on all patients;
(4) in the case of an agency or organization in any
State in which State or applicable local law provides
for the licensing of agencies or organizations of this
nature, (A) is licensed pursuant to such law, or (B) is
approved, by the agency of such State or locality
responsible for licensing agencies or organizations of
this nature, as meeting the standards established for
such licensing;
(5) has in effect an overall plan and budget that
meets the requirements of subsection (z);
(6) meets the conditions of participation specified
in section 1891(a) and such other conditions of
participation as the Secretary may find necessary in
the interest of the health and safety of individuals
who are furnished services by such agency or
organization;
(7) provides the Secretary with a surety bond--
(A) in a form specified by the Secretary and
in an amount that is not less than the minimum
of $50,000; and
(B) that the Secretary determines is
commensurate with the volume of payments to the
home health agency; and
(8) meets such additional requirements (including
conditions relating to bonding or establishing of
escrow accounts as the Secretary finds necessary for
the financial security of the program) as the Secretary
finds necessary for the effective and efficient
operation of the program;
except that for purposes of part A such term shall not include
any agency or organization which is primarily for the care and
treatment of mental diseases. The Secretary may waive the
requirement of a surety bond under paragraph (7) in the case of
an agency or organization that provides a comparable surety
bond under State law.
Outpatient Physical Therapy Services
(p) The term ``outpatient physical therapy services'' means
physical therapy services furnished by a provider of services,
a clinic, rehabilitation agency, or a public health agency, or
by others under an arrangement with, and under the supervision
of, such provider, clinic, rehabilitation agency, or public
health agency to an individual as an outpatient--
(1) who is under the care of a physician (as defined
in paragraph (1), (3), or (4) of section 1861(r)), and
(2) with respect to whom a plan prescribing the type,
amount, and duration of physical therapy services that
are to be furnished such individual has been
established by a physician (as so defined) or by a
qualified physical therapist and is periodically
reviewed by a physician (as so defined);
excluding, however--
(3) any item or service if it would not be included
under subsection (b) if furnished to an inpatient of a
hospital; and
(4) any such service--
(A) if furnished by a clinic or
rehabilitation agency, or by others under
arrangements with such clinic or agency, unless
such clinic or rehabilitation agency--
(i) provides an adequate program of
physical therapy services for
outpatients and has the facilities and
personnel required for such program or
required for the supervision of such a
program, in accordance with such
requirements as the Secretary may
specify,
(ii) has policies, established by a
group of professional personnel,
including one or more physicians
(associated with the clinic or
rehabilitation agency) and one or more
qualified physical therapists, to
govern the services (referred to in
clause (i)) it provides,
(iii) maintains clinical records on
all patients,
(iv) if such clinic or agency is
situated in a State in which State or
applicable local law provides for the
licensing of institutions of this
nature, (I) is licensed pursuant to
such law, or (II) is approved by the
agency of such State or locality
responsible for licensing institutions
of this nature, as meeting the
standards established for such
licensing; and
(v) meets such other conditions
relating to the health and safety of
individuals who are furnished services
by such clinic or agency on an
outpatient basis, as the Secretary may
find necessary, and provides the
Secretary on a continuing basis with a
surety bond in a form specified by the
Secretary and in an amount that is not
less than $50,000, or
(B) if furnished by a public health agency,
unless such agency meets such other conditions
relating to health and safety of individuals
who are furnished services by such agency on an
outpatient basis, as the Secretary may find
necessary.
The term ``outpatient physical therapy services'' also includes
physical therapy services furnished an individual by a physical
therapist (in his office or in such individual's home) who
meets licensing and other standards prescribed by the Secretary
in regulations, otherwise than under an arrangement with and
under the supervision of a provider of services, clinic,
rehabilitation agency, or public health agency, if the
furnishing of such services meets such conditions relating to
health and safety as the Secretary may find necessary. In
addition, such term includes physical therapy services which
meet the requirements of the first sentence of this subsection
except that they are furnished to an individual as an inpatient
of a hospital or extended care facility. Nothing in this
subsection shall be construed as requiring, with respect to
outpatients who are not entitled to benefits under this title,
a physical therapist to provide outpatient physical therapy
services only to outpatients who are under the care of a
physician or pursuant to a plan of care established by a
physician. The Secretary may waive the requirement of a surety
bond under paragraph (4)(A)(v) in the case of a clinic or
agency that provides a comparable surety bond under State law.
Physicians' Services
(q) The term ``physicians' services'' means professional
services performed by physicians, including surgery,
consultation, and home, office, and institutional calls (but
not including services described in subsection (b)(6)).
Physician
(r) The term ``physician'', when used in connection with the
performance of any function or action, means (1) a doctor of
medicine or osteopathy legally authorized to practice medicine
and surgery by the State in which he performs such function or
action (including a physician within the meaning of section
1101(a)(7)), (2) a doctor of dental surgery or of dental
medicine who is legally authorized to practice dentistry by the
State in which he performs such function and who is acting
within the scope of his license when he performs such
functions, (3) a doctor of podiatric medicine for the purposes
of subsections (k), (m), (p)(1), and (s) of this section and
sections 1814(a), 1832(a)(2)(F)(ii), and 1835 but only with
respect to functions which he is legally authorized to perform
as such by the State in which he performs them, (4) a doctor of
optometry, but only for purposes of subsection (p)(1) and with
respect to the provision of items or services described in
subsection (s) which he is legally authorized to perform as a
doctor of optometry by the State in which he performs them, or
(5) a chiropractor who is licensed as such by the State (or in
a State which does not license chiropractors as such, is
legally authorized to perform the services of a chiropractor in
the jurisdiction in which he performs such services), and who
meets uniform minimum standards promulgated by the Secretary,
but only for the purpose of sections 1861(s)(1) and
1861(s)(2)(A) and only with respect to treatment by means of
manual manipulation of the spine (to correct a subluxation)
which he is legally authorized to perform by the State or
jurisdiction in which such treatment is provided. For the
purposes of section 1862(a)(4) and subject to the limitations
and conditions provided in the previous sentence, such term
includes a doctor of one of the arts, specified in such
previous sentence, legally authorized to practice such art in
the country in which the inpatient hospital services (referred
to in such section 1862(a)(4)) are furnished.
Medical and Other Health Services
(s) The term ``medical and other health services'' means any
of the following items or services:
(1) physicians' services;
(2)(A) services and supplies (including drugs and
biologicals which are not usually self-administered by
the patient) furnished as an incident to a physician's
professional service, of kinds which are commonly
furnished in physicians' offices and are commonly
either rendered without charge or included in the
physicians' bills (or would have been so included but
for the application of section 1847B);
(B) hospital services (including drugs and
biologicals which are not usually self-administered by
the patient) incident to physicians' services rendered
to outpatients and partial hospitalization services or
intensive outpatient services incident to such
services;
(C) diagnostic services which are--
(i) furnished to an individual as an
outpatient by a hospital or by others under
arrangements with them made by a hospital, and
(ii) ordinarily furnished by such hospital
(or by others under such arrangements) to its
outpatients for the purpose of diagnostic
study;
(D) outpatient physical therapy services, outpatient
speech-language pathology services, and outpatient
occupational therapy services;
(E) rural health clinic services and Federally
qualified health center services;
(F) home dialysis supplies and equipment, self-care
home dialysis support services, and institutional
dialysis services and supplies, and, for items and
services furnished on or after January 1, 2011, renal
dialysis services (as defined in section
1881(b)(14)(B)), including such renal dialysis services
furnished on or after January 1, 2017, by a renal
dialysis facility or provider of services paid under
section 1881(b)(14) to an individual with acute kidney
injury (as defined in section 1834(r)(2));
(G) antigens (subject to quantity limitations
prescribed in regulations by the Secretary) prepared by
a physician, as defined in section 1861(r)(1), for a
particular patient, including antigens so prepared
which are forwarded to another qualified person
(including a rural health clinic) for administration to
such patient, from time to time, by or under the
supervision of another such physician;
(H)(i) services furnished pursuant to a contract
under section 1876 to a member of an eligible
organization by a physician assistant or by a nurse
practitioner (as defined in subsection (aa)(5)) and
such services and supplies furnished as an incident to
his service to such a member as would otherwise be
covered under this part if furnished by a physician or
as an incident to a physician's service; and
(ii) services furnished pursuant to a risk-sharing
contract under section 1876(g) to a member of an
eligible organization by a clinical psychologist (as
defined by the Secretary) or by a clinical social
worker (as defined in subsection (hh)(2)), and such
services and supplies furnished as an incident to such
clinical psychologist's services or clinical social
worker's services to such a member as would otherwise
be covered under this part if furnished by a physician
or as an incident to a physician's service;
(I) blood clotting factors, for hemophilia patients
competent to use such factors to control bleeding
without medical or other supervision, and items related
to the administration of such factors, subject to
utilization controls deemed necessary by the Secretary
for the efficient use of such factors;
(J) prescription drugs used in immunosuppressive
therapy furnished, to an individual who receives an
organ transplant for which payment is made under this
title;
(K)(i) services which would be physicians' services
and services described in subsections (ww)(1) and (hhh)
if furnished by a physician (as defined in subsection
(r)(1)) and which are performed by a physician
assistant (as defined in subsection (aa)(5)) under the
supervision of a physician (as so defined) and which
the physician assistant is legally authorized to
perform by the State in which the services are
performed, and such services and supplies furnished as
incident to such services as would be covered under
subparagraph (A) if furnished incident to a physician's
professional service, but only if no facility or other
provider charges or is paid any amounts with respect to
the furnishing of such services,
(ii) services which would be physicians' services and
services described in subsections (ww)(1) and (hhh) if
furnished by a physician (as defined in subsection
(r)(1)) and which are performed by a nurse practitioner
or clinical nurse specialist (as defined in subsection
(aa)(5)) working in collaboration (as defined in
subsection (aa)(6)) with a physician (as defined in
subsection (r)(1)) which the nurse practitioner or
clinical nurse specialist is legally authorized to
perform by the State in which the services are
performed, and such services and supplies furnished as
an incident to such services as would be covered under
subparagraph (A) if furnished incident to a physician's
professional service, but only if no facility or other
provider charges or is paid any amounts with respect to
the furnishing of such services;
(L) certified nurse-midwife services;
(M) qualified psychologist services;
(N) clinical social worker services (as defined in
subsection (hh)(2));
(O) erythropoietin for dialysis patients competent to
use such drug without medical or other supervision with
respect to the administration of such drug, subject to
methods and standards established by the Secretary by
regulation for the safe and effective use of such drug,
and items related to the administration of such drug;
(P) prostate cancer screening tests (as defined in
subsection (oo));
(Q) an oral drug (which is approved by the Federal
Food and Drug Administration) prescribed for use as an
anticancer chemotherapeutic agent for a given
indication, and containing an active ingredient (or
ingredients), which is the same indication and active
ingredient (or ingredients) as a drug which the carrier
determines would be covered pursuant to subparagraph
(A) or (B) if the drug could not be self-administered;
(R) colorectal cancer screening tests (as defined in
subsection (pp));
(S) diabetes outpatient self-management training
services (as defined in subsection (qq));
(T) an oral drug (which is approved by the Federal
Food and Drug Administration) prescribed for use as an
acute anti-emetic used as part of an anticancer
chemotherapeutic regimen if the drug is administered by
a physician (or as prescribed by a physician)--
(i) for use immediately before, at, or within
48 hours after the time of the administration
of the anticancer chemotherapeutic agent; and
(ii) as a full replacement for the anti-
emetic therapy which would otherwise be
administered intravenously;
(U) screening for glaucoma (as defined in subsection
(uu)) for individuals determined to be at high risk for
glaucoma, individuals with a family history of glaucoma
and individuals with diabetes;
(V) medical nutrition therapy services (as defined in
subsection (vv)(1)) in the case of a beneficiary with
diabetes or a renal disease who--
(i) has not received diabetes outpatient
self-management training services within a time
period determined by the Secretary;
(ii) is not receiving maintenance dialysis
for which payment is made under section 1881;
and
(iii) meets such other criteria determined by
the Secretary after consideration of protocols
established by dietitian or nutrition
professional organizations;
(W) an initial preventive physical examination (as
defined in subsection (ww));
(X) cardiovascular screening blood tests (as defined
in subsection (xx)(1));
(Y) diabetes screening tests (as defined in
subsection (yy));
(Z) intravenous immune globulin, and items and
services furnished on or after January 1, 2024, related
to the administration of intravenous immune globulin,
for the treatment of primary immune deficiency diseases
in the home (as defined in subsection (zz));
(AA) ultrasound screening for abdominal aortic
aneurysm (as defined in subsection (bbb)) for an
individual--
(i) who receives a referral for such an
ultrasound screening as a result of an initial
preventive physical examination (as defined in
section 1861(ww)(1));
(ii) who has not been previously furnished
such an ultrasound screening under this title;
and
(iii) who--
(I) has a family history of abdominal
aortic aneurysm; or
(II) manifests risk factors included
in a beneficiary category recommended
for screening by the United States
Preventive Services Task Force
regarding abdominal aortic aneurysms;
(BB) additional preventive services (described in
subsection (ddd)(1));
(CC) items and services furnished under a
cardiac rehabilitation program (as defined in
subsection (eee)(1)) or under a pulmonary
rehabilitation program (as defined in
subsection (fff)(1));
(DD) items and services furnished under an
intensive cardiac rehabilitation program (as
defined in subsection (eee)(4));
(EE) kidney disease education services (as defined in
subsection (ggg));
(FF) personalized prevention plan services (as
defined in subsection (hhh));
(GG) home infusion therapy (as defined in subsection
(iii)(1));
(HH) opioid use disorder treatment services (as
defined in subsection (jjj));
(II) marriage and family therapist services (as
defined in subsection (lll)(1)) and mental health
counselor services (as defined in subsection (lll)(3));
(JJ) lymphedema compression treatment items (as
defined in subsection (mmm));
(3) diagnostic X-ray tests (including tests under the
supervision of a physician, furnished in a place of
residence used as the patient's home, if the
performance of such tests meets such conditions
relating to health and safety as the Secretary may find
necessary and including diagnostic mammography if
conducted by a facility that has a certificate (or
provisional certificate) issued under section 354 of
the Public Health Service Act), diagnostic laboratory
tests, and other diagnostic tests;
(4) X-ray, radium, and radioactive isotope therapy,
including materials and services of technicians;
(5) surgical dressings, and splints, casts, and other
devices used for reduction of fractures and
dislocations;
(6) durable medical equipment;
(7) ambulance service where the use of other methods
of transportation is contraindicated by the
individual's condition, but, subject to section
1834(l)(14), only to the extent provided in
regulations;
(8) prosthetic devices (other than dental) which
replace all or part of an internal body organ
(including colostomy bags and supplies directly related
to colostomy care), including replacement of such
devices, and including one pair of conventional
eyeglasses or contact lenses furnished subsequent to
each cataract surgery with insertion of an intraocular
lens;
(9) leg, arm, back, and neck braces, and artificial
legs, arms, and eyes, including replacements if
required because of a change in the patient's physical
condition;
(10)(A) pneumococcal vaccine and its administration
and, subject to section 4071(b) of the Omnibus Budget
Reconciliation Act of 1987, influenza vaccine and its
administration, and COVID-19 vaccine and its
administration; and
(B) hepatitis B vaccine and its administration,
furnished to an individual who is at high or
intermediate risk of contracting hepatitis B (as
determined by the Secretary under regulations);
(11) services of a certified registered nurse
anesthetist (as defined in subsection (bb));
(12) subject to section 4072(e) of the Omnibus Budget
Reconciliation Act of 1987, extra-depth shoes with
inserts or custom molded shoes with inserts for an
individual with diabetes, if--
(A) the physician who is managing the
individual's diabetic condition (i) documents
that the individual has peripheral neuropathy
with evidence of callus formation, a history of
pre-ulcerative calluses, a history of previous
ulceration, foot deformity, or previous
amputation, or poor circulation, and (ii)
certifies that the individual needs such shoes
under a comprehensive plan of care related to
the individual's diabetic condition;
(B) the particular type of shoes are
prescribed by a podiatrist or other qualified
physician (as established by the Secretary);
and
(C) the shoes are fitted and furnished by a
podiatrist or other qualified individual (such
as a pedorthist or orthotist, as established by
the Secretary) who is not the physician
described in subparagraph (A) (unless the
Secretary finds that the physician is the only
such qualified individual in the area);
(13) screening mammography (as defined in subsection
(jj));
(14) screening pap smear and screening pelvic exam;
and
(15) bone mass measurement (as defined in subsection
(rr)).
No diagnostic tests performed in any laboratory, including a
laboratory that is part of a rural health clinic, or a hospital
(which, for purposes of this sentence, means an institution
considered a hospital for purposes of section 1814(d)) shall be
included within paragraph (3) unless such laboratory--
(16) if situated in any State in which State or
applicable local law provides for licensing of
establishments of this nature, (A) is licensed pursuant
to such law, or (B) is approved, by the agency of such
State or locality responsible for licensing
establishments of this nature, as meeting the standards
established for such licensing; and
(17)(A) meets the certification requirements under
section 353 of the Public Health Service Act; and
(B) meets such other conditions relating to the
health and safety of individuals with respect to whom
such tests are performed as the Secretary may find
necessary.
There shall be excluded from the diagnostic services specified
in paragraph (2)(C) any item or service (except services
referred to in paragraph (1)) which would not be included under
subsection (b) if it were furnished to an inpatient of a
hospital. None of the items and services referred to in the
preceding paragraphs (other than paragraphs (1) and (2)(A)) of
this subsection which are furnished to a patient of an
institution which meets the definition of a hospital for
purposes of section 1814(d) shall be included unless such other
conditions are met as the Secretary may find necessary relating
to health and safety of individuals with respect to whom such
items and services are furnished.
Drugs and Biologicals
(t)(1) The term ``drugs'' and the term ``biologicals'',
except for purposes of subsection (m)(5) and paragraph (2),
include only such drugs (including contrast agents) and
biologicals, respectively, as are included (or approved for
inclusion) in the United States Pharmacopoeia, the National
Formulary, or the United States Homeopathic Pharmacopoeia, or
in New Drugs or Accepted Dental Remedies (except for any drugs
and biologicals unfavorably evaluated therein), or as are
approved by the pharmacy and drug therapeutics committee (or
equivalent committee) of the medical staff of the hospital
furnishing such drugs and biologicals for use in such hospital.
(2)(A) For purposes of paragraph (1), the term ``drugs'' also
includes any drugs or biologicals used in an anticancer
chemotherapeutic regimen for a medically accepted indication
(as described in subparagraph (B)).
(B) In subparagraph (A), the term ``medically accepted
indication'', with respect to the use of a drug, includes any
use which has been approved by the Food and Drug Administration
for the drug, and includes another use of the drug if--
(i) the drug has been approved by the Food and Drug
Administration; and
(ii)(I) such use is supported by one or more
citations which are included (or approved for
inclusion) in one or more of the following compendia:
the American Hospital Formulary Service-Drug
Information, the American Medical Association Drug
Evaluations, the United States Pharmacopoeia-Drug
Information (or its successor publications), and other
authoritative compendia as identified by the Secretary,
unless the Secretary has determined that the use is not
medically appropriate or the use is identified as not
indicated in one or more such compendia, or
(II) the carrier involved determines, based upon
guidance provided by the Secretary to carriers for
determining accepted uses of drugs, that such use is
medically accepted based on supportive clinical
evidence in peer reviewed medical literature appearing
in publications which have been identified for purposes
of this subclause by the Secretary.
The Secretary may revise the list of compendia in clause
(ii)(I) as is appropriate for identifying medically accepted
indications for drugs. On and after January 1, 2010, no
compendia may be included on the list of compendia under this
subparagraph unless the compendia has a publicly transparent
process for evaluating therapies and for identifying potential
conflicts of interests.
Provider of Services
(u) The term ``provider of services'' means a hospital,
critical access hospital, rural emergency hospital, skilled
nursing facility, comprehensive outpatient rehabilitation
facility, home health agency, hospice program, or, for purposes
of section 1814(g) and section 1835(e), a fund.
Reasonable Cost
(v)(1)(A) The reasonable cost of any services shall be the
cost actually incurred, excluding therefrom any part of
incurred cost found to be unnecessary in the efficient delivery
of needed health services, and shall be determined in
accordance with regulations establishing the method or methods
to be used, and the items to be included, in determining such
costs for various types or classes of institutions, agencies,
and services; except that in any case to which paragraph (2) or
(3) applies, the amount of the payment determined under such
paragraph with respect to the services involved shall be
considered the reasonable cost of such services. In prescribing
the regulations referred to in the preceding sentence, the
Secretary shall consider, among other things, the principles
generally applied by national organizations or established
prepayment organizations (which have developed such principles)
in computing the amount of payment, to be made by persons other
than the recipients of services, to providers of services on
account of services furnished to such recipients by such
providers. Such regulations may provide for determination of
the costs of services on a per diem, per unit, per capita, or
other basis, may provide for using different methods in
different circumstances, may provide for the use of estimates
of costs of particular items or services, may provide for the
establishment of limits on the direct or indirect overall
incurred costs or incurred costs of specific items or services
or groups of items or services to be recognized as reasonable
based on estimates of the costs necessary in the efficient
delivery of needed health services to individuals covered by
the insurance programs established under this title, and may
provide for the use of charges or a percentage of charges where
this method reasonably reflects the costs. Such regulations
shall (i) take into account both direct and indirect costs of
providers of services (excluding therefrom any such costs,
including standby costs, which are determined in accordance
with regulations to be unnecessary in the efficient delivery of
services covered by the insurance programs established under
this title) in order that, under the methods of determining
costs, the necessary costs of efficiently delivering covered
services to individuals covered by the insurance programs
established by this title will not be borne by individuals not
so covered, and the costs with respect to individuals not so
covered will not be borne by such insurance programs, and (ii)
provide for the making of suitable retroactive corrective
adjustments where, for a provider of services for any fiscal
period, the aggregate reimbursement produced by the methods of
determining costs proves to be either inadequate or excessive.
(B) In the case of extended care services, the regulations
under subparagraph (A) shall not include provision for specific
recognition of a return on equity capital.
(C) Where a hospital has an arrangement with a medical school
under which the faculty of such school provides services at
such hospital, an amount not in excess of the reasonable cost
of such services to the medical school shall be included in
determining the reasonable cost to the hospital of furnishing
services--
(i) for which payment may be made under part A, but
only if--
(I) payment for such services as furnished
under such arrangement would be made under part
A to the hospital had such services been
furnished by the hospital, and
(II) such hospital pays to the medical school
at least the reasonable cost of such services
to the medical school, or
(ii) for which payment may be made under part B, but
only if such hospital pays to the medical school at
least the reasonable cost of such services to the
medical school.
(D) Where (i) physicians furnish services which are either
inpatient hospital services (including services in conjunction
with the teaching programs of such hospital) by reason of
paragraph (7) of subsection (b) or for which entitlement exists
by reason of clause (II) of section 1832(a)(2)(B)(i), and (ii)
such hospital (or medical school under arrangement with such
hospital) incurs no actual cost in the furnishing of such
services, the reasonable cost of such services shall (under
regulations of the Secretary) be deemed to be the cost such
hospital or medical school would have incurred had it paid a
salary to such physicians rendering such services approximately
equivalent to the average salary paid to all physicians
employed by such hospital (or if such employment does not
exist, or is minimal in such hospital, by similar hospitals in
a geographic area of sufficient size to assure reasonable
inclusion of sufficient physicians in development of such
average salary).
(E) Such regulations may, in the case of skilled nursing
facilities in any State, provide for the use of rates,
developed by the State in which such facilities are located,
for the payment of the cost of skilled nursing facility
services furnished under the State's plan approved under title
XIX (and such rates may be increased by the Secretary on a
class or size of institution or on a geographical basis by a
percentage factor not in excess of 10 percent to take into
account determinable items or services or other requirements
under this title not otherwise included in the computation of
such State rates), if the Secretary finds that such rates are
reasonably related to (but not necessarily limited to) analyses
undertaken by such State of costs of care in comparable
facilities in such State. Notwithstanding the previous
sentence, such regulations with respect to skilled nursing
facilities shall take into account (in a manner consistent with
subparagraph (A) and based on patient-days of services
furnished) the costs (including the costs of services required
to attain or maintain the highest practicable physical, mental,
and psychosocial well-being of each resident eligible for
benefits under this title) of such facilities complying with
the requirements of subsections (b), (c), and (d) of section
1819 (including the costs of conducting nurse aide training and
competency evaluation programs and competency evaluation
programs).
(F) Such regulations shall require each provider of services
(other than a fund) to make reports to the Secretary of
information described in section 1121(a) in accordance with the
uniform reporting system (established under such section) for
that type of provider.
(G)(i) In any case in which a hospital provides inpatient
services to an individual that would constitute post-hospital
extended care services if provided by a skilled nursing
facility and a quality improvement organization (or, in the
absence of such a qualified organization, the Secretary or such
agent as the Secretary may designate) determines that inpatient
hospital services for the individual are not medically
necessary but post-hospital extended care services for the
individual are medically necessary and such extended care
services are not otherwise available to the individual (as
determined in accordance with criteria established by the
Secretary) at the time of such determination, payment for such
services provided to the individual shall continue to be made
under this title at the payment rate described in clause (ii)
during the period in which--
(I) such post-hospital extended care services for the
individual are medically necessary and not otherwise
available to the individual (as so determined),
(II) inpatient hospital services for the individual
are not medically necessary, and
(III) the individual is entitled to have payment made
for post-hospital extended care services under this
title,
except that if the Secretary determines that there is not an
excess of hospital beds in such hospital and (subject to clause
(iv)) there is not an excess of hospital beds in the area of
such hospital, such payment shall be made (during such period)
on the basis of the amount otherwise payable under part A with
respect to inpatient hospital services.
(ii)(I) Except as provided in subclause (II), the payment
rate referred to in clause (i) is a rate equal to the estimated
adjusted State-wide average rate per patient-day paid for
services provided in skilled nursing facilities under the State
plan approved under title XIX for the State in which such
hospital is located, or, if the State in which the hospital is
located does not have a State plan approved under title XIX,
the estimated adjusted State-wide average allowable costs per
patient-day for extended care services under this title in that
State.
(II) If a hospital has a unit which is a skilled nursing
facility, the payment rate referred to in clause (i) for the
hospital is a rate equal to the lesser of the rate described in
subclause (I) or the allowable costs in effect under this title
for extended care services provided to patients of such unit.
(iii) Any day on which an individual receives inpatient
services for which payment is made under this subparagraph
shall, for purposes of this Act (other than this subparagraph),
be deemed to be a day on which the individual received
inpatient hospital services.
(iv) In determining under clause (i), in the case of a public
hospital, whether or not there is an excess of hospital beds in
the area of such hospital, such determination shall be made on
the basis of only the public hospitals (including the hospital)
which are in the area of the hospital and which are under
common ownership with that hospital.
(H) In determining such reasonable cost with respect to home
health agencies, the Secretary may not include--
(i) any costs incurred in connection with bonding or
establishing an escrow account by any such agency as a
result of the surety bond requirement described in
subsection (o)(7) and the financial security
requirement described in subsection (o)(8);
(ii) in the case of home health agencies to which the
surety bond requirement described in subsection (o)(7)
and the financial security requirement described in
subsection (o)(8) apply, any costs attributed to
interest charged such an agency in connection with
amounts borrowed by the agency to repay overpayments
made under this title to the agency, except that such
costs may be included in reasonable cost if the
Secretary determines that the agency was acting in good
faith in borrowing the amounts;
(iii) in the case of contracts entered into by a home
health agency after the date of the enactment of this
subparagraph for the purpose of having services
furnished for or on behalf of such agency, any cost
incurred by such agency pursuant to any such contract
which is entered into for a period exceeding five
years; and
(iv) in the case of contracts entered into by a home
health agency before the date of the enactment of this
subparagraph for the purpose of having services
furnished for or on behalf of such agency, any cost
incurred by such agency pursuant to any such contract,
which determines the amount payable by the home health
agency on the basis of a percentage of the agency's
reimbursement or claim for reimbursement for services
furnished by the agency, to the extent that such cost
exceeds the reasonable value of the services furnished
on behalf of such agency.
(I) In determining such reasonable cost, the Secretary may
not include any costs incurred by a provider with respect to
any services furnished in connection with matters for which
payment may be made under this title and furnished pursuant to
a contract between the provider and any of its subcontractors
which is entered into after the date of the enactment of this
subparagraph and the value or cost of which is $10,000 or more
over a twelve-month period unless the contract contains a
clause to the effect that--
(i) until the expiration of four years after the
furnishing of such services pursuant to such contract,
the subcontractor shall make available, upon written
request by the Secretary, or upon request by the
Comptroller General, or any of their duly authorized
representatives, the contract, and books, documents and
records of such subcontractor that are necessary to
certify the nature and extent of such costs, and
(ii) if the subcontractor carries out any of the
duties of the contract through a subcontract, with a
value or cost of $10,000 or more over a twelve-month
period, with a related organization, such subcontract
shall contain a clause to the effect that until the
expiration of four years after the furnishing of such
services pursuant to such subcontract, the related
organization shall make available, upon written request
by the Secretary, or upon request by the Comptroller
General, or any of their duly authorized
representatives, the subcontract, and books, documents
and records of such organization that are necessary to
verify the nature and extent of such costs.
The Secretary shall prescribe in regulation criteria and
procedures which the Secretary shall use in obtaining access to
books, documents, and records under clauses required in
contracts and subcontracts under this subparagraph.
(J) Such regulations may not provide for any inpatient
routine salary cost differential as a reimbursable cost for
hospitals and skilled nursing facilities.
(K)(i) The Secretary shall issue regulations that provide, to
the extent feasible, for the establishment of limitations on
the amount of any costs or charges that shall be considered
reasonable with respect to services provided on an outpatient
basis by hospitals (other than bona fide emergency services as
defined in clause (ii)) or clinics (other than rural health
clinics), which are reimbursed on a cost basis or on the basis
of cost related charges, and by physicians utilizing such
outpatient facilities. Such limitations shall be reasonably
related to the charges in the same area for similar services
provided in physicians' offices. Such regulations shall provide
for exceptions to such limitations in cases where similar
services are not generally available in physicians' offices in
the area to individuals entitled to benefits under this title.
(ii) For purposes of clause (i), the term ``bona fide
emergency services'' means services provided in a hospital
emergency room after the sudden onset of a medical condition
manifesting itself by acute symptoms of sufficient severity
(including severe pain) such that the absence of immediate
medical attention could reasonably be expected to result in--
(I) placing the patient's health in serious jeopardy;
(II) serious impairment to bodily functions; or
(III) serious dysfunction of any bodily organ or
part.
(L)(i) The Secretary, in determining the amount of the
payments that may be made under this title with respect to
services furnished by home health agencies, may not recognize
as reasonable (in the efficient delivery of such services)
costs for the provision of such services by an agency to the
extent these costs exceed (on the aggregate for the agency) for
cost reporting periods beginning on or after--
(I) July 1, 1985, and before July 1, 1986, 120
percent of the mean of the labor-related and nonlabor
per visit costs for freestanding home health agencies,
(II) July 1, 1986, and before July 1, 1987, 115
percent of such mean,
(III) July 1, 1987, and before October 1, 1997, 112
percent of such mean,
(IV) October 1, 1997, and before October 1, 1998, 105
percent of the median of the labor-related and nonlabor
per visit costs for freestanding home health agencies,
or
(V) October 1, 1998, 106 percent of such median.
(ii) Effective for cost reporting periods beginning on or
after July 1, 1986, such limitations shall be applied on an
aggregate basis for the agency, rather than on a discipline
specific basis. The Secretary may provide for such exemptions
and exceptions to such limitation as he deems appropriate.
(iii) Not later than July 1, 1991, and annually thereafter
(but not for cost reporting periods beginning on or after July
1, 1994, and before July 1, 1996, or on or after July 1, 1997,
and before October 1, 1997), the Secretary shall establish
limits under this subparagraph for cost reporting periods
beginning on or after such date by utilizing the area wage
index applicable under section 1886(d)(3)(E) and determined
using the survey of the most recent available wages and wage-
related costs of hospitals located in the geographic area in
which the home health service is furnished (determined without
regard to whether such hospitals have been reclassified to a
new geographic area pursuant to section 1886(d)(8)(B), a
decision of the Medicare Geographic Classification Review Board
under section 1886(d)(10), or a decision of the Secretary).
(iv) In establishing limits under this subparagraph for cost
reporting periods beginning after September 30, 1997, the
Secretary shall not take into account any changes in the home
health market basket, as determined by the Secretary, with
respect to cost reporting periods which began on or after July
1, 1994, and before July 1, 1996.
(v) For services furnished by home health agencies for cost
reporting periods beginning on or after October 1, 1997,
subject to clause (viii)(I), the Secretary shall provide for an
interim system of limits. Payment shall not exceed the costs
determined under the preceding provisions of this subparagraph
or, if lower, the product of--
(I) an agency-specific per beneficiary annual
limitation calculated based 75 percent on 98 percent of
the reasonable costs (including nonroutine medical
supplies) for the agency's 12-month cost reporting
period ending during fiscal year 1994, and based 25
percent on 98 percent of the standardized regional
average of such costs for the agency's census division,
as applied to such agency, for cost reporting periods
ending during fiscal year 1994, such costs updated by
the home health market basket index; and
(II) the agency's unduplicated census count of
patients (entitled to benefits under this title) for
the cost reporting period subject to the limitation.
(vi) For services furnished by home health agencies for cost
reporting periods beginning on or after October 1, 1997, the
following rules apply:
(I) For new providers and those providers without a
12-month cost reporting period ending in fiscal year
1994 subject to clauses (viii)(II) and (viii)(III), the
per beneficiary limitation shall be equal to the median
of these limits (or the Secretary's best estimates
thereof) applied to other home health agencies as
determined by the Secretary. A home health agency that
has altered its corporate structure or name shall not
be considered a new provider for this purpose.
(II) For beneficiaries who use services furnished by
more than one home health agency, the per beneficiary
limitations shall be prorated among the agencies.
(vii)(I) Not later than January 1, 1998, the Secretary shall
establish per visit limits applicable for fiscal year 1998, and
not later than April 1, 1998, the Secretary shall establish per
beneficiary limits under clause (v)(I) for fiscal year 1998.
(II) Not later than August 1 of each year (beginning in 1998)
the Secretary shall establish the limits applicable under this
subparagraph for services furnished during the fiscal year
beginning October 1 of the year.
(viii)(I) In the case of a provider with a 12-month cost
reporting period ending in fiscal year 1994, if the limit
imposed under clause (v) (determined without regard to this
subclause) for a cost reporting period beginning during or
after fiscal year 1999 is less than the median described in
clause (vi)(I) (but determined as if any reference in clause
(v) to ``98 percent'' were a reference to ``100 percent''), the
limit otherwise imposed under clause (v) for such provider and
period shall be increased by \1/3\ of such difference.
(II) Subject to subclause (IV), for new providers and those
providers without a 12-month cost reporting period ending in
fiscal year 1994, but for which the first cost reporting period
begins before fiscal year 1999, for cost reporting periods
beginning during or after fiscal year 1999, the per beneficiary
limitation described in clause (vi)(I) shall be equal to the
median described in such clause (determined as if any reference
in clause (v) to ``98 percent'' were a reference to ``100
percent'').
(III) Subject to subclause (IV), in the case of a new
provider for which the first cost reporting period begins
during or after fiscal year 1999, the limitation applied under
clause (vi)(I) (but only with respect to such provider) shall
be equal to 75 percent of the median described in clause
(vi)(I).
(IV) In the case of a new provider or a provider without a
12-month cost reporting period ending in fiscal year 1994,
subclause (II) shall apply, instead of subclause (III), to a
home health agency which filed an application for home health
agency provider status under this title before September 15,
1998, or which was approved as a branch of its parent agency
before such date and becomes a subunit of the parent agency or
a separate agency on or after such date.
(V) Each of the amounts specified in subclauses (I) through
(III) are such amounts as adjusted under clause (iii) to
reflect variations in wages among different areas.
(ix) Notwithstanding the per beneficiary limit under clause
(viii), if the limit imposed under clause (v) (determined
without regard to this clause) for a cost reporting period
beginning during or after fiscal year 2000 is less than the
median described in clause (vi)(I) (but determined as if any
reference in clause (v) to ``98 percent'' were a reference to
``100 percent''), the limit otherwise imposed under clause (v)
for such provider and period shall be increased by 2 percent.
(x) Notwithstanding any other provision of this subparagraph,
in updating any limit under this subparagraph by a home health
market basket index for cost reporting periods beginning during
each of fiscal years 2000, 2002, and 2003, the update otherwise
provided shall be reduced by 1.1 percentage points. With
respect to cost reporting periods beginning during fiscal year
2001, the update to any limit under this subparagraph shall be
the home health market basket index.
(M) Such regulations shall provide that costs respecting care
provided by a provider of services, pursuant to an assurance
under title VI or XVI of the Public Health Service Act that the
provider will make available a reasonable volume of services to
persons unable to pay therefor, shall not be allowable as
reasonable costs.
(N) In determining such reasonable costs, costs incurred for
activities directly related to influencing employees respecting
unionization may not be included.
(O)(i) In establishing an appropriate allowance for
depreciation and for interest on capital indebtedness with
respect to an asset of a provider of services which has
undergone a change of ownership, such regulations shall
provide, except as provided in clause (iii), that the valuation
of the asset after such change of ownership shall be the
historical cost of the asset, as recognized under this title,
less depreciation allowed, to the owner of record as of the
date of enactment of the Balanced Budget Act of 1997 (or, in
the case of an asset not in existence as of that date, the
first owner of record of the asset after that date).
(ii) Such regulations shall not recognize, as reasonable in
the provision of health care services, costs (including legal
fees, accounting and administrative costs, travel costs, and
the costs of feasibility studies) attributable to the
negotiation or settlement of the sale or purchase of any
capital asset (by acquisition or merger) for which any payment
has previously been made under this title.
(iii) In the case of the transfer of a hospital from
ownership by a State to ownership by a nonprofit corporation
without monetary consideration, the basis for capital
allowances to the new owner shall be the book value of the
hospital to the State at the time of the transfer.
(P) If such regulations provide for the payment for a return
on equity capital (other than with respect to costs of
inpatient hospital services), the rate of return to be
recognized, for determining the reasonable cost of services
furnished in a cost reporting period, shall be equal to the
average of the rates of interest, for each of the months any
part of which is included in the period, on obligations issued
for purchase by the Federal Hospital Insurance Trust Fund.
(Q) Except as otherwise explicitly authorized, the Secretary
is not authorized to limit the rate of increase on allowable
costs of approved medical educational activities.
(R) In determining such reasonable cost, costs incurred by a
provider of services representing a beneficiary in an
unsuccessful appeal of a determination described in section
1869(b) shall not be allowable as reasonable costs.
(S)(i) Such regulations shall not include provision for
specific recognition of any return on equity capital with
respect to hospital outpatient departments.
(ii)(I) Such regulations shall provide that, in determining
the amount of the payments that may be made under this title
with respect to all the capital-related costs of outpatient
hospital services, the Secretary shall reduce the amounts of
such payments otherwise established under this title by 15
percent for payments attributable to portions of cost reporting
periods occurring during fiscal year 1990, by 15 percent for
payments attributable to portions of cost reporting periods
occurring during fiscal year 1991, and by 10 percent for
payments attributable to portions of cost reporting periods
occurring during fiscal years 1992 through 1999 and until the
first date that the prospective payment system under section
1833(t) is implemented.
(II) The Secretary shall reduce the reasonable cost of
outpatient hospital services (other than the capital-related
costs of such services) otherwise determined pursuant to
section 1833(a)(2)(B)(i)(I) by 5.8 percent for payments
attributable to portions of cost reporting periods occurring
during fiscal years 1991 through 1999 and until the first date
that the prospective payment system under section 1833(t) is
implemented.
(III) Subclauses (I) and (II) shall not apply to payments
with respect to the costs of hospital outpatient services
provided by any hospital that is a sole community hospital (as
defined in section 1886(d)(5)(D)(iii)) or a critical access
hospital (as defined in section 1861(mm)(1)).
(IV) In applying subclauses (I) and (II) to services for
which payment is made on the basis of a blend amount under
section 1833(i)(3)(A)(ii) or 1833(n)(1)(A)(ii), the costs
reflected in the amounts described in sections
1833(i)(3)(B)(i)(I) and 1833(n)(1)(B)(i)(I), respectively,
shall be reduced in accordance with such subclause.
(T) In determining such reasonable costs for hospitals, no
reduction in copayments under section 1833(t)(8)(B) shall be
treated as a bad debt and the amount of bad debts otherwise
treated as allowable costs which are attributable to the
deductibles and coinsurance amounts under this title shall be
reduced--
(i) for cost reporting periods beginning during
fiscal year 1998, by 25 percent of such amount
otherwise allowable,
(ii) for cost reporting periods beginning during
fiscal year 1999, by 40 percent of such amount
otherwise allowable,
(iii) for cost reporting periods beginning during
fiscal year 2000, by 45 percent of such amount
otherwise allowable,
(iv) for cost reporting periods beginning during
fiscal years 2001 through 2012, by 30 percent of such
amount otherwise allowable, and
(v) for cost reporting periods beginning during
fiscal year 2013 or a subsequent fiscal year, by 35
percent of such amount otherwise allowable.
(U) In determining the reasonable cost of ambulance services
(as described in subsection (s)(7)) provided during fiscal year
1998, during fiscal year 1999, and during so much of fiscal
year 2000 as precedes January 1, 2000, the Secretary shall not
recognize the costs per trip in excess of costs recognized as
reasonable for ambulance services provided on a per trip basis
during the previous fiscal year (after application of this
subparagraph), increased by the percentage increase in the
consumer price index for all urban consumers (U.S. city
average) as estimated by the Secretary for the 12-month period
ending with the midpoint of the fiscal year involved reduced by
1.0 percentage point. For ambulance services provided after
June 30, 1998, the Secretary may provide that claims for such
services must include a code (or codes) under a uniform coding
system specified by the Secretary that identifies the services
furnished.
(V) In determining such reasonable costs for skilled nursing
facilities and (beginning with respect to cost reporting
periods beginning during fiscal year 2013) for covered skilled
nursing services described in section 1888(e)(2)(A) furnished
by hospital providers of extended care services (as described
in section 1883), the amount of bad debts otherwise treated as
allowed costs which are attributable to the coinsurance amounts
under this title for individuals who are entitled to benefits
under part A and--
(i) are not described in section 1935(c)(6)(A)(ii)
shall be reduced by--
(I) for cost reporting periods beginning on or after
October 1, 2005, but before fiscal year 2013, 30
percent of such amount otherwise allowable; and
(II) for cost reporting periods beginning during
fiscal year 2013 or a subsequent fiscal year, by 35
percent of such amount otherwise allowable.
(ii) are described in such section--
(I) for cost reporting periods beginning on or after
October 1, 2005, but before fiscal year 2013, shall not
be reduced;
(II) for cost reporting periods beginning during
fiscal year 2013, shall be reduced by 12 percent of
such amount otherwise allowable;
(III) for cost reporting periods beginning during
fiscal year 2014, shall be reduced by 24 percent of
such amount otherwise allowable; and
(IV) for cost reporting periods beginning during a
subsequent fiscal year, shall be reduced by 35 percent
of such amount otherwise allowable.
(W)(i) In determining such reasonable costs for providers
described in clause (ii), the amount of bad debts otherwise
treated as allowable costs which are attributable to
deductibles and coinsurance amounts under this title shall be
reduced--
(I) for cost reporting periods beginning during
fiscal year 2013, by 12 percent of such amount
otherwise allowable;
(II) for cost reporting periods beginning during
fiscal year 2014, by 24 percent of such amount
otherwise allowable; and
(III) for cost reporting periods beginning during a
subsequent fiscal year, by 35 percent of such amount
otherwise allowable.
(ii) A provider described in this clause is a provider of
services not described in subparagraph (T) or (V), a supplier,
or any other type of entity that receives payment for bad debts
under the authority under subparagraph (A).
(2)(A) If the bed and board furnished as part of inpatient
hospital services (including inpatient tuberculosis hospital
services and inpatient psychiatric hospital services) or post-
hospital extended care services is in accommodations more
expensive than semi-private accommodations, the amount taken
into account for purposes of payment under this title with
respect to such services may not exceed the amount that would
be taken into account with respect to such services if
furnished in such semi-private accommodations unless the more
expensive accommodations were required for medical reasons.
(B) Where a provider of services which has an agreement in
effect under this title furnishes to an 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 part A or part B, as the case may be, the Secretary shall
take into account for purposes of payment to such provider of
services only the items or services with respect to which such
payment may be made.
(3) If the bed and board furnished as part of inpatient
hospital services (including inpatient tuberculosis hospital
services and inpatient psychiatric hospital services) or post-
hospital extended care services is in accommodations other
than, but not more expensive than, semi-private accommodations
and the use of such other accommodations rather than semi-
private accommodations was neither at the request of the
patient nor for a reason which the Secretary determines is
consistent with the purposes of this title, the amount of the
payment with respect to such bed and board under part A shall
be the amount otherwise payable under this title for such bed
and board furnished in semi-private accommodations minus the
difference between the charge customarily made by the hospital
or skilled nursing facility for bed and board in semi-private
accommodations and the charge customarily made by it for bed
and board in the accommodations furnished.
(4) If a provider of services furnishes items or services to
an individual which are in excess of or more expensive than the
items or services determined to be necessary in the efficient
delivery of needed health services and charges are imposed for
such more expensive items or services under the authority
granted in section 1866(a)(2)(B)(ii), the amount of payment
with respect to such items or services otherwise due such
provider in any fiscal period shall be reduced to the extent
that such payment plus such charges exceed the cost actually
incurred for such items or services in the fiscal period in
which such charges are imposed.
(5)(A) Where physical therapy services, occupational therapy
services, speech therapy services, or other therapy services or
services of other health-related personnel (other than
physicians) are furnished under an arrangement with a provider
of services or other organization, specified in the first
sentence of subsection (p) (including through the operation of
subsection (g)) the amount included in any payment to such
provider or other organization under this title as the
reasonable cost of such services (as furnished under such
arrangements) shall not exceed an amount equal to the salary
which would reasonably have been paid for such services
(together with any additional costs that would have been
incurred by the provider or other organization) to the person
performing them if they had been performed in an employment
relationship with such provider or other organization (rather
than under such arrangement) plus the cost of such other
expenses (including a reasonable allowance for traveltime and
other reasonable types of expense related to any differences in
acceptable methods of organization for the provision of such
therapy) incurred by such person, as the Secretary may in
regulations determine to be appropriate.
(B) Notwithstanding the provisions of subparagraph (A), if a
provider of services or other organization specified in the
first sentence of section 1861(p) requires the services of a
therapist on a limited part-time basis, or only to perform
intermittent services, the Secretary may make payment on the
basis of a reasonable rate per unit of service, even though
such rate is greater per unit of time than salary related
amounts, where he finds that such greater payment is, in the
aggregate, less than the amount that would have been paid if
such organization had employed a therapist on a full- or part-
time salary basis.
(6) For purposes of this subsection, the term ``semi-private
accommodations'' means two-bed, three-bed, or four-bed
accommodations.
(7)(A) For limitation on Federal participation for capital
expenditures which are out of conformity with a comprehensive
plan of a State or areawide planning agency, see section 1122.
(B) For further limitations on reasonable cost and
determination of payment amounts for operating costs of
inpatient hospital services and waivers for certain States, see
section 1886.
(C) For provisions restricting payment for provider-based
physicians' services and for payments under certain percentage
arrangements, see section 1887.
(D) For further limitations on reasonable cost and
determination of payment amounts for routine service costs of
skilled nursing facilities, see subsections (a) through (c) of
section 1888.
(8) Items unrelated to patient care.--Reasonable costs do not
include costs for the following--
(i) entertainment, including tickets to sporting and
other entertainment events;
(ii) gifts or donations;
(iii) personal use of motor vehicles;
(iv) costs for fines and penalties resulting from
violations of Federal, State, or local laws; and
(v) education expenses for spouses or other
dependents of providers of services, their employees or
contractors.
Arrangements for Certain Services
(w)(1) The term ``arrangements'' is limited to arrangements
under which receipt of payment by the hospital, critical access
hospital, skilled nursing facility, home health agency, or
hospice program (whether in its own right or as agent), with
respect to services for which an individual is entitled to have
payment made under this title, discharges the liability of such
individual or any other person to pay for the services.
(2) Utilization review activities conducted, in accordance
with the requirements of the program established under part B
of title XI of the Social Security Act with respect to services
furnished by a hospital or critical access hospital to patients
insured under part A of this title or entitled to have payment
made for such services under part B of this title or under a
State plan approved under title XIX, by a quality improvement
organization designated for the area in which such hospital or
critical access hospital is located shall be deemed to have
been conducted pursuant to arrangements between such hospital
or critical access hospital and such organization under which
such hospital or critical access hospital is obligated to pay
to such organization, as a condition of receiving payment for
hospital or critical access hospital services so furnished
under this part or under such a State plan, such amount as is
reasonably incurred and requested (as determined under
regulations of the Secretary) by such organization in
conducting such review activities with respect to services
furnished by such hospital or critical access hospital to such
patients.
State and United States
(x) The terms ``State'' and ``United States'' have the
meaning given to them by subsections (h) and (i), respectively,
of section 210.
Extended Care in Religious Nonmedical Health Care Institutions
(y)(1) The term ``skilled nursing facility'' also includes a
religious nonmedical health care institution (as defined in
subsection (ss)(1)), but only (except for purposes of
subsection (a)(2)) with respect to items and services
ordinarily furnished by such an institution to inpatients, and
payment may be made with respect to services provided by or in
such an institution only to such extent and under such
conditions, limitations, and requirements (in addition to or in
lieu of the conditions, limitations, and requirements otherwise
applicable) as may be provided in regulations consistent with
section 1821.
(2) Notwithstanding any other provision of this title,
payment under part A may not be made for services furnished an
individual in a skilled nursing facility to which paragraph (1)
applies unless such individual elects, in accordance with
regulations, for a spell of illness to have such services
treated as post-hospital extended care services for purposes of
such part; and payment under part A may not be made for post-
hospital extended care services--
(A) furnished an individual during such spell of
illness in a skilled nursing facility to which
paragraph (1) applies after--
(i) such services have been furnished to him
in such a facility for 30 days during such
spell, or
(ii) such services have been furnished to him
during such spell in a skilled nursing facility
to which such paragraph does not apply; or
(B) furnished an individual during such spell of
illness in a skilled nursing facility to which
paragraph (1) does not apply after such services have
been furnished to him during such spell in a skilled
nursing facility to which such paragraph applies.
(3) The amount payable under part A for post-hospital
extended care services furnished an individual during any spell
of illness in a skilled nursing facility to which paragraph (1)
applies shall be reduced by a coinsurance amount equal to one-
eighth of the inpatient hospital deductible for each day before
the 31st day on which he is furnished such services in such a
facility during such spell (and the reduction under this
paragraph shall be in lieu of any reduction under section
1813(a)(3)).
(4) For purposes of subsection (i), the determination of
whether services furnished by or in an institution described in
paragraph (1) constitute post-hospital extended care services
shall be made in accordance with and subject to such
conditions, limitations, and requirements as may be provided in
regulations.
Institutional Planning
(z) An overall plan and budget of a hospital, skilled nursing
facility, comprehensive outpatient rehabilitation facility, or
home health agency shall be considered sufficient if it--
(1) provides for an annual operating budget which
includes all anticipated income and expenses related to
items which would, under generally accepted accounting
principles, be considered income and expense items
(except that nothing in this paragraph shall require
that there be prepared, in connection with any budget,
an item-by-item identification of the components of
each type of anticipated expenditure or income);
(2)(A) provides for a capital expenditures plan for
at least a 3-year period (including the year to which
the operating budget described in paragraph (1) is
applicable) which includes and identifies in detail the
anticipated sources of financing for, and the
objectives of, each anticipated expenditure in excess
of $600,000 (or such lesser amount as may be
established by the State under section 1122(g)(1) in
which the hospital is located) related to the
acquisition of land, the improvement of land,
buildings, and equipment, and the replacement,
modernization, and expansion of the buildings and
equipment which would, under generally accepted
accounting principles, be considered capital items;
(B) provides that such plan is submitted to the
agency designated under section 1122(b), or if no such
agency is designated, to the appropriate health
planning agency in the State (but this subparagraph
shall not apply in the case of a facility exempt from
review under section 1122 by reason of section
1122(j));
(3) provides for review and updating at least
annually; and
(4) is prepared, under the direction of the governing
body of the institution or agency, by a committee
consisting of representatives of the governing body,
the administrative staff, and the medical staff (if
any) of the institution or agency.
Rural Health Clinic Services and Federally Qualified Health Center
Services
(aa)(1) The term ``rural health clinic services'' means --
(A) physicians' services and such services and
supplies as are covered under section 1861(s)(2)(A) if
furnished as an incident to a physician's professional
service and items and services described in section
1861(s)(10),
(B) such services furnished by a physician assistant
or a nurse practitioner (as defined in paragraph (5)),
by a clinical psychologist (as defined by the
Secretary), by a clinical social worker (as defined in
subsection (hh)(1)), by a marriage and family therapist
(as defined in subsection (lll)(2)), or by a mental
health counselor (as defined in subsection (lll)(4)),
and such services and supplies furnished as an incident
to his service as would otherwise be covered if
furnished by a physician or as an incident to a
physician's service,
(C) in the case of a rural health clinic located in
an area in which there exists a shortage of home health
agencies, part-time or intermittent nursing care and
related medical supplies (other than drugs and
biologicals) furnished by a registered professional
nurse or licensed practical nurse to a homebound
individual under a written plan of treatment (i)
established and periodically reviewed by a physician
described in paragraph (2)(B), or (ii) established by a
nurse practitioner or physician assistant and
periodically reviewed and approved by a physician
described in paragraph (2)(B), and
(D) intensive outpatient services (as defined in
section 1861(ff)(4)),
when furnished to an individual as an outpatient of a rural
health clinic.
(2) The term ``rural health clinic'' means a facility which
--
(A) is primarily engaged in furnishing to outpatients
services described in subparagraphs (A) and (B) of
paragraph (1);
(B) in the case of a facility which is not a
physician-directed clinic, has an arrangement
(consistent with the provisions of State and local law
relative to the practice, performance, and delivery of
health services) with one or more physicians (as
defined in subsection (r)(1)) under which provision is
made for the periodic review by such physicians of
covered services furnished by physician assistants and
nurse practitioners, the supervision and guidance by
such physicians of physician assistants and nurse
practitioners, the preparation by such physicians of
such medical orders for care and treatment of clinic
patients as may be necessary, and the availability of
such physicians for such referral of and consultation
for patients as is necessary and for advice and
assistance in the management of medical emergencies;
and, in the case of a physician-directed clinic, has
one or more of its staff physicians perform the
activities accomplished through such an arrangement;
(C) maintains clinical records on all patients;
(D) has arrangements with one or more hospitals,
having agreements in effect under section 1866, for the
referral and admission of patients requiring inpatient
services or such diagnostic or other specialized
services as are not available at the clinic;
(E) has written policies, which are developed with
the advice of (and with provision for review of such
policies from time to time by) a group of professional
personnel, including one or more physicians and one or
more physician assistants or nurse practitioners, to
govern those services described in paragraph (1) which
it furnishes;
(F) has a physician, physician assistant, or nurse
practitioner responsible for the execution of policies
described in subparagraph (E) and relating to the
provision of the clinic's services;
(G) directly provides routine diagnostic services,
including clinical laboratory services, as prescribed
in regulations by the Secretary, and has prompt access
to additional diagnostic services from facilities
meeting requirements under this title;
(H) in compliance with State and Federal law, has
available for administering to patients of the clinic
at least such drugs and biologicals as are determined
by the Secretary to be necessary for the treatment of
emergency cases (as defined in regulations) and has
appropriate procedures or arrangements for storing,
administering, and dispensing any drugs and
biologicals;
(I) has a quality assessment and performance
improvement program, and appropriate procedures for
review of utilization of clinic services, as the
Secretary may specify;
(J) has a nurse practitioner, a physician assistant,
or a certified nurse-midwife (as defined in subsection
(gg)) available to furnish patient care services not
less than 50 percent of the time the clinic operates;
and
(K) meets such other requirements as the Secretary
may find necessary in the interest of the health and
safety of the individuals who are furnished services by
the clinic.
For the purposes of this title, such term includes only a
facility which (i) is located in an area that is not an
urbanized area (as defined by the Bureau of the Census) and in
which there are insufficient numbers of needed health care
practitioners (as determined by the Secretary), and that,
within the previous 4-year period, has been designated by the
chief executive officer of the State and certified by the
Secretary as an area with a shortage of personal health
services or designated by the Secretary either (I) as an area
with a shortage of personal health services under section
330(b)(3) or 1302(7) of the Public Health Service Act, (II) as
a health professional shortage area described in section
332(a)(1)(A) of that Act because of its shortage of primary
medical care manpower, (III) as a high impact area described in
section 329(a)(5) of that Act, of (IV) as an area which
includes a population group which the Secretary determines has
a health manpower shortage under section 332(a)(1)(B) of that
Act, (ii) has filed an agreement with the Secretary by which it
agrees not to charge any individual or other person for items
or services for which such individual is entitled to have
payment made under this title, except for the amount of any
deductible or coinsurance amount imposed with respect to such
items or services (not in excess of the amount customarily
charged for such items and services by such clinic), pursuant
to subsections (a) and (b) of section 1833, (iii) employs a
physician assistant or nurse practitioner, and (iv) is not a
rehabilitation agency or a facility which is primarily for the
care and treatment of mental diseases. A facility that is in
operation and qualifies as a rural health clinic under this
title or title XIX and that subsequently fails to satisfy the
requirement of clause (i) shall be considered, for purposes of
this title and title XIX, as still satisfying the requirement
of such clause if it is determined, in accordance with criteria
established by the Secretary in regulations, to be essential to
the delivery of primary care services that would otherwise be
unavailable in the geographic area served by the clinic. If a
State agency has determined under section 1864(a) that a
facility is a rural health clinic and the facility has applied
to the Secretary for approval as such a clinic, the Secretary
shall notify the facility of the Secretary's approval or
disapproval not later than 60 days after the date of the State
agency determination or the application (whichever is later).
(3) The term ``Federally qualified health center services''
means--
(A) services of the type described in subparagraphs
(A) through (D) of paragraph (1) and preventive
services (as defined in section 1861(ddd)(3)); and
(B) preventive primary health services that a center
is required to provide under section 330 of the Public
Health Service Act,
when furnished to an individual as an outpatient of a Federally
qualified health center by the center or by a health care
professional under contract with the center and, for this
purpose, any reference to a rural health clinic or a physician
described in paragraph (2)(B) is deemed a reference to a
Federally qualified health center or a physician at the center,
respectively.
(4) The term ``Federally qualified health center'' means an
entity which--
(A)(i) is receiving a grant under section 330 of the
Public Health Service Act, or
(ii)(I) is receiving funding from such a grant under
a contract with the recipient of such a grant, and (II)
meets the requirements to receive a grant under section
330 of such Act;
(B) based on the recommendation of the Health
Resources and Services Administration within the Public
Health Service, is determined by the Secretary to meet
the requirements for receiving such a grant;
(C) was treated by the Secretary, for purposes of
part B, as a comprehensive Federally funded health
center as of January 1, 1990; or
(D) is an outpatient health program or facility
operated by a tribe or tribal organization under the
Indian Self-Determination Act or by an urban Indian
organization receiving funds under title V of the
Indian Health Care Improvement Act.
(5)(A) The term ``physician assistant'' and the term ``nurse
practitioner'' mean, for purposes of this title, a physician
assistant or nurse practitioner who performs such services as
such individual is legally authorized to perform (in the State
in which the individual performs such services) in accordance
with State law (or the State regulatory mechanism provided by
State law), and who meets such training, education, and
experience requirements (or any combination thereof) as the
Secretary may prescribe in regulations.
(B) The term ``clinical nurse specialist'' means, for
purposes of this title, an individual who--
(i) is a registered nurse and is licensed to practice
nursing in the State in which the clinical nurse
specialist services are performed; and
(ii) holds a master's degree in a defined clinical
area of nursing from an accredited educational
institution.
(6) The term ``collaboration'' means a process in which a
nurse practitioner works with a physician to deliver health
care services within the scope of the practitioner's
professional expertise, with medical direction and appropriate
supervision as provided for in jointly developed guidelines or
other mechanisms as defined by the law of the State in which
the services are performed.
(7)(A) The Secretary shall waive for a 1-year period the
requirements of paragraph (2) that a rural health clinic employ
a physician assistant, nurse practitioner or certified nurse
midwife or that such clinic require such providers to furnish
services at least 50 percent of the time that the clinic
operates for any facility that requests such waiver if the
facility demonstrates that the facility has been unable,
despite reasonable efforts, to hire a physician assistant,
nurse practitioner, or certified nurse-midwife in the previous
90-day period.
(B) The Secretary may not grant such a waiver under
subparagraph (A) to a facility if the request for the waiver is
made less than 6 months after the date of the expiration of any
previous such waiver for the facility, or if the facility has
not yet been determined to meet the requirements (including
subparagraph (J) of the first sentence of paragraph (2)) of a
rural health clinic.
(C) A waiver which is requested under this paragraph shall be
deemed granted unless such request is denied by the Secretary
within 60 days after the date such request is received.
Services of a Certified Registered Nurse Anesthetist
(bb)(1) The term ``services of a certified registered nurse
anesthetist'' means anesthesia services and related care
furnished by a certified registered nurse anesthetist (as
defined in paragraph (2)) which the nurse anesthetist is
legally authorized to perform as such by the State in which the
services are furnished.
(2) The term ``certified registered nurse anesthetist'' means
a certified registered nurse anesthetist licensed by the State
who meets such education, training, and other requirements
relating to anesthesia services and related care as the
Secretary may prescribe. In prescribing such requirements the
Secretary may use the same requirements as those established by
a national organization for the certification of nurse
anesthetists. Such term also includes, as prescribed by the
Secretary, an anesthesiologist assistant.
Comprehensive Outpatient Rehabilitation Facility Services
(cc)(1) The term ``comprehensive outpatient rehabilitation
facility services'' means the following items and services
furnished by a physician or other qualified professional
personnel (as defined in regulations by the Secretary) to an
individual who is an outpatient of a comprehensive outpatient
rehabilitation facility under a plan (for furnishing such items
and services to such individual) established and periodically
reviewed by a physician--
(A) physicians' services;
(B) physical therapy, occupational therapy, speech-
language pathology services, and respiratory therapy;
(C) prosthetic and orthotic devices, including
testing, fitting, or training in the use of prosthetic
and orthotic devices;
(D) social and psychological services;
(E) nursing care provided by or under the supervision
of a registered professional nurse;
(F) drugs and biologicals which cannot, as determined
in accordance with regulations, be self-administered;
(G) supplies and durable medical equipment; and
(H) such other items and services as are medically
necessary for the rehabilitation of the patient and are
ordinarily furnished by comprehensive outpatient
rehabilitation facilities,
excluding, however, any item or service if it would not be
included under subsection (b) if furnished to an inpatient of a
hospital. In the case of physical therapy, occupational
therapy, and speech pathology services, there shall be no
requirement that the item or service be furnished at any single
fixed location if the item or service is furnished pursuant to
such plan and payments are not otherwise made for the item or
service under this title.
(2) The term ``comprehensive outpatient rehabilitation
facility'' means a facility which--
(A) is primarily engaged in providing (by or under
the supervision of physicians) diagnostic, therapeutic,
and restorative services to outpatients for the
rehabilitation of injured, disabled, or sick persons;
(B) provides at least the following comprehensive
outpatient rehabilitation services: (i) physicians'
services (rendered by physicians, as defined in section
1861(r)(1), who are available at the facility on a
full- or part-time basis); (ii) physical therapy; and
(iii) social or psychological services;
(C) maintains clinical records on all patients;
(D) has policies established by a group of
professional personnel (associated with the facility),
including one or more physicians defined in subsection
(r)(1) to govern the comprehensive outpatient
rehabilitation services it furnishes, and provides for
the carrying out of such policies by a full- or part-
time physician referred to in subparagraph (B)(i);
(E) has a requirement that every patient must be
under the care of a physician;
(F) in the case of a facility in any State in which
State or applicable local law provides for the
licensing of facilities of this nature (i) is licensed
pursuant to such law, or (ii) is approved by the agency
of such State or locality, responsible for licensing
facilities of this nature, as meeting the standards
established for such licensing;
(G) has in effect a utilization review plan in
accordance with regulations prescribed by the
Secretary;
(H) has in effect an overall plan and budget that
meets the requirements of subsection (z);
(I) provides the Secretary on a continuing basis with
a surety bond in a form specified by the Secretary and
in an amount that is not less than $50,000; and
(J) meets such other conditions of participation as
the Secretary may find necessary in the interest of the
health and safety of individuals who are furnished
services by such facility, including conditions
concerning qualifications of personnel in these
facilities.
The Secretary may waive the requirement of a surety bond under
subparagraph (I) in the case of a facility that provides a
comparable surety bond under State law.
Hospice Care; Hospice Program
(dd)(1) The term ``hospice care'' means the following items
and services provided to a terminally ill individual by, or by
others under arrangements made by, a hospice program under a
written plan (for providing such care to such individual)
established and periodically reviewed by the individual's
attending physician and by the medical director (and by the
interdisciplinary group described in paragraph (2)(B)) of the
program--
(A) nursing care provided by or under the supervision
of a registered professional nurse,
(B) physical or occupational therapy, or speech-
language pathology services,
(C) medical social services under the direction of a
physician,
(D)(i) services of a home health aide who has
successfully completed a training program approved by
the Secretary and (ii) homemaker services,
(E) medical supplies (including drugs and
biologicals) and the use of medical appliances, while
under such a plan,
(F) physicians' services,
(G) short-term inpatient care (including both respite
care and procedures necessary for pain control and
acute and chronic symptom management) in an inpatient
facility meeting such conditions as the Secretary
determines to be appropriate to provide such care, but
such respite care may be provided only on an
intermittent, nonroutine, and occasional basis and may
not be provided consecutively over longer than five
days,
(H) counseling (including dietary counseling) with
respect to care of the terminally ill individual and
adjustment to his death, and
(I) any other item or service which is specified in
the plan and for which payment may otherwise be made
under this title.
The care and services described in subparagraphs (A) and (D)
may be provided on a 24-hour, continuous basis only during
periods of crisis (meeting criteria established by the
Secretary) and only as necessary to maintain the terminally ill
individual at home.
(2) The term ``hospice program'' means a public agency or
private organization (or a subdivision thereof) which--
(A)(i) is primarily engaged in providing the care and
services described in paragraph (1) and makes such
services available (as needed) on a 24-hour basis and
which also provides bereavement counseling for the
immediate family of terminally ill individuals and
services described in section 1812(a)(5),
(ii) provides for such care and services in
individuals' homes, on an outpatient basis, and on a
short-term inpatient basis, directly or under
arrangements made by the agency or organization, except
that--
(I) the agency or organization must routinely
provide directly substantially all of each of
the services described in subparagraphs (A),
(C), and (H) of paragraph (1), except as
otherwise provided in paragraph (5), and
(II) in the case of other services described
in paragraph (1) which are not provided
directly by the agency or organization, the
agency or organization must maintain
professional management responsibility for all
such services furnished to an individual,
regardless of the location or facility in which
such services are furnished; and
(iii) provides assurances satisfactory to the
Secretary that the aggregate number of days of
inpatient care described in paragraph (1)(G) provided
in any 12-month period to individuals who have an
election in effect under section 1812(d) with respect
to that agency or organization does not exceed 20
percent of the aggregate number of days during that
period on which such elections for such individuals are
in effect;
(B) has an interdisciplinary group of personnel
which--
(i) includes at least--
(I) one physician (as defined in
subsection (r)(1)),
(II) one registered professional
nurse, and
(III) one social worker, marriage and
family therapist, or mental health
counselor,
employed by or, in the case of a physician described in
subclause (I), under contract with the agency or
organization, and also includes at least one pastoral
or other counselor,
(ii) provides (or supervises the provision
of) the care and services described in
paragraph (1), and
(iii) establishes the policies governing the
provision of such care and services;
(C) maintains central clinical records on all
patients;
(D) does not discontinue the hospice care it provides
with respect to a patient because of the inability of
the patient to pay for such care;
(E)(i) utilizes volunteers in its provision of care
and services in accordance with standards set by the
Secretary, which standards shall ensure a continuing
level of effort to utilize such volunteers, and (ii)
maintains records on the use of these volunteers and
the cost savings and expansion of care and services
achieved through the use of these volunteers;
(F) in the case of an agency or organization in any
State in which State or applicable local law provides
for the licensing of agencies or organizations of this
nature, is licensed pursuant to such law; and
(G) meets such other requirements as the Secretary
may find necessary in the interest of the health and
safety of the individuals who are provided care and
services by such agency or organization.
(3)(A) An individual is considered to be ``terminally ill''
if the individual has a medical prognosis that the individual's
life expectancy is 6 months or less.
(B) The term ``attending physician'' means, with respect to
an individual, the physician (as defined in subsection (r)(1)),
the nurse practitioner (as defined in subsection (aa)(5)), or
the physician assistant (as defined in such subsection), who
may be employed by a hospice program, whom the individual
identifies as having the most significant role in the
determination and delivery of medical care to the individual at
the time the individual makes an election to receive hospice
care.
(4)(A) An entity which is certified as a provider of services
other than a hospice program shall be considered, for purposes
of certification as a hospice program, to have met any
requirements under paragraph (2) which are also the same
requirements for certification as such other type of provider.
The Secretary shall coordinate surveys for determining
certification under this title so as to provide, to the extent
feasible, for simultaneous surveys of an entity which seeks to
be certified as a hospice program and as a provider of services
of another type.
(B) Any entity which is certified as a hospice program and as
a provider of another type shall have separate provider
agreements under section 1866 and shall file separate cost
reports with respect to costs incurred in providing hospice
care and in providing other services and items under this
title.
(5)(A) The Secretary may waive the requirements of paragraph
(2)(A)(ii)(I) for an agency or organization with respect to all
or part of the nursing care described in paragraph (1)(A) if
such agency or organization--
(i) is located in an area which is not an urbanized
area (as defined by the Bureau of the Census);
(ii) was in operation on or before January 1, 1983;
and
(iii) has demonstrated a good faith effort (as
determined by the Secretary) to hire a sufficient
number of nurses to provide such nursing care directly.
(B) Any waiver, which is in such form and containing such
information as the Secretary may require and which is requested
by an agency or organization under subparagraph (A) or (C),
shall be deemed to be granted unless such request is denied by
the Secretary within 60 days after the date such request is
received by the Secretary. The granting of a waiver under
subparagraph (A) or (C) shall not preclude the granting of any
subsequent waiver request should such a waiver again become
necessary.
(C) The Secretary may waive the requirements of paragraph
(2)(A)(i) and (2)(A)(ii) for an agency or organization with
respect to the services described in paragraph (1)(B) and, with
respect to dietary counseling, paragraph (1)(H), if such agency
or organization--
(i) is located in an area which is not an urbanized
area (as defined by the Bureau of Census), and
(ii) demonstrates to the satisfaction of the
Secretary that the agency or organization has been
unable, despite diligent efforts, to recruit
appropriate personnel.
(D) In extraordinary, exigent, or other non-routine
circumstances, such as unanticipated periods of high patient
loads, staffing shortages due to illness or other events, or
temporary travel of a patient outside a hospice program's
service area, a hospice program may enter into arrangements
with another hospice program for the provision by that other
program of services described in paragraph (2)(A)(ii)(I). The
provisions of paragraph (2)(A)(ii)(II) shall apply with respect
to the services provided under such arrangements.
(E) A hospice program may provide services described in
paragraph (1)(A) other than directly by the program if the
services are highly specialized services of a registered
professional nurse and are provided non-routinely and so
infrequently so that the provision of such services directly
would be impracticable and prohibitively expensive.
Discharge Planning Process
(ee)(1) A discharge planning process of a hospital shall be
considered sufficient if it is applicable to services furnished
by the hospital to individuals entitled to benefits under this
title and if it meets the guidelines and standards established
by the Secretary under paragraph (2).
(2) The Secretary shall develop guidelines and standards for
the discharge planning process in order to ensure a timely and
smooth transition to the most appropriate type of and setting
for post-hospital or rehabilitative care. The guidelines and
standards shall include the following:
(A) The hospital must identify, at an early stage of
hospitalization, those patients who are likely to
suffer adverse health consequences upon discharge in
the absence of adequate discharge planning.
(B) Hospitals must provide a discharge planning
evaluation for patients identified under subparagraph
(A) and for other patients upon the request of the
patient, patient's representative, or patient's
physician.
(C) Any discharge planning evaluation must be made on
a timely basis to ensure that appropriate arrangements
for post-hospital care will be made before discharge
and to avoid unnecessary delays in discharge.
(D) A discharge planning evaluation must include an
evaluation of a patient's likely need for appropriate
post-hospital services, including hospice care and
post-hospital extended care services, and the
availability of those services, including the
availability of home health services through
individuals and entities that participate in the
program under this title and that serve the area in
which the patient resides and that request to be listed
by the hospital as available and, in the case of
individuals who are likely to need post-hospital
extended care services, the availability of such
services through facilities that participate in the
program under this title and that serve the area in
which the patient resides.
(E) The discharge planning evaluation must be
included in the patient's medical record for use in
establishing an appropriate discharge plan and the
results of the evaluation must be discussed with the
patient (or the patient's representative).
(F) Upon the request of a patient's physician, the
hospital must arrange for the development and initial
implementation of a discharge plan for the patient.
(G) Any discharge planning evaluation or discharge
plan required under this paragraph must be developed
by, or under the supervision of, a registered
professional nurse, social worker, or other
appropriately qualified personnel.
(H) Consistent with section 1802, the discharge plan
shall--
(i) not specify or otherwise limit the
qualified provider which may provide post-
hospital home health services, and
(ii) identify (in a form and manner specified
by the Secretary) any entity to whom the
individual is referred in which the hospital
has a disclosable financial interest (as
specified by the Secretary consistent with
section 1866(a)(1)(S)) or which has such an
interest in the hospital.
(3) With respect to a discharge plan for an individual who is
enrolled with a Medicare+Choice organization under a
Medicare+Choice plan and is furnished inpatient hospital
services by a hospital under a contract with the organization--
(A) the discharge planning evaluation under paragraph
(2)(D) is not required to include information on the
availability of home health services through
individuals and entities which do not have a contract
with the organization; and
(B) notwithstanding subparagraph (H)(i), the plan may
specify or limit the provider (or providers) of post-
hospital home health services or other post-hospital
services under the plan.
Partial Hospitalization Services; Intensive Outpatient Services
(ff)(1) The term ``partial hospitalization services'' means
the items and services described in paragraph (2) prescribed by
a physician for an individual determined (not less frequently
than monthly) by a physician to have a need for such services
for a minimum of 20 hours per week and provided under a program
described in paragraph (3) under the supervision of a physician
pursuant to an individualized, written plan of treatment
established and periodically reviewed by a physician (in
consultation with appropriate staff participating in such
program), which plan sets forth the physician's diagnosis, the
type, amount, frequency, and duration of the items and services
provided under the plan, and the goals for treatment under the
plan.
(2) The items and services described in this paragraph are--
(A) individual and group therapy with physicians or
psychologists (or other mental health professionals to
the extent authorized under State law),
(B) occupational therapy requiring the skills of a
qualified occupational therapist,
(C) services of social workers, trained psychiatric
nurses, and other staff trained to work with
psychiatric patients,
(D) drugs and biologicals furnished for therapeutic
purposes (which cannot, as determined in accordance
with regulations, be self-administered),
(E) individualized activity therapies that are not
primarily recreational or diversionary,
(F) family counseling (the primary purpose of which
is treatment of the individual's condition),
(G) patient training and education (to the extent
that training and educational activities are closely
and clearly related to individual's care and
treatment),
(H) diagnostic services, and
(I) such other items and services as the Secretary
may provide (but in no event to include meals and
transportation);
that are reasonable and necessary for the diagnosis or active
treatment of the individual's condition, reasonably expected to
improve or maintain the individual's condition and functional
level and to prevent relapse or hospitalization, and furnished
pursuant to such guidelines relating to frequency and duration
of services as the Secretary shall by regulation establish
(taking into account accepted norms of medical practice and the
reasonable expectation of patient improvement).
(3)(A) A program described in this paragraph is a program
which is furnished by a hospital to its outpatients or by a
community mental health center (as defined in subparagraph
(B)), and which is a distinct and organized intensive
ambulatory treatment service offering less than 24-hour-daily
care other than in an individual's home or in an inpatient or
residential setting.
(B) For purposes of subparagraph (A), the term ``community
mental health center'' means an entity that--
(i)(I) provides the mental health services described
in section 1913(c)(1) of the Public Health Service Act;
or
(II) in the case of an entity operating in a State
that by law precludes the entity from providing itself
the service described in subparagraph (E) of such
section, provides for such service by contract with an
approved organization or entity (as determined by the
Secretary);
(ii) meets applicable licensing or certification
requirements for community mental health centers in the
State in which it is located;
(iii) provides at least 40 percent of its services to
individuals who are not eligible for benefits under
this title; and
(iv) meets such additional conditions as the
Secretary shall specify to ensure (I) the health and
safety of individuals being furnished such services,
(II) the effective and efficient furnishing of such
services, and (III) the compliance of such entity with
the criteria described in section 1931(c)(1) of the
Public Health Service Act.
(4) The term ``intensive outpatient services'' has the
meaning given the term ``partial hospitalization services'' in
paragraph (1), except that--
(A) section 1835(a)(2)(F)(i) shall not apply;
(B) the reference in such paragraph to an individual
``determined (not less frequently than monthly) by a
physician to have a need for such services for a
minimum of 20 hours per week'' shall be treated as a
reference to an individual ``determined (not less
frequently than once every other month) by a physician
to have a need for such services for a minimum of 9
hours per week''; and
(C) the reference to ``a community mental health
center (as defined in subparagraph (B))'' in paragraph
(3) shall be treated as a reference to ``a community
mental health center (as defined in subparagraph (B)),
a Federally qualified health center, or a rural health
clinic''.
Certified Nurse-Midwife Services
(gg)(1) The term ``certified nurse-midwife services'' means
such services furnished by a certified nurse-midwife (as
defined in paragraph (2)) and such services and supplies
furnished as an incident to the nurse-midwife's service which
the certified nurse-midwife is legally authorized to perform
under State law (or the State regulatory mechanism provided by
State law) as would otherwise be covered if furnished by a
physician or as an incident to a physicians' service.
(2) The term ``certified nurse-midwife'' means a registered
nurse who has successfully completed a program of study and
clinical experience meeting guidelines prescribed by the
Secretary, or has been certified by an organization recognized
by the Secretary.
Clinical Social Worker; Clinical Social Worker Services
(hh)(1) The term ``clinical social worker'' means an
individual who--
(A) possesses a master's or doctor's degree in social
work;
(B) after obtaining such degree has performed at
least 2 years of supervised clinical social work; and
(C)(i) is licensed or certified as a clinical social
worker by the State in which the services are
performed, or
(ii) in the case of an individual in a State which
does not provide for licensure or certification--
(I) has completed at least 2 years or 3,000
hours of post-master's degree supervised
clinical social work practice under the
supervision of a master's level social worker
in an appropriate setting (as determined by the
Secretary), and
(II) meets such other criteria as the
Secretary establishes.
(2) The term ``clinical social worker services'' means
services performed by a clinical social worker (as defined in
paragraph (1)) for the diagnosis and treatment of mental
illnesses (other than services furnished to an inpatient of a
hospital and other than services furnished to an inpatient of a
skilled nursing facility which the facility is required to
provide as a requirement for participation) which the clinical
social worker is legally authorized to perform under State law
(or the State regulatory mechanism provided by State law) of
the State in which such services are performed as would
otherwise be covered if furnished by a physician or as an
incident to a physician's professional service.
Qualified Psychologist Services
(ii) The term ``qualified psychologist services'' means such
services and such services and supplies furnished as an
incident to his service furnished by a clinical psychologist
(as defined by the Secretary) which the psychologist is legally
authorized to perform under State law (or the State regulatory
mechanism provided by State law) as would otherwise be covered
if furnished by a physician or as an incident to a physician's
service.
Screening Mammography
(jj) The term ``screening mammography'' means a radiologic
procedure provided to a woman for the purpose of early
detection of breast cancer and includes a physician's
interpretation of the results of the procedure.
Covered Osteoporosis Drug
(kk) The term ``covered osteoporosis drug'' means an
injectable drug approved for the treatment of post-menopausal
osteoporosis provided to an individual by a home health agency
if, in accordance with regulations promulgated by the
Secretary--
(1) the individual's attending physician, nurse
practitioner or clinical nurse specialist (as those
terms are defined in subsection (aa)(5)), certified
nurse-midwife (as defined in subsection (gg)), or
physician assistant (as defined in subsection (aa)(5))
certifies that the individual has suffered a bone
fracture related to post-menopausal osteoporosis and
that the individual is unable to learn the skills
needed to self-administer such drug or is otherwise
physically or mentally incapable of self-administering
such drug; and
(2) the individual is confined to the individual's
home (except when receiving items and services referred
to in subsection (m)(7)).
Speech-Language Pathology Services; Audiology Services
(ll)(1) The term ``speech-language pathology services'' means
such speech, language, and related function assessment and
rehabilitation services furnished by a qualified speech-
language pathologist as the speech-language pathologist is
legally authorized to perform under State law (or the State
regulatory mechanism provided by State law) as would otherwise
be covered if furnished by a physician.
(2) The term ``outpatient speech-language pathology
services'' has the meaning given the term ``outpatient physical
therapy services'' in subsection (p), except that in applying
such subsection--
(A) ``speech-language pathology'' shall be
substituted for ``physical therapy'' each place it
appears; and
(B) ``speech-language pathologist'' shall be
substituted for ``physical therapist'' each place it
appears.
(3) The term ``audiology services'' means such hearing and
balance assessment services furnished by a qualified
audiologist as the audiologist is legally authorized to perform
under State law (or the State regulatory mechanism provided by
State law), as would otherwise be covered if furnished by a
physician.
(4) In this subsection:
(A) The term ``qualified speech-language
pathologist'' means an individual with a master's or
doctoral degree in speech-language pathology who--
(i) is licensed as a speech-language
pathologist by the State in which the
individual furnishes such services, or
(ii) in the case of an individual who
furnishes services in a State which does not
license speech-language pathologists, has
successfully completed 350 clock hours of
supervised clinical practicum (or is in the
process of accumulating such supervised
clinical experience), performed not less than 9
months of supervised full-time speech-language
pathology services after obtaining a master's
or doctoral degree in speech-language pathology
or a related field, and successfully completed
a national examination in speech-language
pathology approved by the Secretary.
(B) The term ``qualified audiologist'' means an
individual with a master's or doctoral degree in
audiology who--
(i) is licensed as an audiologist by the
State in which the individual furnishes such
services, or
(ii) in the case of an individual who
furnishes services in a State which does not
license audiologists, has successfully
completed 350 clock hours of supervised
clinical practicum (or is in the process of
accumulating such supervised clinical
experience), performed not less than 9 months
of supervised full-time audiology services
after obtaining a master's or doctoral degree
in audiology or a related field, and
successfully completed a national examination
in audiology approved by the Secretary.
Critical Access Hospital; Critical Access Hospital Services
(mm)(1) The term ``critical access hospital'' means a
facility certified by the Secretary as a critical access
hospital under section 1820(e).
(2) The term ``inpatient critical access hospital services''
means items and services, furnished to an inpatient of a
critical access hospital by such facility, that would be
inpatient hospital services if furnished to an inpatient of a
hospital by a hospital.
(3) The term ``outpatient critical access hospital services''
means medical and other health services furnished by a critical
access hospital on an outpatient basis.
Screening Pap Smear; Screening Pelvic Exam
(nn)(1) The term ``screening pap smear'' means a diagnostic
laboratory test consisting of a routine exfoliative cytology
test (Papanicolaou test) provided to a woman for the purpose of
early detection of cervical or vaginal cancer and includes a
physician's interpretation of the results of the test, if the
individual involved has not had such a test during the
preceding 2 years, or during the preceding year in the case of
a woman described in paragraph (3).
(2) The term ``screening pelvic exam'' means a pelvic
examination provided to a woman if the woman involved has not
had such an examination during the preceding 2 years, or during
the preceding year in the case of a woman described in
paragraph (3), and includes a clinical breast examination.
(3) A woman described in this paragraph is a woman who--
(A) is of childbearing age and has had a test
described in this subsection during any of the
preceding 3 years that indicated the presence of
cervical or vaginal cancer or other abnormality; or
(B) is at high risk of developing cervical or vaginal
cancer (as determined pursuant to factors identified by
the Secretary).
Prostate Cancer Screening Tests
(oo)(1) The term ``prostate cancer screening test'' means a
test that consists of any (or all) of the procedures described
in paragraph (2) provided for the purpose of early detection of
prostate cancer to a man over 50 years of age who has not had
such a test during the preceding year.
(2) The procedures described in this paragraph are as
follows:
(A) A digital rectal examination.
(B) A prostate-specific antigen blood test.
(C) For years beginning after 2002, such other
procedures as the Secretary finds appropriate for the
purpose of early detection of prostate cancer, taking
into account changes in technology and standards of
medical practice, availability, effectiveness, costs,
and such other factors as the Secretary considers
appropriate.
Colorectal Cancer Screening Tests
(pp)(1) The term ``colorectal cancer screening test'' means
any of the following procedures furnished to an individual for
the purpose of early detection of colorectal cancer:
(A) Screening fecal-occult blood test.
(B) Screening flexible sigmoidoscopy.
(C) Screening colonoscopy.
(D) Such other tests or procedures, and modifications
to tests and procedures under this subsection, with
such frequency and payment limits, as the Secretary
determines appropriate, in consultation with
appropriate organizations.
(2) An ``individual at high risk for colorectal cancer'' is
an individual who, because of family history, prior experience
of cancer or precursor neoplastic polyps, a history of chronic
digestive disease condition (including inflammatory bowel
disease, Crohn's Disease, or ulcerative colitis), the presence
of any appropriate recognized gene markers for colorectal
cancer, or other predisposing factors, faces a high risk for
colorectal cancer.
Diabetes Outpatient Self-Management Training Services
(qq)(1) The term ``diabetes outpatient self-management
training services'' means educational and training services
furnished (at such times as the Secretary determines
appropriate) to an individual with diabetes by a certified
provider (as described in paragraph (2)(A)) in an outpatient
setting by an individual or entity who meets the quality
standards described in paragraph (2)(B), but only if the
physician who is managing the individual's diabetic condition
certifies that such services are needed under a comprehensive
plan of care related to the individual's diabetic condition to
ensure therapy compliance or to provide the individual with
necessary skills and knowledge (including skills related to the
self-administration of injectable drugs) to participate in the
management of the individual's condition.
(2) In paragraph (1)--
(A) a ``certified provider'' is a physician, or other
individual or entity designated by the Secretary, that,
in addition to providing diabetes outpatient self-
management training services, provides other items or
services for which payment may be made under this
title; and
(B) a physician, or such other individual or entity,
meets the quality standards described in this paragraph
if the physician, or individual or entity, meets
quality standards established by the Secretary, except
that the physician or other individual or entity shall
be deemed to have met such standards if the physician
or other individual or entity meets applicable
standards originally established by the National
Diabetes Advisory Board and subsequently revised by
organizations who participated in the establishment of
standards by such Board, or is recognized by an
organization that represents individuals (including
individuals under this title) with diabetes as meeting
standards for furnishing the services.
Bone Mass Measurement
(rr)(1) The term ``bone mass measurement'' means a radiologic
or radioisotopic procedure or other procedure approved by the
Food and Drug Administration performed on a qualified
individual (as defined in paragraph (2)) for the purpose of
identifying bone mass or detecting bone loss or determining
bone quality, and includes a physician's interpretation of the
results of the procedure.
(2) For purposes of this subsection, the term ``qualified
individual'' means an individual who is (in accordance with
regulations prescribed by the Secretary)--
(A) an estrogen-deficient woman at clinical risk for
osteoporosis;
(B) an individual with vertebral abnormalities;
(C) an individual receiving long-term glucocorticoid
steroid therapy;
(D) an individual with primary hyperparathyroidism;
or
(E) an individual being monitored to assess the
response to or efficacy of an approved osteoporosis
drug therapy.
(3) The Secretary shall establish such standards regarding
the frequency with which a qualified individual shall be
eligible to be provided benefits for bone mass measurement
under this title.
Religious Nonmedical Health Care Institution
(ss)(1) The term ``religious nonmedical health care
institution'' means an institution that--
(A) is described in subsection (c)(3) of
section 501 of the Internal Revenue Code of
1986 and is exempt from taxes under subsection
(a) of such section;
(B) is lawfully operated under all applicable
Federal, State, and local laws and regulations;
(C) provides only nonmedical nursing items
and services exclusively to patients who choose
to rely solely upon a religious method of
healing and for whom the acceptance of medical
health services would be inconsistent with
their religious beliefs;
(D) provides such nonmedical items and
services exclusively through nonmedical nursing
personnel who are experienced in caring for the
physical needs of such patients;
(E) provides such nonmedical items and
services to inpatients on a 24-hour basis;
(F) on the basis of its religious beliefs,
does not provide through its personnel or
otherwise medical items and services (including
any medical screening, examination, diagnosis,
prognosis, treatment, or the administration of
drugs) for its patients;
(G)(i) is not owned by, under common
ownership with, or has an ownership interest
in, a provider of medical treatment or
services;
(ii) is not affiliated with--
(I) a provider of medical treatment
or services, or
(II) an individual who has an
ownership interest in a provider of
medical treatment or services;
(H) has in effect a utilization review plan
which--
(i) provides for the review of
admissions to the institution, of the
duration of stays therein, of cases of
continuous extended duration, and of
the items and services furnished by the
institution,
(ii) requires that such reviews be
made by an appropriate committee of the
institution that includes the
individuals responsible for overall
administration and for supervision of
nursing personnel at the institution,
(iii) provides that records be
maintained of the meetings, decisions,
and actions of such committee, and
(iv) meets such other requirements as
the Secretary finds necessary to
establish an effective utilization
review plan;
(I) provides the Secretary with such
information as the Secretary may require to
implement section 1821, including information
relating to quality of care and coverage
determinations; and
(J) meets such other requirements as the
Secretary finds necessary in the interest of
the health and safety of individuals who are
furnished services in the institution.
(2) To the extent that the Secretary finds that the
accreditation of an institution by a State, regional, or
national agency or association provides reasonable assurances
that any or all of the requirements of paragraph (1) are met or
exceeded, the Secretary may treat such institution as meeting
the condition or conditions with respect to which the Secretary
made such finding.
(3)(A)(i) In administering this subsection and section 1821,
the Secretary shall not require any patient of a religious
nonmedical health care institution to undergo medical
screening, examination, diagnosis, prognosis, or treatment or
to accept any other medical health care service, if such
patient (or legal representative of the patient) objects
thereto on religious grounds.
(ii) Clause (i) shall not be construed as preventing the
Secretary from requiring under section 1821(a)(2) the provision
of sufficient information regarding an individual's condition
as a condition for receipt of benefits under part A for
services provided in such an institution.
(B)(i) In administering this subsection and section 1821, the
Secretary shall not subject a religious nonmedical health care
institution or its personnel to any medical supervision,
regulation, or control, insofar as such supervision,
regulation, or control would be contrary to the religious
beliefs observed by the institution or such personnel.
(ii) Clause (i) shall not be construed as preventing the
Secretary from reviewing items and services billed by the
institution to the extent the Secretary determines such review
to be necessary to determine whether such items and services
were not covered under part A, are excessive, or are
fraudulent.
(4)(A) For purposes of paragraph (1)(G)(i), an ownership
interest of less than 5 percent shall not be taken into
account.
(B) For purposes of paragraph (1)(G)(ii), none of the
following shall be considered to create an affiliation:
(i) An individual serving as an uncompensated
director, trustee, officer, or other member of the
governing body of a religious nonmedical health care
institution.
(ii) An individual who is a director, trustee,
officer, employee, or staff member of a religious
nonmedical health care institution having a family
relationship with an individual who is affiliated with
(or has an ownership interest in) a provider of medical
treatment or services.
(iii) An individual or entity furnishing goods or
services as a vendor to both providers of medical
treatment or services and religious nonmedical health
care institutions.
Post-Institutional Home Health Services; Home Health Spell of Illness
(tt)(1) The term ``post-institutional home health services''
means home health services furnished to an individual--
(A) after discharge from a hospital or critical
access hospital in which the individual was an
inpatient for not less than 3 consecutive days before
such discharge if such home health services were
initiated within 14 days after the date of such
discharge; or
(B) after discharge from a skilled nursing facility
in which the individual was provided post-hospital
extended care services if such home health services
were initiated within 14 days after the date of such
discharge.
(2) The term ``home health spell of illness'' with respect to
any individual means a period of consecutive days--
(A) beginning with the first day (not included in a
previous home health spell of illness) (i) on which
such individual is furnished post-institutional home
health services, and (ii) which occurs in a month for
which the individual is entitled to benefits under part
A, and
(B) ending with the close of the first period of 60
consecutive days thereafter on each of which the
individual is neither an inpatient of a hospital or
critical access hospital nor an inpatient of a facility
described in section 1819(a)(1) or subsection (y)(1)
nor provided home health services.
Screening for Glaucoma
(uu) The term ``screening for glaucoma'' means a dilated eye
examination with an intraocular pressure measurement, and a
direct ophthalmoscopy or a slit-lamp biomicroscopic examination
for the early detection of glaucoma which is furnished by or
under the direct supervision of an optometrist or
ophthalmologist who is legally authorized to furnish such
services under State law (or the State regulatory mechanism
provided by State law) of the State in which the services are
furnished, as would otherwise be covered if furnished by a
physician or as an incident to a physician's professional
service, if the individual involved has not had such an
examination in the preceding year.
Medical Nutrition Therapy Services; Registered Dietitian or Nutrition
Professional
(vv)(1) The term ``medical nutrition therapy services'' means
nutritional diagnostic, therapy, and counseling services for
the purpose of disease management which are furnished by a
registered dietitian or nutrition professional (as defined in
paragraph (2)) pursuant to a referral by a physician (as
defined in subsection (r)(1)).
(2) Subject to paragraph (3), the term ``registered dietitian
or nutrition professional'' means an individual who--
(A) holds a baccalaureate or higher degree granted by
a regionally accredited college or university in the
United States (or an equivalent foreign degree) with
completion of the academic requirements of a program in
nutrition or dietetics, as accredited by an appropriate
national accreditation organization recognized by the
Secretary for this purpose;
(B) has completed at least 900 hours of supervised
dietetics practice under the supervision of a
registered dietitian or nutrition professional; and
(C)(i) is licensed or certified as a dietitian or
nutrition professional by the State in which the
services are performed; or
(ii) in the case of an individual in a State that
does not provide for such licensure or certification,
meets such other criteria as the Secretary establishes.
(3) Subparagraphs (A) and (B) of paragraph (2) shall not
apply in the case of an individual who, as of the date of the
enactment of this subsection, is licensed or certified as a
dietitian or nutrition professional by the State in which
medical nutrition therapy services are performed.
Initial Preventive Physical Examination
(ww)(1) The term ``initial preventive physical examination''
means physicians' services consisting of a physical examination
(including measurement of height, weight body mass index,, and
blood pressure) with the goal of health promotion and disease
detection and includes education, counseling, and referral with
respect to screening and other preventive services described in
paragraph (2), end-of-life planning (as defined in paragraph
(3)) upon the agreement with the individual, and the furnishing
of a review of any current opioid prescriptions (as defined in
paragraph (4)), but does not include clinical laboratory tests.
(2) The screening and other preventive services described in
this paragraph include the following:
(A) Pneumococcal, influenza, and hepatitis B vaccine
and administration under subsection (s)(10).
(B) Screening mammography as defined in subsection
(jj).
(C) Screening pap smear and screening pelvic exam as
defined in subsection (nn).
(D) Prostate cancer screening tests as defined in
subsection (oo).
(E) Colorectal cancer screening tests as defined in
subsection (pp).
(F) Diabetes outpatient self-management training
services as defined in subsection (qq)(1).
(G) Bone mass measurement as defined in subsection
(rr).
(H) Screening for glaucoma as defined in subsection
(uu).
(I) Medical nutrition therapy services as defined in
subsection (vv).
(J) Cardiovascular screening blood tests as defined
in subsection (xx)(1).
(K) Diabetes screening tests as defined in subsection
(yy).
(L) Ultrasound screening for abdominal aortic
aneurysm as defined in section 1861(bbb).
(M) An electrocardiogram.
(N) Screening for potential substance use disorders.
(O) Additional preventive services (as defined in
subsection (ddd)(1)).
(3) For purposes of paragraph (1), the term ``end-of-life
planning'' means verbal or written information regarding--
(A) an individual's ability to prepare an advance
directive in the case that an injury or illness causes
the individual to be unable to make health care
decisions; and
(B) whether or not the physician is willing to follow
the individual's wishes as expressed in an advance
directive.
(4) For purposes of paragraph (1), the term ``a review of any
current opioid prescriptions'' means, with respect to an
individual determined to have a current prescription for
opioids--
(A) a review of the potential risk factors to the
individual for opioid use disorder;
(B) an evaluation of the individual's severity of
pain and current treatment plan;
(C) the provision of information on non-opioid
treatment options; and
(D) a referral to a specialist, as appropriate.
Cardiovascular Screening Blood Test
(xx)(1) The term ``cardiovascular screening blood test''
means a blood test for the early detection of cardiovascular
disease (or abnormalities associated with an elevated risk of
cardiovascular disease) that tests for the following:
(A) Cholesterol levels and other lipid or
triglyceride levels.
(B) Such other indications associated with the
presence of, or an elevated risk for, cardiovascular
disease as the Secretary may approve for all
individuals (or for some individuals determined by the
Secretary to be at risk for cardiovascular disease),
including indications measured by noninvasive testing.
The Secretary may not approve an indication under subparagraph
(B) for any individual unless a blood test for such is
recommended by the United States Preventive Services Task
Force.
(2) The Secretary shall establish standards, in consultation
with appropriate organizations, regarding the frequency for
each type of cardiovascular screening blood tests, except that
such frequency may not be more often than once every 2 years.
Diabetes Screening Tests
(yy)(1) The term ``diabetes screening tests'' means testing
furnished to an individual at risk for diabetes (as defined in
paragraph (2)) for the purpose of early detection of diabetes,
including--
(A) a fasting plasma glucose test; and
(B) such other tests, and modifications to tests, as
the Secretary determines appropriate, in consultation
with appropriate organizations.
(2) For purposes of paragraph (1), the term ``individual at
risk for diabetes'' means an individual who has any of the
following risk factors for diabetes:
(A) Hypertension.
(B) Dyslipidemia.
(C) Obesity, defined as a body mass index greater
than or equal to 30 kg/m2.
(D) Previous identification of an elevated impaired
fasting glucose.
(E) Previous identification of impaired glucose
tolerance.
(F) A risk factor consisting of at least 2 of the
following characteristics:
(i) Overweight, defined as a body mass index
greater than 25, but less than 30, kg/
m2.
(ii) A family history of diabetes.
(iii) A history of gestational diabetes
mellitus or delivery of a baby weighing greater
than 9 pounds.
(iv) 65 years of age or older.
(3) The Secretary shall establish standards, in consultation
with appropriate organizations, regarding the frequency of
diabetes screening tests, except that such frequency may not be
more often than twice within the 12-month period following the
date of the most recent diabetes screening test of that
individual.
Intravenous Immune Globulin
(zz) The term ``intravenous immune globulin'' means an
approved pooled plasma derivative for the treatment in the
patient's home of a patient with a diagnosed primary immune
deficiency disease, but not including items or services
furnished before January 1, 2024, related to the administration
of the derivative, if a physician determines administration of
the derivative in the patient's home is medically appropriate.
Extended Care in Religious Nonmedical Health Care Institutions
(aaa)(1) The term ``home health agency'' also includes a
religious nonmedical health care institution (as defined in
subsection (ss)(1)), but only with respect to items and
services ordinarily furnished by such an institution to
individuals in their homes, and that are comparable to items
and services furnished to individuals by a home health agency
that is not religious nonmedical health care institution.
(2)(A) Subject to subparagraphs (B), payment may be made with
respect to services provided by such an institution only to
such extent and under such conditions, limitations, and
requirements (in addition to or in lieu of the conditions,
limitations, and requirements otherwise applicable) as may be
provided in regulations consistent with section 1821.
(B) Notwithstanding any other provision of this title,
payment may not be made under subparagraph (A)--
(i) in a year insofar as such payments exceed
$700,000; and
(ii) after December 31, 2006.
Ultrasound Screening for Abdominal Aortic Aneurysm
(bbb) The term ``ultrasound screening for abdominal aortic
aneurysm'' means--
(1) a procedure using sound waves (or such other
procedures using alternative technologies, of
commensurate accuracy and cost, that the Secretary may
specify) provided for the early detection of abdominal
aortic aneurysm; and
(2) includes a physician's interpretation of the
results of the procedure.
Long-Term Care Hospital
(ccc) The term ``long-term care hospital'' means a hospital
which--
(1) is primarily engaged in providing inpatient
services, by or under the supervision of a physician,
to Medicare beneficiaries whose medically complex
conditions require a long hospital stay and programs of
care provided by a long-term care hospital;
(2) has an average inpatient length of stay (as
determined by the Secretary) of greater than 25 days,
or meets the requirements of clause (II) of section
1886(d)(1)(B)(iv);
(3) satisfies the requirements of subsection (e); and
(4) meets the following facility criteria:
(A) the institution has a patient review
process, documented in the patient medical
record, that screens patients prior to
admission for appropriateness of admission to a
long-term care hospital, validates within 48
hours of admission that patients meet admission
criteria for long-term care hospitals,
regularly evaluates patients throughout their
stay for continuation of care in a long-term
care hospital, and assesses the available
discharge options when patients no longer meet
such continued stay criteria;
(B) the institution has active physician
involvement with patients during their
treatment through an organized medical staff,
physician-directed treatment with physician on-
site availability on a daily basis to review
patient progress, and consulting physicians on
call and capable of being at the patient's side
within a moderate period of time, as determined
by the Secretary; and
(C) the institution has interdisciplinary
team treatment for patients, requiring
interdisciplinary teams of health care
professionals, including physicians, to prepare
and carry out an individualized treatment plan
for each patient.
Additional Preventive Services; Preventive Services
(ddd)(1) The term ``additional preventive services'' means
services not described in subparagraph (A) or (C) of paragraph
(3) that identify medical conditions or risk factors and that
the Secretary determines are--
(A) reasonable and necessary for the prevention or
early detection of an illness or disability;
(B) recommended with a grade of A or B by the United
States Preventive Services Task Force; and
(C) appropriate for individuals entitled to benefits
under part A or enrolled under part B.
(2) In making determinations under paragraph (1) regarding
the coverage of a new service, the Secretary shall use the
process for making national coverage determinations (as defined
in section 1869(f)(1)(B)) under this title. As part of the use
of such process, the Secretary may conduct an assessment of the
relation between predicted outcomes and the expenditures for
such service and may take into account the results of such
assessment in making such determination.
(3) The term ``preventive services'' means the following:
(A) The screening and preventive services described
in subsection (ww)(2) (other than the service described
in subparagraph (M) of such subsection).
(B) An initial preventive physical examination (as
defined in subsection (ww)).
(C) Personalized prevention plan services (as defined
in subsection (hhh)(1)).
Cardiac Rehabilitation Program; Intensive Cardiac Rehabilitation
Program
(eee)(1) The term ``cardiac rehabilitation program'' means a
program (as described in paragraph (2)) that furnishes the
items and services described in paragraph (3) under the
supervision of a physician (as defined in subsection (r)(1)) or
a physician assistant, nurse practitioner, or clinical nurse
specialist (as those terms are defined in subsection (aa)(5)).
(2) A program described in this paragraph is a program under
which--
(A) items and services under the program are
delivered--
(i) in a physician's office;
(ii) in a hospital on an outpatient basis; or
(iii) in other settings determined
appropriate by the Secretary;
(B) a physician (as defined in subsection (r)(1)) or
a physician assistant, nurse practitioner, or clinical
nurse specialist (as those terms are defined in
subsection (aa)(5)) is immediately available and
accessible for medical consultation and medical
emergencies at all times items and services are being
furnished under the program, except that, in the case
of items and services furnished under such a program in
a hospital, such availability shall be presumed; and
(C) individualized treatment is furnished under a
written plan established, reviewed, and signed by a
physician every 30 days that describes--
(i) the individual's diagnosis;
(ii) the type, amount, frequency, and
duration of the items and services furnished
under the plan; and
(iii) the goals set for the individual under
the plan.
(3) The items and services described in this paragraph are--
(A) physician-prescribed exercise;
(B) cardiac risk factor modification, including
education, counseling, and behavioral intervention (to
the extent such education, counseling, and behavioral
intervention is closely related to the individual's
care and treatment and is tailored to the individual's
needs);
(C) psychosocial assessment;
(D) outcomes assessment; and
(E) such other items and services as the Secretary
may determine, but only if such items and services
are--
(i) reasonable and necessary for the
diagnosis or active treatment of the
individual's condition;
(ii) reasonably expected to improve or
maintain the individual's condition and
functional level; and
(iii) furnished under such guidelines
relating to the frequency and duration of such
items and services as the Secretary shall
establish, taking into account accepted norms
of medical practice and the reasonable
expectation of improvement of the individual.
(4)(A) The term ``intensive cardiac rehabilitation program''
means a program (as described in paragraph (2)) that furnishes
the items and services described in paragraph (3) under the
supervision of a physician (as defined in subsection (r)(1)) or
a physician assistant, nurse practitioner, or clinical nurse
specialist (as those terms are defined in subsection (aa)(5))
and has shown, in peer-reviewed published research, that it
accomplished--
(i) one or more of the following:
(I) positively affected the progression of
coronary heart disease; or
(II) reduced the need for coronary bypass
surgery; or
(III) reduced the need for percutaneous
coronary interventions; and
(ii) a statistically significant reduction in 5 or
more of the following measures from their level before
receipt of cardiac rehabilitation services to their
level after receipt of such services:
(I) low density lipoprotein;
(II) triglycerides;
(III) body mass index;
(IV) systolic blood pressure;
(V) diastolic blood pressure; or
(VI) the need for cholesterol, blood
pressure, and diabetes medications.
(B) To be eligible for an intensive cardiac rehabilitation
program, an individual must have--
(i) had an acute myocardial infarction within the
preceding 12 months;
(ii) had coronary bypass surgery;
(iii) stable angina pectoris;
(iv) had heart valve repair or replacement;
(v) had percutaneous transluminal coronary
angioplasty (PTCA) or coronary stenting;
(vi) had a heart or heart-lung transplant;
(vii) stable, chronic heart failure (defined
as patients with left ventricular ejection
fraction of 35 percent or less and New York
Heart Association (NYHA) class II to IV
symptoms despite being on optimal heart failure
therapy for at least 6 weeks); or
(viii) any additional condition for which the
Secretary has determined that a cardiac
rehabilitation program shall be covered, unless
the Secretary determines, using the same
process used to determine that the condition is
covered for a cardiac rehabilitation program,
that such coverage is not supported by the
clinical evidence.
(C) An intensive cardiac rehabilitation program may be
provided in a series of 72 one-hour sessions (as defined in
section 1848(b)(5)), up to 6 sessions per day, over a period of
up to 18 weeks.
(5) The Secretary shall establish standards to ensure that a
physician with expertise in the management of individuals with
cardiac pathophysiology who is licensed to practice medicine in
the State in which a cardiac rehabilitation program (or the
intensive cardiac rehabilitation program, as the case may be)
is offered--
(A) is responsible for such program; and
(B) in consultation with appropriate staff, is
involved substantially in directing the progress of
individual in the program.
Pulmonary Rehabilitation Program
(fff)(1) The term ``pulmonary rehabilitation program'' means
a program (as described in subsection (eee)(2) with respect to
a program under this subsection) that furnishes the items and
services described in paragraph (2) under the supervision of a
physician (as defined in subsection (r)(1)) or a physician
assistant, nurse practitioner, or clinical nurse specialist (as
those terms are defined in subsection (aa)(5)).
(2) The items and services described in this paragraph are--
(A) physician-prescribed exercise;
(B) education or training (to the extent the
education or training is closely and clearly related to
the individual's care and treatment and is tailored to
such individual's needs);
(C) psychosocial assessment;
(D) outcomes assessment; and
(E) such other items and services as the Secretary
may determine, but only if such items and services
are--
(i) reasonable and necessary for the
diagnosis or active treatment of the
individual's condition;
(ii) reasonably expected to improve or
maintain the individual's condition and
functional level; and
(iii) furnished under such guidelines
relating to the frequency and duration of such
items and services as the Secretary shall
establish, taking into account accepted norms
of medical practice and the reasonable
expectation of improvement of the individual.
(3) The Secretary shall establish standards to ensure that a
physician with expertise in the management of individuals with
respiratory pathophysiology who is licensed to practice
medicine in the State in which a pulmonary rehabilitation
program is offered--
(A) is responsible for such program; and
(B) in consultation with appropriate staff, is
involved substantially in directing the progress of
individual in the program.
Kidney Disease Education Services
(ggg)(1) The term ``kidney disease education services'' means
educational services that are--
(A) furnished to an individual with stage IV chronic
kidney disease who, according to accepted clinical
guidelines identified by the Secretary, will require
dialysis or a kidney transplant;
(B) furnished, upon the referral of the physician
managing the individual's kidney condition, by a
qualified person (as defined in paragraph (2)); and
(C) designed--
(i) to provide comprehensive information
(consistent with the standards set under
paragraph (3)) regarding--
(I) the management of comorbidities,
including for purposes of delaying the
need for dialysis;
(II) the prevention of uremic
complications; and
(III) each option for renal
replacement therapy (including
hemodialysis and peritoneal dialysis at
home and in-center as well as vascular
access options and transplantation);
(ii) to ensure that the individual has the
opportunity to actively participate in the
choice of therapy; and
(iii) to be tailored to meet the needs of the
individual involved.
(2)(A) The term ``qualified person'' means--
(i) a physician (as defined in section 1861(r)(1)) or
a physician assistant, nurse practitioner, or clinical
nurse specialist (as defined in section 1861(aa)(5)),
who furnishes services for which payment may be made
under the fee schedule established under section 1848;
and
(ii) a provider of services located in a rural area
(as defined in section 1886(d)(2)(D)).
(B) Such term does not include a provider of services (other
than a provider of services described in subparagraph (A)(ii))
or a renal dialysis facility.
(3) The Secretary shall set standards for the content of such
information to be provided under paragraph (1)(C)(i) after
consulting with physicians, other health professionals, health
educators, professional organizations, accrediting
organizations, kidney patient organizations, dialysis
facilities, transplant centers, network organizations described
in section 1881(c)(2), and other knowledgeable persons. To the
extent possible the Secretary shall consult with persons or
entities described in the previous sentence, other than a
dialysis facility, that has not received industry funding from
a drug or biological manufacturer or dialysis facility.
(4) No individual shall be furnished more than 6 sessions of
kidney disease education services under this title.
Annual Wellness Visit
(hhh)(1) The term ``personalized prevention plan services''
means the creation of a plan for an individual--
(A) that includes a health risk assessment (that
meets the guidelines established by the Secretary under
paragraph (4)(A)) of the individual that is completed
prior to or as part of the same visit with a health
professional described in paragraph (3); and
(B) that--
(i) takes into account the results of the
health risk assessment; and
(ii) may contain the elements described in
paragraph (2).
(2) Subject to paragraph (4)(H), the elements described in
this paragraph are the following:
(A) The establishment of, or an update to, the
individual's medical and family history.
(B) A list of current providers and suppliers that
are regularly involved in providing medical care to the
individual (including a list of all prescribed
medications).
(C) A measurement of height, weight, body mass index
(or waist circumference, if appropriate), blood
pressure, and other routine measurements.
(D) Detection of any cognitive impairment.
(E) The establishment of, or an update to, the
following:
(i) A screening schedule for the next 5 to 10
years, as appropriate, based on recommendations
of the United States Preventive Services Task
Force and the Advisory Committee on
Immunization Practices, and the individual's
health status, screening history, and age-
appropriate preventive services covered under
this title.
(ii) A list of risk factors and conditions
for which primary, secondary, or tertiary
prevention interventions are recommended or are
underway, including any mental health
conditions or any such risk factors or
conditions that have been identified through an
initial preventive physical examination (as
described under subsection (ww)(1)), and a list
of treatment options and their associated risks
and benefits.
(F) The furnishing of personalized health advice and
a referral, as appropriate, to health education or
preventive counseling services or programs aimed at
reducing identified risk factors and improving self-
management, or community-based lifestyle interventions
to reduce health risks and promote self-management and
wellness, including weight loss, physical activity,
smoking cessation, fall prevention, and nutrition.
(G) Screening for potential substance use disorders
and referral for treatment as appropriate.
(H) The furnishing of a review of any current opioid
prescriptions (as defined in subsection (ww)(4)).
(I) Any other element determined appropriate by the
Secretary.
(3) A health professional described in this paragraph is--
(A) a physician;
(B) a practitioner described in clause (i) of section
1842(b)(18)(C); or
(C) a medical professional (including a health
educator, registered dietitian, or nutrition
professional) or a team of medical professionals, as
determined appropriate by the Secretary, under the
supervision of a physician.
(4)(A) For purposes of paragraph (1)(A), the Secretary, not
later than 1 year after the date of enactment of this
subsection, shall establish publicly available guidelines for
health risk assessments. Such guidelines shall be developed in
consultation with relevant groups and entities and shall
provide that a health risk assessment--
(i) identify chronic diseases, injury risks,
modifiable risk factors, and urgent health needs of the
individual; and
(ii) may be furnished--
(I) through an interactive telephonic or web-
based program that meets the standards
established under subparagraph (B);
(II) during an encounter with a health care
professional;
(III) through community-based prevention
programs; or
(IV) through any other means the Secretary
determines appropriate to maximize
accessibility and ease of use by beneficiaries,
while ensuring the privacy of such
beneficiaries.
(B) Not later than 1 year after the date of enactment of this
subsection, the Secretary shall establish standards for
interactive telephonic or web-based programs used to furnish
health risk assessments under subparagraph (A)(ii)(I). The
Secretary may utilize any health risk assessment developed
under section 4004(f) of the Patient Protection and Affordable
Care Act as part of the requirement to develop a personalized
prevention plan to comply with this subparagraph.
(C)(i) Not later than 18 months after the date of enactment
of this subsection, the Secretary shall develop and make
available to the public a health risk assessment model. Such
model shall meet the guidelines under subparagraph (A) and may
be used to meet the requirement under paragraph (1)(A).
(ii) Any health risk assessment that meets the guidelines
under subparagraph (A) and is approved by the Secretary may be
used to meet the requirement under paragraph (1)(A).
(D) The Secretary may coordinate with community-based
entities (including State Health Insurance Programs, Area
Agencies on Aging, Aging and Disability Resource Centers, and
the Administration on Aging) to--
(i) ensure that health risk assessments are
accessible to beneficiaries; and
(ii) provide appropriate support for the completion
of health risk assessments by beneficiaries.
(E) The Secretary shall establish procedures to make
beneficiaries and providers aware of the requirement that a
beneficiary complete a health risk assessment prior to or at
the same time as receiving personalized prevention plan
services.
(F) To the extent practicable, the Secretary shall encourage
the use of, integration with, and coordination of health
information technology (including use of technology that is
compatible with electronic medical records and personal health
records) and may experiment with the use of personalized
technology to aid in the development of self-management skills
and management of and adherence to provider recommendations in
order to improve the health status of beneficiaries.
(G) A beneficiary shall be eligible to receive only an
initial preventive physical examination (as defined under
subsection (ww)(1)) during the 12-month period after the date
that the beneficiary's coverage begins under part B and shall
be eligible to receive personalized prevention plan services
under this subsection each year thereafter provided that the
beneficiary has not received either an initial preventive
physical examination or personalized prevention plan services
within the preceding 12-month period.
(H) The Secretary shall issue guidance that--
(i) identifies elements under paragraph (2) that are
required to be provided to a beneficiary as part of
their first visit for personalized prevention plan
services; and
(ii) establishes a yearly schedule for appropriate
provision of such elements thereafter.
(iii) Home Infusion Therapy.--(1) The term ``home infusion
therapy'' means the items and services described in paragraph
(2) furnished by a qualified home infusion therapy supplier (as
defined in paragraph (3)(D)) which are furnished in the
individual's home (as defined in paragraph (3)(B)) to an
individual--
(A) who is under the care of an applicable provider
(as defined in paragraph (3)(A)); and
(B) with respect to whom a plan prescribing the type,
amount, and duration of infusion therapy services that
are to be furnished such individual has been
established by a physician (as defined in subsection
(r)(1)) and is periodically reviewed by a physician (as
so defined) in coordination with the furnishing of home
infusion drugs (as defined in paragraph (3)(C)) under
part B.
(2) The items and services described in this paragraph are
the following:
(A) Professional services, including nursing
services, furnished in accordance with the plan.
(B) Training and education (not otherwise paid for as
durable medical equipment (as defined in subsection
(n)), remote monitoring, and monitoring services for
the provision of home infusion therapy and home
infusion drugs furnished by a qualified home infusion
therapy supplier.
(3) For purposes of this subsection:
(A) The term ``applicable provider'' means--
(i) a physician;
(ii) a nurse practitioner; and
(iii) a physician assistant.
(B) The term ``home'' means a place of residence used
as the home of an individual (as defined for purposes
of subsection (n)).
(C) The term ``home infusion drug'' means a
parenteral drug or biological administered
intravenously, or subcutaneously for an administration
period of 15 minutes or more, in the home of an
individual through a pump that is an item of durable
medical equipment (as defined in subsection (n)). Such
term does not include the following:
(i) Insulin pump systems.
(ii) A self-administered drug or biological
on a self-administered drug exclusion list.
Clause (ii) shall not apply to a self-administered drug
or biological on a self-administered drug exclusion
list if such drug or biological was included as a
transitional home infusion drug under subparagraph
(A)(iii) of section 1834(u)(7) and was identified by a
HCPCS code described in subparagraph (C)(ii) of such
section.
(D)(i) The term ``qualified home infusion therapy
supplier'' means a pharmacy, physician, or other
provider of services or supplier licensed by the State
in which the pharmacy, physician, or provider or
services or supplier furnishes items or services and
that--
(I) furnishes infusion therapy to individuals
with acute or chronic conditions requiring
administration of home infusion drugs;
(II) ensures the safe and effective provision
and administration of home infusion therapy on
a 7-day-a-week, 24-hour-a-day basis;
(III) is accredited by an organization
designated by the Secretary pursuant to section
1834(u)(5); and
(IV) meets such other requirements as the
Secretary determines appropriate, taking into
account the standards of care for home infusion
therapy established by Medicare Advantage plans
under part C and in the private sector.
(ii) A qualified home infusion therapy supplier may
subcontract with a pharmacy, physician, provider of
services, or supplier to meet the requirements of this
subparagraph.
(jjj) Opioid Use Disorder Treatment Services; Opioid
Treatment Program.--
(1) Opioid use disorder treatment services.--The term
``opioid use disorder treatment services'' means items
and services that are furnished by an opioid treatment
program for the treatment of opioid use disorder,
including--
(A) opioid agonist and antagonist treatment
medications (including oral, injected, or
implanted versions) that are approved by the
Food and Drug Administration under section 505
of the Federal Food, Drug, and Cosmetic Act for
use in the treatment of opioid use disorder;
(B) dispensing and administration of such
medications, if applicable;
(C) substance use counseling by a
professional to the extent authorized under
State law to furnish such services;
(D) individual and group therapy with a
physician or psychologist (or other mental
health professional to the extent authorized
under State law);
(E) toxicology testing, and
(F) other items and services that the
Secretary determines are appropriate (but in no
event to include meals or transportation).
(2) Opioid treatment program.--The term ``opioid
treatment program'' means an entity that is an opioid
treatment program (as defined in section 8.2 of title
42 of the Code of Federal Regulations, or any successor
regulation) that--
(A) is enrolled under section 1866(j);
(B) has in effect a certification by the
Substance Abuse and Mental Health Services
Administration for such a program;
(C) is accredited by an accrediting body
approved by the Substance Abuse and Mental
Health Services Administration; and
(D) meets such additional conditions as the
Secretary may find necessary to ensure--
(i) the health and safety of
individuals being furnished services
under such program; and
(ii) the effective and efficient
furnishing of such services.
Rural Emergency Hospital Services; Rural Emergency Hospital
(kkk)(1) Rural emergency hospital services.--
(A) In general.--The term ``rural emergency hospital
services'' means the following services furnished by a
rural emergency hospital (as defined in paragraph (2))
that do not exceed an annual per patient average of 24
hours in such rural emergency hospital:
(i) Emergency department services and
observation care.
(ii) At the election of the rural emergency
hospital, with respect to services furnished on
an outpatient basis, other medical and health
services as specified by the Secretary through
rulemaking.
(B) Staffed emergency department.--For purposes of
subparagraph (A)(i), an emergency department of a rural
emergency hospital shall be considered a staffed
emergency department if it meets the following
requirements:
(i) The emergency department is staffed 24
hours a day, 7 days a week.
(ii) A physician (as defined in section
1861(r)(1)), nurse practitioner, clinical nurse
specialist, or physician assistant (as those
terms are defined in section 1861(aa)(5)) is
available to furnish rural emergency hospital
services in the facility 24 hours a day.
(iii) Applicable staffing and staffing
responsibilities under section 485.631 of title
42, Code of Federal Regulations (or any
successor regulation).
(2) Rural emergency hospital.--The term ``rural emergency
hospital'' means a facility described in paragraph (3) that--
(A) is enrolled under section 1866(j), submits the
additional information described in paragraph (4)(A)
for purposes of such enrollment, and makes the detailed
transition plan described in clause (i) of such
paragraph available to the public, in a form and manner
determined appropriate by the Secretary;
(B) does not provide any acute care inpatient
services, other than those described in paragraph
(6)(A);
(C) has in effect a transfer agreement with a level I
or level II trauma center;
(D) meets--
(i) licensure requirements as described in
paragraph (5);
(ii) the requirements of a staffed emergency
department as described in paragraph (1)(B);
(iii) such staff training and certification
requirements as the Secretary may require;
(iv) conditions of participation applicable
to--
(I) critical access hospitals, with
respect to emergency services under
section 485.618 of title 42, Code of
Federal Regulations (or any successor
regulation); and
(II) hospital emergency departments
under this title, as determined
applicable by the Secretary;
(v) such other requirements as the Secretary
finds necessary in the interest of the health
and safety of individuals who are furnished
rural emergency hospital services; and
(vi) in the case where the rural emergency
hospital includes a distinct part unit of the
facility that is licensed as a skilled nursing
facility, such distinct part meets the
requirements applicable to skilled nursing
facilities under this title.
(3) Facility described.--A facility described in this
paragraph is a facility that as of the date of the enactment of
this subsection--
(A) was a critical access hospital; or
(B) was a subsection (d) hospital (as defined in
section 1886(d)(1)(B)) with not more than 50 beds
located in a county (or equivalent unit of local
government) in a rural area (as defined in section
1886(d)(2)(D)), or was a subsection (d) hospital (as so
defined) with not more than 50 beds that was treated as
being located in a rural area pursuant to section
1886(d)(8)(E).
(4) Additional information.--
(A) Information.--For purposes of paragraph (2)(A), a
facility that submits an application for enrollment
under section 1866(j) as a rural emergency hospital
shall submit the following information at such time and
in such form as the Secretary may require:
(i) An action plan for initiating rural
emergency hospital services (as defined in
paragraph (1)), including a detailed transition
plan that lists the specific services that the
facility will--
(I) retain;
(II) modify
(III) add; and
(IV) discontinue.
(ii) A description of services that the
facility intends to furnish on an outpatient
basis pursuant to paragraph (1)(A)(ii).
(iii) Information regarding how the facility
intends to use the additional facility payment
provided under section 1834(x)(2), including a
description of the services covered under this
title that the additional facility payment
would be supporting, such as furnishing
telehealth services and ambulance services,
including operating the facility and
maintaining the emergency department to provide
such services covered under this title.
(iv) Such other information as the Secretary
determines appropriate.
(B) Effect of enrollment.--Such enrollment shall
remain effective with respect to a facility until such
time as--
(i) the facility elects to convert back to
its prior designation as a critical access
hospital or a subsection (d) hospital (as
defined in section 1886(d)(1)(B)), subject to
requirements applicable under this title for
such designation and in accordance with
procedures established by the Secretary; or
(ii) the Secretary determines the facility
does not meet the requirements applicable to a
rural emergency hospital under this subsection.
(5) Licensure.--A facility may not operate as a rural
emergency hospital in a State unless the facility--
(A) is located in a State that provides for the
licensing of such hospitals under State or applicable
local law; and
(B)(i) is licensed pursuant to such law; or
(ii) is approved by the agency of such State or
locality responsible for licensing hospitals, as
meeting the standards established for such licensing.
(6) Discretionary authority.--A rural emergency hospital
may--
(A) include a unit of the facility that is a distinct
part licensed as a skilled nursing facility to furnish
post-hospital extended care services; and
(B) be considered a hospital with less than 50 beds
for purposes of the exception to the payment limit for
rural health clinics under section 1833(f).
(7) Quality measurement.--
(A) In general.--The Secretary shall establish
quality measurement reporting requirements for rural
emergency hospitals, which may include the use of a
small number of claims-based outcomes measures or
surveys of patients with respect to their experience in
the rural emergency hospital, in accordance with the
succeeding provisions of this paragraph.
(B) Quality reporting by rural emergency hospitals.--
(i) In general.--With respect to each year
beginning with 2023, (or each year beginning on
or after the date that is one year after one or
more measures are first specified under
subparagraph (C)), a rural emergency hospital
shall submit data to the Secretary in
accordance with clause (ii).
(ii) Submission of quality data.--With
respect to each such year, a rural emergency
hospital shall submit to the Secretary data on
quality measures specified under subparagraph
(C). Such data shall be submitted in a form and
manner, and at a time, specified by the
Secretary for purposes of this subparagraph.
(C) Quality measures.--
(i) In general.--Subject to clause (ii), any
measure specified by the Secretary under this
subparagraph must have been endorsed by the
entity with a contract under section 1890(a).
(ii) 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.
(iii) Consideration of low case volume when
specifying performance measures.--The Secretary
shall, in the selection of measures specified
under this subparagraph, take into
consideration ways to account for rural
emergency hospitals that lack sufficient case
volume to ensure that the performance rates for
such measures are reliable.
(D) Public availability of data submitted.--The
Secretary shall establish procedures for making data
submitted under subparagraph (B) available to the
public regarding the performance of individual rural
emergency hospitals. Such procedures shall ensure that
a rural emergency hospital has the opportunity to
review, and submit corrections for, the data that is to
be made public with respect to the rural emergency
hospital prior to such data being made public. Such
information shall be posted on the Internet website of
the Centers for Medicare & Medicaid Services in an
easily understandable format as determined appropriate
by the Secretary.
(8) Clarification regarding application of provisions
relating to off-campus outpatient department of a provider.--
Nothing in this subsection, section 1833(a)(10), or section
1834(x) shall affect the application of paragraph (1)(B)(v) of
section 1833(t), relating to applicable items and services (as
defined in subparagraph (A) of paragraph (21) of such section)
that are furnished by an off-campus outpatient department of a
provider (as defined in subparagraph (B) of such paragraph).
(9) Implementation.--There shall be no administrative or
judicial review under section 1869, 1878, or otherwise of the
following:
(A) The determination of whether a rural emergency
hospital meets the requirements of this subsection.
(B) The establishment of requirements under this
subsection by the Secretary, including requirements
described in paragraphs (2)(D), (4), and (7).
(C) The determination of payment amounts under
section 1834(x), including the additional facility
payment described in paragraph (2) of such section.
(lll) Marriage and Family Therapist Services; Marriage and
Family Therapist; Mental Health Counselor Services; Mental
Health Counselor.--
(1) Marriage and family therapist services.--The term
``marriage and family therapist services'' means
services furnished by a marriage and family therapist
(as defined in paragraph (2)) for the diagnosis and
treatment of mental illnesses (other than services
furnished to an inpatient of a hospital), which the
marriage and family therapist is legally authorized to
perform under State law (or the State regulatory
mechanism provided by State law) of the State in which
such services are furnished, as would otherwise be
covered if furnished by a physician or as an incident
to a physician's professional service.
(2) Marriage and family therapist.--The term
``marriage and family therapist'' means an individual
who--
(A) possesses a master's or doctor's degree
which qualifies for licensure or certification
as a marriage and family therapist pursuant to
State law of the State in which such individual
furnishes the services described in paragraph
(1);
(B) is licensed or certified as a marriage
and family therapist by the State in which such
individual furnishes such services;
(C) after obtaining such degree has performed
at least 2 years of clinical supervised
experience in marriage and family therapy; and
(D) meets such other requirements as
specified by the Secretary.
(3) Mental health counselor services.--The term
``mental health counselor services'' means services
furnished by a mental health counselor (as defined in
paragraph (4)) for the diagnosis and treatment of
mental illnesses (other than services furnished to an
inpatient of a hospital), which the mental health
counselor is legally authorized to perform under State
law (or the State regulatory mechanism provided by the
State law) of the State in which such services are
furnished, as would otherwise be covered if furnished
by a physician or as incident to a physician's
professional service.
(4) Mental health counselor.--The term ``mental
health counselor'' means an individual who--
(A) possesses a master's or doctor's degree
which qualifies for licensure or certification
as a mental health counselor, clinical
professional counselor, or professional
counselor under the State law of the State in
which such individual furnishes the services
described in paragraph (3);
(B) is licensed or certified as a mental
health counselor, clinical professional
counselor, or professional counselor by the
State in which the services are furnished;
(C) after obtaining such a degree has
performed at least 2 years of clinical
supervised experience in mental health
counseling; and
(D) meets such other requirements as
specified by the Secretary.
(mmm) Lymphedema Compression Treatment Items.--The term
``lymphedema compression treatment items'' means standard and
custom fitted gradient compression garments and other items
determined by the Secretary that are--
(1) furnished on or after January 1, 2024, to an
individual with a diagnosis of lymphedema for the
treatment of such condition;
(2) primarily and customarily used to serve a medical
purpose and for the treatment of lymphedema, as
determined by the Secretary; and
(3) prescribed by a physician (or a physician
assistant, nurse practitioner, or a clinical nurse
specialist (as those terms are defined in section
1861(aa)(5)) to the extent authorized under State law).
* * * * * * *
LIMITATION ON CERTAIN PHYSICIAN REFERRALS
Sec. 1877. (a) Prohibition of Certain Referrals.--
(1) In general.--Except as provided in subsection
(b), if a physician (or an immediate family member of
such physician) has a financial relationship with an
entity specified in paragraph (2), then--
(A) the physician may not make a referral to
the entity for the furnishing of designated
health services for which payment otherwise may
be made under this title, and
(B) the entity may not present or cause to be
presented a claim under this title or bill to
any individual, third party payor, or other
entity for designated health services furnished
pursuant to a referral prohibited under
subparagraph (A).
(2) Financial relationship specified.--For purposes
of this section, a financial relationship of a
physician (or an immediate family member of such
physician) with an entity specified in this paragraph
is--
(A) except as provided in subsections (c) and
(d), an ownership or investment interest in the
entity, or
(B) except as provided in subsection (e), a
compensation arrangement (as defined in
subsection (h)(1)) between the physician (or an
immediate family member of such physician) and
the entity.
An ownership or investment interest described in
subparagraph (A) may be through equity, debt, or other
means and includes an interest in an entity that holds
an ownership or investment interest in any entity
providing the designated health service.
(b) General Exceptions to Both Ownership and Compensation
Arrangement Prohibitions.--Subsection (a)(1) shall not apply in
the following cases:
(1) Physicians' services.--In the case of physicians'
services (as defined in section 1861(q)) provided
personally by (or under the personal supervision of)
another physician in the same group practice (as
defined in subsection (h)(4)) as the referring
physician.
(2) In-office ancillary services.--In the case of
services (other than durable medical equipment
(excluding infusion pumps) and parenteral and enteral
nutrients, equipment, and supplies)--
(A) that are furnished--
(i) personally by the referring
physician, personally by a physician
who is a member of the same group
practice as the referring physician, or
personally by individuals who are
directly supervised by the physician or
by another physician in the group
practice, and
(ii)(I) in a building in which the
referring physician (or another
physician who is a member of the same
group practice) furnishes physicians'
services unrelated to the furnishing of
designated health services, or
(II) in the case of a referring
physician who is a member of a group
practice, in another building which is
used by the group practice--
(aa) for the provision of
some or all of the group's
clinical laboratory services,
or
(bb) for the centralized
provision of the group's
designated health services
(other than clinical laboratory
services),
unless the Secretary determines other
terms and conditions under which the
provision of such services does not
present a risk of program or patient
abuse, and
(B) that are billed by the physician
performing or supervising the services, by a
group practice of which such physician is a
member under a billing number assigned to the
group practice, or by an entity that is wholly
owned by such physician or such group practice,
if the ownership or investment interest in such
services meets such other requirements as the Secretary
may impose by regulation as needed to protect against
program or patient abuse. Such requirements shall, with
respect to magnetic resonance imaging, computed
tomography, positron emission tomography, and any other
designated health services specified under subsection
(h)(6)(D) that the Secretary determines appropriate,
include a requirement that the referring physician
inform the individual in writing at the time of the
referral that the individual may obtain the services
for which the individual is being referred from a
person other than a person described in subparagraph
(A)(i) and provide such individual with a written list
of suppliers (as defined in section 1861(d)) who
furnish such services in the area in which such
individual resides. With respect to services described
in subsection (h)(6)(J) consisting of covered part D
drugs (as defined in section 1860D-2(e)) furnished to
an individual during the period beginning on January 1,
2025, and ending on December 31, 2029, such drugs shall
be treated as having been furnished in accordance with
subparagraph (A)(ii) if such drugs are picked up in a
building described in subclause (I) or (II) of such
subparagraph by such individual, or a family member or
caregiver on behalf of such individual, or delivered to
such individual by a mail, delivery, or courier
service, but only if, during the 1-year period ending
on the date such drugs were so furnished, such
individual had a face-to-face encounter with the
prescriber of such drugs (not including any such
encounter conducted via telehealth), and only if such
individual has an ongoing on preexisting relationship
with such prescriber.
(3) Prepaid plans.--In the case of services furnished
by an organization--
(A) with a contract under section 1876 to an
individual enrolled with the organization,
(B) described in section 1833(a)(1)(A) to an
individual enrolled with the organization,
(C) receiving payments on a prepaid basis,
under a demonstration project under section
402(a) of the Social Security Amendments of
1967 or under section 222(a) of the Social
Security Amendments of 1972, to an individual
enrolled with the organization,
(D) that is a qualified health maintenance
organization (within the meaning of section
1310(d) of the Public Health Service Act) to an
individual enrolled with the organization, or
(E) that is a Medicare+Choice organization
under part C that is offering a coordinated
care plan described in section 1851(a)(2)(A) to
an individual enrolled with the organization.
(4) Other permissible exceptions.--In the case of any
other financial relationship which the Secretary
determines, and specifies in regulations, does not pose
a risk of program or patient abuse.
(5) Electronic prescribing.--An exception established
by regulation under section 1860D-3(e)(6).
(c) General Exception Related Only to Ownership or Investment
Prohibition for Ownership in Publicly Traded Securities and
Mutual Funds.--Ownership of the following shall not be
considered to be an ownership or investment interest described
in subsection (a)(2)(A):
(1) Ownership of investment securities (including
shares or bonds, debentures, notes, or other debt
instruments) which may be purchased on terms generally
available to the public and which are--
(A)(i) securities listed on the New York
Stock Exchange, the American Stock Exchange, or
any regional exchange in which quotations are
published on a daily basis, or foreign
securities listed on a recognized foreign,
national, or regional exchange in which
quotations are published on a daily basis, or
(ii) traded under an automated interdealer
quotation system operated by the National
Association of Securities Dealers, and
(B) in a corporation that had, at the end of
the corporation's most recent fiscal year, or
on average during the previous 3 fiscal years,
stockholder equity exceeding $75,000,000.
(2) Ownership of shares in a regulated investment
company as defined in section 851(a) of the Internal
Revenue Code of 1986, if such company had, at the end
of the company's most recent fiscal year, or on average
during the previous 3 fiscal years, total assets
exceeding $75,000,000.
(d) Additional Exceptions Related Only to Ownership or
Investment Prohibition.--The following, if not otherwise
excepted under subsection (b), shall not be considered to be an
ownership or investment interest described in subsection
(a)(2)(A):
(1) Hospitals in puerto rico.--In the case of
designated health services provided by a hospital
located in Puerto Rico.
(2) Rural providers.--In the case of designated
health services furnished in a rural area (as defined
in section 1886(d)(2)(D)) by an entity, if--
(A) substantially all of the designated
health services furnished by the entity are
furnished to individuals residing in such a
rural area;
(B) effective for the 18-month period
beginning on the date of the enactment of the
Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, the entity is not a
specialty hospital (as defined in subsection
(h)(7)); and
(C) in the case where the entity is a
hospital, the hospital meets the requirements
of paragraph (3)(D).
(3) Hospital ownership.--In the case of designated
health services provided by a hospital (other than a
hospital described in paragraph (1)) if--
(A) the referring physician is authorized to
perform services at the hospital;
(B) effective for the 18-month period
beginning on the date of the enactment of the
Medicare Prescription Drug, Improvement, and
Modernization Act of 2003, the hospital is not
a specialty hospital (as defined in subsection
(h)(7));
(C) the ownership or investment interest is
in the hospital itself (and not merely in a
subdivision of the hospital); and
(D) the hospital meets the requirements
described in subsection (i)(1) not later than
18 months after the date of the enactment of
this subparagraph.
(e) Exceptions Relating to Other Compensation Arrangements.--
The following shall not be considered to be a compensation
arrangement described in subsection (a)(2)(B):
(1) Rental of office space; rental of equipment.--
(A) Office Space.--Payments made by a lessee
to a lessor for the use of premises if--
(i) the lease is set out in writing,
signed by the parties, and specifies
the premises covered by the lease,
(ii) the space rented or leased does
not exceed that which is reasonable and
necessary for the legitimate business
purposes of the lease or rental and is
used exclusively by the lessee when
being used by the lessee, except that
the lessee may make payments for the
use of space consisting of common areas
if such payments do not exceed the
lessee's pro rata share of expenses for
such space based upon the ratio of the
space used exclusively by the lessee to
the total amount of space (other than
common areas) occupied by all persons
using such common areas,
(iii) the lease provides for a term
of rental or lease for at least 1 year,
(iv) the rental charges over the term
of the lease are set in advance, are
consistent with fair market value, and
are not determined in a manner that
takes into account the volume or value
of any referrals or other business
generated between the parties,
(v) the lease would be commercially
reasonable even if no referrals were
made between the parties, and
(vi) the lease meets such other
requirements as the Secretary may
impose by regulation as needed to
protect against program or patient
abuse.
(B) Equipment.--Payments made by a lessee of
equipment to the lessor of the equipment for
the use of the equipment if--
(i) the lease is set out in writing,
signed by the parties, and specifies
the equipment covered by the lease,
(ii) the equipment rented or leased
does not exceed that which is
reasonable and necessary for the
legitimate business purposes of the
lease or rental and is used exclusively
by the lessee when being used by the
lessee,
(iii) the lease provides for a term
of rental or lease of at least 1 year,
(iv) the rental charges over the term
of the lease are set in advance, are
consistent with fair market value, and
are not determined in a manner that
takes into account the volume or value
of any referrals or other business
generated between the parties,
(v) the lease would be commercially
reasonable even if no referrals were
made between the parties, and
(vi) the lease meets such other
requirements as the Secretary may
impose by regulation as needed to
protect against program or patient
abuse.
(C) Holdover lease arrangements.--In the case
of a holdover lease arrangement for the lease
of office space or equipment, which immediately
follows a lease arrangement described in
subparagraph (A) for the use of such office
space or subparagraph (B) for the use of such
equipment and that expired after a term of at
least 1 year, payments made by the lessee to
the lessor pursuant to such holdover lease
arrangement, if--
(i) the lease arrangement met the
conditions of subparagraph (A) for the
lease of office space or subparagraph
(B) for the use of equipment when the
arrangement expired;
(ii) the holdover lease arrangement
is on the same terms and conditions as
the immediately preceding arrangement;
and
(iii) the holdover arrangement
continues to satisfy the conditions of
subparagraph (A) for the lease of
office space or subparagraph (B) for
the use of equipment.
(2) Bona fide employment relationships.--Any amount
paid by an employer to a physician (or an immediate
family member of such physician) who has a bona fide
employment relationship with the employer for the
provision of services if--
(A) the employment is for identifiable
services,
(B) the amount of the remuneration under the
employment--
(i) is consistent with the fair
market value of the services, and
(ii) is not determined in a manner
that takes into account (directly or
indirectly) the volume or value of any
referrals by the referring physician,
(C) the remuneration is provided pursuant to
an agreement which would be commercially
reasonable even if no referrals were made to
the employer, and
(D) the employment meets such other
requirements as the Secretary may impose by
regulation as needed to protect against program
or patient abuse.
Subparagraph (B)(ii) shall not prohibit the payment of
remuneration in the form of a productivity bonus based
on services performed personally by the physician (or
an immediate family member of such physician).
(3) Personal service arrangements.--
(A) In general.--Remuneration from an entity
under an arrangement (including remuneration
for specific physicians' services furnished to
a nonprofit blood center) if--
(i) the arrangement is set out in
writing, signed by the parties, and
specifies the services covered by the
arrangement,
(ii) the arrangement covers all of
the services to be provided by the
physician (or an immediate family
member of such physician) to the
entity,
(iii) the aggregate services
contracted for do not exceed those that
are reasonable and necessary for the
legitimate business purposes of the
arrangement,
(iv) the term of the arrangement is
for at least 1 year,
(v) the compensation to be paid over
the term of the arrangement is set in
advance, does not exceed fair market
value, and except in the case of a
physician incentive plan described in
subparagraph (B), is not determined in
a manner that takes into account the
volume or value of any referrals or
other business generated between the
parties,
(vi) the services to be performed
under the arrangement do not involve
the counseling or promotion or a
business arrangement or other activity
that violates any State or Federal law,
and
(vii) the arrangement meets such
other requirements as the Secretary may
impose by regulation as needed to
protect against program or patient
abuse.
(B) Physician incentive plan exception.--
(i) In general.--In the case of a
physician incentive plan (as defined in
clause (ii)) between a physician and an
entity, the compensation may be
determined in a manner (through a
withhold, capitation, bonus, or
otherwise) that takes into account
directly or indirectly the volume or
value of any referrals or other
business generated between the parties,
if the plan meets the following
requirements:
(I) No specific payment is
made directly or indirectly
under the plan to a physician
or a physician group as an
inducement to reduce or limit
medically necessary services
provided with respect to a
specific individual enrolled
with the entity.
(II) In the case of a plan
that places a physician or a
physician group at substantial
financial risk as determined by
the Secretary pursuant to
section 1876(i)(8)(A)(ii), the
plan complies with any
requirements the Secretary may
impose pursuant to such
section.
(III) Upon request by the
Secretary, the entity provides
the Secretary with access to
descriptive information
regarding the plan, in order to
permit the Secretary to
determine whether the plan is
in compliance with the
requirements of this clause.
(ii) Physician incentive plan
defined.--For purposes of this
subparagraph, the term ``physician
incentive plan'' means any compensation
arrangement between an entity and a
physician or physician group that may
directly or indirectly have the effect
of reducing or limiting services
provided with respect to individuals
enrolled with the entity.
(C) Holdover personal service arrangement.--
In the case of a holdover personal service
arrangement, which immediately follows an
arrangement described in subparagraph (A) that
expired after a term of at least 1 year,
remuneration from an entity pursuant to such
holdover personal service arrangement, if--
(i) the personal service arrangement
met the conditions of subparagraph (A)
when the arrangement expired;
(ii) the holdover personal service
arrangement is on the same terms and
conditions as the immediately preceding
arrangement; and
(iii) the holdover arrangement
continues to satisfy the conditions of
subparagraph (A).
(4) Remuneration unrelated to the provision of
designated health services.--In the case of
remuneration which is provided by a hospital to a
physician if such remuneration does not relate to the
provision of designated health services.
(5) Physician recruitment.--In the case of
remuneration which is provided by a hospital to a
physician to induce the physician to relocate to the
geographic area served by the hospital in order to be a
member of the medical staff of the hospital, if--
(A) the physician is not required to refer
patients to the hospital,
(B) the amount of the remuneration under the
arrangement is not determined in a manner that
takes into account (directly or indirectly) the
volume or value of any referrals by the
referring physician, and
(C) the arrangement meets such other
requirements as the Secretary may impose by
regulation as needed to protect against program
or patient abuse.
(6) Isolated transactions.--In the case of an
isolated financial transaction, such as a one-time sale
of property or practice, if--
(A) the requirements described in
subparagraphs (B) and (C) of paragraph (2) are
met with respect to the entity in the same
manner as they apply to an employer, and
(B) the transaction meets such other
requirements as the Secretary may impose by
regulation as needed to protect against program
or patient abuse.
(7) Certain group practice arrangements with a
hospital.--
(A) In general.--An arrangement between a
hospital and a group under which designated
health services are provided by the group but
are billed by the hospital if--
(i) with respect to services provided
to an inpatient of the hospital, the
arrangement is pursuant to the
provision of inpatient hospital
services under section 1861(b)(3),
(ii) the arrangement began before
December 19, 1989, and has continued in
effect without interruption since such
date,
(iii) with respect to the designated
health services covered under the
arrangement, substantially all of such
services furnished to patients of the
hospital are furnished by the group
under the arrangement,
(iv) the arrangement is pursuant to
an agreement that is set out in writing
and that specifies the services to be
provided by the parties and the
compensation for services provided
under the agreement,
(v) the compensation paid over the
term of the agreement is consistent
with fair market value and the
compensation per unit of services is
fixed in advance and is not determined
in a manner that takes into account the
volume or value of any referrals or
other business generated between the
parties,
(vi) the compensation is provided
pursuant to an agreement which would be
commercially reasonable even if no
referrals were made to the entity, and
(vii) the arrangement between the
parties meets such other requirements
as the Secretary may impose by
regulation as needed to protect against
program or patient abuse.
(8) Payments by a physician for items and services.--
Payments made by a physician--
(A) to a laboratory in exchange for the
provision of clinical laboratory services, or
(B) to an entity as compensation for other
items or services if the items or services are
furnished at a price that is consistent with
fair market value.
(9) Physician wellness programs.--A bona fide mental
health or behavioral health improvement or maintenance
program offered to a physician by an entity, if--
(A) such program--
(i) consists of counseling, mental
health services, a suicide prevention
program, or a substance use disorder
prevention and treatment program;
(ii) is made available to a physician
for the primary purpose of preventing
suicide, improving mental health and
resiliency, or providing training in
appropriate strategies to promote the
mental health and resiliency of such
physician;
(iii) is set out in a written policy,
approved in advance of the operation of
the program by the governing body of
the entity providing such program (and
which shall be updated accordingly in
advance to substantial changes to the
operation of such program), that
includes--
(I) a description of the
content and duration of the
program;
(II) a description of the
evidence-based support for the
design of the program;
(III) the estimated cost of
the program;
(IV) the personnel (including
the qualifications of such
personnel) conducting the
program; and
(V) the method by which such
entity will evaluate the use
and success of the program;
(iv) is offered by an entity
described in subparagraph (B) with a
formal medical staff to all physicians
who practice in the geographic area
served by such entity, including
physicians who hold bona fide
appointments to the medical staff of
such entity or otherwise have clinical
privileges at such entity;
(v) is offered to all such physicians
on the same terms and conditions and
without regard to the volume or value
of referrals or other business
generated by a physician for such
entity;
(vi) is evidence-based and conducted
by a qualified health professional; and
(vii) meets such other requirements
the Secretary may impose by regulation
as needed to protect against program or
patient abuse;
(B) such entity is--
(i) a hospital;
(ii) an ambulatory surgical center;
(iii) a community health center;
(iv) a rural emergency hospital;
(v) a rural health clinic;
(vi) a skilled nursing facility; or
(vii) a similar entity, as determined
by the Secretary; and
(C) neither the provision of such program,
nor the value of such program, are contingent
upon the number or value of referrals made by a
physician to such entity or the amount or value
of other business generated by such physician
for the entity.
(f) Reporting Requirements.--Each entity providing covered
items or services for which payment may be made under this
title shall provide the Secretary with the information
concerning the entity's ownership, investment, and compensation
arrangements, including--
(1) the covered items and services provided by the
entity, and
(2) the names and unique physician identification
numbers of all physicians with an ownership or
investment interest (as described in subsection
(a)(2)(A)), or with a compensation arrangement (as
described in subsection (a)(2)(B)), in the entity, or
whose immediate relatives have such an ownership or
investment interest or who have such a compensation
relationship with the entity.
Such information shall be provided in such form, manner, and at
such times as the Secretary shall specify. The requirement of
this subsection shall not apply to designated health services
provided outside the United States or to entities which the
Secretary determines provides services for which payment may be
made under this title very infrequently.
(g) Sanctions.--
(1) Denial of payment.--No payment may be made under
this title for a designated health service which is
provided in violation of subsection (a)(1).
(2) Requiring refunds for certain claims.--If a
person collects any amounts that were billed in
violation of subsection (a)(1), the person shall be
liable to the individual for, and shall refund on a
timely basis to the individual, any amounts so
collected.
(3) Civil money penalty and exclusion for improper
claims.--Any person that presents or causes to be
presented a bill or a claim for a service that such
person knows or should know is for a service for which
payment may not be made under paragraph (1) or for
which a refund has not been made under paragraph (2)
shall be subject to a civil money penalty of not more
than $15,000 for each such service. The provisions of
section 1128A (other than the first sentence of
subsection (a) and other than subsection (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).
(4) Civil money penalty and exclusion for
circumvention schemes.--Any physician or other entity
that enters into an arrangement or scheme (such as a
cross-referral arrangement) which the physician or
entity knows or should know has a principal purpose of
assuring referrals by the physician to a particular
entity which, if the physician directly made referrals
to such entity, would be in violation of this section,
shall be subject to a civil money penalty of not more
than $100,000 for each such arrangement or scheme. The
provisions of section 1128A (other than the first
sentence of subsection (a) and other than subsection
(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).
(5) Failure to report information.--Any person who is
required, but fails, to meet a reporting requirement of
subsection (f) is subject to a civil money penalty of
not more than $10,000 for each day for which reporting
is required to have been made. The provisions of
section 1128A (other than the first sentence of
subsection (a) and other than subsection (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).
(6) Advisory opinions.--
(A) In general.--The Secretary shall issue
written advisory opinions concerning whether a
referral relating to designated health services
(other than clinical laboratory services) is
prohibited under this section. Each advisory
opinion issued by the Secretary shall be
binding as to the Secretary and the party or
parties requesting the opinion.
(B) Application of certain rules.--The
Secretary shall, to the extent practicable,
apply the rules under subsections (b)(3) and
(b)(4) and take into account the regulations
promulgated under subsection (b)(5) of section
1128D in the issuance of advisory opinions
under this paragraph.
(C) Regulations.--In order to implement this
paragraph in a timely manner, the Secretary may
promulgate regulations that take effect on an
interim basis, after notice and pending
opportunity for public comment.
(D) Applicability.--This paragraph shall
apply to requests for advisory opinions made
after the date which is 90 days after the date
of the enactment of this paragraph and before
the close of the period described in section
1128D(b)(6).
(h) Definitions and Special Rules.--For purposes of this
section:
(1) Compensation arrangement; remuneration.--(A) The
term ``compensation arrangement'' means any arrangement
involving any remuneration between a physician (or an
immediate family member of such physician) and an
entity other than an arrangement involving only
remuneration described in subparagraph (C).
(B) The term ``remuneration'' includes any
remuneration, directly or indirectly, overtly or
covertly, in cash or in kind.
(C) Remuneration described in this subparagraph is
any remuneration consisting of any of the following:
(i) The forgiveness of amounts owed for
inaccurate tests or procedures, mistakenly
performed tests or procedures, or the
correction of minor billing errors.
(ii) The provision of items, devices, or
supplies that are used solely to--
(I) collect, transport, process, or
store specimens for the entity
providing the item, device, or supply,
or
(II) order or communicate the results
of tests or procedures for such entity.
(iii) A payment made by an insurer or a self-
insured plan to a physician to satisfy a claim,
submitted on a fee for service basis, for the
furnishing of health services by that physician
to an individual who is covered by a policy
with the insurer or by the self-insured plan,
if--
(I) the health services are not
furnished, and the payment is not made,
pursuant to a contract or other
arrangement between the insurer or the
plan and the physician,
(II) the payment is made to the
physician on behalf of the covered
individual and would otherwise be made
directly to such individual,
(III) the amount of the payment is
set in advance, does not exceed fair
market value, and is not determined in
a manner that takes into account
directly or indirectly the volume or
value of any referrals, and
(IV) the payment meets such other
requirements as the Secretary may
impose by regulation as needed to
protect against program or patient
abuse.
(D) Written requirement clarified.--In the case of
any requirement pursuant to this section for a
compensation arrangement to be in writing, such
requirement shall be satisfied by such means as
determined by the Secretary, including by a collection
of documents, including contemporaneous documents
evidencing the course of conduct between the parties
involved.
(E) Special rule for signature
requirements.--In the case of any requirement
pursuant to this section for a compensation
arrangement to be in writing and signed by the
parties, such signature requirement shall be
met if--
(i) not later than 90 consecutive
calendar days immediately following the
date on which the compensation
arrangement became noncompliant, the
parties obtain the required signatures;
and
(ii) the compensation arrangement
otherwise complies with all criteria of
the applicable exception.
(2) Employee.--An individual is considered to be
``employed by'' or an ``employee'' of an entity if the
individual would be considered to be an employee of the
entity under the usual common law rules applicable in
determining the employer-employee relationship (as
applied for purposes of section 3121(d)(2) of the
Internal Revenue Code of 1986).
(3) Fair market value.--The term ``fair market
value'' means the value in arms length transactions,
consistent with the general market value, and, with
respect to rentals or leases, the value of rental
property for general commercial purposes (not taking
into account its intended use) and, in the case of a
lease of space, not adjusted to reflect the additional
value the prospective lessee or lessor would attribute
to the proximity or convenience to the lessor where the
lessor is a potential source of patient referrals to
the lessee.
(4) Group practice.--
(A) Definition of group practice.--The term
``group practice'' means a group of 2 or more
physicians legally organized as a partnership,
professional corporation, foundation, not-for-
profit corporation, faculty practice plan, or
similar association--
(i) in which each physician who is a
member of the group provides
substantially the full range of
services which the physician routinely
provides, including medical care,
consultation, diagnosis, or treatment,
through the joint use of shared office
space, facilities, equipment and
personnel,
(ii) for which substantially all of
the services of the physicians who are
members of the group are provided
through the group and are billed under
a billing number assigned to the group
and amounts so received are treated as
receipts of the group,
(iii) in which the overhead expenses
of and the income from the practice are
distributed in accordance with methods
previously determined,
(iv) except as provided in
subparagraph (B)(i), in which no
physician who is a member of the group
directly or indirectly receives
compensation based on the volume or
value of referrals by the physician,
(v) in which members of the group
personally conduct no less than 75
percent of the physician-patient
encounters of the group practice, and
(vi) which meets such other standards
as the Secretary may impose by
regulation.
(B) Special Rules.--
(i) Profits and productivity
bonuses.--A physician in a group
practice may be paid a share of overall
profits of the group, or a productivity
bonus based on services personally
performed or services incident to such
personally performed services, so long
as the share or bonus is not determined
in any manner which is directly related
to the volume or value of referrals by
such physician.
(ii) Faculty practice plans.--In the
case of a faculty practice plan
associated with a hospital, institution
of higher education, or medical school
with an approved medical residency
training program in which physician
members may provide a variety of
different specialty services and
provide professional services both
within and outside the group, as well
as perform other tasks such as
research, subparagraph (A) shall be
applied only with respect to the
services provided within the faculty
practice plan.
(5) Referral; referring physician.--
(A) Physicians' services.--Except as provided
in subparagraph (C), in the case of an item or
service for which payment may be made under
part B, the request by a physician for the item
or service, including the request by a
physician for a consultation with another
physician (and any test or procedure ordered
by, or to be performed by (or under the
supervision of) that other physician),
constitutes a ``referral'' by a ``referring
physician''.
(B) Other items.--Except as provided in
subparagraph (C), the request or establishment
of a plan of care by a physician which includes
the provision of the designated health service
constitutes a ``referral'' by a ``referring
physician''.
(C) Clarification respecting certain services
integral to a consultation by certain
specialists.--A request by a pathologist for
clinical diagnostic laboratory tests and
pathological examination services, a request by
a radiologist for diagnostic radiology
services, and a request by a radiation
oncologist for radiation therapy, if such
services are furnished by (or under the
supervision of) such pathologist, radiologist,
or radiation oncologist pursuant to a
consultation requested by another physician
does not constitute a ``referral'' by a
``referring physician''.
(6) Designated health services.--The term
``designated health services'' means any of the
following items or services:
(A) Clinical laboratory services.
(B) Physical therapy services.
(C) Occupational therapy services.
(D) Radiology services, including magnetic
resonance imaging, computerized axial
tomography scans, and ultrasound services.
(E) Radiation therapy services and supplies.
(F) Durable medical equipment and supplies.
(G) Parenteral and enteral nutrients,
equipment, and supplies.
(H) Prosthetics, orthotics, and prosthetic
devices and supplies.
(I) Home health services.
(J) Outpatient prescription drugs.
(K) Inpatient and outpatient hospital
services.
(L) Outpatient speech-language pathology
services.
(7) Specialty hospital.--
(A) In general.--For purposes of this
section, except as provided in subparagraph
(B), the term ``specialty hospital'' means a
subsection (d) hospital (as defined in section
1886(d)(1)(B)) that is primarily or exclusively
engaged in the care and treatment of one of the
following categories:
(i) Patients with a cardiac
condition.
(ii) Patients with an orthopedic
condition.
(iii) Patients receiving a surgical
procedure.
(iv) Any other specialized category
of services that the Secretary
designates as inconsistent with the
purpose of permitting physician
ownership and investment interests in a
hospital under this section.
(B) Exception.--For purposes of this section,
the term ``specialty hospital'' does not
include any hospital--
(i) determined by the Secretary--
(I) to be in operation before
November 18, 2003; or
(II) under development as of
such date;
(ii) for which the number of
physician investors at any time on or
after such date is no greater than the
number of such investors as of such
date;
(iii) for which the type of
categories described in subparagraph
(A) at any time on or after such date
is no different than the type of such
categories as of such date;
(iv) for which any increase in the
number of beds occurs only in the
facilities on the main campus of the
hospital and does not exceed 50 percent
of the number of beds in the hospital
as of November 18, 2003, or 5 beds,
whichever is greater; and
(v) that meets such other
requirements as the Secretary may
specify.
(i) Requirements for Hospitals To Qualify for Rural Provider
and Hospital Exception to Ownership or Investment
Prohibition.--
(1) Requirements described.--For purposes of
subsection (d)(3)(D), the requirements described in
this paragraph for a hospital are as follows:
(A) Provider agreement.--The hospital had--
(i) physician ownership or investment
on December 31, 2010; and
(ii) a provider agreement under
section 1866 in effect on such date.
(B) Limitation on expansion of facility
capacity.--Except as provided in paragraph (3),
the number of operating rooms, procedure rooms,
and beds for which the hospital is licensed at
any time on or after the date of the enactment
of this subsection is no greater than the
number of operating rooms, procedure rooms, and
beds for which the hospital is licensed as of
such date.
(C) Preventing conflicts of interest.--
(i) The hospital submits to the
Secretary an annual report containing a
detailed description of--
(I) the identity of each
physician owner or investor and
any other owners or investors
of the hospital; and
(II) the nature and extent of
all ownership and investment
interests in the hospital.
(ii) The hospital has procedures in
place to require that any referring
physician owner or investor discloses
to the patient being referred, by a
time that permits the patient to make a
meaningful decision regarding the
receipt of care, as determined by the
Secretary--
(I) the ownership or
investment interest, as
applicable, of such referring
physician in the hospital; and
(II) if applicable, any such
ownership or investment
interest of the treating
physician.
(iii) The hospital does not condition
any physician ownership or investment
interests either directly or indirectly
on the physician owner or investor
making or influencing referrals to the
hospital or otherwise generating
business for the hospital.
(iv) The hospital discloses the fact
that the hospital is partially owned or
invested in by physicians--
(I) on any public website for
the hospital; and
(II) in any public
advertising for the hospital.
(D) Ensuring bona fide investment.--
(i) The percentage of the total value
of the ownership or investment
interests held in the hospital, or in
an entity whose assets include the
hospital, by physician owners or
investors in the aggregate does not
exceed such percentage as of the date
of enactment of this subsection.
(ii) Any ownership or investment
interests that the hospital offers to a
physician owner or investor are not
offered on more favorable terms than
the terms offered to a person who is
not a physician owner or investor.
(iii) The hospital (or any owner or
investor in the hospital) does not
directly or indirectly provide loans or
financing for any investment in the
hospital by a physician owner or
investor.
(iv) The hospital (or any owner or
investor in the hospital) does not
directly or indirectly guarantee a
loan, make a payment toward a loan, or
otherwise subsidize a loan, for any
individual physician owner or investor
or group of physician owners or
investors that is related to acquiring
any ownership or investment interest in
the hospital.
(v) Ownership or investment returns
are distributed to each owner or
investor in the hospital in an amount
that is directly proportional to the
ownership or investment interest of
such owner or investor in the hospital.
(vi) Physician owners and investors
do not receive, directly or indirectly,
any guaranteed receipt of or right to
purchase other business interests
related to the hospital, including the
purchase or lease of any property under
the control of other owners or
investors in the hospital or located
near the premises of the hospital.
(vii) The hospital does not offer a
physician owner or investor the
opportunity to purchase or lease any
property under the control of the
hospital or any other owner or investor
in the hospital on more favorable terms
than the terms offered to an individual
who is not a physician owner or
investor.
(E) Patient safety.--
(i) Insofar as the hospital admits a
patient and does not have any physician
available on the premises to provide
services during all hours in which the
hospital is providing services to such
patient, before admitting the patient--
(I) the hospital discloses
such fact to a patient; and
(II) following such
disclosure, the hospital
receives from the patient a
signed acknowledgment that the
patient understands such fact.
(ii) The hospital has the capacity
to--
(I) provide assessment and
initial treatment for patients;
and
(II) refer and transfer
patients to hospitals with the
capability to treat the needs
of the patient involved.
(F) Limitation on application to certain
converted facilities.--The hospital was not
converted from an ambulatory surgical center to
a hospital on or after the date of enactment of
this subsection.
(2) Publication of information reported.--The
Secretary shall publish, and update on an annual basis,
the information submitted by hospitals under paragraph
(1)(C)(i) on the public Internet website of the Centers
for Medicare & Medicaid Services.
(3) Exception to prohibition on expansion of facility
capacity.--
(A) Process.--
(i) Establishment.--The Secretary
shall establish and implement a process
under which a hospital that is an
applicable hospital (as defined in
subparagraph (E)) or is a high Medicaid
facility described in subparagraph (F)
may apply for an exception from the
requirement under paragraph (1)(B).
(ii) Opportunity for community
input.--The process under clause (i)
shall provide individuals and entities
in the community in which the
applicable hospital applying for an
exception is located with the
opportunity to provide input with
respect to the application.
(iii) Timing for implementation.--The
Secretary shall implement the process
under clause (i) on February 1, 2012.
(iv) Regulations.--Not later than
January 1, 2012, the Secretary shall
promulgate regulations to carry out the
process under clause (i).
(B) Frequency.--The process described in
subparagraph (A) shall permit an applicable
hospital to apply for an exception up to once
every 2 years.
(C) Permitted increase.--
(i) In general.--Subject to clause
(ii) and subparagraph (D), an
applicable hospital granted an
exception under the process described
in subparagraph (A) may increase the
number of operating rooms, procedure
rooms, and beds for which the
applicable hospital is licensed above
the baseline number of operating rooms,
procedure rooms, and beds of the
applicable hospital (or, if the
applicable hospital has been granted a
previous exception under this
paragraph, above the number of
operating rooms, procedure rooms, and
beds for which the hospital is licensed
after the application of the most
recent increase under such an
exception).
(ii) 100 percent increase
limitation.--The Secretary shall not
permit an increase in the number of
operating rooms, procedure rooms, and
beds for which an applicable hospital
is licensed under clause (i) to the
extent such increase would result in
the number of operating rooms,
procedure rooms, and beds for which the
applicable hospital is licensed
exceeding 200 percent of the baseline
number of operating rooms, procedure
rooms, and beds of the applicable
hospital.
(iii) Baseline number of operating
rooms, procedure rooms, and beds.--In
this paragraph, the term ``baseline
number of operating rooms, procedure
rooms, and beds'' means the number of
operating rooms, procedure rooms, and
beds for which the applicable hospital
is licensed as of the date of enactment
of this subsection (or, in the case of
a hospital that did not have a provider
agreement in effect as of such date but
does have such an agreement in effect
on December 31, 2010, the effective
date of such provider agreement).
(D) Increase limited to facilities on the
main campus of the hospital.--Any increase in
the number of operating rooms, procedure rooms,
and beds for which an applicable hospital is
licensed pursuant to this paragraph may only
occur in facilities on the main campus of the
applicable hospital.
(E) Applicable hospital.--In this paragraph,
the term ``applicable hospital'' means a
hospital--
(i) that is located in a county in
which the percentage increase in the
population during the most recent 5-
year period (as of the date of the
application under subparagraph (A)) is
at least 150 percent of the percentage
increase in the population growth of
the State in which the hospital is
located during that period, as
estimated by Bureau of the Census;
(ii) whose annual percent of total
inpatient admissions that represent
inpatient admissions under the program
under title XIX is equal to or greater
than the average percent with respect
to such admissions for all hospitals
located in the county in which the
hospital is located;
(iii) that does not discriminate
against beneficiaries of Federal health
care programs and does not permit
physicians practicing at the hospital
to discriminate against such
beneficiaries;
(iv) that is located in a State in
which the average bed capacity in the
State is less than the national average
bed capacity; and
(v) that has an average bed occupancy
rate that is greater than the average
bed occupancy rate in the State in
which the hospital is located.
(F) High medicaid facility described.--A high
Medicaid facility described in this
subparagraph is a hospital that--
(i) is not the sole hospital in a
county;
(ii) with respect to each of the 3
most recent years for which data are
available, has an annual percent of
total inpatient admissions that
represent inpatient admissions under
title XIX that is estimated to be
greater than such percent with respect
to such admissions for any other
hospital located in the county in which
the hospital is located; and
(iii) meets the conditions described
in subparagraph (E)(iii).
(G) Procedure rooms.--In this subsection, the
term ``procedure rooms'' includes rooms in
which catheterizations, angiographies,
angiograms, and endoscopies are performed,
except such term shall not include emergency
rooms or departments (exclusive of rooms in
which catheterizations, angiographies,
angiograms, and endoscopies are performed).
(H) Publication of final decisions.--Not
later than 60 days after receiving a complete
application under this paragraph, the Secretary
shall publish in the Federal Register the final
decision with respect to such application.
(I) Limitation on review.--There shall be no
administrative or judicial review under section
1869, section 1878, or otherwise of the process
under this paragraph (including the
establishment of such process).
(4) Collection of ownership and investment
information.--For purposes of subparagraphs (A)(i) and
(D)(i) of paragraph (1), the Secretary shall collect
physician ownership and investment information for each
hospital.
(5) Physician owner or investor defined.--For
purposes of this subsection, the term ``physician owner
or investor'' means a physician (or an immediate family
member of such physician) with a direct or an indirect
ownership or investment interest in the hospital.
(6) Clarification.--Nothing in this subsection shall
be construed as preventing the Secretary from revoking
a hospital's provider agreement if not in compliance
with regulations implementing section 1866.
* * * * * * *
medicare improvement fund
Sec. 1898.
(a) Establishment.--The Secretary shall establish under this
title a Medicare Improvement Fund (in this section referred to
as the ``Fund'') which shall be available to the Secretary to
make improvements under the original Medicare fee-for-service
program under parts A and B for individuals entitled to, or
enrolled for, benefits under part or enrolled under part B
including adjustments to payments for items and services
furnished by providers of services and suppliers under such
original Medicare fee-for-service program.
(b) Funding.--
(1) In general.--There shall be available to the
Fund, for expenditures from the Fund for services
furnished during and after fiscal year 2022, [$0]
$114,000,000.
(2) Payment from trust funds.--The amount specified
under paragraph (1) shall be available to the Fund, as
expenditures are made from the Fund, from the Federal
Hospital Insurance Trust Fund and the Federal
Supplementary Medical Insurance Trust Fund in such
proportion as the Secretary determines appropriate.
(3) Funding limitation.--Amounts in the Fund shall be
available in advance of appropriations but only if the
total amount obligated from the Fund does not exceed
the amount available to the Fund under paragraph (1).
The Secretary may obligate funds from the Fund only if
the Secretary determines (and the Chief Actuary of the
Centers for Medicare & Medicaid Services and the
appropriate budget officer certify) that there are
available in the Fund sufficient amounts to cover all
such obligations incurred consistent with the previous
sentence.
(4) No effect on payments in subsequent years.--In
the case that expenditures from the Fund are applied
to, or otherwise affect, a payment rate for an item or
service under this title for a year, the payment rate
for such item or service shall be computed for a
subsequent year as if such application or effect had
never occurred.
* * * * * * *
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