Therapist

What are the 5 p’s in mental health nursing

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Table of Contents

Compilation of the Social Security Laws

Part E—Miscellaneous ProvisionsDEFINITIONS OF SERVICES, INSTITUTIONS, ETC.[495]

Sec. 1861. [42 U.S.C. 1395x]  For purposesof this title—

Spell of Illness

(a) The term “spell of illness” withrespect to any individual means a period of consecutive days—

(1) beginning withthe first day (not included in a previous spell of illness) (A) onwhich such individual is furnished inpatient hospital services, inpatientcritical access hospital services or extended care services, and (B)which occurs in a month for which he is entitled to benefits underpart A, and

(2) ending with theclose of the first period of 60 consecutive days thereafter on eachof which he is neither an inpatient of a hospital or critical accesshospital 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 inpatientof a hospital and (except as provided in paragraph (3)) by the hospital—

(1) bed and board;

(2) such nursing servicesand other related services, such use of hospital facilities, and suchmedical social services as are ordinarily furnished by the hospitalfor the care and treatment of inpatients, and such drugs, biologicals,supplies, appliances, and equipment, for use in the hospital, as areordinarily furnished by such hospital for the care and treatment ofinpatients; and

(3) such other diagnosticor therapeutic items or services, furnished by the hospital or byothers under arrangements with them made by the hospital, as are ordinarilyfurnished to inpatients either by such hospital or by others undersuch arrangements;

excluding, however—

(4) medical or surgicalservices provided by a physician, resident, or intern, services describedby subsection (s)(2)(K), certified nurse-midwife services, qualifiedpsychologist services, and services of a certified registered nurseanesthetist; and

(5) the services ofa private-duty nurse or other private-duty attendant.

Paragraph (4) shall not apply to services provided in a hospitalby—

(6) an intern or aresident-in-training under a teaching program approved by the Councilon Medical Education of the American Medical Association or, in thecase of an osteopathic hospital, approved by the Committee on Hospitalsof the Bureau of Professional Education of the American OsteopathicAssociation, or, in the case of services in a hospital or osteopathichospital by an intern or resident-in-training in the field of dentistry,approved by the Council on Dental Education of the American DentalAssociation, or in the case of services in a hospital or osteopathichospital by an intern or resident-in-training in the field of podiatry,approved by the Council on Podiatric Medical Education of the AmericanPodiatric Medical Association; or

(7) a physician wherethe hospital has a teaching program approved as specified in paragraph(6), if (A) the hospital elects to receive any payment due under thistitle for reasonable costs of such services, and (B) all physiciansin such hospital agree not to bill charges for professional servicesrendered in such hospital to individuals covered under the insuranceprogram established by this title.

Inpatient Psychiatric Hospital Services

(c) The term “inpatient psychiatric hospitalservices” means inpatient hospital services furnished to aninpatient of a psychiatric hospital.

Supplier

(d) The term “supplier” means, unlessthe context otherwise requires, a physician or other practitioner,a facility, or other entity (other than a provider of services) thatfurnishes items or services under this title.

Hospital

(e) The term “hospital” (except forpurposes 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 institutionwhich—

(1) is primarily engagedin 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 clinicalrecords on all patients;

(3) has bylaws ineffect with respect to its staff of physicians;

(4) has a requirementthat every patient with respect to whom payment may be made underthis title must be under the care of a physician except that a patientreceiving qualified psychologist services (as defined in subsection(ii)) may be under the care of a clinical psychologist with respectto such services to the extent permitted under State law;

(5) provides 24-hournursing service rendered or supervised by a registered professionalnurse, and has a licensed practical nurse or registered professionalnurse on duty at all times; except that until January 1, 1979, theSecretary is authorized to waive the requirement of this paragraphfor any one-year period with respect to any institution, insofar assuch requirement relates to the provision of twenty-four-hour nursingservice rendered or supervised by a registered professional nurse(except that in any event a registered professional nurse must bepresent on the premises to render or supervise the nursing serviceprovided, during at least the regular daytime shift), where immediatelypreceding such one-year period he finds that—

(A) such institutionis located in a rural area and the supply of hospital services insuch area is not sufficient to meet the needs of individuals residingtherein,

(B) the failureof such institution to qualify as a hospital would seriously reducethe availability of such services to such individuals, and

(C) such institutionhas made and continues to make a good faith effort to comply withthis paragraph, but such compliance is impeded by the lack of qualifiednursing personnel in such area;

(6)(A) has in effecta hospital utilization review plan which meets the requirements ofsubsection (k) and

(B) has in placea discharge planning process that meets the requirements of subsection(ee);

(7) in the case ofan institution in any State in which State or applicable local lawprovides for the licensing of hospitals, (A) is licensed pursuantto such law or (B) is approved, by the agency of such State or localityresponsible for licensing hospitals, as meeting the standards establishedfor such licensing;

(8) has in effectan overall plan and budget that meets the requirements of subsection(z); and

(9) meets such otherrequirements as the Secretary finds necessary in the interest of thehealth and safety of individuals who are furnished services in theinstitution.

For purposes of subsection (a)(2), such term includes any institutionwhich meets the requirements of paragraph (1) of this subsection.For purposes of sections 1814(d) and 1835(b) (including determinationof whether an individual received inpatient hospital services or diagnosticservices for purposes of such sections), section 1814(f)(2), and subsection (i) ofthis section, such term includes any institution which (i) meets therequirements of paragraphs (5) and (7) of this subsection, (ii) isnot primarily engaged in providing the services described in section 1861(j)(1)(A) and(iii) is primarily engaged in providing, by or under the supervisionof individuals referred to in paragraph (1) of section 1861(r), to inpatientsdiagnostic services and therapeutic services for medical diagnosis,treatment, and care of injured, disabled, or sick persons, or rehabilitationservices for the rehabilitation of injured, disabled, or sick persons.For purposes of section 1814(f)(1), such term includes an institution which (i) isa hospital for purposes of sections 1814(d), 1814(f)(2), and 1835(b) and (ii) is accredited by theJoint Commission on Accreditation of Hospitals, or is accredited byor approved by a program of the country in which such institutionis located if the Secretary finds the accreditation or comparableapproval standards of such program to be essentially equivalent tothose of the Joint Commission on Accreditation of Hospitals. Notwithstandingthe preceding provisions of this subsection, such term shall not,except for purposes of subsection (a)(2), include any institutionwhich is primarily for the care and treatment of mental diseases unlessit is a psychiatric hospital (as defined in subsection (f)). The term “hospital” also includes a religious nonmedical health careinstitution (as defined in subsection (ss)(1)), with respect to itemsand services ordinarily furnished by such institution to inpatients,and payment may be made with respect to services provided by or insuch 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 providedin regulations consistent with section 1821. For provisions deeming certain requirementsof this subsection to be met in the case of accredited institutions,see section 1865. The term “hospital” also includes a facility of fiftybeds or less which is located in an area determined by the Secretaryto meet the definition relating to a rural area described in subparagraph(A) of paragraph (5) of this subsection and which meets the otherrequirements of this subsection, except that—

(A) with respectto the requirements for nursing services applicable after December31, 1978, such requirements shall provide for temporary waiver ofthe requirements, for such period as the Secretary deems appropriate,where (i) the facility’s failure to fully comply with the requirementsis attributable to a temporary shortage of qualified nursing personnelin the area in which the facility is located, (ii) a registered professionalnurse is present on the premises to render or supervise the nursingservice provided during at least the regular daytime shift, and (iii)the Secretary determines that the employment of such nursing personnelas are available to the facility during such temporary period willnot adversely affect the health and safety of patients;

(B) with respectto the health and safety requirements promulgated under paragraph(9), such requirements shall be applied by the Secretary to a facilityherein defined in such manner as to assure that personnel requirementstake into account the availability of technical personnel and theeducational opportunities for technical personnel in the area in whichsuch facility is located, and the scope of services rendered by suchfacility; and the Secretary, by regulations, shall provide for thecontinued participation of such a facility where such personnel requirementsare not fully met, for such period as the Secretary determines that(i) the facility is making good faith efforts to fully comply withthe personnel requirements, (ii) the employment by the facility ofsuch personnel as are available to the facility will not adverselyaffect the health and safety of patients, and (iii) if the Secretaryhas determined that because of the facility’s waiver under thissubparagraph the facility should limit its scope of services in ordernot to adversely affect the health and safety of the facility’spatients, the facility is so limiting the scope of services it provides;and

(C) with respectto 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 appliedwould 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 applicableState codes relating to fire and safety in lieu of compliance withthe 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 thecontext otherwise requires, a critical access hospital (as definedin section 1861(mm)(1)).

Psychiatric Hospital

(f) The term “psychiatric hospital” means an institution which—

(1) is primarily engagedin providing, by or under the supervision of a physician, psychiatricservices for the diagnosis and treatment of mentally ill persons;

(2) satisfies therequirements of paragraphs (3) through (9) of subsection (e);

(3) maintains clinicalrecords on all patients and maintains such records as the Secretaryfinds to be necessary to determine the degree and intensity of thetreatment provided to individuals entitled to hospital insurance benefitsunder part A; and

(4) meets such staffingrequirements as the Secretary finds necessary for the institutionto carry out an active program of treatment for individuals who arefurnished 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 partwhich also satisfies paragraphs (3) and (4) of such sentence, suchdistinct part shall be considered to be a “psychiatric hospital”.

Outpatient Occupational Therapy Services

(g) The term “outpatient occupational therapyservices” has the meaning given the term “outpatientphysical 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 inpatientof a skilled nursing facility and (except as provided in paragraphs(3), (6), and (7)) by such skilled nursing facility—

(1) nursing care providedby or under the supervision of a registered professional nurse;

(2) bed and boardin connection with the furnishing of such nursing care;

(3) physical or occupationaltherapy or speech-language pathology services furnished by the skillednursing facility or by others under arrangements with them made bythe facility;

(4) medical socialservices;

(5) such drugs, biologicals,supplies, appliances, and equipment, furnished for use in the skillednursing facility, as are ordinarily furnished by such facility forthe care and treatment of inpatients;

(6) medical servicesprovided by an intern or resident-in-training of a hospital with whichthe facility has in effect a transfer agreement (meeting the requirementsof subsection (l)), under a teaching program of such hospital approvedas provided in the last sentence of subsection (b), and other diagnosticor therapeutic services provided by a hospital with which the facilityhas such an agreement in effect; and

(7) such other servicesnecessary to the health of the patients as are generally providedby skilled nursing facilities, or by others under arrangements withthem made by the facility; able).

excluding, however, any item or service if it would not be includedunder subsection (b) if furnished to an inpatient of a hospital.

Post-Hospital Extended Care Services

(i) The term “post-hospital extended careservices” means extended care services furnished an individualafter transfer from a hospital in which he was an inpatient for notless than 3 consecutive days before his discharge from the hospitalin connection with such transfer. For purposes of the preceding sentence,items and services shall be deemed to have been furnished to an individualafter transfer from a hospital, and he shall be deemed to have beenan inpatient in the hospital immediately before transfer therefrom,if he is admitted to the skilled nursing facility (A) within 30 daysafter discharge from such hospital, or (B) within such time as itwould be medically appropriate to begin an active course of treatment,in the case of an individual whose condition is such that skillednursing facility care would not be medically appropriate within 30days after discharge from a hospital; and an individual shall be deemednot to have been discharged from a skilled nursing facility if, within30 days after discharge therefrom, he is admitted to such facilityor 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 orskilled nursing facility shall be considered sufficient if it is applicableto services furnished by the institution to individuals entitled toinsurance benefits under this title and if it provides—

(1) for the review,on a sample or other basis, of admissions to the institution, theduration of stays therein, and the professional services (includingdrugs and biologicals) furnished, (A) with respect to the medicalnecessity of the services, and (B) for the purpose of promoting themost efficient use of available health facilities and services;

(2) for such reviewto be made by either (A) a staff committee of the institution composedof two or more physicians (of which at least two must be physiciansdescribed in subsection (r)(1) of this section), with or without participation of other professional personnel, or (B) a group outsidethe institution which is similarly composed and (i) which is establishedby the local medical society and some or all of the hospitals andskilled nursing facilities in the locality, or (ii) if (and for aslong as) there has not been established such a group which servessuch institution, which is established in such other manner as maybe approved by the Secretary;

(3) for such review,in each case of inpatient hospital services or extended care servicesfurnished to such an individual during a continuous period of extendedduration, as of such days of such period (which may differ for differentclasses of cases) as may be specified in regulations, with such reviewto be made as promptly as possible, after each day so specified, andin no event later than one week following such day; and

(4) for prompt notificationto the institution, the individual, and his attending physician ofany finding (made after opportunity for consultation to such attendingphysician) by the physician members of such committee or group thatany 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 suchparagraph in the case of any hospital or skilled nursing facilitywhere, because of the small size of the institution, or (in the caseof a skilled nursing facility) because of lack of an organized medicalstaff, or for such other reason or reasons as may be included in regulations,it is impracticable for the institution to have a properly functioningstaff committee for the purposes of this subsection. If the Secretarydetermines that the utilization review procedures established pursuantto title XIX are superior in their effectiveness to the proceduresrequired under this section, he may, to the extent that he deems itappropriate, require for purposes of this title that the proceduresestablished pursuant to title XIX be utilized instead of the proceduresrequired by this section.

Agreements for Transfer Between Skilled Nursing Facilitiesand Hospitals

(l) A hospital and a skilled nursing facility shallbe considered to have a transfer agreement in effect if, by reasonof a written agreement between them or (in case the two institutionsare under common control) by reason of a written undertaking by theperson or body which controls them, there is reasonable assurancethat—

(1) transfer of patientswill be effected between the hospital and the skilled nursing facilitywhenever such transfer is medically appropriate as determined by theattending physician; and

(2) there will beinterchange of medical and other information necessary or useful inthe care and treatment of individuals transferred between the institutions,or in determining whether such individuals can be adequately caredfor otherwise than in either of such institutions.

Any skilled nursing facility which does not have such an agreementin effect, but which is found by a State agency (of the State in whichsuch 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 undersection 1864,by the Secretary) to have attempted in good faith to enter into suchan agreement with a hospital sufficiently close to the facility tomake feasible the transfer between them of patients and the informationreferred to in paragraph (2), shall be considered to have such anagreement 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 interestand essential to assuring extended care services for persons in thecommunity who are eligible for payments with respect to such servicesunder 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, by a home health agency or byothers under arrangements with them made by such agency, under a plan(for furnishing such items and services to such individual) establishedand periodically reviewed by a physician, which items and servicesare, except as provided in paragraph (7), provided on a visiting basisin a place of residence used as such individual’s home—

(1) part-time or intermittentnursing care provided by or under the supervision of a registeredprofessional nurse;

(2) physical or occupationaltherapy or speech-language pathology services;

(3) medical socialservices under the direction of a physician;

(4) to the extentpermitted in regulations, part-time or intermittent services of ahome health aide who has successfully completed a training programapproved by the Secretary;

(5) medical supplies(including catheters, catheter supplies, ostomy bags, and suppliesrelated to ostomy care, and a covered osteoporosis drug (as definedin subsection (kk)), but excluding other drugs and biologicals) anddurable medical equipment and applicable disposable devices (as definedin section 1834(s)(2)) while under such a plan;[496]

(6) in the case ofa home health agency which is affiliated or under common control witha hospital, medical services provided by an intern or resident-in-trainingof such hospital, under a teaching program of such hospital approvedas provided in the last sentence of subsection (b); and

(7) any of the foregoingitems and services which are provided on an outpatient basis, underarrangements made by the home health agency, at a hospital or skillednursing facility, or at a rehabilitation center which meets such standardsas may be prescribed in regulations, and—

(A) the furnishingof which involves the use of equipment of such a nature that the itemsand services cannot readily be made available to the individual insuch place of residence, or

(B) which arefurnished at such facility while he is there to receive any such itemor service described in clause (A),

but not including transportation of the individual in connectionwith any such item or service;

excluding, however, any item or service if it would not be includedunder subsection (b) if furnished to an inpatient of a hospital andhome infusion therapy (as defined in subsection (iii)(i)). For purposesof paragraphs (1) and (4), the term “part–time or intermittentservices” means skilled nursing and home health aide servicesfurnished 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 forcare, 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 providedor needed on fewer than 7 days each week, or less than 8 hours ofeach day for periods of 21 days or less (with extensions in exceptionalcircumstances when the need for additional care is finite and predictable).[497]

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 appropriatelyused as a wheelchair, but only where the use of such a vehicle isdetermined to be necessary on the basis of the individual’smedical and physical condition and the vehicle meets such safety requirementsas the Secretary may prescribe) used in the patient’s home (includingan institution used as his home other than an institution that meetsthe requirements of subsection (e)(1) of this section or section 1819(a)(1)), whetherfurnished on a rental basis or purchased, and includes blood-testingstrips and blood glucose monitors for individuals with diabetes withoutregard to whether the individual has Type I or Type II diabetes orto the individual’s use of insulin (as determined under standardsestablished by the Secretary in consultation with the appropriateorganizations) and eye tracking and gaze interaction accessories forspeech generating devices furnished to individuals with a demonstratedmedical need for such accessories; except that such term does notinclude such equipment furnished by a supplier who has used, for thedemonstration and use of specific equipment, an individual who hasnot met such minimum training standards as the Secretary may establishwith respect to the demonstration and use of such specific equipment.With respect to a seat-lift chair, such term includes only the seat-liftmechanism and does not include the chair[498].

Home Health Agency

(o) The term “home health agency” meansa public agency or private organization, or a subdivision of suchan agency or organization, which—

(1) is primarily engagedin providing skilled nursing services and other therapeutic services;

(2) has policies,established by a group of professional personnel (associated withthe agency or organization), including one or more physicians andone or more registered professional nurses, to govern the services(referred to in paragraph (1)) which it provides, and provides forsupervision of such services by a physician or registered professionalnurse;

(3) maintains clinicalrecords on all patients;

(4) in the case ofan agency or organization in any State in which State or applicablelocal law provides for the licensing of agencies or organizationsof this nature, (A) is licensed pursuant to such law, or (B) is approved,by the agency of such State or locality responsible for licensingagencies or organizations of this nature, as meeting the standardsestablished for such licensing;

(5) has in effectan overall plan and budget that meets the requirements of subsection(z);

(6) meets the conditionsof participation specified in section 1891(a) and such other conditions ofparticipation as the Secretary may find necessary in the interestof the health and safety of individuals who are furnished servicesby such agency or organization;

(7) provides the Secretarywith a surety bond—

(A) in a formspecified by the Secretary and in an amount that is not less thanthe minimum of $50,000; and

(B) that the Secretarydetermines is commensurate with the volume of payments to the homehealth agency; and[499]

(8) meets such additionalrequirements (including conditions relating to bonding or establishingof escrow accounts as the Secretary finds necessary for the financialsecurity of the program) as the Secretary finds necessary for theeffective and efficient operation of the program;

except that for purposes of part A such term shall not includeany agency or organization which is primarily for the care and treatmentof mental diseases. The Secretary may waive the requirement of a suretybond under paragraph (7) in the case of an agency or organizationthat provides a comparable surety bond under State law.

Outpatient Physical Therapy Services

(p) The term “outpatient physical therapyservices” means physical therapy services furnished by a providerof services, a clinic, rehabilitation agency, or a public health agency,or by others under an arrangement with, and under the supervisionof, such provider, clinic, rehabilitation agency, or public healthagency to an individual as an outpatient—

(1) who is under thecare of a physician (as defined in paragraph (1), (3), or (4) of section 1861(r)), and

(2) with respect towhom a plan prescribing the type, amount, and duration of physicaltherapy services that are to be furnished such individual has beenestablished by a physician (as so defined) or by a qualified physicaltherapist and is periodically reviewed by a physician (as so defined);

excluding, however—

(3) any item or serviceif it would not be included under subsection (b) if furnished to aninpatient of a hospital; and

(4) any such service—

(A) if furnishedby a clinic or rehabilitation agency, or by others under arrangementswith such clinic or agency, unless such clinic or rehabilitation agency—

(i) provides an adequateprogram of physical therapy services for outpatients and has the facilitiesand personnel required for such program or required for the supervisionof such a program, in accordance with such requirements as the Secretarymay specify,

(ii) has policies,established by a group of professional personnel, including one ormore 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) maintainsclinical records on all patients,

(iv) if such clinicor agency is situated in a State in which State or applicable locallaw provides for the licensing of institutions of this nature, (I)is licensed pursuant to such law, or (II) is approved by the agencyof such State or locality responsible for licensing institutions ofthis nature, as meeting the standards established for such licensing;and

(v) meets such otherconditions relating to the health and safety of individuals who arefurnished services by such clinic or agency on an outpatient basis,as the Secretary may find necessary, and provides the Secretary ona continuing basis with a surety bond in a form specified by the Secretaryand in an amount that is not less than $50,000, or

(B) if furnishedby a public health agency, unless such agency meets such other conditionsrelating to health and safety of individuals who are furnished servicesby 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 individualby a physical therapist (in his office or in such individual’shome) who meets licensing and other standards prescribed by the Secretaryin regulations, otherwise than under an arrangement with and underthe supervision of a provider of services, clinic, rehabilitationagency, or public health agency, if the furnishing of such servicesmeets such conditions relating to health and safety as the Secretarymay find necessary. In addition, such term includes physical therapyservices which meet the requirements of the first sentence of thissubsection except that they are furnished to an individual as an inpatientof a hospital or extended care facility. The term “outpatientphysical therapy services” also includes speech-language pathologyservices furnished by a provider of services, a clinic, rehabilitationagency, or by a public health agency, or by others under an arrangementwith, and under the supervision of, such provider, clinic, rehabilitationagency, or public health agency to an individual as an outpatient,subject to the conditions prescribed in this subsection. Nothing inthis subsection shall be construed as requiring, with respect to outpatientswho are not entitled to benefits under this title, a physical therapistto provide outpatient physical therapy services only to outpatientswho are under the care of a physician or pursuant to a plan of careestablished by a physician. The Secretary may waive the requirementof a surety bond under paragraph (4)(A)(v) in the case of a clinicor 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 includingservices described in subsection (b)(6)).

Physician

(r) The term “physician”, when usedin connection with the performance of any function or action, means(1) a doctor of medicine or osteopathy legally authorized to practicemedicine and surgery by the State in which he performs such functionor 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 authorizedto practice dentistry by the State in which he performs such functionand who is acting within the scope of his license when he performssuch functions, (3) a doctor of podiatric medicine for the purposesof 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 functionswhich he is legally authorized to perform as such by the State inwhich he performs them, (4) a doctor of optometry, but only for purposesof subsection (p)(1) of this section and with respect to the provisionof items or services described in subsection (s) which he is legallyauthorized to perform as a doctor of optometry by the State in whichhe performs them, or (5)[500] a chiropractor who is licensed as such by the State (or in a Statewhich does not license chiropractors as such, is legally authorizedto perform the services of a chiropractor in the jurisdiction in whichhe performs such services), and who meets uniform minimum standardspromulgated by the Secretary, but only for the purpose of sections 1861(s)(1) and 1861(s)(2)(A) and only with respectto treatment by means of manual manipulation of the spine (to correcta subluxation) which he is legally authorized to perform by the Stateor jurisdiction in which such treatment is provided. For the purposesof section 1862(a)(4) and subject to the limitations and conditions provided in the previoussentence, such term includes a doctor of one of the arts, specifiedin such previous sentence, legally authorized to practice such artin the country in which the inpatient hospital services (referredto 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) servicesand supplies (including drugs and biologicals which are not usuallyself-administered by the patient) furnished as an incident to a physician’sprofessional service, of kinds which are commonly furnished in physicians’offices and are commonly either rendered without charge or includedin the physicians’ bills (or would have been so included butfor the application of section 1847B);

(B) hospitalservices (including drugs and biologicals which are not usually self-administeredby the patient) incident to physicians’ services rendered tooutpatients and partial hospitalization services incident to suchservices;

(C) diagnosticservices which are—

(i) furnished toan individual as an outpatient by a hospital or by others under arrangementswith them made by a hospital, and

(ii) ordinarilyfurnished by such hospital (or by others under such arrangements)to its outpatients for the purpose of diagnostic study;

(D) outpatientphysical therapy services and outpatient occupational therapy services;

(E) rural healthclinic services and Federally qualified health center services;

(F) home dialysissupplies and equipment, self-care home dialysis support services,and institutional dialysis services and supplies, and, for items andservices furnished on or after January 1, 2011, renal dialysis services(as defined in section 1881(b)(14)(B)), including suchrenal dialysis services furnished on or after January 1, 2017, bya renal dialysis facility or provider of services paid under section1881(b)(14) to an individual with acute kidney injury (as definedin section 1834(r)(2));[501]

(G) antigens(subject to quantity limitations prescribed in regulations by theSecretary) prepared by a physician, as defined in section 1861(r)(1), fora particular patient, including antigens so prepared which are forwardedto another qualified person (including a rural health clinic) foradministration to such patient, from time to time, by or under thesupervision of another such physician;

(H)(i) services furnishedpursuant to a contract under section 1876 to a member of an eligible organizationby a physician assistant or by a nurse practitioner (as defined insubsection (aa)(5)) and such services and supplies furnished as anincident to his service to such a member as would otherwise be coveredunder this part if furnished by a physician or as an incident to aphysician’s service; and

(ii) services furnishedpursuant to a risk-sharing contract under section 1876(g) to a memberof an eligible organization by a clinical psychologist (as definedby the Secretary) or by a clinical social worker (as defined in subsection(hh)(2)), and such services and supplies furnished as an incidentto such clinical psychologist’s services or clinical socialworker’s services to such a member as would otherwise be coveredunder this part if furnished by a physician or as an incident to aphysician’s service;

(I) blood clottingfactors, for hemophilia patients competent to use such factors tocontrol bleeding without medical or other supervision, and items relatedto the administration of such factors, subject to utilization controlsdeemed necessary by the Secretary for the efficient use of such factors;

(J) prescriptiondrugs used in immunosuppressive therapy furnished, to an individualwho receives an organ transplant for which payment is made under thistitle;

(K)(i) services whichwould 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 supervisionof a physician (as so defined) and which the physician assistant islegally authorized to perform by the State in which the services areperformed, and such services and supplies furnished as incident tosuch services as would be covered under subparagraph (A) if furnishedincident to a physician’s professional service, but only ifno facility or other provider charges or is paid any amounts withrespect to the furnishing of such services,

(ii) services whichwould 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 clinicalnurse 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 nursepractitioner or clinical nurse specialist is legally authorized toperform by the State in which the services are performed, and suchservices and supplies furnished as an incident to such services aswould be covered under subparagraph (A) if furnished incident to aphysician’s professional service, but only if no facility orother provider charges or is paid any amounts with respect to thefurnishing of such services;

(L) certifiednurse-midwife services;

(M) qualifiedpsychologist services;

(N) clinicalsocial worker services (as defined in subsection (hh)(2));

(O) erythropoietinfor dialysis patients competent to use such drug without medical orother supervision with respect to the administration of such drug,subject to methods and standards established by the Secretary by regulationfor the safe and effective use of such drug, and items related tothe administration of such drug;

(P) prostatecancer screening tests (as defined in subsection (oo));

(Q) an oral drug(which is approved by the Federal Food and Drug Administration) prescribedfor use as an anticancer chemotherapeutic agent for a given indication,and containing an active ingredient (or ingredients), which is thesame indication and active ingredient (or ingredients) as a drug whichthe carrier determines would be covered pursuant to subparagraph (A)or (B) if the drug could not be self-administered;

(R) colorectalcancer screening tests (as defined in subsection (pp));

(S) diabetesoutpatient self-management training services (as defined in subsection(qq));

(T) an oral drug(which is approved by the Federal Food and Drug Administration) prescribedfor use as an acute anti-emetic used as part of an anticancer chemotherapeuticregimen if the drug is administered by a physician (or as prescribedby a physician)—

(i) for use immediatelybefore, at, or within 48 hours after the time of the administrationof the anticancer chemotherapeutic agent; and

(ii) as a full replacementfor the anti-emetic therapy which would otherwise be administeredintravenously;

(U) screeningfor glaucoma (as defined in subsection (uu)) for individuals determinedto be at high risk for glaucoma, individuals with a family historyof glaucoma and individuals with diabetes;

(V) medical nutritiontherapy services (as defined in subsection (vv)(1)) in the case ofa beneficiary with diabetes or a renal disease who—

(i) has not receiveddiabetes outpatient self-management training services within a timeperiod determined by the Secretary;

(ii) is not receivingmaintenance dialysis for which payment is made under section 1881; and

(iii) meets suchother criteria determined by the Secretary after consideration ofprotocols established by dietitian or nutrition professional organizations;

(W) an initialpreventive physical examination (as defined in subsection (ww));

(X) cardiovascularscreening blood tests (as defined in subsection (xx)(1));

(Y) diabetesscreening tests (as defined in subsection (yy));

(Z) intravenousimmune globulin for the treatment of primary immune deficiency diseasesin the home (as defined in subsection (zz));

(AA) ultrasoundscreening for abdominal aortic aneurysm (as defined in subsection(bbb)) for an individual—

(i) who receivesa referral for such an ultrasound screening as a result of an initialpreventive physical examination (as defined in section 1861(ww)(1));

(ii) who has notbeen previously furnished such an ultrasound screening under thistitle; and

(iii) who—

(I) has afamily history of abdominal aortic aneurysm; or

(II) manifestsrisk factors included in a beneficiary category recommended for screeningby the United States Preventive Services Task Force regarding abdominalaortic aneurysms; and

(BB) additionalpreventive services (described in subsection (ddd)(1));

(CC) items andservices furnished under a cardiac rehabilitation program (as definedin subsection (eee)(1)) or under a pulmonary rehabilitation program(as defined in subsection (fff)(1)); and

(DD) items andservices furnished under an intensive cardiac rehabilitation program(as defined in subsection (eee)(4));

(EE) kidneydisease education services (as defined in subsection (ggg));

(FF) personalizedprevention plan services (as defined in subsection (hhh));

(GG) home infusiontherapy (as defined in subsection (iii)(1)); and[502]

(HH) opioid use disorder treatmentservices (as defined in subsection (jjj)).[503]

(3) diagnostic X-raytests (including tests under the supervision of a physician, furnishedin a place of residence used as the patient’s home, if the performanceof such tests meets such conditions relating to health and safetyas the Secretary may find necessary and including diagnostic mammographyif conducted by a facility that has a certificate (or provisionalcertificate) issued under section 354 of the Public Health ServiceAct[504]), diagnostic laboratory tests, and other diagnostic tests;

(4) X-ray, radium,and radioactive isotope therapy, including materials and servicesof technicians;

(5) surgical dressings,and splints, casts, and other devices used for reduction of fracturesand dislocations;

(6) durable medicalequipment;

(7) ambulance servicewhere the use of other methods of transportation is contraindicatedby the individual’s condition, but only to the extent providedin regulations;

(8) prosthetic devices(other than dental) which replace all or part of an internal bodyorgan (including colostomy bags and supplies directly related to colostomycare), including replacement of such devices, and including one pairof conventional eyeglasses or contact lenses furnished subsequentto each cataract surgery with insertion of an intraocular lens;

(9) leg, arm, back,and neck braces, and artificial legs, arms, and eyes, including replacementsif required because of a change in the patient’s physical condition;

(10)(A) pneumococcalvaccine and its administration and, subject to section 4071(b) ofthe Omnibus Budget Reconciliation Act of 1987[505], influenzavaccine and its administration; and

(B) hepatitisB vaccine and its administration, furnished to an individual who isat high or intermediate risk of contracting hepatitis B (as determinedby the Secretary under regulations);

(11) services ofa certified registered nurse anesthetist (as defined in subsection(bb));

(12) subject to section4072(e) of the Omnibus Budget Reconciliation Act of 1987[506], extra-depth shoes with inserts or custom molded shoeswith inserts for an individual with diabetes, if—

(A) the physicianwho is managing the individual’s diabetic condition (i) documentsthat the individual has peripheral neuropathy with evidence of callusformation, a history of pre-ulcerative calluses, a history of previousulceration, foot deformity, or previous amputation, or poor circulation,and (ii) certifies that the individual needs such shoes under a comprehensiveplan of care related to the individual’s diabetic condition;

(B) the particulartype of shoes are prescribed by a podiatrist or other qualified physician(as established by the Secretary); and

(C) the shoesare 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 theSecretary finds that the physician is the only such qualified individualin the area);

(13) screening mammography(as defined in subsection (jj));

(14) screening papsmear and screening pelvic exam; and

(15) bone mass measurement(as defined in subsection (rr)).

No diagnostic tests performed in any laboratory, including alaboratory that is part of a rural health clinic, or a hospital (which,for purposes of this sentence, means an institution considered a hospitalfor purposes of section 1814(d)) shall be included within paragraph (3) unless suchlaboratory—

(16) if situatedin any State in which State or applicable local law provides for licensingof establishments of this nature, (A) is licensed pursuant to suchlaw, or (B) is approved, by the agency of such State or locality responsiblefor licensing establishments of this nature, as meeting the standardsestablished for such licensing; and

(17)(A) meets thecertification requirements under section 353 of the Public HealthService Act;[507] and

(B) meets suchother conditions relating to the health and safety of individualswith respect to whom such tests are performed as the Secretary mayfind necessary.

There shall be excluded from the diagnostic services specifiedin paragraph (2)(C) any item or service (except services referredto in paragraph (1)) which would not be included under subsection(b) if it were furnished to an inpatient of a hospital. None of theitems and services referred to in the preceding paragraphs (otherthan paragraphs (1) and (2)(A)) of this subsection which are furnishedto a patient of an institution which meets the definition of a hospitalfor purposes of section 1814(d) shall be included unless such other conditions aremet as the Secretary may find necessary relating to health and safetyof individuals with respect to whom such items and services are furnished.

Drugs and Biologicals

(t)(1) The term “drugs” and the term “biologicals”, except forpurposes of subsection (m)(5) and paragraph (2), include only suchdrugs (including contrast agents) and biologicals, respectively, asare 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 drugsand biologicals unfavorably evaluated therein), or as are approvedby the pharmacy and drug therapeutics committee (or equivalent committee)of the medical staff of the hospital furnishing such drugs and biologicalsfor use in such hospital.

(2)(A) For purposesof paragraph (1), the term “drugs” also includes anydrugs or biologicals used in an anticancer chemotherapeutic regimenfor a medically accepted indication (as described in subparagraph(B)).

(B) In subparagraph(A), the term “medically accepted indication”, with respectto the use of a drug, includes any use which has been approved bythe Food and Drug Administration for the drug, and includes anotheruse of the drug if—

(i) the drug hasbeen approved by the Food and Drug Administration; and

(ii)(I) such useis supported by one or more citations which are included (or approvedfor inclusion) in one or more of the following compendia: the AmericanHospital Formulary Service-Drug Information, the American MedicalAssociation Drug Evaluations, the United States Pharmacopoeia-DrugInformation, and other authoritative compendia as identified by theSecretary, unless the Secretary has determined that the use is notmedically appropriate or the use is identified as not indicated inone or more such compendia, or

(II) the carrierinvolved determines, based upon guidance provided by the Secretaryto carriers for determining accepted uses of drugs, that such useis medically accepted based on supportive clinical evidence in peerreviewed m edical literature appearing in publications which havebeen 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 fordrugs. On and after January 1, 2010, no compendia may be includedon the list of compendia under this subparagraph unless the compendiahas a publicly transparent process for evaluating therapies and foridentifying potential conflicts of interests.

Provider of Services

(u) The term “provider of services” means a hospital, critical access 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 reasonablecost of any services shall be the cost actually incurred, excludingtherefrom any part of incurred cost found to be unnecessary in theefficient delivery of needed health services, and shall be determinedin accordance with regulations establishing the method or methodsto be used, and the items to be included, in determining such costsfor various types or classes of institutions, agencies, and services;except that in any case to which paragraph (2) or (3) applies, theamount of the payment determined under such paragraph with respectto the services involved shall be considered the reasonable cost ofsuch services. In prescribing the regulations referred to in the precedingsentence, the Secretary shall consider, among other things, the principlesgenerally applied by national organizations or established prepaymentorganizations (which have developed such principles) in computingthe amount of payment, to be made by persons other than the recipientsof services, to providers of services on account of services furnishedto such recipients by such providers. Such regulations may providefor determination of the costs of services on a per diem, per unit,per capita, or other basis, may provide for using different methodsin different circumstances, may provide for the use of estimates ofcosts of particular items or services, may provide for the establishmentof limits on the direct or indirect overall incurred costs or incurredcosts of specific items or services or groups of items or servicesto be recognized as reasonable based on estimates of the costs necessaryin the efficient delivery of needed health services to individualscovered by the insurance programs established under this title, andmay provide for the use of charges or a percentage of charges wherethis method reasonably reflects the costs. Such regulations shall(i) take into account both direct and indirect costs of providersof services (excluding therefrom any such costs, including standbycosts, which are determined in accordance with regulations to be unnecessaryin the efficient delivery of services covered by the insurance programsestablished under this title) in order that, under the methods ofdetermining costs, the necessary costs of efficiently delivering coveredservices to individuals covered by the insurance programs establishedby this title will not be borne by individuals not so covered, andthe costs with respect to individuals not so covered will not be borneby such insurance programs, and (ii) provide for the making of suitableretroactive corrective adjustments where, for a provider of servicesfor any fiscal period, the aggregate reimbursement produced by themethods of determining costs proves to be either inadequate or excessive.

(B) In the caseof extended care services, the regulations under subparagraph (A)shall not include provision for specific recognition of a return onequity capital.

(C) Where a hospitalhas an arrangement with a medical school under which the faculty ofsuch school provides services at such hospital, an amount not in excessof the reasonable cost of such services to the medical school shallbe included in determining the reasonable cost to the hospital offurnishing services—

(i) for which paymentmay be made under part A, but only if—

(I) paymentfor such services as furnished under such arrangement would be madeunder part A to the hospital had such services been furnished by thehospital, and

(II) such hospitalpays to the medical school at least the reasonable cost of such servicesto the medical school, or

(ii) for which paymentmay be made under part B, but only if such hospital pays to the medicalschool at least the reasonable cost of such services to the medicalschool.

(D) Where (i)physicians furnish services which are either inpatient hospital services(including services in conjunction with the teaching programs of suchhospital) by reason of paragraph (7) of subsection (b) or for whichentitlement exists by reason of clause (II) of section 1832(a)(2)(B)(i), and (ii) such hospital (or medical school under arrangement withsuch hospital) incurs no actual cost in the furnishing of such services,the reasonable cost of such services shall (under regulations of theSecretary) be deemed to be the cost such hospital or medical schoolwould have incurred had it paid a salary to such physicians renderingsuch services approximately equivalent to the average salary paidto all physicians employed by such hospital (or if such employmentdoes not exist, or is minimal in such hospital, by similar hospitalsin a geographic area of sufficient size to assure reasonable inclusionof sufficient physicians in development of such average salary).

(E) Such regulationsmay, in the case of skilled nursing facilities in any State, providefor the use of rates, developed by the State in which such facilitiesare located, for the payment of the cost of skilled nursing facilityservices furnished under the State’s plan approved under titleXIX (and such rates may be increased by the Secretary on a class orsize of institution or on a geographical basis by a percentage factornot in excess of 10 percent to take into account determinable itemsor services or other requirements under this title not otherwise includedin the computation of such State rates), if the Secretary finds thatsuch rates are reasonably related to (but not necessarily limitedto) analyses undertaken by such State of costs of care in comparablefacilities in such State. Notwithstanding the previous sentence, suchregulations with respect to skilled nursing facilities shall takeinto account (in a manner consistent with subparagraph (A) and basedon patient-days of services furnished) the costs (including the costsof services required to attain or maintain the highest practicablephysical, mental, and psychosocial well-being of each resident eligiblefor benefits under this title) of such facilities complying with therequirements of subsections (b), (c), and (d) of section 1819 (including thecosts of conducting nurse aide training and competency evaluationprograms and competency evaluation programs).

(F) Such regulationsshall require each provider of services (other than a fund) to makereports to the Secretary of information described in section 1121(a)in accordancewith the uniform reporting system (established under such section)for that type of provider.

(G)(i) In any case inwhich a hospital provides inpatient services to an individual thatwould constitute post-hospital extended care services if providedby a skilled nursing facility and a quality improvement[508] organization (or, in the absence ofsuch a qualified organization, the Secretary or such agent as theSecretary may designate) determines that inpatient hospital servicesfor the individual are not medically necessary but post-hospital extendedcare services for the individual are medically necessary and suchextended 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 providedto the individual shall continue to be made under this title at thepayment rate described in clause (ii) during the period in which—

(I) such post-hospitalextended care services for the individual are medically necessaryand not otherwise available to the individual (as so determined),

(II) inpatienthospital services for the individual are not medically necessary,and

(III) theindividual is entitled to have payment made for post-hospital extendedcare services under this title,

except that if the Secretary determines that there is not anexcess 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 theamount otherwise payable under part A with respect to inpatient hospitalservices.

(ii)(I) Exceptas provided in subclause (II), the payment rate referred to in clause(i) is a rate equal to the estimated adjusted State-wide average rateper patient-day paid for services provided in skilled nursing facilitiesunder the State plan approved under title XIX for the State in whichsuch hospital is located, or, if the State in which the hospital islocated does not have a State plan approved under title XIX, the estimatedadjusted State-wide average allowable costs per patient-day for extendedcare services under this title in that State.

(II) If ahospital has a unit which is a skilled nursing facility, the paymentrate referred to in clause (i) for the hospital is a rate equal tothe lesser of the rate described in subclause (I) or the allowablecosts in effect under this title for extended care services providedto patients of such unit.

(iii) Any day onwhich an individual receives inpatient services for which paymentis made under this subparagraph shall, for purposes of this Act (otherthan this subparagraph), be deemed to be a day on which the individualreceived inpatient hospital services.

(iv) In determiningunder clause (i), in the case of a public hospital, whether or notthere 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 andwhich are under common ownership with that hospital.

(H) In determiningsuch reasonable cost with respect to home health agencies, the Secretarymay not include—

(i) any costs incurredin connection with bonding or establishing an escrow account by anysuch agency as a result of the surety bond requirement described insubsection (o)(7) and the financial security requirement describedin subsection (o)(8);

(ii) in the caseof home health agencies to which the surety bond requirement describedin subsection (o)(7) and the financial security requirement describedin subsection (o)(8) apply, any costs attributed to interest chargedsuch an agency in connection with amounts borrowed by the agency torepay overpayments made under this title to the agency, except thatsuch costs may be included in reasonable cost if the Secretary determinesthat the agency was acting in good faith in borrowing the amounts;

(iii) in the caseof contracts entered into by a home health agency after the date ofthe enactment of this subparagraph[509] for the purposeof having services furnished for or on behalf of such agency, anycost incurred by such agency pursuant to any such contract which isentered into for a period exceeding five years; and

(iv) in the caseof contracts entered into by a home health agency before the dateof the enactment of this subparagraph[510] for thepurpose of having services furnished for or on behalf of such agency,any cost incurred by such agency pursuant to any such contract, whichdetermines the amount payable by the home health agency on the basisof a percentage of the agency’s reimbursement or claim for reimbursementfor services furnished by the agency, to the extent that such costexceeds the reasonable value of the services furnished on behalf ofsuch agency.

(I) In determiningsuch reasonable cost, the Secretary may not include any costs incurredby a provider with respect to any services furnished in connectionwith matters for which payment may be made under this title and furnishedpursuant to a contract between the provider and any of its subcontractorswhich is entered into after the date of the enactment of this subparagraph[511] and the value or cost of which is $10,000 or more overa twelve-month period unless the contract contains a clause to theeffect that—

(i) until the expirationof four years after the furnishing of such services pursuant to suchcontract, the subcontractor shall make available, upon written requestby the Secretary, or upon request by the Comptroller General, or anyof their duly authorized representatives, the contract, and books,documents and records of such subcontractor that are necessary tocertify the nature and extent of such costs, and

(ii) if the subcontractorcarries 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 clauseto the effect that until the expiration of four years after the furnishingof such services pursuant to such subcontract, the related organizationshall make available, upon written request by the Secretary, or uponrequest by the Comptroller General, or any of their duly authorizedrepresentatives, the subcontract, and books, documents and recordsof such organization that are necessary to verify the nature and extentof such costs.

The Secretary shall prescribe in regulation criteria and procedureswhich the Secretary shall use in obtaining access to books, documents,and records under clauses required in contracts and subcontracts underthis subparagraph.

(J) Such regulationsmay not provide for any inpatient routine salary cost differentialas a reimbursable cost for hospitals and skilled nursing facilities.

(K)(i) The Secretaryshall issue regulations that provide, to the extent feasible, forthe establishment of limitations on the amount of any costs or chargesthat shall be considered reasonable with respect to services providedon an outpatient basis by hospitals (other than bona fide emergencyservices as defined in clause (ii)) or clinics (other than rural healthclinics), which are reimbursed on a cost basis or on the basis ofcost related charges, and by physicians utilizing such outpatientfacilities. Such limitations shall be reasonably related to the chargesin the same area for similar services provided in physicians’offices. Such regulations shall provide for exceptions to such limitationsin cases where similar services are not generally available in physicians’offices in the area to individuals entitled to benefits under thistitle.

(ii) For purposesof clause (i), the term “bona fide emergency services” means services provided in a hospital emergency room after the suddenonset of a medical condition manifesting itself by acute symptomsof sufficient severity (including severe pain) such that the absenceof immediate medical attention could reasonably be expected to resultin—

(I) placingthe patient’s health in serious jeopardy;

(II) seriousimpairment to bodily functions; or

(III) seriousdysfunction of any bodily organ or part.

(L)(i) The Secretary,in determining the amount of the payments that may be made under thistitle with respect to services furnished by home health agencies,may not recognize as reasonable (in the efficient delivery of suchservices) costs for the provision of such services by an agency tothe extent these costs exceed (on the aggregate for the agency) forcost reporting periods beginning on or after—

(I) July 1,1985, and before July 1, 1986, 120 percent of the mean of the labor-relatedand nonlabor per visit costs for freestanding home health agencies,

(II) July 1,1986, and before July 1, 1987, 115 percent of such mean,

(III) July1, 1987, and before October 1, 1997, 112 percent of such mean,

(IV) October1, 1997, and before October 1, 1998, 105 percent of the median ofthe labor-related and nonlabor per visit costs for freestanding homehealth agencies; or

(V) October1, 1998, 106 percent of such median.

(ii) Effective forcost reporting periods beginning on or after July 1, 1986, such limitationsshall be applied on an aggregate basis for the agency, rather thanon a discipline specific basis. The Secretary may provide for suchexemptions and exceptions to such limitation as he deems appropriate.[512]

(iii) Not laterthan July 1, 1991, and annually thereafter (but not for cost reportingperiods 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 Secretaryshall establish limits under this subparagraph for cost reportingperiods beginning on or after such date by utilizing the area wageindex applicable under section 1886(d)(3)(E) and determined usingthe survey of the most recent available wages and wage-related costsof hospitals located in the geographic area in which the home healthservice is furnished (determined without regard to whether such hospitalshave been reclassified to a new geographic area pursuant to section 1886(d)(8)(B),a decision of the Medicare Geographic Classification Review Boardunder section 1886(d)(10), or a decision of the Secretary).

(iv) In establishinglimits under this subparagraph for cost reporting periods beginningafter September 30, 1997, the Secretary shall not take into accountany changes in the home health market basket, as determined by theSecretary, with respect to cost reporting periods which began on orafter July 1, 1994, and before July 1, 1996.

(v) For servicesfurnished by home health agencies for cost reporting periods beginningon or after October 1, 1997, subject to clause (viii)(I), the Secretaryshall provide for an interim system of limits. Payment shall not exceedthe costs determined under the preceding provisions of this subparagraphor, if lower, the product of—

(I) an agency-specificper beneficiary annual limitation calculated based 75 percent on 98percent of the reasonable costs (including nonroutine medical supplies)for the agency’s 12-month cost reporting period ending duringfiscal year 1994, and based 25 percent on 98 percent of the standardizedregional average of such costs for the agency’s census division,as applied to such agency, for cost reporting periods ending duringfiscal year 1994, such costs updated by the home health market basketindex; and

(II) the agency’sunduplicated census count of patients (entitled to benefits underthis title) for the cost reporting period subject to the limitation.

(vi) For servicesfurnished by home health agencies for cost reporting periods beginningon or after October 1, 1997, the following rules apply:

(I) For newproviders and those providers without a 12-month cost reporting periodending in fiscal year 1994 subject to clauses (viii)(II) and (viii)(III),the per beneficiary limitation shall be equal to the median of theselimits (or the Secretary’s best estimates thereof) applied toother home health agencies as determined by the Secretary. A homehealth agency that has altered its corporate structure or name shallnot be considered a new provider for this purpose.

(II) For beneficiarieswho use services furnished by more than one home health agency, theper beneficiary limitations shall be prorated among the agencies.

(vii)(I) Not laterthan January 1, 1998, the Secretary shall establish per visit limitsapplicable 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) Notlater than August 1 of each year (beginning in 1998) the Secretaryshall establish the limits applicable under this subparagraph forservices furnished during the fiscal year beginning October 1 of theyear.

(viii)(I) In thecase of a provider with a 12-month cost reporting period ending infiscal year 1994, if the limit imposed under clause (v) (determinedwithout regard to this subclause) for a cost reporting period beginningduring or after fiscal year 1999 is less than the median describedin 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 providerand period shall be increased by 1/3 of such difference.

(II) Subjectto subclause (IV), for new providers and those providers without a12-month cost reporting period ending in fiscal year 1994, but forwhich 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 beequal to the median described in such clause (determined as if anyreference in clause (v) to “98 percent” were a referenceto “100 percent”).

(III) Subjectto subclause (IV), in the case of a new provider for which the firstcost reporting period begins during or after fiscal year 1999, thelimitation applied under clause (vi)(I) (but only with respect tosuch provider) shall be equal to 75 percent of the median describedin clause (vi)(I).

(IV) Inthe case of a new provider or a provider without a 12-month cost reportingperiod ending in fiscal year 1994, subclause (II) shall apply, insteadof subclause (III), to a home health agency which filed an applicationfor home health agency provider status under this title before September15, 1998, or which was approved as a branch of its parent agency beforesuch date and becomes a subunit of the parent agency or a separateagency on or after such date.

(V) Eachof the amounts specified in subclauses (I) through (III) are suchamounts as adjusted under clause (iii) to reflect variations in wagesamong different areas.

(ix) Notwithstandingthe per beneficiary limit under clause (viii), if the limit imposedunder clause (v) (determined without regard to this clause) for acost reporting period beginning during or after fiscal year 2000 isless than the median described in clause (vi)(I) (but determined asif any reference in clause (v) to “98 percent” were areference to “100 percent”), the limit otherwise imposedunder clause (v) for such provider and period shall be increased by2 percent.

(x) Notwithstandingany other provision of this subparagraph, in updating any limit underthis subparagraph by a home health market basket index for cost reportingperiods 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 year2001, the update to any limit under this subparagraph shall be thehome health market basket index.

(M) Such regulationsshall provide that costs respecting care provided by a provider ofservices, pursuant to an assurance under title VI or XVI of the PublicHealth Service Act[513] that the provider will make available a reasonable volume of servicesto persons unable to pay therefor, shall not be allowable as reasonablecosts.

(N) In determiningsuch reasonable costs, costs incurred for activities directly relatedto influencing employees respecting unionization may not be included.

(O)(i) In establishingan appropriate allowance for depreciation and for interest on capitalindebtedness with respect to an asset of a provider of services whichhas undergone a change of ownership, such regulations shall provide,except as provided in clause (iii), that the valuation of the assetafter such change of ownership shall be the historical cost of theasset, as recognized under this title, less depreciation allowed,to the owner of record as of the date of enactment of the BalancedBudget Act of 1997[514] (or, in the case of an assetnot in existence as of that date, the first owner of record of theasset after that date).

(ii) Such regulationsshall not recognize, as reasonable in the provision of health careservices, costs (including legal fees, accounting and administrativecosts, travel costs, and the costs of feasibility studies) attributableto the negotiation or settlement of the sale or purchase of any capitalasset (by acquisition or merger) for which any payment has previouslybeen made under this title.

(iii) In the caseof the transfer of a hospital from ownership by a State to ownershipby a nonprofit corporation without monetary consideration, the basisfor capital allowances to the new owner shall be the book value ofthe hospital to the State at the time of the transfer.

(P) If such regulationsprovide for the payment for a return on equity capital (other thanwith respect to costs of inpatient hospital services), the rate ofreturn to be recognized, for determining the reasonable cost of servicesfurnished in a cost reporting period, shall be equal to the averageof the rates of interest, for each of the months any part of whichis included in the period, on obligations issued for purchase by theFederal Hospital Insurance Trust Fund.

(Q) Except asotherwise explicitly authorized, the Secretary is not authorized tolimit the rate of increase on allowable costs of approved medicaleducational activities.

(R) In determiningsuch reasonable cost, costs incurred by a provider of services representinga beneficiary in an unsuccessful appeal of a determination describedin section 1869(b) shall not be allowable as reasonable costs.

(S)(i) Such regulationsshall not include provision for specific recognition of any returnon equity capital with respect to hospital outpatient departments.

(ii)(I) Such regulationsshall provide that, in determining the amount of the payments thatmay be made under this title with respect to all the capital-relatedcosts of outpatient hospital services, the Secretary shall reducethe amounts of such payments otherwise established under this titleby 15 percent for payments attributable to portions of cost reportingperiods occurring during fiscal year 1990, by 15 percent for paymentsattributable to portions of cost reporting periods occurring duringfiscal year 1991, and by 10 percent for payments attributable to portionsof cost reporting periods occurring during fiscal years 1992 through1999 and until the first date that the prospective payment systemunder section 1833(t)is implemented.

(II) The Secretaryshall reduce the reasonable cost of outpatient hospital services (otherthan the capital-related costs of such services) otherwise determinedpursuant to section 1833(a)(2)(B)(i)(I) by 5.8 percentfor payments attributable to portions of cost reporting periods occurringduring fiscal years 1991 through 1999 and until the first date thatthe prospective payment system under section 1833(t) is implemented during fiscalyear 2000 before January 1, 2000.

(III) Subclauses(I) and (II) shall not apply to payments with respect to the costsof hospital outpatient services provided by any hospital that is asole community hospital (as defined in section 1886(d)(5)(D)(iii)) or a criticalaccess hospital (as defined in section 1861(mm)(1)).

(IV) In applyingsubclauses (I) and (II) to services for which payment is made on thebasis of a blend amount under section 1833(i)(3)(A)(ii) or 1833(n)(1)(A)(ii), the costsreflected 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 determiningsuch reasonable costs for hospitals, no reduction in copayments undersection 1833(t)(8)(B) shall be treated as a bad debt and the amount of bad debts otherwisetreated as allowable costs which are attributable to the deductiblesand coinsurance amounts under this title shall be reduced—

(i) for cost reportingperiods beginning during fiscal year 1998, by 25 percent of such amountotherwise allowable,

(ii) for cost reportingperiods beginning during fiscal year 1999, by 40 percent of such amountotherwise allowable,

(iii) for costreporting periods beginning during fiscal year 2000, by 45 percentof such amount otherwise allowable[515]

(iv) for cost reportingperiods beginning during fiscal years 2001 through 2012[516], by 30 percentof such amount otherwise allowable, and[517]

(v)[518] for cost reporting periods beginning duringfiscal year 2013 or a subsequent fiscal year, by 35 percent of suchamount otherwise allowable.

(U) In determiningthe 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 ofcosts recognized as reasonable for ambulance services provided ona per trip basis during the previous fiscal year (after applicationof this subparagraph), increased by the percentage increase in theconsumer price index for all urban consumers (U.S. city average) asestimated by the Secretary for the 12-month period ending with themidpoint of the fiscal year involved reduced by 1.0 percentage point.For ambulance services provided after June 30, 1998, the Secretarymay provide that claims for such services must include a code (orcodes) under a uniform coding system specified by the Secretary thatidentifies the services furnished.

(V) In determiningsuch reasonable costs for skilled nursing facilities and (beginningwith respect to cost reporting periods beginning during fiscal year2013) for covered skilled nursing services described in section 1888(e)(2)(A) furnishedby hospital providers of extended care services (as described in section 1883)[519], the amount ofbad debts otherwise treated as allowed costs which are attributableto the coinsurance amounts under this title for individuals who areentitled to benefits under part A and—

(i)[520] are not described insection 1935(c)(6)(A)(ii) shall be reduced by—

(I) for costreporting periods beginning on or after October 1, 2005, but beforefiscal year 2013, 30 percent of such amount otherwise allowable; and

(II) for costreporting periods beginning during fiscal year 2013 or a subsequentfiscal year, by 35 percent of such amount otherwise allowable.

(ii) are describedin such section—

(I) for costreporting periods beginning on or after October 1, 2005, but beforefiscal year 2013, shall not be reduced;

(II) for costreporting periods beginning during fiscal year 2013, shall be reducedby 12 percent of such amount otherwise allowable;

(III) forcost reporting periods beginning during fiscal year 2014, shall bereduced by 24 percent of such amount otherwise allowable; and

(IV) for costreporting periods beginning during a subsequent fiscal year, shallbe reduced by 35 percent of such amount otherwise allowable.[521]

(W)[522](i) In determiningsuch reasonable costs for providers described in clause (ii), theamount of bad debts otherwise treated as allowable costs which areattributable to deductibles and coinsurance amounts under this titleshall be reduced—

(I) for costreporting periods beginning during fiscal year 2013, by 12 percentof such amount otherwise allowable;

(II) for costreporting periods beginning during fiscal year 2014, by 24 percentof such amount otherwise allowable; and

(III) forcost reporting periods beginning during a subsequent fiscal year,by 35 percent of such amount otherwise allowable.

(ii) A providerdescribed in this clause is a provider of services not described insubparagraph (T) or (V), a supplier, or any other type of entity thatreceives payment for bad debts under the authority under subparagraph(A).

(2)(A) If the bedand board furnished as part of inpatient hospital services (includinginpatient tuberculosis hospital services and inpatient psychiatrichospital services) or post-hospital extended care services is in accommodationsmore expensive than semi-private accommodations, the amount takeninto account for purposes of payment under this title with respectto such services may not exceed the amount that would be taken intoaccount with respect to such services if furnished in such semi-privateaccommodations unless the more expensive accommodations were requiredfor medical reasons.

(B) Where a providerof services which has an agreement in effect under this title furnishesto an individual items or services which are in excess of or moreexpensive than the items or services with respect to which paymentmay be made under part A or part B, as the case may be, the Secretaryshall take into account for purposes of payment to such provider ofservices only the items or services with respect to which such paymentmay be made.[523]

(3) If the bed andboard furnished as part of inpatient hospital services (includinginpatient tuberculosis hospital services and inpatient psychiatrichospital services) or post-hospital extended care services is in accommodationsother than, but not more expensive than, semi-private accommodationsand the use of such other accommodations rather than semi-privateaccommodations was neither at the request of the patient nor for areason which the Secretary determines is consistent with the purposesof this title, the amount of the payment with respect to such bedand board under part A shall be the amount otherwise payable underthis title for such bed and board furnished in semi-private accommodationsminus the difference between the charge customarily made by the hospitalor skilled nursing facility for bed and board in semi-private accommodationsand the charge customarily made by it for bed and board in the accommodationsfurnished.

(4) If a providerof services furnishes items or services to an individual which arein excess of or more expensive than the items or services determinedto be necessary in the efficient delivery of needed health servicesand charges are imposed for such more expensive items or servicesunder the authority granted in section 1866(a)(2)(B)(ii), the amountof payment with respect to such items or services otherwise due suchprovider in any fiscal period shall be reduced to the extent thatsuch payment plus such charges exceed the cost actually incurred forsuch items or services in the fiscal period in which such chargesare imposed.

(5)(A) Where physicaltherapy 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 aprovider of services or other organization, specified in the firstsentence of subsection (p) (including through the operation of subsection(g)) the amount included in any payment to such provider or otherorganization under this title as the reasonable cost of such services(as furnished under such arrangements) shall not exceed an amountequal to the salary which would reasonably have been paid for suchservices (together with any additional costs that would have beenincurred by the provider or other organization) to the person performingthem if they had been performed in an employment relationship withsuch provider or other organization (rather than under such arrangement)plus the cost of such other expenses (including a reasonable allowancefor traveltime and other reasonable types of expense related to anydifferences in acceptable methods of organization for the provisionof such therapy) incurred by such person, as the Secretary may inregulations determine to be appropriate.

(B) Notwithstandingthe provisions of subparagraph (A), if a provider of services or otherorganization specified in the first sentence of section 1861(p) requires theservices of a therapist on a limited part-time basis, or only to performintermittent services, the Secretary may make payment on the basisof a reasonable rate per unit of service, even though such rate isgreater per unit of time than salary related amounts, where he findsthat such greater payment is, in the aggregate, less than the amountthat would have been paid if such organization had employed a therapiston a full-or part-time salary basis.

(6) For purposes ofthis subsection, the term “semi-private accommodations” means two-bed, three-bed, or four-bed accommodations.

(7)(A) For limitationon Federal participation for capital expenditures which are out ofconformity with a comprehensive plan of a State or areawide planningagency, see section 1122.

(B) For furtherlimitations on reasonable cost and determination of payment amountsfor operating costs of inpatient hospital services and waivers forcertain States, see section 1886.

(C) For provisionsrestricting payment for provider-based physicians’ servicesand for payments under certain percentage arrangements, see section 1887.

(D) For furtherlimitations on reasonable cost and determination of payment amountsfor routine service costs of skilled nursing facilities, see subsections(a) through (c) of section 1888.

(8) Items unrelatedto patient care—Reasonable costs do not include costs for thefollowing—

(i) entertainment,including tickets to sporting and other entertainment events;

(ii) gifts or donations;

(iii) personal useof motor vehicles;

(iv) costs for finesand penalties resulting from violations of Federal, State, or locallaws; and

(v) education expensesfor spouses or other dependents of providers of services, their employeesor contractors.

Arrangements for Certain Services

(w)(1) The term “arrangements” is limited to arrangements under which receiptof payment by the hospital, critical access hospital, skilled nursingfacility, home health agency, or hospice program (whether in its ownright or as agent), with respect to services for which an individualis entitled to have payment made under this title, discharges theliability of such individual or any other person to pay for the services.

(2) Utilization reviewactivities conducted, in accordance with the requirements of the programestablished under part B of title XI of the Social Security Act withrespect to services furnished by a hospital or critical access hospitalto patients insured under part A of this title or entitled to havepayment made for such services under part B of this title or undera State plan approved under title XIX, by a quality improvement[524] organization designated for the areain which such hospital or critical access hospital is located shallbe deemed to have been conducted pursuant to arrangements betweensuch hospital or critical access hospital and such organization underwhich such hospital or critical access hospital is obligated to payto such organization, as a condition of receiving payment for hospitalor critical access hospital services so furnished under this partor under such a State plan, such amount as is reasonably incurredand requested (as determined under regulations of the Secretary) bysuch organization in conducting such review activities with respectto services furnished by such hospital or critical access hospitalto such patients.

State and United States

(x) The terms “State” and “UnitedStates” 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 nonmedicalhealth care institution (as defined in subsection (ss)(1)), (exceptfor purposes of subsection (a)(2)) with respect to items and servicesordinarily furnished by such an institution to inpatients, and paymentmay be made with respect to services provided by or in such an institutiononly to such extent and under such conditions, limitations, and requirements(in addition to or in lieu of the conditions, limitations, and requirementsotherwise applicable) as may be provided in regulations.

(2) Notwithstandingany other provision of this title, payment under part A may not bemade for services furnished an individual in a skilled nursing facilityto which paragraph (1) applies unless such individual elects, in accordancewith regulations, for a spell of illness to have such services treatedas post-hospital extended care services for purposes of such part;and payment under part A may not be made for post-hospital extendedcare services—

(A) furnishedan individual during such spell of illness in a skilled nursing facilityto which paragraph (1) applies after—

(i) such serviceshave been furnished to him in such a facility for 30 days during suchspell, or

(ii) such serviceshave been furnished to him during such spell in a skilled nursingfacility to which such paragraph does not apply; or

(B) furnishedan individual during such spell of illness in a skilled nursing facilityto which paragraph (1) does not apply after such services have beenfurnished to him during such spell in a skilled nursing facility towhich such paragraph applies.

(3) The amount payableunder part A for post-hospital extended care services furnished anindividual during any spell of illness in a skilled nursing facilityto which paragraph (1) applies shall be reduced by a coinsurance amountequal to one-eighth of the inpatient hospital deductible for eachday before the 31st day on which he is furnished such services insuch a facility during such spell (and the reduction under this paragraphshall be in lieu of any reduction under section 1813(a)(3)).

(4) For purposes ofsubsection (i), the determination of whether services furnished byor in an institution described in paragraph (1) constitute post-hospitalextended care services shall be made in accordance with and subjectto such conditions, limitations, and requirements as may be providedin regulations.

Institutional Planning

(z) An overall plan and budget of a hospital, skillednursing facility, comprehensive outpatient rehabilitation facility,or home health agency shall be considered sufficient if it—

(1) provides for anannual operating budget which includes all anticipated income andexpenses related to items which would, under generally accepted accountingprinciples, be considered income and expense items (except that nothingin this paragraph shall require that there be prepared, in connectionwith any budget, an item-by-item identification of the componentsof each type of anticipated expenditure or income);

(2)(A) providesfor a capital expenditures plan for at least a 3-year period (includingthe year to which the operating budget described in paragraph (1)is applicable) which includes and identifies in detail the anticipatedsources of financing for, and the objectives of, each anticipatedexpenditure in excess of $600,000 (or such lesser amount as may beestablished by the State under section 1122(g)(1) in which the hospital islocated) related to the acquisition of land, the improvement of land,buildings, and equipment, and the replacement, modernization, andexpansion of the buildings and equipment which would, under generallyaccepted accounting principles, be considered capital items;

(B) providesthat such plan is submitted to the agency designated under section 1122(b), or if nosuch agency is designated, to the appropriate health planning agencyin the State (but this subparagraph shall not apply in the case ofa facility exempt from review under section 1122 by reason of section 1122(j));

(3) provides for reviewand updating at least annually; and

(4) is prepared, underthe 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 institutionor agency.

Rural Health Clinic Services and Federally Qualified HealthCenter 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) iffurnished as an incident to a physician’s professional serviceand items and services described in section 1861(s)(10),

(B) such servicesfurnished by a physician assistant or a nurse practitioner (as definedin paragraph (5)), by a clinical psychologist (as defined by the Secretary)or by a clinical social worker (as defined in subsection (hh)(1)),and such services and supplies furnished as an incident to his serviceas would otherwise be covered if furnished by a physician or as anincident to a physician’s service, and

(C) in the caseof a rural health clinic located in an area in which there existsa shortage of home health agencies, part-time or intermittent nursingcare and related medical supplies (other than drugs and biologicals)furnished by a registered professional nurse or licensed practicalnurse to a homebound individual under a written plan of treatment(i) established and periodically reviewed by a physician describedin paragraph (2)(B), or (ii) established by a nurse practitioner orphysician assistant and periodically reviewed and approved by a physiciandescribed in paragraph (2)(B),

when furnished to an individual as an outpatient of a ruralhealth clinic.

(2) The term “rural health clinic” means a facility which—

(A) is primarilyengaged in furnishing to outpatients services described in subparagraphs(A) and (B) of paragraph (1);

(B) in the caseof a facility which is not a physician-directed clinic, has an arrangement(consistent with the provisions of State and local law relative tothe practice, performance, and delivery of health services) with oneor more physicians (as defined in subsection (r)(1)) under which provisionis made for the periodic review by such physicians of covered servicesfurnished by physician assistants and nurse practitioners, the supervisionand guidance by such physicians of physician assistants and nursepractitioners, the preparation by such physicians of such medicalorders for care and treatment of clinic patients as may be necessary,and the availability of such physicians for such referral of and consultationfor patients as is necessary and for advice and assistance in themanagement of medical emergencies; and, in the case of a physician-directedclinic, has one or more of its staff physicians perform the activitiesaccomplished through such an arrangement;

(C) maintainsclinical records on all patients;

(D) has arrangementswith one or more hospitals, having agreements in effect under section 1866, for the referraland admission of patients requiring inpatient services or such diagnosticor other specialized services as are not available at the clinic;

(E) has writtenpolicies, which are developed with the advice of (and with provisionfor review of such policies from time to time by) a group of professionalpersonnel, including one or more physicians and one or more physicianassistants or nurse practitioners, to govern those services describedin paragraph (1) which it furnishes;

(F) has a physician,physician assistant, or nurse practitioner responsible for the executionof policies described in subparagraph (E) and relating to the provisionof the clinic’s services;

(G) directlyprovides routine diagnostic services, including clinical laboratoryservices, as prescribed in regulations by the Secretary, and has promptaccess to additional diagnostic services from facilities meeting requirementsunder this title;

(H) in compliancewith State and Federal law, has available for administering to patientsof the clinic at least such drugs and biologicals as are determinedby the Secretary to be necessary for the treatment of emergency cases(as defined in regulations) and has appropriate procedures or arrangementsfor storing, administering, and dispensing any drugs and biologicals;

(I) has a qualityassessment and performance improvement program, and appropriate proceduresfor review of utilization of clinic services, as the Secretary mayspecify;

(J) has a nursepractitioner, a physician assistant, or a certified nurse-midwife(as defined in subsection (gg)) available to furnish patient careservices not less than 50 percent of the time the clinic operates;and

(K) meets suchother requirements as the Secretary may find necessary in the interestof the health and safety of the individuals who are furnished servicesby the clinic.

For the purposes of this title, such term includes only a facilitywhich (i) is located in an area that is not an urbanized area (asdefined by the Bureau of the Census) and in which there are insufficientnumbers of needed health care practitioners (as determined by theSecretary), and that, within the previous 4-year period, has beendesignated by the chief executive officer of the State and certifiedby the Secretary as an area with a shortage of personal health servicesor designated by the Secretary either (I) as an area with a shortageof personal health services under section 330(b)(3) or 1302(7) ofthe Public Health Service Act, (II) as a health professional shortagearea described in section 332(a)(1)(A) of that Act because of itsshortage of primary medical care manpower, (III) as a high impactarea described in section 329(a)(5) of that Act, of (IV) as an areawhich includes a population group which the Secretary determines hasa health manpower shortage under section 332(a)(1)(B) of that Act[525], (ii) has filed an agreement with theSecretary by which it agrees not to charge any individual or otherperson for items or services for which such individual is entitledto have payment made under this title, except for the amount of anydeductible or coinsurance amount imposed with respect to such itemsor services (not in excess of the amount customarily charged for suchitems 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 primarilyfor the care and treatment of mental diseases. A facility that isin operation and qualifies as a rural health clinic under this titleor title XIX and that subsequently fails to satisfy the requirementof clause (i) shall be considered, for purposes of this title andtitle XIX, as still satisfying the requirement of such clause if itis determined, in accordance with criteria established by the Secretaryin regulations, to be essential to the delivery of primary care servicesthat would otherwise be unavailable in the geographic area servedby the clinic. If a State agency has determined under section 1864(a) that a facilityis a rural health clinic and the facility has applied to the Secretaryfor approval as such a clinic, the Secretary shall notify the facilityof the Secretary’s approval or disapproval later than 60 daysafter the date of the State agency determination or the application(whichever is later).

(3) The term “Federally qualified health center services” means—

(A) servicesof the type described in subparagraphs (A) through (C) of paragraph(1) and preventive services (as defined in section 1861(ddd)(3));and

(B) preventiveprimary health services that a center is required to provide undersection 330 of the Public Health Service Act,[526]

when furnished to an individual as an outpatient of a Federallyqualified health center and, for this purpose, any reference to arural health clinic or a physician described in paragraph (2)(B) isdeemed a reference to a Federally qualified health center by the centeror by a health care professional under contract with the center ora physician at the center, respectively.

(4) The term “Federally qualified health center” means an entity which—

(A)(i) is receivinga grant under section 330 of the Public Health Service Act, or

(ii)(I) is receivingfunding from such a grant under a contract with the recipient of sucha grant, and (II) meets the requirements to receive a grant undersection 330 of such Act;

(B) based onthe recommendation of the Health Resources and Services Administrationwithin the Public Health Service, is determined by the Secretary tomeet the requirements for receiving such a grant;

(C) was treatedby the Secretary, for purposes of part B, as a comprehensive Federallyfunded health center as of January 1, 1990; or

(D) is an outpatienthealth program or facility operated by a tribe or tribal organizationunder the Indian Self-Determination Act or by an urban Indian organizationreceiving funds under title V of the Indian Health Care ImprovementAct[527].

(5)(A) The term “physician assistant” and the term “nurse practitioner” mean, for purposes of this title, a physician assistant or nursepractitioner who performs such services as such individual is legallyauthorized to perform (in the State in which the individual performssuch services) in accordance with State law (or the State regulatorymechanism provided by State law), and who meets such training, education,and experience requirements (or any combination thereof) as the Secretarymay prescribe in regulations.

(B) The term “clinical nurse specialist” means, for purposes of this title,an individual who—

(i) is a registerednurse and is licensed to practice nursing in the State in which theclinical nurse specialist services are performed; and

(ii) holds a master’sdegree in a defined clinical area of nursing from an accredited educationalinstitution.

(6) The term “collaboration” means a process in which a nurse practitionerworks with a physician to deliver health care services within thescope of the practitioner’s professional expertise, with medicaldirection and appropriate supervision as provided for in jointly developedguidelines or other mechanisms as defined by the law of the Statein which the services are performed.

(7)(A) The Secretaryshall waive for a 1-year period the requirements of paragraph (2)that a rural health clinic employ a physician assistant, nurse practitioneror certified nurse midwife or that such clinic require such providersto furnish services at least 50 percent of the time that the clinicoperates for any facility that requests such waiver if the facilitydemonstrates that the facility has been unable, despite reasonableefforts, to hire a physician assistant, nurse practitioner, or certifiednurse-midwife in the previous 90-day period.

(B) The Secretarymay not grant such a waiver under subparagraph (A) to a facility ifthe request for the waiver is made less than 6 months after the dateof the expiration of any previous such waiver for the facility, orif 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 waiverwhich is requested under this paragraph shall be deemed granted unlesssuch request is denied by the Secretary within 60 days after the datesuch request is received.

Services of a Certified Registered Nurse Anesthetist

(bb)(1) The term “services of a certified registered nurse anesthetist” meansanesthesia services and related care furnished by a certified registerednurse anesthetist (as defined in paragraph (2)) which the nurse anesthetistis legally authorized to perform as such by the State in which theservices are furnished.

(2) The term “certified registered nurse anesthetist” means a certifiedregistered nurse anesthetist licensed by the State who meets sucheducation, training, and other requirements relating to anesthesiaservices and related care as the Secretary may prescribe. In prescribingsuch requirements the Secretary may use the same requirements as thoseestablished by a national organization for the certification of nurseanesthetists. 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 physicianor other qualified professional personnel (as defined in regulationsby the Secretary) to an individual who is an outpatient of a comprehensiveoutpatient rehabilitation facility under a plan (for furnishing suchitems and services to such individual) established and periodicallyreviewed by a physician—

(A) physicians’services;

(B) physicaltherapy, occupational therapy, speech-language pathology services,and respiratory therapy;

(C) prostheticand orthotic devices, including testing, fitting, or training in theuse of prosthetic and orthotic devices;

(D) social andpsychological services;

(E) nursingcare provided by or under the supervision of a registered professionalnurse;

(F) drugs andbiologicals which cannot, as determined in accordance with regulations,be self-administered;

(G) suppliesand durable medical equipment; and

(H) such otheritems and services as are medically necessary for the rehabilitationof the patient and are ordinarily furnished by comprehensive outpatientrehabilitation facilities,

excluding, however, any item or service if it would not be includedunder subsection (b) if furnished to an inpatient of a hospital. Inthe case of physical therapy, occupational therapy, and speech pathologyservices, there shall be no requirement that the item or service befurnished at any single fixed location if the item or service is furnishedpursuant to such plan and payments are not otherwise made for theitem or service under this title.

(2) The term “comprehensive outpatient rehabilitation facility” means afacility which—

(A) is primarilyengaged in providing (by or under the supervision of physicians) diagnostic,therapeutic, and restorative services to outpatients for the rehabilitationof injured, disabled, or sick persons;

(B) providesat least the following comprehensive outpatient rehabilitation services:(i) physicians’ services (rendered by physicians, as definedin 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) maintainsclinical records on all patients;

(D) has policiesestablished by a group of professional personnel (associated withthe facility), including one or more physicians defined in subsection(r)(1) to govern the comprehensive outpatient rehabilitation servicesit furnishes, and provides for the carrying out of such policies bya full-or part-time physician referred to in subparagraph (B)(i);

(E) has a requirementthat every patient must be under the care of a physician;

(F) in the caseof a facility in any State in which State or applicable local lawprovides for the licensing of facilities of this nature (i) is licensedpursuant to such law, or (ii) is approved by the agency of such Stateor locality, responsible for licensing facilities of this nature,as meeting the standards established for such licensing;

(G) has in effecta utilization review plan in accordance with regulations prescribedby the Secretary;

(H) has in effectan overall plan and budget that meets the requirements of subsection(z);

(I) providesthe Secretary on a continuing basis with a surety bond in a form specifiedby the Secretary and in an amount that is not less than $50,000; and

(J) meets suchother conditions of participation as the Secretary may find necessaryin the interest of the health and safety of individuals who are furnishedservices by such facility, including conditions concerning qualificationsof personnel in these facilities.

Hospice Care; Hospice Program

(dd)(1) Theterm “hospice care” means the following items and servicesprovided to a terminally ill individual by, or by others under arrangementsmade by, a hospice program under a written plan (for providing suchcare to such individual) established and periodically reviewed bythe individual’s attending physician and by the medical director(and by the interdisciplinary group described in paragraph (2)(B))of the program—

(A) nursingcare provided by or under the supervision of a registered professionalnurse,

(B) physicalor occupational therapy, or speech-language pathology services,

(C) medicalsocial services under the direction of a physician,

(D)(i) services ofa home health aide who has successfully completed a training programapproved by the Secretary and

(ii) homemakerservices,

(E) medicalsupplies (including drugs and biologicals) and the use of medicalappliances, while under such a plan,

(F) physicians’services,

(G) short-terminpatient care (including both respite care and procedures necessaryfor pain control and acute and chronic symptom management) in an inpatientfacility meeting such conditions as the Secretary determines to beappropriate to provide such care, but such respite care may be providedonly on an intermittent, nonroutine, and occasional basis and maynot be provided consecutively over longer than five days,

(H) counseling(including dietary counseling) with respect to care of the terminallyill individual and adjustment to his death, and

(I) any otheritem or service which is specified in the plan and for which paymentmay 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 periodsof crisis (meeting criteria established by the Secretary) and onlyas necessary to maintain the terminally ill individual at home.

(2) Theterm “hospice program” means a public agency or privateorganization (or a subdivision thereof) which—

(A)(i) is primarilyengaged in providing the care and services described in paragraph(1) and makes such services available (as needed) on a 24-hour basisand which also provides bereavement counseling for the immediate familyof terminally ill individuals and services described in section 1812(a)(5),

(ii) provides forsuch care and services in individuals’ homes, on an outpatientbasis, and on a short-term inpatient basis, directly or under arrangementsmade by the agency or organization, except that—

(I) the agencyor organization must routinely provide directly substantially allof each of the services described in subparagraphs (A), (C), and (H)of paragraph (1), except as otherwise provided in paragraph (5), and

(II) in thecase of other services described in paragraph (1) which are not provideddirectly by the agency or organization, the agency or organizationmust maintain professional management responsibility for all suchservices furnished to an individual, regardless of the location orfacility in which such services are furnished; and

(iii) providesassurances satisfactory to the Secretary that the aggregate numberof days of inpatient care described in paragraph (1)(G) provided inany 12-month period to individuals who have an election in effectunder section 1812(d) with respect to that agency or organization does not exceed 20 percentof the aggregate number of days during that period on which such electionsfor such individuals are in effect;

(B) has an interdisciplinarygroup of personnel which—

(i) includes atleast—

(I) one physician(as defined in subsection (r)(1)),

(II) one registeredprofessional nurse, and

(III) onesocial worker,

employed by or, in the case of a physician described in subclause(I), under contract with the agency or organization, and also includesat least one pastoral or other counselor,

(ii) provides (orsupervises the provision of) the care and services described in paragraph(1), and

(iii) establishesthe policies governing the provision of such care and services;

(C) maintainscentral clinical records on all patients;

(D) does notdiscontinue the hospice care it provides with respect to a patientbecause of the inability of the patient to pay for such care;

(E)(i) utilizes volunteersin its provision of care and services in accordance with standardsset by the Secretary, which standards shall ensure a continuing levelof effort to utilize such volunteers, and

(ii) maintainsrecords on the use of these volunteers and the cost savings and expansionof care and services achieved through the use of these volunteers;

(F) in the caseof an agency or organization in any State in which State or applicablelocal law provides for the licensing of agencies or organizationsof this nature, is licensed pursuant to such law; and

(G) meets suchother requirements as the Secretary may find necessary in the interestof the health and safety of the individuals who are provided careand services by such agency or organization.

(3)(A) An individualis considered to be “terminally ill” if the individualhas a medical prognosis that the individual’s life expectancyis 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 (asdefined in such subsection), who may be employed by a hospice program,whom the individual identifies as having the most significant rolein the determination and delivery of medical care to the individualat the time the individual makes an election to receive hospice care.[528]

(4)(A) An entitywhich is certified as a provider of services other than a hospiceprogram shall be considered, for purposes of certification as a hospiceprogram, to have met any requirements under paragraph (2) which arealso the same requirements for certification as such other type ofprovider. The Secretary shall coordinate surveys for determining certificationunder this title so as to provide, to the extent feasible, for simultaneoussurveys of an entity which seeks to be certified as a hospice programand as a provider of services of another type.

(B) Any entitywhich is certified as a hospice program and as a provider of anothertype shall have separate provider agreements under section 1866 and shall fileseparate cost reports with respect to costs incurred in providinghospice care and in providing other services and items under thistitle.

(C)[529] Any entity that is certified as a hospice program shall besubject to a standard survey by an appropriate State or local surveyagency, or an approved accreditation agency, as determined by theSecretary, not less frequently than once every 36 months beginning6 months after the date of the enactment of this subparagraph andending September 30, 2025.

(5)(A) The Secretarymay waive the requirements of paragraph (2)(A)(ii)(I) for an agencyor organization with respect to all or part of the nursing care describedin paragraph (1)(A) if such agency or organization—

(i) is located inan area which is not an urbanized area (as defined by the Bureau ofthe Census);

(ii) was in operationon or before January 1, 1983; and

(iii) has demonstrateda good faith effort (as determined by the Secretary) to hire a sufficientnumber of nurses to provide such nursing care directly.

(B) Any waiver,which is in such form and containing such information as the Secretarymay require and which is requested by an agency or organization undersubparagraph (A) or (C), shall be deemed to be granted unless suchrequest is denied by the Secretary within 60 days after the date suchrequest is received by the Secretary. The granting of a waiver undersubparagraph (A) or (C) shall not preclude the granting of any subsequentwaiver request should such a waiver again become necessary.

(C) The Secretarymay waive the requirements of paragraph (2)(A)(i) and (2)(A)(ii) foran agency or organization with respect to the services described inparagraph (1)(B) and, with respect to dietary counseling, paragraph(1)(H), if such agency or organization—

(i) is located inan area which is not an urbanized area (as defined by the Bureau ofCensus), and

(ii) demonstratesto the satisfaction of the Secretary that the agency or organizationhas been unable, despite diligent efforts, to recruit appropriatepersonnel.

(D) In extraordinary,exigent, or other non-routine circumstances, such as unanticipatedperiods of high patient loads, staffing shortages due to illness orother events, or temporary travel of a patient outside a hospice program’sservice area, a hospice program may enter into arrangements with anotherhospice program for the provision by that other program of servicesdescribed in paragraph (2)(A)(ii)(I). The provisions of paragraph(2)(A)(ii)(II) shall apply with respect to the services provided undersuch arrangements.

(E) A hospiceprogram may provide services described in paragraph (1)(A) other thandirectly by the program if the services are highly specialized servicesof a registered professional nurse and are provided non-routinelyand so infrequently so that the provision of such services directlywould be impracticable and prohibitively expensive.

Discharge Planning Process

(ee)(1) A discharge planningprocess of a hospital shall be considered sufficient if it is applicableto services furnished by the hospital to individuals entitled to benefitsunder this title and if it meets the guidelines and standards establishedby the Secretary under paragraph (2).

(2) The Secretaryshall develop guidelines and standards for the discharge planningprocess in order to ensure a timely and smooth transition to the mostappropriate type of and setting for post-hospital or rehabilitativecare. The guidelines and standards shall include the following:

(A) The hospitalmust identify, at an early stage of hospitalization, those patientswho are likely to suffer adverse health consequences upon dischargein the absence of adequate discharge planning.

(B) Hospitalsmust provide a discharge planning evaluation for patients identifiedunder subparagraph (A) and for other patients upon the request ofthe patient, patient’s representative, or patient’s physician.

(C) Any dischargeplanning evaluation must be made on a timely basis to ensure thatappropriate arrangements for post-hospital care will be made beforedischarge and to avoid unnecessary delays in discharge.

(D) A dischargeplanning evaluation must include an evaluation of a patient’slikely need for appropriate post-hospital services, including hospicecare and post-hospital extended care services and the availabilityof those services, including the availability of home health servicesthrough individuals and entities that participate in the program underthis title and that serve the area in which the patient resides andthat request to be listed by the hospital as available and, in thecase of individuals who are likely to need post-hospital extendedcare services, the availability of such services through facilitiesthat participate in the program under this title and that serve thearea in which the patient resides.

(E) The dischargeplanning evaluation must be included in the patient’s medicalrecord for use in establishing an appropriate discharge plan and theresults of the evaluation must be discussed with the patient (or thepatient’s representative).

(F) Upon therequest of a patient’s physician, the hospital must arrangefor the development and initial implementation of a discharge planfor the patient.

(G) Any dischargeplanning evaluation or discharge plan required under this paragraphmust be developed by, or under the supervision of, a registered professionalnurse, social worker, or other appropriately qualified personnel.

(H) Consistentwith section 1802, the discharge plan shall—

(i) not specifyor otherwise limit the qualified provider which may provide post-hospitalhome health services, and

(ii) identify (ina form and manner specified by the Secretary) any entity to whom theindividual is referred in which the hospital has a disclosable financialinterest (as specified by the Secretary consistent with section 1866(a)(1)(S))or which has such an interest in the hospital.

(3) With respectto a discharge plan for an individual who is enrolled with a Medicare+Choiceorganization under a Medicare+Choice plan and is furnished inpatienthospital services by a hospital under a contract with the organization—

(A) the dischargeplanning evaluation under paragraph (2)(D) is not required to includeinformation on the availability of home health services through individualsand entities which do not have a contract with the organization; and

(B) notwithstandingsubparagraph (H)(i), the plan may specify or limit the provider (orproviders) of post-hospital home health services or other post-hospitalservices under the plan.

Partial Hospitalization Services

(ff)(1) The term “partial hospitalization services” means the items and servicesdescribed in paragraph (2) prescribed by a physician and providedunder a program described in paragraph (3) under the supervision ofa physician pursuant to an individualized, written plan of treatmentestablished and periodically reviewed by a physician (in consultationwith appropriate staff participating in such program), which plansets forth the physician’s diagnosis, the type, amount, frequency,and duration of the items and services provided under the plan, andthe goals for treatment under the plan.

(2) The items andservices described in this paragraph are—

(A) individualand group therapy with physicians or psychologists (or other mentalhealth professionals to the extent authorized under State law),

(B) occupationaltherapy requiring the skills of a qualified occupational therapist,

(C) servicesof social workers, trained psychiatric nurses, and other staff trainedto work with psychiatric patients,

(D) drugs andbiologicals furnished for therapeutic purposes (which cannot, as determinedin accordance with regulations, be self-administered),

(E) individualizedactivity therapies that are not primarily recreational or diversionary,

(F) family counseling(the primary purpose of which is treatment of the individual’scondition),

(G) patienttraining and education (to the extent that training and educationalactivities are closely and clearly related to individual’s careand treatment),

(H) diagnosticservices, and

(I) such otheritems and services as the Secretary may provide (but in no event toinclude meals and transportation);

that are reasonable and necessary for the diagnosis or activetreatment of the individual’s condition, reasonably expectedto improve or maintain the individual’s condition and functionallevel and to prevent relapse or hospitalization, and furnished pursuantto such guidelines relating to frequency and duration of servicesas the Secretary shall by regulation establish (taking into accountaccepted norms of medical practice and the reasonable expectationof patient improvement).

(3)(A) A programdescribed in this paragraph is a program which is furnished by a hospitalto its outpatients or by a community mental health center (as definedin subparagraph (B)), and which is a distinct and organized intensiveambulatory treatment service offering less than 24-hour-daily careother than in an individual’s home or in an inpatient or residentialsetting.

(B) For purposesof subparagraph (A), the term “community mental health center” means an entity that—

(i)(I) providesthe mental health services described in section 1913(c)(1) of thePublic Health Service Act; or

(II) in thecase of an entity operating in a State that by law precludes the entityfrom providing itself the service described in subparagraph (E) ofsuch section, provides for such service by contract with an approvedorganization or entity (as determined by the Secretary);

(ii) meets applicablelicensing or certification requirements for community mental healthcenters in the State in which it is located;

(iii) providesat least 40 per cent of its services to individuals who are not eligiblefor benefits under this title; and

(iv) meets suchadditional 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 insection 1931(c)(1) of the Public Health Service Act.

Certified Nurse-Midwife Services

(gg)(1) The term “certified nurse-midwife services” means such services furnishedby a certified nurse-midwife (as defined in paragraph (2)) and suchservices and supplies furnished as an incident to the nurse-midwife’sservice which the certified nurse-midwife is legally authorized toperform under State law (or the State regulatory mechanism providedby State law) as would otherwise be covered if furnished by a physicianor as an incident to a physicians’ service.

(2) The term “certified nurse-midwife” means a registered nurse who hassuccessfully completed a program of study and clinical experiencemeeting guidelines prescribed by the Secretary, or has been certifiedby 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) possessesa master’s or doctor’s degree in social work;

(B) after obtainingsuch degree has performed at least 2 years of supervised clinicalsocial work; and

(C)(i) is licensedor certified as a clinical social worker by the State in which theservices are performed, or

(ii) in the caseof an individual in a State which does not provide for licensure orcertification—

(I) has completedat least 2 years or 3,000 hours of post-master’s degree supervisedclinical social work practice under the supervision of a master’slevel social worker in an appropriate setting (as determined by theSecretary), and

(II) meetssuch other criteria as the Secretary establishes.

(2) The term “clinical social worker services” means services performedby a clinical social worker (as defined in paragraph (1)) for thediagnosis and treatment of mental illnesses (other than services furnishedto an inpatient of a hospital and other than services furnished toan inpatient of a skilled nursing facility which the facility is requiredto provide as a requirement for participation) which the clinicalsocial worker is legally authorized to perform under State law (orthe State regulatory mechanism provided by State law) of the Statein which such services are performed as would otherwise be coveredif furnished by a physician or as an incident to a physician’sprofessional service.

Qualified Psychologist Services

(ii) The term “qualified psychologist services” means such services and such services and supplies furnished asan incident to his service furnished by a clinical psychologist (asdefined by the Secretary) which the psychologist is legally authorizedto perform under State law (or the State regulatory mechanism providedby State law) as would otherwise be covered if furnished by a physicianor 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 purposeof early detection of breast cancer and includes a physician’sinterpretation 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-menopausalosteoporosis provided to an individual by a home health agency if,in accordance with regulations promulgated by the Secretary—

(1) the individual’sattending physician certifies that the individual has suffered a bonefracture related to post-menopausal osteoporosis and that the individualis unable to learn the skills needed to self-administer such drugor is otherwise physically or mentally incapable of self-administeringsuch drug; and

(2) the individualis confined to the individual’s home (except when receivingitems 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 furnishedby a qualified speech-language pathologist as the speech-languagepathologist is legally authorized to perform under State law (or theState regulatory mechanism provided by the State law) as would otherwisebe covered if furnished by a physician.

(2)[530] The term “outpatient speech-language pathologyservices” has the meaning given the term “outpatientphysical therapy services” in subsection (p), except that inapplying such subsection—

(A) “speech-languagepathology” shall be substituted for “physical therapy” each place it appears; and

(B) “speech-languagepathologist” shall be substituted for “physical therapist” each place it appears.

(3) The term “audiology services” means such hearing and balance assessmentservices furnished by a qualified audiologist as the audiologist islegally authorized to perform under State law (or the State regulatorymechanism provided by State law), as would otherwise be covered iffurnished by a physician.

(4) In this subsection:

(A) The term “qualified speech-language pathologist” means an individualwith a masters’s or doctoral degree in speech-language pathologywho—

(i) is licensedas a speech-language pathologist by the State in which the individualfurnishes such services, or

(ii) in the caseof an individual who furnishes services in a State which does notlicense speech-language pathologists, has successfully completed 350clock hours of supervised clinical practicum (or is in the processof accumulating such supervised clinical experience), performed notless than 9 months of supervised full-time speech-language pathologyservices after obtaining a master’s or doctoral degree in speech-languagepathology or a related field, and successfully completed a nationalexamination in speech-language pathology approved by the Secretary.

(B) The term “qualified audiologist” means an individual with a master’sor doctoral degree in audiology who—

(i) is licensedas an audiologist by the State in which the individual furnishes suchservices, or

(ii) in the caseof an individual who furnishes services in a State which does notlicense audiologists, has successfully completed 350 clock hours ofsupervised clinical practicum (or is in the process of accumulatingsuch supervised clinical experience), performed not less than 9 monthsof supervised full-time audiology services after obtaining a master’sor doctoral degree in audiology or a related field, and successfullycompleted 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 theSecretary as a critical access hospital under section 1820(e).

(2) The term “inpatient critical access hospital services” means items andservices, furnished to an inpatient of a critical access hospitalby such facility, that would be inpatient hospital services if furnishedto an inpatient of a hospital by a hospital.

(3) The term “outpatient critical access hospital services” means medicaland other health services furnished by a critical access hospitalon an outpatient basis.

Screening Pap Smear; Screening Pelvic Exam

(nn)(1) The term “screening pap smear” means a diagnostic laboratory test consistingof a routine exfoliative cytology test (Papanicolaou test) providedto a woman for the purpose of early detection of cervical or vaginalcancer and includes a physician’s interpretation of the resultsof the test, if the individual involved has not had such a test duringthe preceding 2 years, or during the preceding year in the case ofa woman described in paragraph (3).

(2) The term “screening pelvic exam” means a pelvic examination providedto a woman if the woman involved has not had such an examination duringthe preceding 2 years, or during the preceding year in the case ofa woman described in paragraph (3), and includes a clinical breastexamination.

(3) A woman describedin this paragraph is a woman who—

(A) is of childbearingage and has had a test described in this subsection during any ofthe preceding 3 years that indicated the presence of cervical or vaginalcancer or other abnormality; or

(B) is at highrisk of developing cervical or vaginal cancer (as determined pursuantto factors identified by the Secretary).

Prostate Cancer Screening Tests

(oo)(1) The term “prostate cancer screening test” means a test that consistsof any (or all) of the procedures described in paragraph (2) providedfor the purpose of early detection of prostate cancer to a man over50 years of age who has not had such a test during the preceding year.

(2) The proceduresdescribed in this paragraph are as follows:

(A) A digitalrectal examination.

(B) A prostate-specificantigen blood test.

(C) For yearsbeginning after 2002, such other procedures as the Secretary findsappropriate for the purpose of early detection of prostate cancer,taking into account changes in technology and standards of medicalpractice, availability, effectiveness, costs, and such other factorsas the Secretary considers appropriate.

Colorectal Cancer Screening Tests

(pp)(1) The term “colorectal cancer screening test” means any of the followingprocedures furnished to an individual for the purpose of early detectionof colorectal cancer:

(A) Screeningfecal-occult blood test.

(B) Screeningflexible sigmoidoscopy.

(C) Screeningcolonoscopy.

(D) Such othertests or procedures, and modifications to tests and procedures underthis subsection, with such frequency and payment limits, as the Secretarydetermines appropriate, in consultation with appropriate organizations.

(2) An “individualat high risk for colorectal cancer” is an individual who, becauseof family history, prior experience of cancer or precursor neoplasticpolyps, a history of chronic digestive disease condition (includinginflammatory bowel disease, Crohn’s Disease, or ulcerative colitis),the presence of any appropriate recognized gene markers for colorectalcancer, or other predisposing factors, faces a high risk for colorectalcancer.[531]

Diabetes Outpatient Self-Management Training Services

(qq)(1) The term “diabetes outpatient self-management training services” meanseducational and training services furnished (at such times as theSecretary determines appropriate) to an individual with diabetes bya certified provider (as described in paragraph (2)(A)) in an outpatientsetting by an individual or entity who meets the quality standardsdescribed in paragraph (2)(B), but only if the physician who is managingthe individual’s diabetic condition certifies that such servicesare needed under a comprehensive plan of care related to the individual’sdiabetic condition to ensure therapy compliance or to provide theindividual with necessary skills and knowledge (including skills relatedto the self-administration of injectable drugs) to participate inthe management of the individual’s condition.

(2) In paragraph(1)—

(A) a “certified provider” is a physician, or other individual orentity designated by the Secretary, that, in addition to providingdiabetes outpatient self-management training services, provides otheritems 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 describedin this paragraph if the physician, or individual or entity, meetsquality standards established by the Secretary, except that the physicianor other individual or entity shall be deemed to have met such standardsif the physician or other individual or entity meets applicable standardsoriginally established by the National Diabetes Advisory Board andsubsequently revised by organizations who participated in the establishmentof standards by such Board, or is recognized by an organization thatrepresents individuals (including individuals under this title) withdiabetes as meeting standards for furnishing the services.

Bone Mass Measurement

(rr)(1) The term “bone mass measurement” means a radiologic or radioisotopicprocedure or other procedure approved by the Food and Drug Administrationperformed on a qualified individual (as defined in paragraph (2))for the purpose of identifying bone mass or detecting bone loss ordetermining bone quality, and includes a physician’s interpretationof the results of the procedure.

(2) For purposesof this subsection, the term “qualified individual” meansan individual who is (in accordance with regulations prescribed bythe Secretary)—

(A) an estrogen-deficientwoman at clinical risk for osteoporosis;

(B) an individualwith vertebral abnormalities;

(C) an individualreceiving long-term glucocorticoid steroid therapy;

(D) an individualwith primary hyperparathyroidism; or

(E) an individualbeing monitored to assess the response to or efficacy of an approvedosteoporosis drug therapy.

(3) The Secretaryshall establish such standards regarding the frequency with whicha qualified individual shall be eligible to be provided benefits forbone mass measurement under this title.

Religious Nonmedical Health Care Institution

(ss)(1) The term “religious nonmedical health care institution” means an institutionthat—

(A) is describedin subsection (c)(3) of section 501 of the Internal Revenue Code of1986[532] and is exempt from taxes under subsection (a) of suchsection;

(B) is lawfullyoperated under all applicable Federal, State, and local laws and regulations;

(C) providesonly nonmedical nursing items and services exclusively to patientswho choose to rely solely upon a religious method of healing and forwhom the acceptance of medical health services would be inconsistentwith their religious beliefs;

(D) providessuch nonmedical items and services exclusively through nonmedicalnursing personnel who are experienced in caring for the physical needsof such patients;

(E) providessuch nonmedical items and services to inpatients on a 24-hour basis;

(F) on the basisof its religious beliefs, does not provide through its personnel orotherwise medical items and services (including any medical screening,examination, diagnosis, prognosis, treatment, or the administrationof drugs) for its patients;

(G)(i) is not ownedby, under common ownership with, or has an ownership interest in,a provider of medical treatment or services;

(ii) is not affiliatedwith—

(I) a providerof medical treatment or services, or

(II) an individualwho has an ownership interest in a provider of medical treatment orservices;

(H) has in effecta utilization review plan which—

(i) provides forthe review of admissions to the institution, of the duration of staystherein, of cases of continuous extended duration, and of the itemsand services furnished by the institution,

(ii) requires thatsuch reviews be made by an appropriate committee of the institutionthat includes the individuals responsible for overall administrationand for supervision of nursing personnel at the institution,

(iii) providesthat records be maintained of the meetings, decisions, and actionsof such committee, and

(iv) meets suchother requirements as the Secretary finds necessary to establish aneffective utilization review plan;

(I) providesthe Secretary with such information as the Secretary may require toimplement section 1821, including information relating to quality of care and coveragedeterminations; and

(J) meets suchother requirements as the Secretary finds necessary in the interestof the health and safety of individuals who are furnished servicesin the institution.

(2) To the extentthat the Secretary finds that the accreditation of an institutionby a State, regional, or national agency or association provides reasonableassurances that any or all of the requirements of paragraph (1) aremet or exceeded, the Secretary may treat such institution as meetingthe condition or conditions with respect to which the Secretary madesuch finding.

(3)(A)(i) In administeringthis subsection and section 1821, the Secretary shall not require any patient of a religiousnonmedical health care institution to undergo medical screening, examination,diagnosis, prognosis, or treatment or to accept any other medicalhealth care service, if such patient (or legal representative of thepatient) objects thereto on religious grounds.

(ii) Clause (i)shall not be construed as preventing the Secretary from requiringunder section 1821(a)(2) the provision of sufficient information regarding an individual’scondition as a condition for receipt of benefits under part A forservices provided in such an institution.

(B)(i) In administeringthis subsection and section 1821, the Secretary shall not subject a religious nonmedicalhealth care institution or its personnel to any medical supervision,regulation, or control, insofar as such supervision, regulation, orcontrol would be contrary to the religious beliefs observed by theinstitution or such personnel.

(ii) Clause (i)shall not be construed as preventing the Secretary from reviewingitems and services billed by the institution to the extent the Secretarydetermines such review to be necessary to determine whether such itemsand services were not covered under part A, are excessive, or arefraudulent.

(4)(A) For purposesof paragraph (1)(G)(i), an ownership interest of less than 5 percentshall not be taken into account.

(B) For purposesof paragraph (1)(G)(ii), none of the following shall be consideredto create an affiliation:

(i) An individualserving as an uncompensated director, trustee, officer, or other memberof the governing body of a religious nonmedical health care institution.

(ii) An individualwho is a director, trustee, officer, employee, or staff member ofa religious nonmedical health care institution having a family relationshipwith an individual who is affiliated with (or has an ownership interestin) a provider of medical treatment or services.

(iii) An individualor entity furnishing goods or services as a vendor to both providersof medical treatment or services and religious nonmedical health careinstitutions.

(tt)(1) The term “post-institutional home health services” means home healthservices furnished to an individual—

(A) after dischargefrom a hospital or critical access hospital in which the individualwas an inpatient for not less than 3 consecutive days before suchdischarge if such home health services were initiated within 14 daysafter the date of such discharge; or

(B) after dischargefrom a skilled nursing facility in which the individual was providedpost–hospital extended care services if such home health serviceswere initiated within 14 days after the date of such discharge.

(2) The term “home health spell of illness” with respect to any individualmeans a period of consecutive days—

(A) beginningwith the first day (not included in a previous home health spell ofillness) (i) on which such individual is furnished post-institutionalhome health services, and (ii) which occurs in a month for which theindividual is entitled to benefits under part A, and

(B) ending withthe close of the first period of 60 consecutive days thereafter oneach of which the individual is neither an inpatient of a hospitalor critical access hospital nor an inpatient of a facility describedin section 1819(a)(1) or subsection (y)(1) nor provided home health services.

(uu) The term “screening for glaucoma” means a dilated eye examination withan intraocular pressure measurement, and a direct ophthalmoscopy ora slit–lamp biomicroscopic examination for the early detectionof glaucoma which is furnished by or under the direct supervisionof an optometrist or ophthalmologist who is legally authorized tofurnish such services under State law (or the State regulatory mechanismprovided by State law) of the State in which the services are furnished,as would otherwise be covered if furnished by a physician or as anincident to a physician’s professional service, if the individualinvolved has not had such an examination in the preceding year.

Medical Nutrition Therapy Services; Registered Dietitian orNutrition Professional

(vv)(1) The term “medical nutrition therapy services” means nutritional diagnostic,therapy, and counseling services for the purpose of disease managementwhich 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 abaccalaureate or higher degree granted by a regionally accreditedcollege or university in the United States (or an equivalent foreigndegree) with completion of the academic requirements of a programin nutrition or dietetics, as accredited by an appropriate nationalaccreditation organization recognized by the Secretary for this purpose;

(B) has completedat least 900 hours of supervised dietetics practice under the supervisionof a registered dietitian or nutrition professional; and

(C)(i) is licensedor certified as a dietitian or nutrition professional by the Statein which the services are performed; or

(ii) in the caseof an individual in a State that does not provide for such licensureor 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 individualwho, as of the date of the enactment of this subsection, is licensedor certified as a dietitian or nutrition professional by the Statein which medical nutrition therapy services are performed.

Initial Preventive Physical Examination

(ww)(1) The term “initial preventive physical examination” means physicians’servicesconsisting of a physical examination (including measurement of height,weight, body mass index, and blood pressure) with the goal of healthpromotion and disease detection and includes education, counseling,and referral with respect to screening and other preventive servicesdescribed in paragraph (2), end-of-life planning (as defined in paragraph(3)) upon the agreement with the individual, and the furnishing ofa review of any current opioid prescriptions (as defined in paragraph(4)), but does not include clinical laboratory tests.[533]

(2) The screeningand other preventive services described in this paragraph includethe following:

(A) Pneumococcal,influenza, and hepatitis B vaccine and administration under subsection(s)(10).

(B) Screeningmammography as defined in subsection (jj).

(C) Screeningpap smear and screening pelvic exam as defined in subsection (nn).

(D) Prostatecancer screening tests as defined in subsection (oo).

(E) Colorectalcancer screening tests as defined in subsection (pp).

(F) Diabetesoutpatient self-management training services as defined in subsection(qq)(1).

(G) Bone massmeasurement as defined in subsection (rr).

(H) Screeningfor glaucoma as defined in subsection (uu).

(I) Medicalnutrition therapy services as defined in subsection (vv).

(J) Cardiovascularscreening blood tests as defined in subsection (xx)(1).

(K) Diabetesscreening tests as defined in subsection (yy).

(L) Ultrasoundscreening for abdominal aortic aneurysm as defined in section 1861(bbb).

(M) An electrocardiogram.

(N) Screeningfor potential substance use disorders.[534]

(O) Additionalpreventive services (as defined in subsection (ddd)(1)).

(3) For purposesof paragraph (1), the term “end-of-life planning” meansverbal or written information regarding—

(A) an individual’sability to prepare an advance directive in the case that an injuryor illness causes the individual to be unable to make health caredecisions; and

(B) whetheror not the physician is willing to follow the individual’s wishesas expressed in an advance directive.

(4) For purposes ofparagraph (1), the term “a review of any current opioid prescriptions” means, with respect to an individual determined to have a currentprescription for opioids—

(A) a reviewof the potential risk factors to the individual for opioid use disorder;

(B) an evaluationof the individual’s severity of pain and current treatment plan;

(C) the provisionof information on non-opioid treatment options; and

(D) a referralto a specialist, as appropriate.[535]

Cardiovascular Screening Blood Test

(xx)(1) The term “cardiovascular screening blood test” means a blood test forthe early detection of cardiovascular disease (or abnormalities associatedwith an elevated risk of cardiovascular disease) that tests for thefollowing:

(A) Cholesterollevels and other lipid or triglyceride levels.

(B) Such otherindications 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 riskfor cardiovascular disease), including indications measured by noninvasivetesting. The Secretary may not approve an indication under subparagraph(B) for any individual unless a blood test for such is recommendedby the United States Preventive Services Task Force.

(2) The Secretaryshall establish standards, in consultation with appropriate organizations,regarding the frequency for each type of cardiovascular screeningblood tests, except that such frequency may not be more often thanonce every 2 years.

Diabetes Screening Tests

(yy)(1) The term “diabetes screening tests” means testing furnished to an individualat risk for diabetes (as defined in paragraph (2)) for the purposeof early detection of diabetes, including—

(A) a fastingplasma glucose test; and

(B) such othertests, and modifications to tests, as the Secretary determines appropriate,in consultation with appropriate organizations.

(2) For purposesof paragraph (1), the term “individual at risk for diabetes” means an individual who has any of the following risk factors fordiabetes:

(A) Hypertension.

(B) Dyslipidemia.

(C) Obesity,defined as a body mass index greater than or equal to 30 kg/m 2.

(D) Previousidentification of an elevated impaired fasting glucose.

(E) Previousidentification of impaired glucose tolerance.

(F) A risk factorconsisting of at least 2 of the following characteristics:

(i) Overweight,defined as a body mass index greater than 25, but less than 30, kg/m 2 .

(ii) A family historyof diabetes.

(iii) A historyof gestational diabetes mellitus or delivery of a baby weighing greaterthan 9 pounds.

(iv) 65 years ofage or older.

(3) The Secretaryshall establish standards, in consultation with appropriate organizations,regarding the frequency of diabetes screening tests, except that suchfrequency may not be more often than twice within the 12-month periodfollowing the date of the most recent diabetes screening test of thatindividual.

Intravenous Immune Globulin

(zz) The term “intravenous immune globulin” means an approved pooled plasma derivative for the treatment inthe patient’s home of a patient with a diagnosed primary immunedeficiency disease, but not including items or services related tothe administration of the derivative, if a physician determines administrationof 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 healthcare institution (as defined in subsection (ss)(1)), but only withrespect to items and services ordinarily furnished by such an institutionto individuals in their homes, and that are comparable to items andservices furnished to individuals by a home health agency that isnot religious nonmedical health care institution.

(2)(A) Subjectto subparagraphs (B), payment may be made with respect to servicesprovided by such an institution only to such extent and under suchconditions, limitations, and requirements (in addition to or in lieuof the conditions, limitations, and requirements otherwise applicable)as may be provided in regulations consistent with section 1821.

(B) Notwithstandingany other provision of this title, payment may not be made under subparagraph(A)—

(i) in a year insofaras such payments exceed $700,000; and

(ii) after December31, 2006.

Ultrasound Screening for Abdominal Aortic Aneurysm

(bbb) The term “ultrasound screening forabdominal aortic aneursym” means—

(1) a procedureusing sound waves (or such other procedures using alternative technologies,of commensurate accurary and cost, that the Secretary may specify)provided for the early detection of abdominal aortic aneursym;

(2) includes a physician’sinterpretation 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 providinginpatient services, by or under the supervision of a physician, toMedicare beneficiaries whose medically complex conditions requirea long hospital stay and programs of care provided by a long-termcare hospital;

(2) has an average inpatient lengthof 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 patientreview process, documented in the patient medical record, that screenspatients prior to admission for appropriateness of admission to along-term care hospital, validates within 48 hours of admission thatpatients meet admission criteria for long-term care hospitals, regularlyevaluates patients throughout their stay for continuation of carein a long-term care hospital, and assesses the available dischargeoptions when patients no longer meet such continued stay criteria;

(B) the institution has active physicianinvolvement with patients during their treatment through an organizedmedical staff, physician-directed treatment with physician on-siteavailability on a daily basis to review patient progress, and consultingphysicians on call and capable of being at the patient’s sidewithin a moderate period of time, as determined by the Secretary;and

(C) the institution has interdisciplinaryteam treatment for patients, requiring interdisciplinary teams ofhealth care professionals, including physicians, to prepare and carryout an individualized treatment plan for each patient.

Additional Preventive Services; Preventive Services

(ddd)(1) The term “additional preventive services” means services not describedin subparagraph (A) or (C) of paragraph (3) that identify medicalconditions or risk factors and that the Secretary determines are—

(A) reasonableand necessary for the prevention or early detection of an illnessor disability;

(B) recommendedwith a grade of A or B by the United States Preventive Services TaskForce; and

(C) appropriatefor individuals entitled to benefits under part A or enrolled underpart B.

(2) In making determinationsunder paragraph (1) regarding the coverage of a new service, the Secretaryshall 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 assessmentof the relation between predicted outcomes and the expenditures forsuch service and may take into account the results of such assessmentin making such determination.

(3) The term “preventive services” means the following:

(A) The screeningand preventive services described in subsection (ww)(2) (other thanthe service described in subparagraph (M) of such subsection).

(B) An initialpreventive physical examination (as defined in subsection (ww)).

(C) Personalizedprevention plan services (as defined in subsection (hhh)(1)).

Cardiac Rehabilitation Program; Intensive Cardiac RehabilitationProgram

(eee)(1) The term “cardiac rehabilitation program” means a program (as describedin paragraph (2)) that furnishes the items and services describedin paragraph (3) under the supervision of a physician (as definedin subsection (r)(1)) or a physician assistant, nurse practitioner,or clinical nurse specialist (as those terms are defined in subsection(aa)(5)).[536]

(2) A program describedin this paragraph is a program under which—

(A) items andservices under the program are delivered—

(i) in a physician’soffice;

(ii) in a hospitalon an outpatient basis; or

(iii) in othersettings determined appropriate by the Secretary;[537]

(B) a physician(as defined in subsection (r)(1)) or a physician assistant, nursepractitioner, or clinical nurse specialist (as those terms are definedin subsection (aa)(5)) is immediately available and accessible formedical consultation and medical emergencies at all times items andservices are being furnished under the program, except that, in thecase of items and services furnished under such a program in a hospital,such availability shall be presumed; and[538]

(C) individualizedtreatment is furnished under a written plan established, reviewed,and signed by a physician every 30 days that describes—

(i) the individual’sdiagnosis;

(ii) the type,amount, frequency, and duration of the items and services furnishedunder the plan; and

(iii) the goalsset for the individual under the plan.

(3) The items andservices described in this paragraph are—

(A) physician-prescribedexercise;

(B) cardiacrisk factor modification, including education, counseling, and behavioralintervention (to the extent such education, counseling, and behavioralintervention is closely related to the individual’s care andtreatment and is tailored to the individual’s needs);

(C) psychosocialassessment;

(D) outcomesassessment; and

(E) such otheritems and services as the Secretary may determine, but only if suchitems and services are—

(i) reasonableand necessary for the diagnosis or active treatment of the individual’scondition;

(ii) reasonablyexpected to improve or maintain the individual’s condition andfunctional level; and

(iii) furnishedunder such guidelines relating to the frequency and duration of suchitems and services as the Secretary shall establish, taking into accountaccepted norms of medical practice and the reasonable expectationof 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 servicesdescribed in paragraph (3) under the supervision of a physician (asdefined 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, thatit accomplished—[539]

(i) one or moreof the following:

(I) positivelyaffected the progression of coronary heart disease; or

(II) reducedthe need for coronary bypass surgery; or

(III) reducedthe need for percutaneous coronary interventions; and

(ii) a statisticallysignificant reduction in 5 or more of the following measures fromtheir level before receipt of cardiac rehabilitation services to theirlevel after receipt of such services:

(I) low densitylipoprotein;

(II) triglycerides;

(III) bodymass index;

(IV) systolicblood pressure;

(V) diastolicblood pressure; or

(VI) theneed for cholesterol, blood pressure, and diabetes medications.

(B) To be eligiblefor an intensive cardiac rehabilitation program, an individual musthave—

(i) had an acutemyocardial infarction within the preceding 12 months;

(ii) had coronarybypass surgery;

(iii) stableangina pectoris;

(iv) had heartvalve repair or replacement;

(v) had percutaneoustransluminal coronary angioplasty (PTCA) or coronary stenting;

(vi) had a heartor heart-lung transplant;

(vii)[540] stable, chronic heart failure(defined as patients with left ventricular ejection fraction of 35percent or less and New York Heart Association (NYHA) class II toIV symptoms despite being on optimal heart failure therapy for atleast 6 weeks); or

(viii) any additionalcondition for which the Secretary has determined that a cardiac rehabilitationprogram shall be covered, unless the Secretary determines, using thesame process used to determine that the condition is covered for acardiac rehabilitation program, that such coverage is not supportedby the clinical evidence.

(C) An intensivecardiac rehabilitation program may be provided in a series of 72 one-hoursessions (as defined in section 1848(b)(5)), up to 6 sessions perday, over a period of up to 18 weeks.

(5) The Secretaryshall establish standards to ensure that a physician with expertisein the management of individuals with cardiac pathophysiology whois licensed to practice medicine in the State in which a cardiac rehabilitationprogram (or the intensive cardiac rehabilitation program, as the casemay be) is offered—

(A) is responsiblefor such program; and

(B) in consultationwith appropriate staff, is involved substantially in directing theprogress of individual in the program.

Pulmonary Rehabilitation Program

(fff)(1) The term “pulmonary rehabilitation program” means a program (as describedin subsection (eee)(2) with respect to a program under this subsection)that furnishes the items and services described in paragraph (2) underthe supervision of a physician (as defined in subsection (r)(1)) ora physician assistant, nurse practitioner, or clinical nurse specialist(as those terms are defined in subsection (aa)(5)).[541]

(2) The items andservices described in this paragraph are—

(A) physician-prescribedexercise;

(B) educationor training (to the extent the education or training is closely andclearly related to the individual’s care and treatment and istailored to such individual’s needs);

(C) psychosocialassessment;

(D) outcomesassessment; and

(E) such otheritems and services as the Secretary may determine, but only if suchitems and services are—

(i) reasonableand necessary for the diagnosis or active treatment of the individual’scondition;

(ii) reasonablyexpected to improve or maintain the individual’s condition andfunctional level; and

(iii) furnishedunder such guidelines relating to the frequency and duration of suchitems and services as the Secretary shall establish, taking into accountaccepted norms of medical practice and the reasonable expectationof improvement of the individual.

(3) The Secretaryshall establish standards to ensure that a physician with expertisein the management of individuals with respiratory pathophysiologywho is licensed to practice medicine in the State in which a pulmonaryrehabilitation program is offered—

(A) is responsiblefor such program; and

(B) in consultationwith appropriate staff, is involved substantially in directing theprogress of individual in the program.

Kidney Disease Education Services

(ggg)(1) The term “kidney disease education services” means educational servicesthat are—

(A) furnishedto an individual with stage IV chronic kidney disease who, accordingto accepted clinical guidelines identified by the Secretary, willrequire dialysis or a kidney transplant;

(B) furnished,upon the referral of the physician managing the individual’skidney condition, by a qualified person (as defined in paragraph (2));and

(C) designed—

(i) to providecomprehensive information (consistent with the standards set underparagraph (3)) regarding—

(I) the managementof comorbidities, including for purposes of delaying the need fordialysis;

(II) the preventionof uremic complications; and

(III) eachoption for renal replacement therapy (including hemodialysis and peritonealdialysis at home and in-center as well as vascular access optionsand transplantation);

(ii) to ensurethat the individual has the opportunity to actively participate inthe choice of therapy; and

(iii) to be tailoredto 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)), whofurnishes services for which payment may be made under the fee scheduleestablished under section 1848; and

(ii) a providerof services located in a rural area (as defined in section 1886(d)(2)(D)).

(B) Such termdoes not include a provider of services (other than a provider ofservices described in subparagraph (A)(ii)) or a renal dialysis facility.

(3) The Secretaryshall set standards for the content of such information to be providedunder paragraph (1)(C)(i) after consulting with physicians, otherhealth professionals, health educators, professional organizations,accrediting organizations, kidney patient organizations, dialysisfacilities, transplant centers, network organizations described insection 1881(c)(2), and other knowledgeable persons. To the extent possible the Secretaryshall consult with persons or entities described in the previous sentence,other than a dialysis facility, that has not received industry fundingfrom a drug or biological manufacturer or dialysis facility.

(4) No individualshall be furnished more than 6 sessions of kidney disease educationservices under this title.

Annual Wellness Visit

(hhh)(1) The term “personalized prevention plan services” means the creationof a plan for an individual—

(A) that includesa health risk assessment (that meets the guidelines established bythe Secretary under paragraph (4)(A)) of the individual that is completedprior to or as part of the same visit with a health professional describedin paragraph (3); and

(B) that—

(i) takes intoaccount the results of the health risk assessment; and

(ii) may containthe elements described in paragraph (2).

(2) Subject to paragraph(4)(H), the elements described in this paragraph are the following:

(A) The establishmentof, or an update to, the individual’s medical and family history.

(B) A listof current providers and suppliers that are regularly involved inproviding medical care to the individual (including a list of allprescribed medications).

(C) A measurementof height, weight, body mass index (or waist circumference, if appropriate),blood pressure, and other routine measurements.

(D) Detectionof any cognitive impairment.

(E) The establishmentof, or an update to, the following:

(i) A screeningschedule for the next 5 to 10 years, as appropriate, based on recommendationsof the United States Preventive Services Task Force and the AdvisoryCommittee on Immunization Practices, and the individual’s healthstatus, screening history, and age-appropriate preventive servicescovered under this title.

(ii) A list ofrisk factors and conditions for which primary, secondary, or tertiaryprevention interventions are recommended or are underway, includingany mental health conditions or any such risk factors or conditionsthat have been identified through an initial preventive physical examination(as described under subsection (ww)(1)), and a list of treatment optionsand their associated risks and benefits.

(F) The furnishingof personalized health advice and a referral, as appropriate, to healtheducation or preventive counseling services or programs aimed at reducingidentified risk factors and improving self-management, or community-basedlifestyle interventions to reduce health risks and promote self-managementand wellness, including weight loss, physical activity, smoking cessation,fall prevention, and nutrition.

(G) Screening for potential substanceuse disorders and referral for treatment as appropriate.

(H) The furnishing of a review ofany current opioid prescriptions (as defined in subsection (ww)(4)).[542]

(I) Any otherelement determined appropriate by the Secretary.

(3) A health professionaldescribed in this paragraph is—

(A) a physician;

(B) a practitionerdescribed in clause (i) of section 1842(b)(18)(C); or

(C) a medicalprofessional (including a health educator, registered dietitian, ornutrition professional) or a team of medical professionals, as determinedappropriate by the Secretary, under the supervision of a physician.

(4)(A) For purposesof paragraph (1)(A), the Secretary, not later than 1 year after thedate of enactment of this subsection, shall establish publicly availableguidelines for health risk assessments. Such guidelines shall be developedin consultation with relevant groups and entities and shall providethat a health risk assessment—

(i) identify chronicdiseases, injury risks, modifiable risk factors, and urgent healthneeds of the individual; and

(ii) may be furnished—

(I) throughan interactive telephonic or web-based program that meets the standardsestablished under subparagraph (B);

(II) duringan encounter with a health care professional;

(III) throughcommunity-based prevention programs; or

(IV) throughany other means the Secretary determines appropriate to maximize accessibilityand ease of use by beneficiaries, while ensuring the privacy of suchbeneficiaries.

(B) Not laterthan 1 year after the date of enactment of this subsection, the Secretaryshall establish standards for interactive telephonic or web-basedprograms used to furnish health risk assessments under subparagraph(A)(ii)(I). The Secretary may utilize any health risk assessment developedunder section 4004(f) of the Patient Protection and Affordable CareAct as part of the requirement to develop a personalized preventionplan to comply with this subparagraph.

(C)(i) Not later than18 months after the date of enactment of this subsection, the Secretaryshall develop and make available to the public a health risk assessmentmodel. Such model shall meet the guidelines under subparagraph (A)and may be used to meet the requirement under paragraph (1)(A).

(ii) Any healthrisk assessment that meets the guidelines under subparagraph (A) andis approved by the Secretary may be used to meet the requirement underparagraph (1)(A).

(D) The Secretarymay coordinate with community-based entities (including State HealthInsurance Programs, Area Agencies on Aging, Aging and Disability ResourceCenters, and the Administration on Aging) to—

(i) ensure thathealth risk assessments are accessible to beneficiaries; and

(ii) provide appropriatesupport for the completion of health risk assessments by beneficiaries.

(E) The Secretaryshall establish procedures to make beneficiaries and providers awareof the requirement that a beneficiary complete a health risk assessmentprior to or at the same time as receiving personalized preventionplan services.

(F) To theextent practicable, the Secretary shall encourage the use of, integrationwith, and coordination of health information technology (includinguse of technology that is compatible with electronic medical recordsand personal health records) and may experiment with the use of personalizedtechnology to aid in the development of self-management skills andmanagement of and adherence to provider recommendations in order toimprove the health status of beneficiaries.

(G) A beneficiaryshall be eligible to receive only an initial preventive physical examination(as defined under subsection (ww)(1)) during the 12-month period afterthe date that the beneficiary’s coverage begins under part Band shall be eligible to receive personalized prevention plan servicesunder this subsection each year thereafter provided that the beneficiaryhas not received either an initial preventive physical examinationor personalized prevention plan services within the preceding 12-monthperiod.

(H) The Secretaryshall issue guidance that—

(i) identifieselements under paragraph (2) that are required to be provided to abeneficiary as part of their first visit for personalized preventionplan services; and

(ii) establishesa yearly schedule for appropriate provision of such elements thereafter.

(iii)HomeInfusion Therapy

(1) The term “home infusion therapy” means the items and services describedin paragraph (2) furnished by a qualified home infusion therapy supplier(as defined in paragraph (3)(D)) which are furnished in the individual’shome (as defined in paragraph (3)(B)) to an individual—

(A) who is under the care of an applicableprovider (as defined in paragraph (3)(A)); and

(B) with respect to whom a plan prescribingthe type, amount, and duration of infusion therapy services that areto be furnished such individual has been established by a physician(as defined in subsection (r)(1)) and is periodically reviewed bya physician (as so defined) in coordination with the furnishing ofhome infusion drugs (as defined in paragraph (3)(C)) under part B.

(2) The items andservices described in this paragraph are the following:

(A) Professional services, includingnursing services, furnished in accordance with the plan.

(B) Training and education (not otherwisepaid for as durable medical equipment (as defined in subsection (n)),remote monitoring, and monitoring services for the provision of homeinfusion therapy and home infusion drugs furnished by a qualifiedhome infusion therapy supplier.

(3) For purposesof this subsection:

(A) The term “applicable provider” means—

(i) a physician;

(ii) a nurse practitioner; and

(iii) a physician assistant.

(B) The term “home” meansa place of residence used as the home of an individual (as definedfor purposes of subsection (n)).

(C) The term “home infusiondrug” 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 durablemedical equipment (as defined in subsection (n)). Such term does notinclude the following:

(i) Insulin pump systems.

(ii) A self-administered drug or biologicalon a self- administered drug exclusion list.

(D)(i) The term “qualified home infusiontherapy supplier” means a pharmacy, physician, or other providerof services or supplier licensed by the State in which the pharmacy,physician, or provider or services or supplier furnishes items orservices and that—

(I) furnishes infusion therapy to individualswith acute or chronic conditions requiring administration of homeinfusion drugs;

(II) ensures the safe and effective provisionand administration of home infusion therapy on a 7-day-a-week, 24-hour-a-daybasis;

(III) is accredited by an organizationdesignated by the Secretary pursuant to section 1834(u)(5); and

(IV) meets such other requirements asthe Secretary determines appropriate, taking into account the standardsof care for home infusion therapy established by Medicare Advantageplans under part C and in the private sector.

(ii) A qualified home infusion therapy suppliermay subcontract with a pharmacy, physician, provider of services,or supplier to meet the requirements of this subparagraph.[543]

(jjj)[544]Opioid Use DisorderTreatement Services; Opioid Treatment Program.—

(1) Opioiduse disorder treatment services.—Theterm “opioid use disorder treatment services” means itemsand services that are furnished by an opioid treatment program forthe treatment of opioid use disorder, including—

(A) opioid agonistand antagonist treatment medications (including oral, injected, orimplanted versions) that are approved by the Food and Drug Administrationunder section 505 of the Federal Food, Drug, and Cosmetic Act[545] for use in thetreatment of opioid use disorder;

(B) dispensingand administration of such medications, if applicable;

(C) substanceuse counseling by a professional to the extent authorized under Statelaw to furnish such services;

(D) individualand group therapy with a physician or psychologist (or other mentalhealth professional to the extent authorized under State law);

(E) toxicologytesting, and

(F) other itemsand services that the Secretary determines are appropriate (but inno event to include meals or transportation).

(2) Opioidtreatment Program.—The term “opioidtreatment program” means an entity that is an opioid treatmentprogram (as defined in section 8.2[546] of title 42 of the Codeof Federal Regulations, or any successor regulation) that—

(A) is enrolledunder section 1866(j)

(B) has in effecta certification by the Substance Abuse and Mental Health ServicesAdministration for such a program;

(C) is accreditedby an accrediting body approved by the Substance Abuse and MentalHealth Services Administration; and

(D) meets suchadditional conditions as the Secretary may find necessary to ensure—

(i) the health andsafety of individuals being furnished services under such program;and

(ii) the effectiveand efficient furnishing of such services.

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