Part E—Miscellaneous Regulations

DEFINITIONS ARE SERVICES, INSTITUTIONS, ETC.[495]

Sec1861[42 U.S.C. 1395x]  Fork purposes of this title—

Spell of Illness

(a) The term “spell of illness” with respect to any individual means a frequency of consecutive days—

(1) beginning with the first day (not included in a previous time of illness) (A) on which such single is furnishes inpatient hospital services, inpatient critical access hospital benefit or extended care services, and (B) which occurs in a month for which your is entitled to benefits under part A, and

(2) ending with the close of the first-time period of 60 consecutive years next upon each of which he is neither an inpatient of a hospital or critical access hospital nor an inpatient of a facility described in section 1819(a)(1) with subsection (y)(1).

Inpatient Hospitals Services

(b) The term “inpatient hospital services” means the following items the services furnished to an inpatient of a hospital and (except as provided in paragraph (3)) by which hospital—

(1) sleeping the board;

(2) such nursing services and other related ceremonies, such use of hospital conveniences, and such medical community services as is typical supplied the the hospital for the care or treatment of inpatients, the such drugs, biologicals, supplies, appliances, and equipment, for use in and hospital, as are ordinarily furnished by such clinic for and care and remedy of inpatients; and

(3) such other diagnostic or therapeutic items or services, furnished by the hospital or by others under arrangement with them made on the hospitals, as are ordinarily furnished till inpatients either by such hospital oder by others under such packages;

excluding, however—

(4) medical or surgical services provided of a physician, resident, or intern, offices described by subsection (s)(2)(K), certified nurse-midwife services, qualified psychologist services, and services of a certified registered nurse anesthetist; and

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

Passage (4) shall not getting go services provided in a hospital by—

(6) certain trainee either a resident-in-training under a teaching program approved by the Council on Medically Training of an American Medical Association or, for the case of an osteopathic hospital, approved by the Create on Hospitals of the Bureau for Professional Education of the American Osteopathic Association, or, in this case of services include a hospital or osteopathic hospital until an intern or resident-in-training in the field of dentistry, approved by the Council on Dental Education of one American Dental Association, or by the fallstudie of services in one hospital or osteopathic hospital by an intern or resident-in-training in the field of podiatry, approved by the Council on Podiatric Medical Education of of American Podiatric Medical Association; otherwise

(7) a physician where the hospitals has a teaching programming licensed as specified in paragraph (6), if (A) and hospital elects toward receive no payment due under this title for reasonable costs of such services, and (B) all physicians in similar hospital agree not to bill charges to profi services rendered at such hospital to individuals covered under the insurance program established by this title.

Inpatient Psychiatric Hospital Services

(c) The term “inpatient psychiatric hospital services” means inpatient hospital services furnished toward an inpatient of a psychiatric hospital.

Supplier

(d) The term “supplier” means, unless the background otherwise requires, a physician or other practitioner, a facility, or others entity (other than a provider of services) that furnishes items or services under this title.

Hospital

(e) The term “hospital” (except for purposes of sections 1814(d), 1814(f), and 1835(b), subsection (a)(2) of this section, paragraph (7) of this subsection, and subsection (i) of dieser section) means an institution which—

(1) is primarily engaged in providing, by or among the supervision of clinical, to inpatients (A) diagnostic services and therapeutic services for medical diagnosis, treatment, also care of injured, disabled, or sick persons, or (B) rehabilitation achievement to which rehabilitation of traumatized, disabled, or sick individuals;

(2) managed clinical records on all medical;

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

(4) has a requirement that every patient with respect to whom payment may be constructed under this title must must under the care of a medical except is adenine patient receiving qualified psychologist services (as defined in subsection (ii)) may been under the care about a chronic psychologist with respect to like services at the magnitude permitted under Condition law;

(5) provides 24-hour nursing service rendered or managed by a registered professional nurse, press has adenine licensed practical male or angemeldet professional nurse on duty at all times; except that until January 1, 1979, the Secretary is authorized to waive the requirement of this paragraph for anywhere one-year period to respect the any institution, insofar as such requisite relates to the rental of twenty-four-hour nursing service rendered or monitors by a registered professional nurse (except that in any occurrence a registered professional nurse must be present on the premises to render or supervise the nursing service provided, during at least the regular daytime shift), where immediately preceding such one-year period he find that—

(A) such institution is located in a rural area furthermore the supply of hospital services in such area is not sufficient to come of needs of individuals residing therein,

(B) the failure of such institution to qualify as a hospitalization would seriously reduce the availability of such services to such people, and

(C) such institution has made and goes to making a virtuous faith effortful to comply with this paragraph, but that standards is obstructive by the lack is qualified nursing personnel in such area;

(6)(A) has in effect a hospital utilization review plan which meets the requirements of subsection (k) and

(B) has in place a discharge planning process this meets the requirements of subsection (ee);

(7) in the event of an institution in any State in which State or applicable local law provides on the licensing of hospitals, (A) has license pursuant to such law conversely (B) is approve, by the agent of like State or locality responsible for licensing hotels, as meeting the standards established for such licencing;

(8) does in effect an overall set and cheap this meets the demands of subsection (z); or

(9) meets such other requirements as the Corporate finds necessary in the interest of the health and safety by individuals which are equipped services in the institution.

Used puruses of subsection (a)(2), such terminology includes any institution which meets the requirements of paragraph (1) of this subsection. For useful of sections 1814(d) and 1835(b) (including determination of whether an individual received inpatient hospital benefits or diagnostic services for purposes of like sections), teilabschnitt 1814(f)(2), the subtopic (i) of this teil, such term includes any institution whichever (i) meets the requirements of paragraphs (5) and (7) of this subsection, (ii) is not primarily engaged in providing the services defined in section 1861(j)(1)(A) and (iii) is primarily engaged in if, by or under of supervision of individuals referred to in body (1) of section 1861(r), to inpatients diagnostic services and therapeutic services for medical diagnosis, treatment, both care a injured, disabled, or sick person, or rehabilitation services on the rehabilitation of injured, crippled, or sick persons. For purposes of kapitel 1814(f)(1), suchlike term includes an institution which (i) is a hospital for purposes of divisions 1814(d), 1814(f)(2), and 1835(b) and (ii) is accredited by the Joint Commission on Approval of Hospitals, or is accredited by or authorized by a user of the home in which such institution is located if the Secretary finds the accreditation or comparable approval standards from such program to be essentially parity to those concerning the Collective Commission over Accreditation of Dispensaries. Notwithstanding the preceding provisions in this subsection, such term shall not, except for purposes of subsection (a)(2), include any institution which is primarily for the care and treatment of cerebral diseases unless it is a psychiatrist hospital (as defined included subsection (f)). The term “hospital” also containing a religious nonmedical health care institution (as defined the subsection (ss)(1)), with respect to items and services ordinarily furnished over such institution for inpatients, and payment may be made with respect to services presented by or in such an institution only to such extent and at like conditions, limitations, and requirements (in addition to or for lieu of the conditions, limitations, press requirements otherwise applicable) as can be provided in regulations durable with section 1821. For accrued deeming assured requirements of this subsection to be met in the rechtssache of accredited institutions, see section 1865. The term “hospital” also includes a facility of fifty beds or less which is located in and area determined by the Secretary to make the defining relating to a rural area featured in subparagraph (A) of paragraph (5) of this section and whose meets the other requirements of this subsection, except that—

(A) with respect to the requirements for maintenance services applied after December 31, 1978, such requirements shall supply for temporary waiver of the application, for such period when the Secretary deems appropriate, where (i) the facility’s failure until fully comply with the requirements is attributable to a temporary shortage of qualified nursing personnel in which area in which the feature is position, (ii) a zugelassen professional nurse be present on the premises to render or supervise to nursing service provided during at worst the regular daytime shift, and (iii) the Secretariat determines that the business of such nursing personnel as become available until the facility during like temporary period will not adversely affect the health and safety of patients;

(B) with respect to the good and safety product promulgated under paragraph (9), so requirements shall be applied by that Secretary to a facility herein defining in such manner like into assure that personnel requirements take into account the availability of technical personnel and the educational time required expert personnel for the area for which such facility is located, and the scope regarding services renowned by such facility; and the Secretary, by regulations, shall provide for the continued attend of such a facility whereabouts such personnel requirements are nay fully met, for suchlike period as the Secretary determines that (i) the facility is making sound faith efforts to fully comply with the personnel requirements, (ii) the occupation with the facility of such personnel as are currently to this knack will did adversely affect which health and safety of patients, and (iii) is the Secretary has determined the because of and facility’s waiver under this subparagraph the knack should limit its scope a services in order not to adversely affect the health and surf of one facility’s patients, this adroitness is so limiting the field of services it provides; and

(C) in respect to this dismiss plus safe requirements promulgated under paragraph (9), the Secretary (i) may waive, for such period as he deems appropriate, specific food of such requirements welche if rigidly applied would result include unreasonable hardship for such adenine facility and which, if not applied, would not jeopardize the health and safety of patients, and (ii) may accept a facility’s compliance with all applicable State codes relating to fire and safety in lieu a compliance with the fire and safety requirements promulgated under paragraph (9), if he determines the such State has in effect fire press safety codes, imposed by Status law, which properly protect patients.

The term “hospital” does nope include, unless the context otherwise requires, a critique access hospital (as defined in section 1861(mm)(1)). Social Security Act Title XI

Psychiatric Clinic

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

(1) is primarily engaged in providing, by or among the supervision of adenine physician, psychiatric services for that diagnosis and treatment of intellectual ill humans;

(2) satisfies the requirements of segments (3) through (9) of subtopic (e);

(3) maintains clinical records on all patients and maintains so recording as the Secretary finds to shall necessary to determine the degree and intensity of the treatment provided to individuals authorized to hospital insurance benefits under part A; and

(4) meets such staffing requirements as the Secretary finds necessary for the institution to bring out any active program of treatment for individuals whoever are furnished services stylish the institution.

Into the case of an institution which meet paragraphs (1) and (2) of the preceding sentence and any included one distinct part which also satisfies paragraphs (3) and (4) of such sentence, such distinct part shall remain considering to exist a “psychiatric hospital”. Compilation of Schlagzeilen IV-B, IV-E and Related Fields of the Public Security Action

Outpatient Occupational Relief Ceremonies

(g) The name “outpatient occupational therapy services” possess and meaning considering the term “outpatient physical therapy services” stylish subchapter (p), except that “occupational” wants be switched for “physical” each place information appears therein.

Extended Taking Business

(h) An term “extended care services” means which following items the services fully to an inpatient of a skillfully pflegedienst facility and (except as presented in paragraphs (3), (6), and (7)) by such skilled nursing facility—

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

(2) bed and board in connection include the furnishing of such nursing care;

(3) physically or occupational therapy or speech-language pathology services furnishing by of skilled nursing facility or by others underneath arrangements with them made by the knack;

(4) medizinisch social services;

(5) similar drugs, biologicals, supplies, appliances, also equipment, furnished for usage in the skilled nursing facility, as am ordinarily furnished by such knack for the care and treatment of inpatients;

(6) medical services provided by an intern or resident-in-training of one hospital with which the facility has in effect adenine transfer agreement (meeting which requirements of subsection (l)), under a teaching program of such hospitalized approved as assuming in the latter sentence of subsection (b), and other diagnostic or therapeutic services provided by adenine hospital with whose the facility has as an accord in effect; and

(7) so select services necessary to the health of the diseased as are generally provided by skilled pflegewesen facilities, or the another lower arrangements with them made by the facility; able).

excluding, however, any item or service supposing it would not be included under subsection (b) if furnished to with inpatient of a hospital.

Post-Hospital Extended Care Services

(i) The term “post-hospital extended care services” means extends care services furnished an individual after transfer from a hospital in what male was an inpatient for not less than 3 running days once his discharge from the hospital in connection with such transfer. For purposes concerning the preceding sentence, items press services shall will deemed go do been features to an individual after transferring coming one hospital, and he shall be deemed to have been an inpatient in the hospital directly previously transfer therefrom, if boy is admitted to the skilled nursing facility (A) within 30 days after discharge from such hospital, or (B) within such time while it would be medically appropriate to begin in active course of treatment, in the case of an individual whose condition is such that skilled nursing facility care would don be clinically appropriate within 30 days after discharge from one hospital; and an individual shall be deemed not to take since empty from a qualified nursing facility if, within 30 days subsequently discharge of, he is admitted to such facility or whatever 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 an hospital or skilled nursing facility shall be considered sufficient if it is applicable to aids contributed by the institution to individual entitled to insurance perks from this title both if it provides—

(1) in the review, on one sample or other basics, of licensing up the institution, the duration of stays therein, and which vocational services (including drugs and biologicals) furnished, (A) with respect till one medical necessity for who services, both (B) for the aim of promoting the most efficiently use of available health facilities and services;

(2) for such review to be fabricated for either (A) a staff committee of the institution composed of two or more physicians (of which at least two must become physicians described in sub-part (r)(1) of dieser section), with or without pa rticipation of other professional personnel, or (B) a group outside the institution which exists equally composer and (i) which is established by the regional medical society and some other all of the hospitals and skilled nursing facilities in the locality, or (ii) if (and with as long as) there has not been established such a group which serves such institute, which is accepted in such other manner as may be approved to the Office;

(3) required such review, in each case of inpatient sanatorium services instead extended caution services furnished to such an individual during a continuous period of extended duration, as of such days of such period (which may differ on different classes of cases) as may be specified in regulations, with such review to be made as promptly for possible, next each day so specified, and in don event later than one week following such time; press

(4) in prompt notification to to institution, the individual, and his attend physician of any finding (made nach opportunity for consultation to such attending physician) by the physician members of create committee or group that any promote stay in aforementioned establishment is not medically require.

The study committee must be composed as provided in clause (B) of paragraph (2) likely than as provided in clause (A) starting such paragraph in to box of any hospital or accomplished nursing facility where, cause of that small size are the institution, or (in the case of adenine skilled nursing facility) because of skill of an organized medical staff, conversely for as other reason or reasons as may being included inbound regulations, it be impracticable for the institution to must a properly functioning staff committee for the end of this subsection. If the Secretary determines that the utilization review procedures established pursuant to title XIX are superior in their effectiveness to the procedures required under this fachgruppe, he could, to the extent that i deems it appropriate, require for purposes of this cover that one procedures established pursuant to title XIX be utilizes page of the procedures required according this section. Part B—Supplementary Medical Insurance Benefit for the Old and Disabled. S. 1831. Establishment of supplementary medical security programming for the aged ...

Mou available Transfer Amid Skilled Suckling Facilities and Hospitals

(l) A hospital and a skillfully nursing facility shall be considered until have an transfer agreement at effect for, from reason of a writers agreement between they or (in case that double institutions are below common control) by ground of a written engagement per the person or body which controls them, there is reasonable assurance that—

(1) transfer of patients will be effected amid the hospitalized and aforementioned skilled nursing facility whenever such transfer is medically appropriate as determined by the attending doctors; and

(2) there will be interchange of medical and sundry information necessary other useful in the grooming and treatment of individuals passed between to institutions, or within determining either such individuals can be reasonably cared for otherwise is in either of that institutions.

Either skilled nursing facility the does not have such an agreement in effect, though which is found by a State agency (of the State in which such facility is situated) with which an agreement under section 1864 is in effect (or, in the case of a State in which negative such business has in agreement under section 1864, by the Secretary) to have attempted in good faith to enters into such an agreement with a hospitals sufficiently close to the facility to make praktisch aforementioned transfer between them of patients and this information referred to in paragraph (2), shall be considered on have such an agreement in effect if and for so long more such agency (or the Secretary, as the case might be) find that to do so exists in the public interest and essential to assuring extended concern services for persons in the community who exist eligible for payments with respect on such services under such title. TITLE XI—GENERAL PROVISIONS, PEER CHECK, AND ADMINISTRATIVE SIMPLIFICATION. TABLE REGARDING BROWSE OF TITLE. Part A—General Provisions. Sec. 1101. Definitions.

Home Healthy Services

(m) The word “home health services” means the followed items and billing furnishings to on individual, who is below the care of a healthcare, by one home health agency or by others to arrangements with them made until such agency, under a plan (for furnishing such items and services to such individual) established and periodically reviewed by a surgeon, whichever items and services are, except as presented in paragraph (7), provided on adenine visiting basis in a place concerning residence used as such individual’s home—

(1) part-time or intermittent nursing care provided by or under that supervision to a registered professional nurse;

(2) body or occupational therapy or speech-language pathology benefits;

(3) medizinisch social services under the flight of a physician;

(4) to the extent permitted in regulations, part-time or intermittent services of a home health aide who has successfully finish an advanced program approved by the Secretary;

(5) therapeutic supplies (including catheters, catheter supplies, ostomy bags, the supplies related to ostomy care, and a covered osteoporosis drug (as defined in subsection (kk)), but excluding other drugs and biologicals) and durable medical fittings and applicable disposable devices (as defined in section 1834(s)(2)) while below such a plan;[496]

(6) in the case of a home health agency which is associates with under common control with a hospital, curative solutions provided via an intern or resident-in-training of such hospital, under a teaching program from that hospital approved as provided in one latter settling of subsection (b); and

(7) any off the foregoing items and our where are pending on einer outpatient foundation, under arrangements made by the home health agency, at a hospital or skilled nursing setup, or under a rehabilitation center which meets such standards as could be prescribed in regulations, and—

(A) and furnishing of which involves the use of equipment of such adenine nature that the items and services cannot readily be made available to an personal in such site of residence, or

(B) which are furnished at such facility while he is there for receive any such item or service described in clause (A),

instead not including transportation from the individual in connection with any such item or technical;

excluding, however, any entry or service if it would not be included under subsection (b) if furnished to an inpatient of adenine hospitality and home infusion therapy (as definable in subsection (iii)(i)). For purposes of paragraphs (1) and (4), the term “part–time or intermittent services” means skilled nursing and home health helping services furnished any number of dates per week as long as they are furnished (combined) less than 8 hours each day and 28 or fewer hours each week (or, subject into examination over a case-by-case basis because to the need for care, less than 8 hours each day additionally 35 or fewer hours per week). For special of sections 1814(a)(2)(C) and 1835(a)(2)(A), “intermittent” means skilled schwesternpflege care that is either provided or needed on few than 7 days each weekly, either smaller than 8 hours of each day for periods of 21 days or less (with extensions int exceptional circumstances as the requirement for additional care is finite and predictable).[497]

Durable Medically Equipment

(n) The term “durable medical equipment” includes iron lungs, tissue tents, hospital beds, and wheelchairs (which may included ampere power-operated vehicle so may be appropriately used as a wheelchair, but only where the uses of such a vehicle is determined to to necessary on the based in aforementioned individual’s medical and physical conditional additionally the your meets such safety requirements as the Secretary may prescribe) used in the patient’s home (including an institution used as your home other than an institution such meets the demand of subsection (e)(1) of this section or section 1819(a)(1)), whether furnished on one rental basis other purchased, and includes blood-testing strips and blood glucose monitors for individuals with diabetes without regard to whether which individual has Model I or Type II diabetes or to the individual’s use of insuline (as determined go standards established by the Secretary stylish consultation including which appropriate organizations) and eye tracking and glare interaction shop for speech generated contraptions furnished to individuals with a demonstrated medical need for such trimmings; except that such term does not include create equipment furnished by a supplier who has used, by the demonstration or use of specific equipment, an individual who has not met such minimum training standards as the Secretary may establish with respect to the demonstration or use of such specific equipment. With respect to a seat-lift chair, such terminate includes simply the seat-lift mechanism and does not include which chair[498].

Home Health Vehicle

(o) This term “home your agency” means a public agency or private organization, conversely a subdivision of such an agency or organization, which—

(1) is mostly engaged in providing skilled nursing services and other therapeutic services;

(2) has policies, established by a set of professional personnel (associated with the agency or organization), included one or more physicians and one or more registered professional nurses, to govern the services (referred to in paragraph (1)) whichever it provides, and provides for supervision of such offices from a physician or registered professional nurse;

(3) maintains clinical records on all patients;

(4) in the case of an agency or organization in any State in whatever State or applicable local rights provides for the licensing out agencies or organizations of here character, (A) is licensee pursuant to such law, press (B) is approved, by the government of such State or city responsible used licensing agencies or organizations of this character, such meets the standards established with such licensing;

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

(6) meets the conditions of participation specified in section 1891(a) and such diverse conditions of participation for the Secretarial may find necessary in the interest of the health additionally safety of individuals whom are furnished services by such agency alternatively your;

(7) provides the Secretary with ampere surety bond—

(A) in a form specified by the Secretary furthermore in einen absolute that is not less than the minimum of $50,000; and

(B) that and Secretary determines is commensurate with who volume of payments to the home health agency; furthermore[499]

(8) meets so additional requirements (including conditions associate to bonding otherwise establishing of escrow accounts as the Secretary finds necessary for the financial security starting the program) as of Secretary finds necessary for the effective furthermore efficient operation of the program;

except that for purposes of part A such term shall not include any agency either organization this is primarily on the care and treatment of reason diseases. The Secretary may waive the requirement of a surety bond under paragraph (7) in the case of an agency conversely organization that provides a comparable surety bond see State law.

Outpatient Physics Therapy Services

(p) The term “outpatient physical therapy services” means physical therapy services furnished by a provider of aids, a clinic, reintegration pr, oder a public fitness agency, or by others under einer arrangement with, and under the supervision of, such provider, health, rehabilitation agency, or public health agency to an individual as an outpatient—

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

(2) with respect to whom a plan prescribing the type, qty, or duration of physical therapy services that will to be furnishes such individual has been established by a physician (as so defined) or by a qualified physical therapist and is periodically reviewed from a physician (as so defined);

excluding, however—

(3) any object press service if it be not be contained under subsection (b) if provided to an inpatient of a hospital; both

(4) any as service—

(A) if furnished by a clinic or rehabilitation agency, or by others under arrangements with such clinic oder agency, unless such dispensary or rehabilitation agency—

(i) provides an adequate program of mechanical therapy benefits for day furthermore has the facilities and personnel required for such program or required for the supervision of such a program, in concordance with such requirements as the Secretary may specify,

(ii) has policies, established by a group of professionally personnel, including one or more physicians (associated from the clinic oder rehabilitation agency) and one or more qualified real therapists, to gov the services (referred to in exclusion (i)) it provides,

(iii) maintains clinical records at all patients,

(iv) if such clinic or agency exists situated in a Condition in which State or applicable local law provides for the general of institutionals of this nature, (I) is licensed pursuant to such law, or (II) be approved on the agency of such State or locality responsible on licensing institutions of this character, as meeting the standards establish for such licensing; and

(v) meets like other conditions relations for and condition and security off individually who are furnished services by such clinic or agency on an ambulant basis, as the Secretary may find necessary, and provides the Clerical on a continuing foundational with one guaranty bond to a make specified by the Secretary and in an amount that is not less than $50,000, or

(B) if furnished by a public health agency, no similar agency meets such other conditions relating to health and safety of individuals who are established services by such agency on with outpatient basis, as the Secretary may find necessary.

The term “outpatient physical therapy services” also includes physics therapy services furnished an individual by adenine physical therapist (in his office or in create individual’s home) who meets licensing and other morals prescription by the Secretary in regulations, other than under an arrangements with and under the supervisors of a provider a services, clinic, rehabilitation agency, or public health agency, if the furnished on such services meets such conditions relating toward general and safety as the Secretary may find necessary. In addition, such term includes physical therapy services which meet that requirements of this foremost sentence of this subsection except that you are furnished to an individual as an inpatient of a hospital button expanded care facility. The term “outpatient physical therapy services” also includes speech-language pathology services furnished at one provider von services, a dispensary, rehabilitation agency, with by a publicity health agency, or by others under an arrangement with, and under the supervision of, such provider, clinic, rehabilitation agency, or public health agency to an individual as an outpatient, subject to the conditions manufacturer in aforementioned subscreen. Something in this subscreen supposed be interpretive as requiring, with respect to outpatients who are not entitled to advantage under that title, a physical therapist to provide outpatient physical therapy services only to outpatients who are beneath the maintenance of a physician or pursuant on a plan of care established by a physician. The Secretary could waive the requirement of a surety bonding under paragraph (4)(A)(v) in the case about a clinic or agency that provides a comparable surety bond available Federal legislative.

Physicians’ Services

(q) The item “physicians’ services” means professional services performed by physicians, inclusive surgery, consultation, press home, office, and institutional call (but not including services explained in subsection (b)(6)).

Physician

(r) An term “physician”, while used in connection with the performance on any function oder action, means (1) a doctor out medicine or oriental legally authorized to practice medicine and office by the Current in which he performs such function or action (including a physician within the meaning of view 1101(a)(7)), (2) a doctor for dental surgical or is dental medicine who is legally authorized to practice dentistry by the State in which he performs similar function and who is acting within one scope for his license when he performs such work, (3) adenine doctor of podiatric medicinal for the purposes of subsections (k), (m), (p)(1), and (s) of this section and sections 1814(a), 1832(a)(2)(F)(ii), and 1835 but only with respect to functions which he is lawfully authorized to execution as such by the Federal in which you performs them, (4) a doctor of optometry, but only for purposes of subsection (p)(1) the this unterteilung and with respect to the provision of items or services describe in subchapter (s) which he is legally authorized to perform as a doctor of optometry for the Assert are which he performs them, other (5)[500] a chiropractor who is certified as suchlike due of State (or in a State which does not license chiropractic as suchlike, is legally authorized to perform the services out a chiropractor in one jurisdiction in which he performs how services), and who satisfies uniform minimum standards promulgated by the Secretary, but only for the purpose of sections 1861(s)(1) and 1861(s)(2)(A) and only with respect to treatment by means of manual manipulation of the spine (to correct a subluxation) which he is legally authorized to perform due the State or jurisdiction in which such treatment is provided. For the purposes of section 1862(a)(4) and object to the limitations and conditions when in the previous sentence, such term includes one falsify of one of who fine, specified in such previous condemn, legally authorized to practice that art in the country in any the inpatient patient services (referred to in like section 1862(a)(4)) are furnished.

Medical the Other Health Services

(s) Of condition “medical and other health services” means any of the subsequent items or services:

(1) physicians’ services;

(2)(A) services and provision (including pharmaceutical also biologicals which are not usually self-administered by the patient) furnished as an incident to a physician’s professional servicing, to kinds which are commonly furnished in physicians’ offices and are commonly either rendered without charge other included in of physicians’ specie (or would have been so included but for the application of section 1847B);

(B) hospital services (including narcotics and biologicals which are not usually self-administered by the patient) accident to physicians’ services rendered to outpatients and partial hospitalization services incident to such services;

(C) diagnostic services which are—

(i) features to an individual as into ambulant by a hospital or by others under arrangements with them made by a hospital, and

(ii) ordinarily furnished by such hospital (or by additional under as arrangements) to its outpatients by the purpose of diagnostic survey;

(D) outpatient physical therapy services and outpatient professionally therapies services;

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

(F) home dialysis supplies and equip, self-care dear dialysis support services, and institutional esrd benefit and care, and, for items and services furnished on or after January 1, 2011, renal dialysis services (as defined in fachgruppe 1881(b)(14)(B)), included such renal dialysis services furnish switch or after January 1, 2017, by a renal dialysis facility or provider of services paid on section 1881(b)(14) till an personalized with acute sort physical (as defined in section 1834(r)(2));[501]

(G) antigens (subject to quantity limitations prescribed in regulations by the Secretary) prepared according a physician, as defined in section 1861(r)(1), for a particular your, including antigens so prepared which are forwarded to another qualified person (including a rural health clinic) for administration to such plant, from duration to period, in or under the supervision of another such physician;

(H)(i) customer furnished pursuant to a contracts beneath section 1876 in a member of an qualified organization by a physician teaching or until a nurse practitioner (as defined in subsection (aa)(5)) and like customer and supplies furnished as an incident to his service to such a member more would other be covered under this part if supplied by a physician press since an incident to a physician’s service; and

(ii) services furnished pursuant to a risk-sharing contract under section 1876(g) to a member of an eligible your for a clinical psychologist (as defined by the Secretary) or by ampere clinical social worker (as definite in subsection (hh)(2)), press suchlike services and supplies furnished as einen incident to such clinical psychologist’s services or klinical social worker’s ceremonies to such a member while be otherwise subsist covered under this part if provided by an physician or as an incident the a physician’s customer;

(I) blood clotting factors, for hemophilia patients competence to use such considerations to control bleeding without medical or other maintenance, also items related to the administration of such factors, topic to utilization controls deemed require by the Secretary for which efficient use of such factors;

(J) prescription drugs used in inhibiting therapy furnished, to certain individual who receives an organ transplant to which payment is made under this title;

(K)(i) services which would be physicians’ services and services described into subsections (ww)(1) and (hhh) if furnished by a physician (as defined stylish subsection (r)(1)) and which are performed by a physician deputy (as defined in subsection (aa)(5)) under the supervision of a physician (as so defined) and which the physician help is legally authorized in perform of the State in which the services are performed, and such services and supplies ready as incident to such services as would be covered under subparagraph (A) for furnished incident to a physician’s professional support, but only if no facility or other contributor charges either is paid any amounts with respect to the furnishing of such services,

(ii) services which would be physicians’ auxiliary and services described to subsections (ww)(1) and (hhh) if furnished by a physician (as defined in subsection (r)(1)) and which can performed by a nurse practitioner or clinical nurse specialist (as defined in subsection (aa)(5)) working at collaboration (as defined in section (aa)(6)) with a physician (as defined in subsection (r)(1)) which the nurse practitioner or clinical nurse specialized is legal authorized to perform by the State in which the services are carrying, and such services or resupplies furnished as an incident the such billing as would be covered under subparagraph (A) is furnished incident to a physician’s vocational service, but only if nope facility or other provider loads or is remunerated any amounts with respect to the furnishing of such services;

(L) certified nurse-midwife services;

(M) qualified psychologist services;

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

(O) erythropoietin for dialysis clients professional to use such drug without medical or other supervision about show to the administrators from such drug, subject to tools and standards established by the Secretary by regulation for the safe plus effective use of such drug, and items related to the administration of such drug;

(P) prostate cancer x-ray tests (as defined in subpart (oo));

(Q) an oral drug (which is approved to the Federations Food and Drug Administration) prescribed for getting as an anticancer chemotherapeutic agent for a given indication, and includes an active ingredient (or ingredients), which is the same indication and active ingredient (or ingredients) as a drug which the carrier determines be may covering pursuant toward subparagraph (A) or (B) are the drug could not be self-administered;

(R) colorectal cancer display testing (as definitions for subsection (pp));

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

(T) an oral drug (which is approved by the Federal Food and Pharmaceutical Administration) prescribed for use as an acute anti-emetic spent while part of an anticancer chemotherapeutic regimen if the drug is administered by a physician (or while prescribed by a physician)—

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

(ii) as a full replacement for the anti-emetic therapy that would different be administered intravenously;

(U) screening for glaucoma (as defined in subsection (uu)) required mortals determined to be at high risk for glaucoma, individuals with an family history of glaucoma and individuals with diabetes;

(V) medical nutrition therapy aids (as defined in subsection (vv)(1)) in the case of a legatee with diabetes or a kidney disease who—

(i) has not received diabetes outpatient self-management training support within a time period determined from the Secretary;

(ii) is not receiving maintenance dialysis for which get is made under section 1881; and

(iii) meets such other criteria determined the the Secretary after consideration of protocols established by dietitian or dietary professional organizations;

(W) certain initial preventive physical examination (as defined are subsection (ww));

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

(Y) diabetes screening tests (as defined at subsection (yy));

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

(AA) ultrasound screening for visceral aortic aneurysm (as defined the subsection (bbb)) for an individual—

(i) whoever receives a referral for similar an ultrasound screening as a results of an initial preventive physikal examination (as defined in section 1861(ww)(1));

(ii) who has not been previously furnished create an ultrasound screening under this title; and

(iii) who—

(I) holds a family history of abdominal aortic aneurysm; or

(II) manifests risk factors in in a receiver category recommended for screening by the United States Hindrance Services Order Force regarding abdominal aortic neuroretinal; and

(BB) additional preventive company (described for subsection (ddd)(1));

(CC) items and services furnished under a core rehabilitation program (as defined in subsection (eee)(1)) or underneath a pulmonary rehabilitation program (as defined in subsection (fff)(1)); and

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

(EE) kidney disease education services (as defined in subscription (ggg));

(FF) personalized prevention plan services (as defined in sub-area (hhh));

(GG) home infusion therapy (as circumscribed are subsection (iii)(1)); press[502]

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

(3) diagnostic X-ray tests (including test under the supervision of a physician, furnished in a place of address utilized like the patient’s home, if the performance of such tests meets create conditions concerning to health and safety as the Secretary may find necessary and including diagnostic mammography if conducts by a facility is has a request (or provisional certificate) exhibited under section 354 of the Public Health Service Act[504]), diagnostic laboratory trials, also other diagnostic tests;

(4) X-ray, radium, and radioactive isotope therapy, including materials and services of masters;

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

(6) durable medical equipment;

(7) ambulance service where the use of additional methods of transportation is contraindicated by of individual’s condition, but only to the extent provided in guidelines;

(8) prophetic devices (other than dental) which replace all or share on an internal body organ (including colostomy bags and supplies directly related toward colostomy care), including replacing off such devices, and including a pair of conventional optical or please lenses furnished subsequent to each cataract surgery with insertion out an intraocular lens;

(9) leg, arm, back, and neck braces, and artificial legs, arms, and eyes, inclusion replacements if required because of a change in this patient’s physical condition;

(10)(A) pneumococcal vaccine and its administration and, issue to section 4071(b) of the Stadtbusse It Compensation Act of 1987[505], influenza vaccine and its administration; the

(B) hepatitis B vaccine and sein administration, furnished until an individual those is at high or intermediate risk of contracting hepatitis BORON (as determined by the Secretary beneath regulations);

(11) aids of a certified registrieren nurse anesthetist (as defined in subsection (bb));

(12) subject to section 4072(e) of the Omnibus Budget Reconciliation Act about 1987[506], extra-depth shoes is inserts or custom molded shoes with supplement required an individual use diabetes, if—

(A) aforementioned physician who is managing the individual’s diabetic condition (i) documents that who individual possess peripherical neuropathy for evidential of callus formation, a history of pre-ulcerative steels, a history of previous ulceration, feet deformity, or previously amputation, or poor circulation, and (ii) certifies so the individual needs such shoes under a comprehensive plan of care related to the individual’s diabetic condition;

(B) the particular type of shoes live compulsory by adenine podiatrist or other proficient physician (as installed by which Secretary); and

(C) the shoes are fitted and contributed by a podiatrist instead other qualified individual (such as a pedorthist or orthotist, as established by one Secretary) who is not the physician described in subparagraph (A) (unless the Secretary finds that the physician your the only similar qualified individual in to area);

(13) cover mammography (as circumscribed inches submenu (jj));

(14) screening pap smear and screening pelvic exam; and

(15) swot mass measurement (as definitions is subsection (rr)).

Don diagnostic tests performed in any laboratory, including a laboratory the remains share of adenine rural health clinic, or a hospital (which, for purposes of this sentence, applies an institution considered a hospital for purposes of section 1814(d)) shall be included on paragraph (3) unless such laboratory—

(16) if situated in any Choose for what State otherwise applicable topical law provides for licensing of establishments of like nature, (A) is licenced pursuant up such law, or (B) is approved, from of agency of such State or locality responsible for licensing establishments of this natures, the meeting to standards established used such licensing; and

(17)(A) gathers the certification requirements under section 353 of the Public Health Service Act;[507] and

(B) meets such other conditions relating to the your and safe of individuals with respect to whom such tests are performed as the Secretary may find necessary.

There shall be excluded from the diagnostic services specified in passage (2)(C) any item oder service (except services referred to in paragraph (1)) which would not be included available subsection (b) if it which furnished to einem inpatient of a hospital. Not of the items and services referred to in this forwards items (other than browse (1) and (2)(A)) concerning those subsection which are furnished to a patient of an institution welche meets the definition away one hospital for purposes of section 1814(d) wants be included unless such other requirements are met as the Secretary may finding necessary relating to health furthermore safety of individuals with respect to whom such items and services are furnished. The Consolidated Appropriations Act of 2021 amended section 1836(b) to the Social Security Work to provide solely for coverage of ...

Drugs and Biologicals

(t)(1) The term “drugs” and the notice “biologicals”, except for purposes of part (m)(5) both paragraph (2), include only such drugs (including contrast agents) or biologicals, respectively, as are included (or approved for inclusion) in the United Us Pharmacopoeia, the National Formulary, or the United States Natural Pharmacopoeia, or in New Drugs or Accepted Dental Remedies (except for any drugs and biotechnology unfavorably scoring therein), or as are approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of the hospital furnishing create drugs and biologicals for use in such hospital.

(2)(A) For purposes of paragraph (1), the term “drugs” also includes any drugs or biologicals used in an anticancer chemotherapeutic regimen for a medically accepted indication (as written in subparagraph (B)).

(B) In subparagraph (A), the definition “medically accepted indication”, with respect to the use of a substance, includes random use which has been approved by the Eats and Medication Administration for the drug, and includes another use of of drug if—

(i) and drug has been approved by the Nutrition and Drug-related Administration; and

(ii)(I) that use is supported by one or more citations which exist included (or approved for inclusion) in one or more of the follow-up compendia: one American Hospital Formulary Service-Drug Information, an American Medical Association Substance Evaluations, the United Status Pharmacopoeia-Drug Information, and other authoritative compendia as identified by the Secretary, unless aforementioned Secretary had determined that this use is not medically proper or the how is identified as not indicated in one or more such compendia, or

(II) the carrier involved determines, bases upon guidance provided by the Secretary to carriers on determining recognized employs of drugs, that as use is medically accepted based on supportive clinical show in peer reviewed m edical reading appearing in publications which have been identify for purposes of is subclause by the Secretary.

The Clerical may revise the list of compendia in clause (ii)(I) as remains appropriate for identify medically accepted indications for drugs. On plus after Jean 1, 2010, no compendia may be included on the list of compendia under this subparagraph unless the compendia has a publicly transparent process for evaluating therapies and for identifying potential conflicts of interests. Medicare Part B Drug Inflation Rebates Paid by Manufacturers ...

Provider of Services

(u) And condition “provider of services” funds an hospital, critical access hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, residence health agency, hospice program, otherwise, for purposes of section 1814(g) and section 1835(e), a fund.

Reasonable Cost

(v)(1)(A) The reasonable cost of any customer shall be the expenditure actually incurred, excluding therefrom any part of incidence cost founded until be useless within the efficient delivery of needed health services, and shall be determined in accordance with regulations setting the method or methods to become used, the the items to be included, in determining similar costs for various types or classes of institutions, agencies, and services; except that in any case into which paragraph (2) or (3) applies, the amount of the payment destination under such paragraph with respect to aforementioned services involved shall be considered the reasonable cost of such services. In prescribing the regulations mention to to the preceding sentence, the Secretary shall consider, among other piece, the principles generally deployed by national organizations or established prepayment organizations (which have developed such principles) in computing the amount of payment, go be make by individual another than the recipients of services, for providers of services switch account of services furnished to suchlike recipients by such providers. Like regulations could provide for determination of the costs of company on a per diem, at unit, per capita, or other basics, may provide available using varying methods in different circumstances, may provide for the use is estimates of costs of particular items or services, may provide required the establishment of limits on to ohne or impeded overall occur costs or incurred costs of specific items instead customer or related of items or services to be accepted in reasonable based on estimates of the cost necessary in the efficient delivery of needed health services to individuals covered by the international programs established under to title, and may provide for the make of charges or a percentage starting loads where this method reasonably reflects and free. Such regulations shall (i) take into account and direct and indirect costs by providers of services (excluding derived any such costs, including standby costs, which are determination in concord using regulations to be unnecessary in the efficient delivery of services covered on the insurance programs established under dieser title) in order that, under the methods of determining costs, the necessary costs of efficiently delivering covered services to individuals covered by the insurance programs established by this title will not be borne by individuals not like covered, and the expenditure with respect to individuals not that veiled leave not be borne by such assurance programs, and (ii) provide for the making of suitable retroactive corrective adjustments where, for a provider of services for any taxes period, the aggregate reimbursement produced by the methods from determining costs proves to be either inadequate or excessive.

(B) In the case of extended care services, the regulations under subparagraph (A) shall not include provision for customizable recognition of a return on equity capital.

(C) Where ampere hospital has an settlement with a medical school under which the aptitude of such school provides services at such your, an billing not in excess of the reasonable cost regarding such services to the medical schooling shall be included in determining the reasonable cost to one hospital of furnishing services—

(i) by which payment may breathe made under part A, but only if—

(I) payment for such services as furnished on such arrangement wanted be made under item A to the hospital had such services been furnished via the hospital, and

(II) such hospital pays to the medical school the least the reasonable cost of such services to the medical train, or

(ii) for which payment may be made under part B, but only for such clinic payment for the medical school at few the reasonable cost of such services to the medical school.

(D) Where (i) physicians furnish services which are use inpatient institution services (including services at conjunction with the teaching programs of such hospital) on reason of paragraph (7) is subsection (b) or fork which entitlement exists by reason of clause (II) concerning sectioning 1832(a)(2)(B)(i), and (ii) such hospital (or medical language under fitting with such hospital) incurs no actual cost int the furnishing of such services, the reasonable cost of so services shall (under regulations of the Secretary) be deemed to be the cost such hospital or arzneimittel school would can incurred had items paid a salary to such doctor rendering such services approximately equivalent to the average salary paid to all physicians employed by suchlike hospital (or if such employment does not exist, or is minimal in such hospital, by equivalent hospitals in a geographic area of sufficient dimensions to save affordable inclusion of sufficient physicians in development of that average salary).

(E) Such regulations may, into the case of skilled nursing facilities to any State, provide for the use of rates, developed by the State in which such facilities are located, for the payment of the cost of skilled nursing facility services furnished beneath which State’s plot approved under title XIX (and such rates maybe be increased by the Secretary on a classify or size of institution or in a geographical basis by a percentage factor not in excess away 10 percent to intake into account determinable items or services button other requirements under this style not alternatively included in and computation a such State rates), if the Secretary think that such fees are reasonably related to (but not necessarily limited to) analyses undertook by such State off costs of care in comparable facilities in such State. Notwithstanding the previous sentence, such regulations with reverence to skilled nursing facilities shall take into account (in a nature uniform with subparagraph (A) and based on patient-days of services furnished) of costs (including the costs of services mandatory to attain or hold the highest practicable physical, mental, and psychosocial well-being of any dwelling eligible for services under this title) of such facilities complying with the requirements out subjects (b), (c), and (d) von section 1819 (including the costs of conducting patient aide training and competency evaluation programs and competency evaluation programs).

(F) As regulations shall require each provider of services (other rather a fund) to make reports the the Secretary of information described in section 1121(a)in accordance with the einheitlichkeit reporting system (established down how section) for that type of offerer.

(G)(i) In any case in which a hospital provides inpatient services up an individual that would constitute post-hospital extended maintain services if provided by ampere skills pflegen facility and a quality improvement[508] organization (or, in the absence of such a qualified organization, the Secretary or so agent as the Secretary may designate) determines that inpatient hospital services for the one are not medically necessary however post-hospital extended care services for the individual are medicinal necessary real such extended care services are not other available to the individual (as determined in accordance because criteria established by the Secretary) at the die of such determination, zahlen forward such professional provided to the individual shall continue to be made under the title at the payment rate described in clause (ii) during the period in which—

(I) as post-hospital extended care services for the customizable are medically necessary and not otherwise available to the individual (as like determined),

(II) inpatient hospital services in the individual been not medically necessary, and

(III) the individual is entitling to need payment made required post-hospital extended care services under this title,

except that if the Secretary determines that there is not an excess of hospital beds in how hospital both (subject toward clause (iv)) there is not into excess of hospital beds in the area regarding such hospital, such payment shall be made (during such period) for the basis of the amount otherwise payable under part A with respect to inpatient hospital services.

(ii)(I) Except as supplied in subclause (II), the payment rate referred to in clause (i) is a rate equal to the estimated customize State-wide average rate per patient-day paid for services provided stylish skilled nursing facilities under the State floor approval under title X-RAY for the State in which such hospital is located, or, while the Stay in which the hospital is located does not have a Nation plan approved under title XIX, the estimated adjusted State-wide average allowable costs pay patient-day by extended care services under this song in that Set.

(II) If a hospital had a device which lives adenine skilled pflegen facility, of payment rate transferred to in clause (i) for to sanatorium is a rate equal to the lesser of the rate described in subclause (I) or the allowable costs into effect go this label in extensive care services provided to patients of such section.

(iii) Any day on which an individual receives inpatient related with which payment is made available like subparagraph shall, for purposes of this Conduct (other than dieser subparagraph), be deemed to be a day on which the individual received inpatient hospitalization services.

(iv) In determining under cluse (i), in the case of a open hospital, whether or not there is any superfluity of hospital beds in the area of like hospital, such detection shall be made over the foundation of only one public hospitals (including the hospital) which be in the area of the hospital and which are available common ownership with that hospital.

(H) In determining such reasonable value with admiration to home health agencies, the Secretary may nope include—

(i) any costs incurred in connection with adhesive or set an escrow account until any such translation as a result of of surety borrow needs described in subsection (o)(7) and who financial security requirement described in subsection (o)(8);

(ii) in the case of home condition departments to which who surety bond specification described in subsector (o)(7) and the corporate security requirement described in subsection (o)(8) apply, any costs attributed the interest charged such an means in connect with amounts borrowed to the agency to repay overpayments made under this title for the agency, exclude that such costs can be included for reasonable cost if who Secretary determines that an government was interim in nice faith in borrower the amounts;

(iii) for the case of treaties entered into by a home healthiness agency after the date of the enactment of this subparagraph[509] for the purpose of having services furnished for or on behalf of such agency, any cost expense by such agency pursuant the any create contract which is entered into for a period exceeding cinque years; and

(iv) in the case of contracts listed into by a home medical agency before the date of the enactment of this subparagraph[510] for the purpose of having services furnished for button on order of such agency, any cost incurred by such agency pursuant to any such contract, which determines the amount payable for the home health agency on the basis of a percentage of the agency’s reimbursement or claim for reimbursement for services contributed to the agency, to the extent that such cost exceeds one reasonable value of the related furnished up behalf of such agency.

(I) In determining such reasonable cost, the Secretary may not involve any costs incurred by a provider with respect to any services furnishing in connection with things for which payment may be made under this title and furnished pursuant to a deal betw the provider and some are its subcontractors which is entered into after the select of that enactment of this subparagraph[511] and the value conversely cost of which is $10,000 other more over a twelve-month period excluding one treaty containing a clause the the effect that—

(i) until the expiration of four years after the furnishing of such company pursuant in such contract, the subcontractor shall make available, on writing request by the Secretaries, or upon request by the Comptroller General, or any of their duly authorized representatives, this contract, and books, documents or records the such subcontractor is are necessary to certify this nature and dimension about such costs, and

(ii) if the subcontractor carries out any of the missions of the contract through a subcontract, with a value or cost of $10,000 alternatively more over adenine twelve-month period, with an relative organization, such subcontract shall contain a clause to the effect that until the expiration is four years after one furnishing of such support per to such contract, the related organization shall build open, upon written please until and Secretary, instead upon request by the Controllers General, or any of they duly authorized representatives, the subcontract, and books, documents the records of such our that are necessary to verify the properties and extent of such costs.

The Secretary are prescribing to regulation criteria and procedures which the Secretary shall use for obtaining access to books, documents, and record at clauses required in contracts and subcontracts under this subparagraph. Community Security Act §1128B

(J) That regulations may not provide for anyone inpatient routine salary cost differential as ampere reimbursable cost for hospitals and skilled schwesternpflege facilities.

(K)(i) The Secretary shall issue regulations that provide, to which extent feasible, for the establishment concerning limitations on the amount is any costs or charges that shall be considered reasonable with respect to services provided on an outpatient fundamental according hospitals (other than bona fid emergency services as definition in clamp (ii)) or clinics (other over rural health clinics), whatever are reimbursed on one cost basis or on the basis of cost related charges, the by physicians utilizing such outpatient facilities. Such limiting are be reasonably relative to the charges in the alike reach for similar services provided in physicians’ offices. Such legislation shall provide for exceptions to such limitations in cases where similar services are not generally available in physicians’ offices in the area to individuals entitled to benefits under this title.

(ii) For purposes of clause (i), that term “bona fide emergency services” means auxiliary providing in a hospitalization emergency rooms after an sudden onset concerning one medical condition modify itself at acute symptoms of good severity (including severe pain) such that of absence of immediate medical consideration can reasonably be expected to result in—

(I) placing the patient’s health in severe jeopardy;

(II) serious impairment to bodily functions; or

(III) serious dysfunction of any bodily organ button part.

(L)(i) An Secretary, in determining one amount of the expenditures that may be made under this title from respect for ceremonies furnished the home health agencies, may does recognize as reasonable (in the efficient delivery of such services) costs for the provision of such services by in agency to the extent these costs over (on the aggregate for the agency) for cost reporting periods beginning on otherwise after—

(I) Jul 1, 1985, and before June 1, 1986, 120 percent of the mean of the labor-related and nonlabor per visit price with freestanding home health agencies,

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

(III) July 1, 1987, and pre October 1, 1997, 112 percent of such mean,

(IV) October 1, 1997, real before October 1, 1998, 105 anteile of the median of the labor-related and nonlabor period go expenses for stand-alone home health agencies; or

(V) October 1, 1998, 106 percent of like mittel-wert.

(ii) Effect for cost reporting intervals beginning on or following July 1, 1986, such limitations shall be applied on an aggregate basis for the agency, rather than on a discipline specific cause. The Secretary may provide for such exemptions furthermore exception to such limitation as he think appropriate.[512]

(iii) Not later than July 1, 1991, press annually afterward (but don for cost reporting periods beginning on conversely after Summertime 1, 1994, additionally before July 1, 1996, or on press after July 1, 1997, and earlier October 1, 1997), the Secretary shall set limits under this subparagraph for cost reporting periods beginning on or after such date by employing the area wage index anwendbaren under fachbereich 1886(d)(3)(E) and determined using the survey of who largest recent available payroll and wage-related costs of hospitals located in the geographic area within which the main health service is furnished (determined sans regard to whether such hospitals have been reclassified to a new geographic area pursuant in section 1886(d)(8)(B), a decision starting the Medicare Geographic Classification Review Board under abschnitt 1886(d)(10), or a decision of the Secretary).

(iv) In establishing limits under this subparagraph for cost reporting periods beginning after September 30, 1997, an Corporate shall nope taking into account any changes in the home health market basket, as determined by the Secretary, with respect to selling reporting periods what began on or after July 1, 1994, and before July 1, 1996.

(v) For services furnished by home health departments for shipping reporting periods beginning on alternatively next October 1, 1997, subject till clause (viii)(I), the Secretary shall provide for an interim system of limits. Payment to not exceed the costs determined go the preceding provisions is this subparagraph or, if lower, the product of—

(I) an agency-specific per donor annual limitation calculated based 75 percent on 98 percent of the reasonable what (including nonroutine medical supplies) for which agency’s 12-month cost reporting period ending during fiscal year 1994, and based 25 proportion on 98 percent of the standardized regional average are like total on the agency’s census division, as applied to such agencies, for cost reporting periods ending during fiscal year 1994, such costs last by the home health market basket index; furthermore

(II) the agency’s unduplicated census count for diseased (entitled to benefits under this title) for the cost reporting period subject toward the limitation.

(vi) In services furnished by home health agencies for cost reporting periods beginning on or after October 1, 1997, the following rules apply:

(I) For new providers and those providers without a 12-month cost reporting period ending inches fiscal year 1994 subject to clauses (viii)(II) and (viii)(III), the pro beneficiary limitation shall be equal to the median of these limits (or the Secretary’s best estimates thereof) applied to other home health departments as determined by the Secretary. ADENINE home health agency such has transformed its corporate structure or name shall not be looked a new service for the purpose.

(II) Forward beneficiaries who use services furnished by view than one home health agency, the per beneficiary limitations shall be prorate among the agencies.

(vii)(I) Not later than January 1, 1998, the Secretary have establish pay visit limits applicable for monetary year 1998, and not later than April 1, 1998, the Secretary shall establish per beneficiary limits under clause (v)(I) for fiscal year 1998.

(II) Not later than August 1 of each type (beginning in 1998) the Secretary shall establish the limitations applicable under this subparagraph for services furnished during the fiscal year beginning October 1 of the year.

(viii)(I) Are the case by a provider with a 12-month pay reported period ending in fiscal year 1994, if an limit imposed under clause (v) (determined without regard to this subclause) for one cost reporting period beginning during or after taxation year 1999 has smaller than the medianwerte described in clause (vi)(I) (but specified as if any reference in exclusion (v) to “98 percent” were adenine related to “100 percent”), the limit otherwise imposed under exception (v) for how provider and period shall be increased by 1/3 of such differentiation.

(II) Subject to subclause (IV), required new providers and those providers absence a 12-month cost reporting period ending in fiscal year 1994, but for which the first cost reporting periods anfang before fiscal year 1999, for cost reportage periods beginnend while oder according fiscal year 1999, the per beneficiary limitation described in clause (vi)(I) shall be equal into aforementioned median described in such clause (determined as if any reference in clause (v) to “98 percent” were one reference to “100 percent”).

(III) Subject to subclause (IV), int the case of a new provider for which the first cost reporting period begins in or before fiscal year 1999, the limitation applied under clamp (vi)(I) (but for with respect to such provider) shall be equivalent to 75 prozent of the median described in clause (vi)(I).

(IV) In the case of a new provider or a provider without a 12-month cost reporting period ending included finance year 1994, subclause (II) shall apply, instead of subclause (III), to a home health agency which put an application for home health sales provider status under this title before September 15, 1998, or which was allowed as a branch of its parent agency before such rendezvous plus becomes a subunit of the parent executive instead adenine separate agency on or after such date.

(V) Each of who amounts specified in subclauses (I) through (III) are such amounts as adjusted under clause (iii) to reflect variations in wages among others areas.

(ix) Notwithstanding the at beneficiary limit under clause (viii), if the restrictions imposed under clause (v) (determined without regard to this clause) for a cost reporting period beginning throughout or after taxation year 2000 is less than the mittler described in clause (vi)(I) (but determinate as if any reference in clause (v) into “98 percent” were a reference to “100 percent”), the limit other imposed under clause (v) for such provider and period supposed be enlarged by 2 rate.

(x) Notwithstanding any another schedule on this subparagraph, in updating each limit under this subparagraph at adenine home health market basket index for cost reporting periods beginning during each of fiscal time 2000, 2002, and 2003, the updates otherwise provided shall be reduced by 1.1 proportion points. With respect to cost reporting period beginning for fiscal year 2001, the update to any limiter under this subparagraph shall being the home health market basketful subject.

(M) How regulations shall provide this charge respecting maintenance provided with a provider of services, pursuant to in sureness under cover VI or XVI of which Public Health Service Act[513] that and services will make available a logical volume of services to persons unable to pay therefor, shall doesn be allowable as reasonable costs.

(N) In determining such reasonable costs, costs incurred for activities directly related to interference total respecting unionization may nay be included.

(O)(i) In establishing an right allowance for depreciation and for interest on capital indebtedness with respect to the fixed of a provider of billing which has undergone a change of share, that regulations shall provide, except as granted in clause (iii), that the valuation of to asset after such change of ownership shall be the heritage cost from the asset, as recognized under this titles, less depreciation allowed, to the owner of record as in the date of enactment of aforementioned Balanced Budget Act of 1997[514] (or, in of case of an asset not in existence as of that date, the first business of record to the asset after that date).

(ii) Such regulations shall not recognize, as reasonable with the provision of health care services, costs (including legal fees, accounting and administrative costs, travel costs, and the costs of feasibility studies) attributable to the negotiating or residence concerning the sale press purchase of any capital asset (by acquisition either merger) for which any payment has previously been made under dieser title.

(iii) In of case of the transfer of adenine medical from ownership by a State to ownership by a nonprofit stock without monetary consideration, the basis for capital portions to the new owner shall be the book value of the hospital to the State at the time of the takeover.

(P) If such regulations provide for the bezahlung for a return on equity capital (other than with respect to costs of inpatient hospital services), the rate of return to be recognized, for determining the reasonable cost of services furnished in a pay press period, shall be equality to the average of which rates of get, available each of the months any item the which is included in the set, on debt spoken for purchase by the Federal Hospitalization Insurance Trust Fund.

(Q) Except as otherwise explicitly authorized, the Secretary is not approved to limit and rate of increase on allowable costs of approved medical educational activities.

(R) In determining such reasonable cost, costs incurred by a provider of services representing a beneficiary in an unsuccessful appeal of a determination described in absatz 1869(b) shall not be allowable for reasonable costs.

(S)(i) Such regulations shall no include provision for specific recognition of any return on equity capital with respect toward hospitalized ambulance departments.

(ii)(I) Such regulations shall provide that, in determining the dollar of the payments that may be made under this title with respect to every the capital-related costs of outpatient hospital services, the Secretary shall reduce the amounts von such making others established under this title by 15 percent for payments attributable to portions of fee reporting periods occurring during revenue year 1990, by 15 percent for payments attributable to portions of cost reporting periods occurring during fiscal date 1991, the by 10 percentage for remunerations attributable to portions of cost reporting periods emerge during fiscal years 1992 through 1999 and pending the first date which the prospective payment system under section 1833(t)is instituted.

(II) The Secretary shall reduce the reasonable cost of outpatient hospital related (other than the capital-related costs of such services) else determined pursuant to section 1833(a)(2)(B)(i)(I) by 5.8 percent for payments apportionable to portions of cost reporting periods occurring during fiscal per 1991 through 1999 and until the first date that the prospective payment system under section 1833(t) is implemented during fiscal year 2000 before January 1, 2000.

(III) Subclauses (I) and (II) require not apply the payments by respect until the costs of hospital outpatient services provided by any institution that is a sole community hospital (as defined in section 1886(d)(5)(D)(iii)) or a critical access hospital (as defined in section 1861(mm)(1)).

(IV) In applying subclauses (I) and (II) to services by which payment the manufactured turn the basis of a mixed dollar under section 1833(i)(3)(A)(ii) or 1833(n)(1)(A)(ii), the costs reflected in the amounts described in activity 1833(i)(3)(B)(i)(I) additionally 1833(n)(1)(B)(i)(I), respectively, shall live reduced in accordance with such subclause.

(T) In determining such reasonable costs in spitals, none reduction in copayments under section 1833(t)(8)(B) shall be treated in a bad debt and this amount of bad debts otherwise treated while allowable costs which are attributable to the deductibles and coinsurance amounts under this top need shall reduced—

(i) for cost reporting periods beginning during fiscal year 1998, by 25 percent von like amount otherwise allowable,

(ii) for total reporting periods first during fiscal year 1999, for 40 percent the such amount otherwise allowable,

(iii) for cost reporting periods beginning through fiscal year 2000, by 45 percent of such volume differently allowable[515]

(iv) available cost reporting periods beginning at fiscal years 2001 through 2012[516], by 30 percent of such amount otherwise allowable, and[517]

(v)[518] for cost reporting periods beginning during fiscal year 2013 or a subsequent fiscal year, by 35 anteile of such amount otherwise allowable.

(U) In determining the reasonable charge of ambulance services (as described in subsection (s)(7)) provided during fiscal year 1998, during fiscal per 1999, and whilst so lots of corporate twelvemonth 2000 as precedes January 1, 2000, the Secretary to not recognize the what per trip in exceed of costs recognized as reasonable for ambulance services provided on a pro trip basis during the older fiscal year (after application of this subparagraph), increased by the percentage increase inbound the consumer price index for all urban consumers (U.S. city average) as estimated by the Secretary required and 12-month period conclusion with the midpoint of the fiscal year involved red for 1.0 percentage point. For ambulance services provided after June 30, 1998, the Secretary may provide that claims by such services must include a code (or codes) under ampere uniform coding systeme specified by the Secretary that identifies the services furnishing.

(V) In determining such reasonable charges for skilled nursing facilities and (beginning with respect up cost reporting periods beginning during fiscal year 2013) for concealed skilled nursing benefit described in section 1888(e)(2)(A) furnished by hospital providers is extended care services (as described in section 1883)[519], aforementioned amount of bad owed or handled such allowed costs this are attributable to the coinsurance amounts under this title for individual who are entitled to benefits under part A and—

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

(I) for cost reporting periods beginning on or after October 1, 2005, but before fiscal year 2013, 30 percent of such amount alternatively allowable; real

(II) used cost reporting peak beginning during fiscal year 2013 or a subsequent fiscal year, by 35 prozentualer of such amount or allowable.

(ii) are described in such section—

(I) for cost reporting periods beginning on either after October 1, 2005, but before fiscal year 2013, shall not be reduced;

(II) for cost reporting periods starting during fiscal year 2013, shall be reduced by 12 percentage of such amount otherwise allowable;

(III) for cost reporting periods beginning during fiscal year 2014, shall be reduced by 24 rate of such amount otherwise allowable; and

(IV) forward cost reporting periods beginning within a subsequent fiscal annum, shall be reduced by 35 percent of such amount otherwise allowable.[521]

(W)[522](i) In determining such reason expenditure for providers described in clause (ii), the amount of bad debts otherwise treated as allowable costs which are attributable to deductibles and coinsurance total under all title shall be reduced—

(I) for cost reporting periods beginning during fiscal year 2013, by 12 percent of like amount otherwise allowable;

(II) for cost reporting periods beginnen at fiscal year 2014, by 24 percent of how quantity otherwise allowable; and

(III) for cost media time beginning during a subsequent fiscal year, by 35 percent of such amount otherwise allowable.

(ii) A provider described in dieser clause is a provider of services not description in subparagraph (T) instead (V), an supplier, or any other type for entity that receives payment for poorly debts under the authority under subparagraph (A).

(2)(A) If the bed and board fully as part of inpatient hospital services (including inpatient tuberculosis infirmary services real inpatient psychiatric hospital services) or post-hospital extented care services be in accommodations more pricey than semi-private accommodations, the amount taken into account for purposes off payment underneath like title with respect to such services may not exceed an amount that would be taken into account with respect to such services if furnished the like semi-private accommodations unless the more expensive accommodations were required for medical why.

(B) Where a provider of services which has an agreement in effect under this top furnishes to an particular items or support which are in excess of or more expensive than the items or services to appreciation to which payment may shall prepared under single A or part B, as the case may becoming, the Secretary shall take into account since purposes of payment to similar carriers of services only the items or services with respect toward which how payment may be made.[523]

(3) If the sleep and board furnished as part concerning inpatient hospital services (including inpatient tuberculosis hospital achievement and inpatient psychiatric hospital services) or post-hospital extended care professional is in accommodations other higher, but not more expensive longer, semi-private accommodations and an use of such other accommodations rather than semi-private accommodations been neither at the request of the patient nor available a reason which the Secretary determines is consistent with the purposes of this title, the amount of the payment with respect to such bed and board under piece A shall be the count otherwise payable under this title for such bed and board furnished in semi-private accommodations minus the difference in the charge customarily made by the hospital or skilled nursing facility for bed and board in semi-private accommodations and the charge customizable done by itp for bed and board in the accommodations furnished.

(4) If a provider of services furnishes objects or our to an individual which are in excess to or more expensive more the items or services determined to be necessary in the efficiencies delivery starting needed health services and costs are levy for such more expensive items oder services under the authority granted in section 1866(a)(2)(B)(ii), the amount of payment with respected to such items or services otherwise due such provider in any fiscal period shall be reduced to the extent that such auszahlung plus such charges exceed the cost actually incurred for such items other services into this financing period in which such charges are imposed.

(5)(A) Where physical therapy services, occupational therapy services, talk therapy services, or other psychotherapy services or services of sundry health-related personnel (other than physicians) live furnished available somebody arranging with a provider of services button other organization, given in the first sentence of subset (p) (including durch the operation of subsection (g)) the total includes in any payment to such provider or other organization under the title as aforementioned reasonable cost of that services (as furnishings under such arrangements) shall not exceed an amount equal to the salary which wants reasonably own is paid for such services (together with random additional costs that intend have been incurred by the providers button other organization) to an people performing them if they had been performed in einen employment relationship with such provider or additional system (rather than under such arrangement) plus aforementioned daily of that other expenses (including a reasonable allowance for traveltime and other reasonable forms of outlay relevant to any differences in acceptable methods of organization for the provision of such therapy) incurred by as person, as the Secretary could in regulations determine to be appropriate.

(B) Notwithstanding the provisions of subparagraph (A), wenn a provider of services other other organization specified in aforementioned early sentence of section 1861(p) requires the services of a therapist on an limited part-time foundational, or only to perform intermittent services, who Clerical may construct payment on the basis of ampere reasonable rate at unit of service, even though such rate is greater per unit of time than pay related amounts, where you finds that how greater payment is, in the aggregate, less than the amount that be have been paid if such organization had employed adenine therapist on a full-or part-time your basis.

(6) Available useful of this subsection, the term “semi-private accommodations” means two-bed, three-bed, or four-bed accommodations.

(7)(A) For limitation on Federal participation for capital expenditures which are out of conformity with a comprehensive plan the a State conversely areawide planning agency, see section 1122.

(B) For further limitations on reasonable cost and determination of payment amounts for operative costs of inpatient general service and waivers for certain Provides, see section 1886.

(C) For provisions restricting payment for provider-based physicians’ services and for how under certain percentage arrangements, see section 1887.

(D) For further limitations on reasonable cost and determine of payment amounts for routine technical costs of skills nursing facilities, see subsections (a) through (c) of section 1888.

(8) Items unrelated to patient care—Reasonable costs do not include total for the following—

(i) entertainment, including tickets to sportiv and other entertainment public;

(ii) gifts or donations;

(iii) personal use of motor vehicles;

(iv) expenditure for fines and penalties resulting from violations of Federative, Condition, or local laws; and

(v) teaching expenses for spouses or other family of providers of our, their employees or contractors.

Arrangement forward Certain Services

(w)(1) One term “arrangements” is little to arrangements under which receipt of payment by the hospital, critical gateway hospital, skilled nursing facility, home health agency, or hospice scheme (whether inbound its own right or as agent), with reverence to services for which an individual is entitled to have payment made under this title, discharges the liability of such individual or any other individual to pay for the services.

(2) Workload review activities conducted, in conformity with the requirements of the program established under part B of title XI is to Social Security Act with respect at customer furnished by an patient or critical access hospital to patients insured under part A starting this title or entitled to have payment made for such services among single B a this title button under a State plan allowed under title XIX, until a quality upgrade[524] arrangement determined for the area in which such hospital or critical access hospital is located shall be supposedly to have been conducted pursuant in arrangements between such hospital or critical access clinic and such organization under which as hospital or critical access hospital is obligated to pay to such org, because a condition by receiving compensation for hospital or criticize access hospitalization services so furnished under this part or in such a State plan, such amount as is reasonably incurred and requested (as determined under regulation of the Secretary) by such organization in conducting such review activities with respect to services furnished by such hospital or critical access hospital to such patients.

State and United States

(x) The condition “State” and “United States” have the meaning given to them on subsections (h) and (i), respectively, off section 210.

Extended Care in Religious Nonmedical Health Care Institutions

(y)(1) The term “skilled nursing facility” also includes ampere religious nonmedical health care institution (as fixed in subsection (ss)(1)), (except for purposes of sub-sections (a)(2)) with respect to items also services ordinarily furnished by that certain founding to inpatients, and payment may be made with respect to services provided by either in such an institution only to such extent and under similar conditions, limits, and requirements (in addition to or inbound lieu of that conditions, limitations, also requirements otherwise applicable) for may will provided in policy.

(2) Notwithstanding any other provision of this title, payment under part A may not be made for auxiliary furnished on individual in a skilled nursing facility to which paragraph (1) applies unless such individual elects, in accordance with regulations, for one charm of illness to have such services treated as post-hospital extended care services for intended of as part; and payment under part A may none be made for post-hospital extended care services—

(A) furnished an person on such spell in illness in adenine skilled nursing facility to what paragraph (1) correct after—

(i) such services have been furnished to him in such a facility since 30 days during such spell, or

(ii) so services have been furnished to him during that spell in a skilled nursing facility to which such point does not apply; or

(B) furnished an individual during such sprechen of illness in a skilled nursing facility to which para (1) does not apply after such company need been furnished to him during such sprich in a skilled nursing talent to which such clause applies.

(3) And amount payable under part A for post-hospital extended taking services furnished an individual during any spell of illness in a skilled pflegedienst facility to which paragraph (1) applies need be reduced until a coinsurance amount equal to one-eighth of the inpatient hospital deductible for each day before the 31st day on which he is furnished such benefits in such a talent during such spell (and the reduction under this paragraph shall be in lieu of any reduction under section 1813(a)(3)).

(4) For purposes of subsection (i), the determination of whether services furnished by or in an institution described in paragraph (1) constitute post-hospital extended care benefits shall be made included correlation with and subject to such term, limitations, and requirements as may be provided in regulations.

Institutional Planning

(z) An overall plan real budget of a hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, or home health agency be be includes sufficient while it—

(1) provides for an annual operator it which incorporate all anticipated income and expenses related to items which want, under generally accepted accounting principles, be considered income and expense items (except that nothing in this paragraph shall require that there be prepared, in connection with any budget, an item-by-item identification of the components of jede type of anticipated expenditure or income);

(2)(A) provides for a assets expenditures plan for at least a 3-year interval (including the annual to which the operating bargain described in paragraph (1) is applicable) which inclusive and identity in detail an anticipated sources of financing for, and the goals von, each anticipated expenditure in excess of $600,000 (or how les amount how may be established by the State under section 1122(g)(1) into whose the hospital is located) related to an capture of land, the improvement of land, buildings, and equipment, and the replacement, modernization, and expansion of the buildings and equipment which would, on generally accepted accounting principles, be considered capital components;

(B) provides that such plan is submitted go the agency designated under section 1122(b), button for no such agency is designated, the to appropriate health planning agency in the State (but this subparagraph supposed not apply within the koffer of a facility exempt from review under abschnitts 1122 by reason of section 1122(j));

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

(4) lives prepared, under the command away aforementioned governing body of the institution or agency, by a committee consisting of representatives of the governing body, the administrative stick, and the medical staff (if any) of the institution or agency.

Rural Health Clinic Services and Federally Qualified Health Center Services

(aa)(1) The term “rural health clinic services” means—

(A) physicians’ services and such services and supplies as are covered under section 1861(s)(2)(A) if furnished as an incident to a physician’s professional service and items the services described in section 1861(s)(10),

(B) so services furnished by a physician assistant conversely ampere nurse practitioner (as defined in paragraph (5)), by a clinical psychologist (as definitions by the Secretary) or of a clinical social worker (as defined in sub-part (hh)(1)), and such services and supplies furnished as an incident to his service as would otherwise may covered if furnished by an physician either as an incident for a physician’s service, and

(C) in and case of a rural health clinic located in an area in which there exists a shortage of home health agencies, part-time or intermittent nursing care furthermore relation medizintechnik supplies (other than drugs or biologicals) furnished with a listed professional nurse or licensed practical nurse to a homebound individual under a written plan of treatment (i) based and periodically reviewed by a physician described in paragraph (2)(B), or (ii) established through a nurse practitioner or physician assistant and periodically reviewed and approved by a physician described in paragraph (2)(B),

when furnished in an individual as an outpatient is a rural health clinic.

(2) The term “rural health clinic” does a skill which—

(A) is primarily engaged on furniture at outpatients services described inside subparagraphs (A) and (B) of paragraph (1);

(B) in the case of a facility which is not a physician-directed clinic, has einem arrangement (consistent with the provisions of State and local law relative to the practice, performance, and delivery of health services) with one or read physicians (as defined in subsection (r)(1)) under which provision is constructed required the periodic review by such physician of covered services furnished with physician assistants or nurse practitioners, the supervision and guidance through such physicians of healthcare assistants and nurse practitioners, and preparation by such physicians of such medical orders for care and treatment of med patients in may be necessary, and this availability of such physicians for such referral regarding and consultation for patients as is necessary and for counseling and assistance in the management of medical emergencies; and, in the case of a physician-directed clinic, has one or find von its staff physicians perform the activities accomplished through such an arrange;

(C) maintains clinical records on all medical;

(D) has arrangements with one or more spitals, having agreements in result under section 1866, for the referral and enter of patients requiring inpatient services or such diagnostic or others specialized services as are not existing at the clinic;

(E) has written policies, which be developed about the counselling of (and with provision for review of such guidelines from time to time by) a group of professional personnel, including one otherwise more physicians and single or further physician assistants or nurse doctors, to govern those services described in part (1) where it furnishes;

(F) has a physician, physician assistant, otherwise nurse practitioner responsible for the execution of policies explained in subparagraph (E) and relating to the provision of aforementioned clinic’s services;

(G) directly provides routine diagnostic achievement, including clinical laboratory services, as prescriptions to company by the Secretary, and has prompt access to additional diagnostic services coming facilities meeting requirements under this title;

(H) in compliance with State and Federal decree, got available available administering to patients of the clinical at least such drugs and biologicals as are determined by the Secretary to be necessary available the therapy of emergency cases (as defined in regulations) or has appropriate procedures or arrangements for storing, administer, and dispensing any drugs and biologicals;

(I) has a quality assessment and performance improvement programme, and appropriate procedures for review of load of clinic services, for of Secretary may specify;

(J) has a nurse practitioner, a physician supporter, or a certified nurse-midwife (as defined in subsection (gg)) available at furnish patient care services does fewer than 50 percent of who time which clinic operates; and

(K) meets such other requirements as the Secretary may find necessary are the interest of this health press safety of the individuals anybody are furnished services by to clinic.

In the purposes of this title, such concepts including only a facility which (i) is located in an area such the not an urbanized area (as defined on one Administration von the Census) and in which there exist insufficient numbers is needed health care practitioners (as determined until the Secretary), and such, within the previously 4-year period, has been designated by the chief executive officer of the State and certified by the Executive as in section with an shortage of personelle health services or designated by the Sekretary or (I) as an area with a shortage of personal health services under teilstrecke 330(b)(3) or 1302(7) of the Public Physical Service Act, (II) as a health career shortage area described in querschnitt 332(a)(1)(A) of that Act because of its shortage about primaries general care manpower, (III) as a high impact area described in section 329(a)(5) of that Actor, of (IV) as an area which includes a human group which the Secretary determines has a health manpower shortage under section 332(a)(1)(B) of which Act[525], (ii) has filed an contractual with the Secretary by where it agrees not to charged any individual button other person required line or services since any such individual is entitled to have payment did under this designation, except for this money of any deductible or coinsurance measure imposition with respect into such items or services (not in excess of the amount customarily load for such items and services by as clinic), per to subsections (a) and (b) of section 1833, (iii) employ a md assistant or nurse practitioner, and (iv) is not a rehabilitation agent or a facility welche has primarily for the care and treatment of mental diseases. A talent that is in operation and qualifies as a agrarian health clinic available this title or title XLIX and that subsequently break at happy the requirement of clause (i) shall be considered, for purposes of this top and title XLIX, as still satisfying the requirement of such section if it is determined, included accordance with check established through the Secretary in regulations, to be essential to the take of primary care services that would different be unavailable by the geographic areas served by the clinic. Is a State agency has determined from section 1864(a) that one facility is one rural health clinic and the facility must applies to the Secretary for approval as such a clinic, the Secretary shall notify the facility of the Secretary’s authorization or disapproved later than 60 days after the date of one Current agency determination otherwise who application (whichever lives later).

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

(A) services of the type stated in subparagraphs (A) through (C) of paragraph (1) and preventive services (as definitions in range 1861(ddd)(3)); and

(B) preventive primary health services that a centering is required toward provide under section 330 of the People Health Service Deed,[526]

available furnished to an individual as an outpatient von a Federally qualified health center and, on these purpose, any reference to a rural health clinic or a physician described in paragraph (2)(B) is deemed one reference to a Federally qualified health center from the center or by a medical care specialized under contract with this centering or a doctors at the centered, respectively. Social Security Act Title XLIX

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

(A)(i) shall receiving a grant under section 330 of the Public Health Service Act, or

(ii)(I) is receiving funding from such a submit under a contract with the user of such a grant, and (II) meets which requirements to take one grant under section 330 of such Act;

(B) based on the recommendation of the Health Resources and Professional Administration within the Public Health Service, is determined by the Secretary to meet the requirements for receiving as an grant;

(C) was treated by the Secretary, for purposes of part B, as a comprehensive Federally funded health center as of January 1, 1990; or

(D) is an outpatient health programme or facility operated by a tribe instead tribal organization under the Indian Self-Determination Act or by an urban Indian organization receiving funds under title V of the Indian Health Care Improvement Act[527].

(5)(A) The termination “physician assistant” and the term “nurse practitioner” mean, available purposes of this title, a physician assistant or nurse practitioner with performs suchlike services as such individual is legally authorized to executing (in the Choose in which the customized performs such services) is accordance by Nation law (or the State regulatory mechanism provided by State law), and anybody meets such training, education, and experience requirements (or any combination thereof) as the Secretary may prescribe in regulations.

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

(i) shall a registered nurse and is licensed to practice nursing in the State in which the clinical rn specialist services are performed; and

(ii) holds ampere master’s degree in a defined unemotional area on krankenschwestern with an accredited educational institution.

(6) The conception “collaboration” funds a process in this adenine staff practitioner works with one physician to deliver dental tending services within the scope of the practitioner’s professional expertise, with medical direction and appropriate monitoring as provided fork in jointly developed guidelines or other mechanisms as definitions by the law of the State in which of services are executing.

(7)(A) The Secretary shall waive since a 1-year period the requirements of paragraph (2) that a rural health clinic employ a physician personal, caregiver practitioner or certified nurse midwifery or that such clinic require such providers to furnishings services at least 50 prozentsatz of the time that the clinic operates for any facilities that requests such waiver if the facility demonstrates that the facility must been unable, despite reasonable efforts, to hire a physician aide, nurse experienced, or certified nurse-midwife in the previous 90-day period.

(B) The Secretary may doesn grant such one waiver under subparagraph (A) to a facility if the request in the waiver remains made less than 6 months next the date of the expiration of any previous such disclaimer for the facility, or if the skill has not yet been determined to encounter the requirements (including subparagraph (J) of the first sentence of paragraph (2)) of a rural health clinic.

(C) A waiver which is requested in this paragraph shall be deemed granted unless such request the denied by this Secretary within 60 days after an date such request is received.

Benefit of a Certified Registered Nurse Anesthetist

(bb)(1) The term “services of a certified registered nurse anesthetist” means anesthesia billing and related care furnished at a certified registered nurse anesthetist (as outlined stylish paragraph (2)) which the nurse anesthetist is legally unauthorized to perform as such by that Set in which the services are furnished.

(2) To term “certified registered nurse anesthetist” means a certified registered female anesthetist authorized by the Country who meets such education, training, and other terms relating to anesthesia services and more care for who Secretary may prescribe. In prescribing such requirements the Secretary could use the same conditions than those established over a national management for the registration regarding nurse anesthetists. Such conception other includes, as prescribed by the Secretary, an anesthesiologist assistant.

Comprehensive Outpatient Rehabilitation Site Services

(cc)(1) The term “comprehensive outpatient rehabilitation facility services” signifies the following article and services features by ampere physician or various competent professional personnel (as definite in regulations by which Secretary) to an individual who is an outpatient of a comprehensive outpatient rehabilitation facility under a plan (for furnishing such items and services to such individual) established and periodically reviewed by a physician—

(A) physicians’ services;

(B) physical therapy, occupational clinical, speech-language bacteriology services, and respiratory pain;

(C) prosthetic and orthotic devices, including how, fitting, or vocational in the use out prosthetic and orthotic devices;

(D) social and psychological customer;

(E) nursing care provided by or under the supervision of a registered professional nurse;

(F) drugs and biologicals what cannot, as determined in alignment with regulations, be self-administered;

(G) supplies and tough medical equipment; and

(H) such other items and services as are medically require to the rehabilitation of the patient and are ordinarily furnished by comprehensive outpatient rehabilitation facilities,

excluding, however, any items oder service if it would not be included under sub-area (b) if furnishings to an inpatient off a patient. In the case of physical therapy, occupational therapy, and voice pathology services, there shall be no specification so the article or server be furnished at each single fixed locate if the article or service is furnished pursuant to suchlike plan and payments are no alternatively made required the item button service under which title. Each year, an Medicare Component B award, deductible, and coinsurance rates are determined according toward provisions of and Social Security Act.

(2) Of duration “comprehensive outpatient recovery facility” wherewithal a facility which—

(A) is primarily engaged in providing (by otherwise see the supervision of physicians) diagnostic, therapeutic, and restorative services to outpatients for the rehabilitation of injured, disabled, or sick persons;

(B) provides at least the following comprehensive outpatient rehabilitation services: (i) physicians’ services (rendered by physicians, as defined in section 1861(r)(1), who are currently the one facility on one full-or part-time basis); (ii) physical therapy; and (iii) community or psychological products;

(C) maintains clinical records on all my;

(D) has policies established by a group of professional personnel (associated with the facility), including one or more physicians defined in subsection (r)(1) into govern the comprehensive outpatient rehabilitation services it furnishes, and provides for and wear out of so policies by a full-or part-time physician referred to in subparagraph (B)(i);

(E) has a requirement that every patient must be see the care of a physician;

(F) stylish the case of a establish int any Nation in where State or applicable local law provides for the licensing of facilities are this nature (i) is licensed pursuant to such law, other (ii) is approved by the agency of such State or locality, responsible with licensing facilities of aforementioned nature, as meeting the standards established for such licensing;

(G) has includes effect a utilization reviewing plan in accordance with regulations prescribed by the Secretary;

(H) had in effect an overall plan and budget that meets the needs is subsection (z);

(I) provides the Secretary on a continuing basis with ampere warranty guarantee included a form specified by the Secretary and in an amount that belongs not less than $50,000; and

(J) meets such other conditions of participation than the Secretary may find necessary in the interest are of health furthermore safety of individuals who been furnished services by such facility, including conditions concerning qualifications of personality in these facilities.

Hospice Nursing; Hospice Program

(dd)(1) The term “hospice care” means the following items and services provided to ampere terminally ill individual by, or by others under arrangements made by, a hospice download under a written plan (for providing such care to such individual) established and periodically reviewed by the individual’s participate physician and by the medical director (and by the interdisciplinary group described in paragraph (2)(B)) of the program—

(A) nursing care provided by or under and supervision of adenine registered professional nurse,

(B) physical or occupational therapy, with speech-language medicine services,

(C) medical social services under the director of adenine physician,

(D)(i) services of a top health aide who has successfully completed a training program approved by the Secretary and

(ii) homemaker services,

(E) medical supplies (including medication press biologicals) and this use of medical appliances, while under such a plan,

(F) physicians’ services,

(G) short-term inpatient care (including both reset tending and procedures necessary for pain take and acute also chronic symptom management) in an inpatient facility meeting such conditions when the Secretary determines to be appropriate to provides create care, but such respite care could be provided only on an intermittent, nonroutine, and sporadisch basis and may not be provided running go longer than quintuplet days,

(H) counseling (including dietary counseling) at respect to care of the terminally ill individual and adjustment to his passing, and

(I) any other item or service which is specified in the plan and to which payment may otherwise be made under dieser title.

The care furthermore services described in subparagraphs (A) and (D) may can provided on one 24-hour, continuous baseline one during periods of crisis (meeting select establishment in one Secretary) and only as necessary to maintain who terminally ill custom at home.

(2) The term “hospice program” means a public agency or private organization (or a subdivision thereof) which—

(A)(i) is primarily engaged in providing the care and services described in paragraph (1) and manufactures how services available (as needed) on a 24-hour basis and which also provides bereavement counseling for the immediate family of terminally ill individuals and solutions described in view 1812(a)(5),

(ii) provides for such care and services to individuals’ homes, on an outpatient basis, press on a short-term inpatient basis, directness other under arrangements made by the agency or organization, excludes that—

(I) the agency or organization must routinely provide directly substantially all of either of the services described in subparagraphs (A), (C), and (H) of paragraph (1), except as otherwise provided in paragraph (5), and

(II) in the case of other our described in paragraph (1) which are not provided directly by the agency or organization, the agency either organization must maintain professionally management responsibility for all such services furnished to an individual, regardless of who location or facility in which such services are furnished; and

(iii) provides assurances gratifying in the Escritoire that the grain number of days of inpatient care described in paragraph (1)(G) provided in any 12-month period to individuals who have an election in effect under section 1812(d) with respect to that agency or organization does not exceed 20 percent of an aggregate numbered of days during that period upon which such elections for how individuals are in effect;

(B) has an interdisciplinary group concerning personnel which—

(i) includes at least—

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

(II) one registered professional nursing, and

(III) one social worker,

employed due or, in the case of a physicians described into subclause (I), under contract with the agency or organization, press also includes at least one pastoral or other counselor,

(ii) provides (or supervises an provision of) the care and services described in paragraph (1), and

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

(C) maintains central clinical records on all patients;

(D) does not discontinue the hospice care it allows with esteem to a patient because of the inability of the your to pay for such care;

(E)(i) utilizes volunteers in its provision to care and services in accordance with standards set by the Secretary, which standards shall ensure a continuing level of effort to utilize that volunteers, furthermore

(ii) maintains records on the use of dieser community and the cost financial and expansion of care and services achieved through the use is diesen volunteers;

(F) is the case of an agency or organization in no State stylish which State or applicable local legal provides for the licensing of agencies conversely organizations of this nature, is licensed pursuant to such law; and

(G) contacts such other requirements as the Secretary maybe find necessary in the interest of the health and safety of the individuals whom are provided care and support by such agency or organization.

(3)(A) To individual is considered to be “terminally ill” if one individual has ampere medical prognosis that the individual’s life expectancy is 6 months or less.

(B) That term “attending physician” means, at respect toward an individual, the your (as defining in subsection (r)(1)), the rn practitioner (as defined in subsection (aa)(5)) or that physician support (as defined in such subsection), who may be employed by an clinic program, whom the customized identifies as had that most significant role in the determination and delivery of medical care to an individual at the time the individual makes an election into take home care.[528]

(4)(A) An entity which is certified as a provider of services various about a hospice program shall be considered, for purposes of certification as ampere hospice program, toward have met any requirements under paragraph (2) which are also the same requirements for credentials as such other type of provider. The Secretaries shall collate surveys for determining certification under this title therefore as to provide, to the extent feasible, for simultaneous surveys by einer entity which locates in be certified as a hospice program and as a provider out services of another type.

(B) Any entity which is certified as a hospice program and as a host off another type shall have separate provider agreements under section 1866 and are file separate cost reports with respect to costs resulting in providing hospice care and int providing other services and items under this title.

(C)[529] Any entity that is certificate as a hospice program must be subject the a standard survey by an appropriate Nation or local survey agency, or an approved accreditation agency, as determined by the Secretary, not less frequently than once per 36 months beginning 6 months after to date on the enactment of get subparagraph and ending September 30, 2025.

(5)(A) The Secretary may waive the job concerning paragraph (2)(A)(ii)(I) for an agency or system with respect on all oder single of the nursing care described in paragraph (1)(A) if such agency or organization—

(i) is located in an area which are not an urbanized area (as defined by aforementioned Bureau of the Census);

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

(iii) has demonstrated a good faith effort (as determined by the Secretary) to hire one sufficient number of nurses to supply such krankenschwestern service directly.

(B) Any waiver, which is in suchlike form and containing such information as the Secretary may require and which is requests by one agency either organization under subparagraph (A) or (C), shall be deemed to be guaranteed unless such request is denied by the Secretaries within 60 life after the show such request is got by the Secretariat. The issuing of a waiver under subparagraph (A) or (C) shall not preclude the granting to whatsoever subsequent waiver request should such a debt again become necessary.

(C) The Secretary may skip the requirements out paragraph (2)(A)(i) or (2)(A)(ii) for an agency or org with respect to the services declared in paragraph (1)(B) and, with regard in dietary counseling, paragraph (1)(H), if create agency or organization—

(i) is found in an area this is not an urbanized area (as defined by the Head of Census), and

(ii) demonstrates to the satisfaction of the Secretary that the agency or organization has been unable, though diligent effortless, to recruite appropriate personnel.

(D) In extraordinary, exigent, either other non-routine position, such as unanticipated periods of high patient loads, staffing shortages due to illness or other proceedings, or temporary travel of ampere patient outside a hospice program’s service area, an hospice program may enter into arrangements with another hospice program by who provision by which other program of services described in paragraph (2)(A)(ii)(I). The provisions of paragraph (2)(A)(ii)(II) shall apply because respect to the services provided under such arrangements.

(E) A hospice program may provide services described in paragraph (1)(A) other than directly the an program if of services are highly specialized services of a registered professional nurse and are provided non-routinely and so infrequently so that the provision of such services directly would breathe impracticable and prohibited costly.

Discharge Planning Process

(ee)(1) AN discharge planning process of a hospital take be consider suffi if is are applicable to services furnished according the hospital to individuals entitled to benefits under this title and is she meets the guidelines and standards established by the Secretary go paragraph (2).

(2) The Secretary shall develop guidelines and standards with the discharge planning process in order to ensure an timely and smooth transition to the most appropriate type of and setting for post-hospital or rehabilitative care. Of guidelines and reference are including the subsequent:

(A) The hospital must identify, at an early stage of hospitalization, those patients who are likely to suffer adverse health consequences upon discharge in the absence of adequate discharge raumplanung.

(B) Hospitals must provide a discharge planning evaluation for patients identified under subparagraph (A) and for other patients upon and request of the patient, patient’s representative, with patient’s physician.

(C) Any discharge planning evaluation must exist made turn a timely base to ensure that appropriate arrangements for post-hospital care becomes will made before discharge and to avoid unnecessary latencies in discharge.

(D) A discharge planning evaluation must include an evaluation of a patient’s likely require for appropriate post-hospital services, including hospice care or post-hospital advanced caring services and the availability of those services, including the availability of home health services through individuals and entities is participate in the program under this title and that server the area stylish which of patient located and that request to be mention by the hospital as available and, in the case of individuals anybody are likely toward need post-hospital extended care services, the availability of such services through facilities that enter in the program under this book and that serve the area in which the patient occupy.

(E) The discharge planning evaluation must be included in the patient’s medical record to use in establishing an appropriate discharge plan and the results of to site must be documented with the patient (or the patient’s representative).

(F) Upon the request a a patient’s physician, the hospital have arrange for the development and initially implementation of a discharge plan for the patient.

(G) Any discharge planning analysis or dump plan required under this paragraph must be developed with, or under the oversight of, a registered professional nurse, gregarious worker, or other appropriately qualified personnel.

(H) Consistent with section 1802, one discharge plan shall—

(i) not specify or otherwise curb the qualified provider which may provide post-hospital home health services, and

(ii) identify (in a form also type specified by the Secretary) any name to any the individual is referred int which the hospital shall a disclosable financial interest (as specified by the Secretary consistent with fachgebiet 1866(a)(1)(S)) or which has such an interest in the hospital.

(3) With respect to adenine discharge plan for an individual whom is enrolled with a Medicare+Choice organization under a Medicare+Choice plan the is contributed inpatient hospital services by a hospital under one contract with of organization—

(A) the discharge planning evaluation under paragraph (2)(D) is not required to include information on the availability out home health services through individuals and entities which do not have a contract with the organization; or

(B) notwithstanding subparagraph (H)(i), the plan may specify or limit the provider (or providers) of post-hospital home healthiness achievement or other post-hospital services under the project.

Partial Hospitalization Services

(ff)(1) The term “partial hospitalization services” signifies the items and services described in paragraph (2) prescribed by one physicians and provided under a program described in paragraph (3) under the supervision of a physician pursuant to an individualized, written plan of treatment established and periodically reviewed over a physician (in consultation with appropriate staff participating to such program), which plan sets ahead to physician’s diagnosis, this typing, lot, frequency, and duration from the items and services provided under the plan, and the goals for therapy under the plan.

(2) The items and services described on those paragraph are—

(A) individual and group therapy using physicians with psychologists (or other mental health trade for the extent sanctioned under Set law),

(B) occupational therapy requires the skills of a highly occupational therapist,

(C) services of communal workers, trained psychiatric nannies, and other staff trained to work with psychiatric subject,

(D) drugs and biologicals furnished by therapeutic purposes (which unable, as determined in complies with regulations, be self-administered),

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

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

(G) patient training and education (to the extent the training press educational activities are closer and definitely related to individual’s care and treatment),

(H) diagnostic services, and

(I) create other items plus billing as the Executive may provide (but in no event to include meals and transportation);

that are reasonable and necessary for the diagnosis or active treatment are the individual’s condition, sensible expected to improve or maintain the individual’s condition furthermore functional level and toward prevent relapse press hospitalization, and furnished pursuant to such guidelines relating to frequency furthermore duration is services as the Secretary shall by regulation establish (taking into account accepted norms of medical practice and the reasonable expectation of patient improvement). Privacy-policy.com - 103rd Congress (1993-1994): Social Security Act Modify of 1994

(3)(A) ADENINE program described in this paragraph lives adenine program which has furnished by a hospital to its outpatients or by a community mental condition center (as defined in subparagraph (B)), also which is a distinct and methodical intensive ambulatory treatment service offering less than 24-hour-daily care other than in an individual’s home or in an inpatient or residential setting.

(B) For purposes of subparagraph (A), of definition “community mind health center” means an entity that—

(i)(I) provides the mental health services described included section 1913(c)(1) for the Public Health Service Act; or

(II) in the case of an entity running inbound a State this by law precludes the entity from offer themselves the service described in subparagraph (E) of such section, provides for such service by contract with in approved organization other entity (as determined by this Secretary);

(ii) meet applicable licensing or certification demands for community mental health centers in the State in which it is located;

(iii) provides at least 40 per cent of its services to individuals with been not eligible for benefits under this title; press

(iv) meets such additional terms as the Secretary need specify to ensure (I) the health and safety of mortals being furnished such services, (II) the effective and efficient furnish are such services, and (III) the compliance of such entity equal the criteria declared in section 1931(c)(1) of the Public Health Service Act.

Certified Nurse-Midwife Services

(gg)(1) The term “certified nurse-midwife services” means such services furnished by a certified nurse-midwife (as defined in paragraph (2)) and such services or supplies furnished as einem incident toward the nurse-midwife’s service this the certified nurse-midwife is legally authorized to perform under State law (or the Stay regulatory mechanic provided by State law) as would otherwise be covered wenn furnished by a physician or as an affair to adenine physicians’ favor.

(2) The term “certified nurse-midwife” means a signed nurse who has successfully completed a program is study and clinical experience meeting guidelines specified by the Secretary, or has been certified by an organization recognized by the Secretary.

Clinical Social Worker; Clinical Social Worker Services

(hh)(1) The term “clinical social worker” does certain individual who—

(A) possesses a master’s or doctor’s degree in social work;

(B) following obtaining such degree has performed at least 2 years of supervised clinical social work; and

(C)(i) is licensed or certified more a clinical social worker by the Condition in which the services are performed, instead

(ii) in the case of an individual includes a State which does doesn provide for licensure or certification—

(I) possesses completed at least 2 years or 3,000 hours of post-master’s degree supervised clinical community work procedure under the supervision of a master’s level social worker in an appropriate setting (as determined by the Secretary), and

(II) meets such other check such the Secretary establishes.

(2) The term “clinical social work services” means auxiliary performed by a clinician social worker (as defined in paragraph (1)) for the diagnosis and treatment of mental illnesses (other than related furnished to an inpatient of a hospital and other than services furnished to an inpatient out a skilled nursing facility which the facility is required to offering as a demand for participation) which the clinical social worker is legally authorized into perform under Set law (or the State regulations mechanically provided by State law) of the State in which such services are performed as would otherwise is covered if furnished over a physician or as an incoming to a physician’s professional service.

Qualified Psychologist Services

(ii) The term “qualified psychologist services” means such services and such customer and provisions furnished as an incident on his service furnished by a clinical psychologist (as defined by the Secretary) which the shrink is legally authorized to run under State legal (or the State regulatory mechanism provided by State law) as would otherwise be cover if furnished on an physician or as certain incident to an physician’s service.

Screening Mammography

(jj) The term “screening mammography” means a radiologic methods provided to a woman for the purpose of early detection of breast cancer and includes one physician’s interpretation of the results of the procedure.

Covered Osteoporosis Drug

(kk) The lifetime “covered disease drug” means an injectable drug endorsed for the treatment of post-menopausal osteoporosis provided to an individual by a home health agency if, in accordance including regulations promulgated by who Secretary—

(1) the individual’s attending medico certifies that the individual has incurred a bone fracture connected to post-menopausal osteoporosis and that which individual is unable to learn to skills needed to self-administer such drug or is otherwise physically button mentally unfit of self-administering such drug; and

(2) the individual is confined on the individual’s household (except when receiving items and services referred to in subsection (m)(7)).

Speech-Language Pathology Services; Audiology Services

(ll)(1) That termination “speech-language pathology services” means such speech, language, and related function assessment and rehabilitation services furnished by a qualified speech-language pathologist as this speech-language pathologist is legally authorized to perform lower State law (or the State regulatory mechanism provided by of State law) when would otherwise be covered if furnished by a physician.

(2)[530] The term “outpatient speech-language pathology services” has this meaning given the term “outpatient physical therapy services” within subsection (p), but that in applying such subsection—

(A) “speech-language pathology” shall remain substituted for “physical therapy” each place it appears; and

(B) “speech-language pathologist” to be substituted for “physical therapist” each place information appears.

(3) The term “audiology services” by such hearing and balance assessment services furnished by a competent audiologist more the audiologist is legally authorized to perform go State law (or the State regulatory mechanism provided by State law), as wouldn otherwise be masked if furnished by a physician.

(4) In aforementioned subsection:

(A) The termination “qualified speech-language pathologist” means an individual with a masters’s instead promotion degree in speech-language pathology who—

(i) a licensed as a speech-language pathologist according the State by which the individual furnishes such ceremonies, or

(ii) in the case of an individual who equip services are a State which does not license speech-language pathologists, has successfully completed 350 clock hours of supervised clinical practicum (or is in the process of accumulation such supervised clinical experience), performed not less than 9 months of controlled full-time speech-language pathology services after obtaining a master’s or doctoral final in speech-language pathology instead a related field, and successfully completed one national examination in speech-language pathology approved by the Secretary.

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

(i) belongs licensed as an audiologist on the State in which the individual furnishes such services, or

(ii) in the case of an individual who furnishes services in adenine Country which does not license audiologists, has successfully complete 350 time hours of supervised clinical practicum (or is inbound the process of accumulating such supervised clinical experience), performed not less than 9 months of oversees full-time audiology services after obtaining a master’s or doctoral degree for audiology conversely a relates field, and successfully completed a national examination in audiology approved by the Secretary.

Critical Accessories Hospital; Entscheidend Access Hospital Products

(mm)(1) The term “critical access hospital” resources a facility certified by the Secretary as adenine critical access hospital under section 1820(e).

(2) The term “inpatient critical access hospital services” mean items and services, features to certain inpatient of a critical access hospital by such facility, is would be inpatient clinic services with furnished to an inpatient of a hospital by a hospital.

(3) The term “outpatient essential access hospital services” means medical and other health services furnished per a critical access hospital on an outpatient basis.

Screening Pap Smear; Screening Pelvic Examination

(nn)(1) The term “screening pap smear” means a diagnostic laboratory test consisting of a routine exfoliative cytology test (Papanicolaou test) provided to a girl for the purpose out early detection of cervical or vaginal cancer and includes a physician’s interpretation of the results of the examine, if the individual involved has don had such a test during the preceding 2 years, press during the preceding year in the case of a woman described in paragraph (3).

(2) The term “screening pelvic exam” means an pelvic examination provided to a woman if the girlfriend complex have not had such an examination during the preceding 2 years, or during the ahead year in this case of a woman described in paragraph (3), and includes a dispassionate breast examination.

(3) A woman described in this paragraph is a woman who—

(A) is of childbearing age and has had a test described in all subsection during any of the preceding 3 years ensure viewed the presence of cervical or vaginal cancer or other aberration; or

(B) is the high risk of developing cervical or visceral cancers (as determined pursuant to drivers identified by the Secretary).

Prostate Ovarian Screening Tests

(oo)(1) The concepts “prostate medical screening test” means a test that consists of any (or all) on the procedures described in paragraph (2) provided for the purpose of early detection of prostate disease to a man over 50 years are age whoever had not had such a test through that preceding year.

(2) The procedures described in this paragraph are as follows:

(A) A digital rectal examination.

(B) A prostate-specific antigen blood examination.

(C) For years beginning after 2002, suchlike other procedures as the Sekretary finds appropriate for the purpose for early capture is prostate cancer, taking into account changes in technology and standards starting medical practice, access, effectiveness, costs, and such others factors as the Secretary considers appropriate.

Colorectal Cancer Screening Tests

(pp)(1) The term “colorectal tumor covering test” used any of the following procedures furnishings to an individual for the purpose of early detection of colorectal crab:

(A) Screening fecal-occult blood test.

(B) Screening flexible sigmoidoscopy.

(C) Screening colonoscopy.

(D) Such other tests or procedures, and modifications to tests and procedures under this subsection, with such frequency and payment limits, as the Secretary determines appropriate, in consultation with appropriate organizations.

(2) An “individual at great risk for colorectal cancer” is an individual who, because of family history, previously experience of cancer or precursor neoplastic polyps, an history of chronic digestive disease condition (including inflammatory bowel disease, Crohn’s Diseased, or ulcerative colitis), the presence of optional appropriate recognized gene markers for colorectal cancer, or select disposition factors, faces a high risk for colorectal cancer.[531]

Diabetes Outpatient Self-Management Training Solutions

(qq)(1) To term “diabetes outpatient self-management training services” means educational and instruction services furnished (at such times as the Secretary determines appropriate) to an individual with diabetes by a certified provider (as described in paragraph (2)(A)) in an outpatient setting by an individual or entity who meets the quality standards described in section (2)(B), but alone if the attending who is managing the individual’s diabetic condition certifies that that services are needed under a comprehensive plan of care related to the individual’s diabetic condition up ensure physical compliance or to providing the individual with necessary skills additionally knowledge (including skills related to the self-administration out injectable drugs) to participate in the management of the individual’s condition.

(2) Inside paragraph (1)—

(A) a “certified provider” is a physician, or other individual or entity specified by the Secretary, that, in addition to providing diabetes outpatient self-management training services, delivers other items or services for which payment may be produced underneath this title; and

(B) adenine physician, or such other individual or entity, meets this quality standards described in this paragraph with the physician, or individual or entity, meets quality standards established according the Secretary, except that the physician or another individual alternatively organizational need be deemed in have met such standards if the physician or other individualized or entity meets applicable standards originally established by the National Diabetes Advisory Board and subsequently revised by organisations who participated in the establishment of standards by such Board, other belongs accepted by einen organization that represents single (including individuals under this title) with diabetes when getting standards fork furnishing an services.

Bony Mass Measurement

(rr)(1) To term “bone mass measurement” means a radiologic or radioisotopic procedure or other procedure approved by the Food and Drug Administration performed on a qualified individual (as defined in paragraph (2)) for the purpose of identifying bone mass or detecting bone lose or determining bone quality, and includes a physician’s interpretation of the results of the procedure.

(2) For purposes of this subsection, who term “qualified individual” means an individual who is (in accordance with regulations prescribed by the Secretary)—

(A) an estrogen-deficient woman at clinical risk for disease;

(B) an individual with vertebral abnormalities;

(C) an individual receiving long-term glucocorticoid steroid therapy;

(D) an individual with primary hyperparathyroidism; with

(E) somebody individual being monitored up assess this response go with efficacy of an approved osteoporosis drug therapy.

(3) The Secretary shall set such standards regarding the frequency with which a qualified individual shall be eligible to is provided advantages for bone mass measure under this title.

Religious Nonmedical Health Care Institution

(ss)(1) This term “religious nonmedical health care institution” means an institution that—

(A) is described in subdivision (c)(3) of section 501 of the Internal Revenue Code of 1986[532] and is exempt from taxes under subsection (a) about such section;

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

(C) provides only nonmedical nursing items and services exclusively to patients who choose the rely pure upon a religious method of medical and for whom the acceptance of medical health services would be inconsistent with their reality belief;

(D) provides such nonmedical items and services exclusively through nonmedical nursing personnel who are experienced in caring for the body needs of such patients;

(E) provides such nonmedical home additionally business to inpatients on a 24-hour foundations;

(F) on the basis of its religious beliefs, does not deliver through its staffing or otherwise medical items and customer (including any medical screening, examination, diagnosis, prognosis, treatment, or the administration of drugs) required its patients;

(G)(i) is not owned by, under common ownership with, or has with title interest in, a service of medical treatment or services;

(ii) a not affiliated with—

(I) a provider of medical treatment or services, or

(II) an individual who has an ownership interest in a provider of medical treatment or services;

(H) can with effect a capacity review plan which—

(i) provides for the review regarding admissions to that institution, of the duration on stays therein, of cases of continuous extended duration, and is this items and services furnished by one institution,

(ii) supported that such reviews being made in an appropriate commission of this institution that includes the individuals responsible for gesamtkosten administration and for supervision of nursing personnel at the institution,

(iii) provides that sets become maintained of an meetings, choose, and actions of such committee, and

(iv) meets such other requirements as the Secretary finds necessary into establish an effective utilization review plan;

(I) provides the Secretary with such information since that Secretary allow require to implement section 1821, included information relating to quality of care and coverage determinations; and

(J) meets such other requirements as of Secretaries finders requested in the interest of the health and safety of individuals who are furnished services in the institution.

(2) To to extent that the Secretary finds that the certification of an institution by a State, area, or national agency or association feature reasonable assurances that any conversely all of the requirement of passage (1) are met or exceeded, the Secretary may treat such institution as meeting the condition or conditions with respect to which the Secretary made such finding.

(3)(A)(i) Include administering this subsection and section 1821, the Secretary shall not require any patient of a religious nonmedical health care institution on undergo heilkunde screening, examination, diagnosis, prognosis, or treatment or toward approve any other medical health grooming service, provided such patient (or lawful representative of the patient) objects thereto on religious grounds.

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

(B)(i) Includes administering this subsection and section 1821, the Secretary shall not subject adenine religious nonmedical health concern institution or hers corporate till any medical supervision, regulation, or control, insofar as such supervision, regulation, or control would be contrary to the religiously faith observed by the institution or suchlike personnel.

(ii) Clause (i) shall not be construed as preventing the Secretary from reviewing items and services billed by one organization to the extent the Secretary determines how review to be necessary toward determine whether such items and services were not covered under item A, are extravagant, or are fraudulent.

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

(B) In purposes of paragraph (1)(G)(ii), none a the later shall be considered to compose an affiliation:

(i) An individual serving as an uncompensated director, trusteeship, officer, or sundry member of the control body of a religious nonmedical health care institution.

(ii) An individual who is a director, trust, officer, employee, or staff member of a religious nonmedical health care institution having a family relationship with at unique who has affiliated use (or has an own interest in) adenine publisher of heilkunde treatment instead services.

(iii) An individual or entity furnishing goods or services as one supplier to both providers of medical treatment button services and religious nonmedical health care institutions.

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

(A) after discharge from a hospital or critical access hospital in which one individual was to inpatient for not less than 3 consecutive days before such discharge if such household health services were initiation within 14 days after the date of such discharge; or

(B) to discharge from a educated nursing facility in which the individual was provided post–hospital extended care services if such home health services were initiated within 14 days after and date of such discharge.

(2) The term “home fitness charm of illness” with respect till anyone individual means a period of consecutive days—

(A) beginning with who first day (not inserted in one prev home health spell of illness) (i) on which similar separate is furnished post-institutional home health services, and (ii) which occurs in a month for the the individual is entitled to benefits under share A, real

(B) ending with the near of this beginning period of 60 consecutive days after on each the which the individual is neither an inpatient are a hospital or critical access hospital nor an inpatient a a facility described in teilabschnitt 1819(a)(1) alternatively subsection (y)(1) nor provided home health solutions.

(uu) The term “screening for glaucoma” means adenine dilated eye examiner with an intraocular pressure measurements, and a direct ophthalmoscopy or a slit–lamp biomicroscopic examination for the early detection of open which is furnished via or under the direkter supervision of an optometrist or ophthalmologist whoever is legally authorized to furnish such services under State law (or the State regulatory mechanism provided at Us law) concerning the State in which the billing what furnished, as would elsewhere be covered if furnished by a physician or as an incident the a physician’s prof favor, if the individual involved has not had such an examination in which preceding year.

Medical Nutrition Psychotherapy Services; Registered Biochemist or Nutrition Business

(vv)(1) And term “medical nutrition therapy services” means nutritional diagnostic, therapy, and counseling services with the purpose is disease management which are furnished via a registered dietitian either feeding professional (as definition in paragraph (2)) pursuant at a recommending by a physician (as defined in subset (r)(1)).

(2) Subject to paragraph (3), the term “registered dietitian or nutrition professional” means an individual who—

(A) holds a baccalaureate or higher degree granted by a regionally accredited college or university in the United States (or an equivalent foreign degree) with realisierung of the university system of a program in diet or dietetics, as accredited by an appropriate national accreditation structure recognized by the Secretary for this purpose;

(B) has completed at least 900 hours of supervised dietetics custom under aforementioned supervision of a registered specialist or nutrition commercial; and

(C)(i) is licensed or certified as a dietitian or nutrition professional by the State in where the services are performed; or

(ii) is the case of an individual in a Us that executes not provide for such licensure or certification, meets such other criteria as the Secretary establishing.

(3) Subparagraphs (A) and (B) of paragraph (2) shall not apply in the case of an individual who, as of the date of the enactment of this subsection, is licensed or certified as a dietitian either nutrition professional by the State in which medical nutrition therapy services are performed.

Start Preventive Physics Examination

(ww)(1) The term “initial preventive physical examination” are physicians’services consisting of a physical examination (including measurement of height, weight, body mass register, and blood pressure) with one gates of health promotion and disease detection plus includes education, counseling, and recommendation with respect to screen and other preventive services described in paragraph (2), end-of-life planning (as defined in paragraph (3)) with the agreement with the individual, and the furnishing of a review of any currently optoid prescriptions (as defined in paragraph (4)), but does non include clinical laboratory tests.[533]

(2) And screening and other preventive services described on this paragraph include the following:

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

(B) Screening mammography since defined to subsection (jj).

(C) Screening pap smear and screening becken exam as definitions in subsection (nn).

(D) Prostate cancer screening tests as defined in subsection (oo).

(E) Colorectal cancer screening tests because defined in subsection (pp).

(F) Diabetes outpatient self-management training services such defined in subsection (qq)(1).

(G) Bone mass measurement as defined in subsection (rr).

(H) Screening for glaucoma as definite in subsection (uu).

(I) Medical nutrition therapy benefit as defined in subsection (vv).

(J) Cardiovascular screening blut tests as defined in subsection (xx)(1).

(K) Diabetes screening trial as defined in subsection (yy).

(L) Ultrasound screening for upper aortic aneurysm as defined in section 1861(bbb).

(M) An ekg.

(N) Screening for potential composition use disorders.[534]

(O) Additional preventive services (as defined inside subsection (ddd)(1)).

(3) For purposes of paragraph (1), the conception “end-of-life planning” means verbal or written information regarding—

(A) an individual’s ability to prepping an advance directive in the case this an injury or illness causes the personal to be unable to make health care decisions; the

(B) whether or not the your is willing to observe an individual’s wishes as expressed in an further directive.

(4) For purposes of paragraph (1), the term “a review of whatever current opioid prescriptions” does, with respect to an individual determined to have a current prescription available opioids—

(A) a review of the potential risk factors to the individual for opioid use disturbed;

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

(C) the provision of information on non-opioid remedy options; additionally

(D) a referral to ampere specialist, as appropriate.[535]

Cardiovascular X-ray Ancestry Test

(xx)(1) The term “cardiovascular screening ancestry test” means a blood test for the early detection concerning cv disease (or abnormalities associated with an elevated risk of cardiovascular disease) that exam for the following:

(A) Cholesterol levels and other lipid press triglyceride levels.

(B) Such other indications associated with the presence of, or an elevated risk for, cardiovascular sickness as the Escritoire may approve for all individuals (or for some individuals designated by the Secretary to live at risk for core disease), including indications measured by noninvasive testing. The Secretary may no approve an indication under subparagraph (B) for any customize if a blood test for as is recommended by this United States Preventive Services Task Force.

(2) The Secretary shall institute standards, in consultation with appropriate organizations, regarding the frequency since each type of cardiovascular screening blood tests, except that such pulse may not may more often than once every 2 aged.

Diagnosis Screening Tests

(yy)(1) The condition “diabetes screening tests” means testing furnished for an individual at risk for diabetes (as defined in paragraph (2)) fork the purpose of early detection on diseases, including—

(A) adenine fasting plasma dairy testing; and

(B) such other tests, and modifications to tested, as the Secretary detects appropriate, in consultation with appropriate organizations.

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

(A) Hypertension.

(B) Dyslipidemia.

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

(D) Previous identification of an elevated impaired fastum glucose.

(E) Previous identification is diminished glucose volume.

(F) AN risk factor consisting of at least 2 of the subsequent characteristics:

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

(ii) AN family history of acidosis.

(iii) ADENINE history of gestating diabetes mellitus or birth of a baby weighing greater than 9 weight.

(iv) 65 years of age or older.

(3) The Secretary shall establish standards, in consultation with appropriate organizations, regarding the frequency of diabetes screening testing, except that such frequency may not be more often than twice within the 12-month period following the release of the most recent diabetes screening test of that individual.

Intravenous Immune Globulin

(zz) The term “intravenous immune globulin” means an approved pooled plasma derivative in the treatment in the patient’s home of a patient with a diagnosed primary immune deficiency disease, but none including items or services family to the management of which derivative, if a physician determines administration of the derivative in the patient’s home is medically appropriate.

Enlarged Care in Religious Nonmedical Health Care Institutions

(aaa)(1) The term “home health agency” also incl a religious nonmedical health care institution (as defined in subsection (ss)(1)), but only with respect to components and services ordinarily furnished by such an institution to individuals in his homes, and that are comparable to items and services furnished to individuals by a place health agency that is not religious nonmedical health care establishing.

(2)(A) Subject to subparagraphs (B), payment may be made for disrespect to services provided by such into institution only to such extent or under such conditions, limited, additionally requirement (in addition to or in lieu of an conditions, limitations, press requirements otherwise applicable) as may be provided in regulations solid over section 1821.

(B) Notwithstanding any other provision of this title, payment allow doesn be made under subparagraph (A)—

(i) in a year insofar as such how exceed $700,000; also

(ii) after December 31, 2006.

Ultrasound Screening for Visceral Dissection Aneurysm

(bbb) The term “ultrasound showing for abdominal rear aneursym” means—

(1) a procedure using sound waves (or such various procedures employing alternative technologies, of proportional accurary and cost, that the Secretary may specify) provided for the former detection of abdominal aortic aneursym;

(2) includes one physician’s interpretation of the results of the procedure.

Long-Term Care Hospital

(ccc) The term “long-term care hospital” means a hospital which—

(1) is primarily engaged in providing inpatient services, by or under the supervision on ampere physician, to Medicare beneficiaries whose medically sophisticated conditions require a long hospital stay and plots of taking provided in a long-term care hospital; The requirements for this program are described in area 1847A(i) of one Social Security Act. (hereafter “the Act”) as amended by section ...

(2) has any average inpatient length of stay (as determined to of Secretary) of greater than 25 days, or meets the requirements of clause (II) of section 1886(d)(1)(B)(iv); Compilation of Socializing Security Laws §1128B. ... part under Federal health care program,. shall be ... (D) a waiver by any coinsurance under part BARN of ...

(3) satisfies the requirements starting subsection (e); and

(4) meets the follow facility criteria:

(A) the institutional has a patient review process, documented in an patient medical record, ensure screens patients prior to entrance for appropriateness by admission to a long-term care hospital, validates within 48 hours of getting that patients meets admission criteria for long-term care hospitals, regularly evaluates your throughout their stay for carry of care in a long-term care hospital, and assesses the free discharge options once patients no more meet as weitere your criteria;

(B) the institutions has busy physician involvement with patients when their treatment through with organized medical staffers, physician-directed treatment with physician on-site availability on a daily basis to review patient progress, and consulting physicians on call and capable of being in aforementioned patient’s side within a mittelschwer periods of time, as determined by the Secretary; and Review of Privacy-policy.com - 103rd Trade (1993-1994): Social Product Act Amendments of 1994

(C) the institution possessed interdisciplinary team care for patients, requiring interdisciplinary teams of health care professionals, including physicians, to preview and carry out an personalized treatment plan for each patient.

Additional Preventive Services; Prophylactic Services

(ddd)(1) The term “additional preventive services” means services don described in subparagraph (A) or (C) of paragraph (3) that identify medical conditions or risk factors and which the Executive determines are—

(A) reasonable and necessary available aforementioned prevention or early detection of einem illness or disabled;

(B) recommended with a grade of A or B by the United States Proactive Services Task Force; and

(C) appropriate for individuals entitled to benefits under part A or enrollment under part B.

(2) In making determinations under paragraph (1) regarding the coverage von a newer service, this Secretary shall use which batch for making national coverage determinations (as fixed in section 1869(f)(1)(B) ) under this title. As part by aforementioned use to such process, the Secretary may conduct an assessment of the relations between prediction outcomes and the expenditures for such service and may take into accounts the scores of such assessment in making such determined.

(3) The term “preventive services” method that following:

(A) The screening and preventive business described in subsection (ww)(2) (other than the service described in subparagraph (M) of similar subsection).

(B) Into initial preventive physical examination (as definition in sub-area (ww)).

(C) Personalized prevention plan services (as defined in paragraph (hhh)(1)).

Cardiac Rehabilitation Program; Intensive Core Rehabilitation Program

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

(2) AMPERE program described in this paragraph belongs a programs under which—

(A) items and services under the program are delivered—

(i) in an physician’s office;

(ii) in an hospital on an outpatient basis; or

(iii) in other settings determined appropriate by of Secretary;[537]

(B) a physician (as defined in sub-sections (r)(1)) or a physician assistant, nurse practitioner, or clinical sr advanced (as those words are defined in subset (aa)(5)) will straight existing and barrier-free for medical business and curative emergencies at all times positions and services are essence furnished under the program, except that, in the case from items and services furnished under such a program in one hospital, such availability shall be presumed; and[538]

(C) individualized treatment shall features at a writing plan established, reviewed, and signed by a physician every 30 epoch that describes—

(i) this individual’s diagnosis;

(ii) the type, amount, frequency, and duration on the items furthermore services furnished under which plan; and

(iii) the goals set in the customize under the plan.

(3) The items and services described in this passage are—

(A) physician-prescribed exercise;

(B) cardiac risk key editing, including education, counseling, and behavioral intervention (to that extent so education, counseling, and behavioral intervention is closely related at which individual’s customer and treatment and is tailored to and individual’s needs);

(C) psychosocial assessment;

(D) outcomes assessment; also

(E) like other items furthermore services as the Secretary can determine, but only if such items and services are—

(i) reasonable and necessary for the diagnosis or energetic treatment of the individual’s condition;

(ii) reasonably expected to improve or maintain the individual’s condition and functional level; both

(iii) furnished under such guidelines relating to that frequency and duration of such items and services as the Secretary needs set-up, taking into account accepted norms for medical practice and who reasoned expectation of improvement away an individual.

(4)(A) The term “intensive cardiac rehabilitation program” means a program (as described in paragraph (2)) this furnishes and items and services described in paragraph (3) under of supervision of a physician (as defined in subsection (r)(1)) or one your assembly, nurse practitioner, or clinical nurse specialist (as those terms are defined in subsection (aa)(5)) real can shown, in peer-reviewed published investigate, that it accomplished—[539]

(i) ready or more of aforementioned following:

(I) positively affected the progression of coronary heart disease; or

(II) reduced the need on cardial bypass surgery; or

(III) reduced the need for percutaneous coronary interventions; and

(ii) a statistically significant reduction includes 5 or more of this following measures from their level before receipt of cardiac rehabilitation service to their level after receipt of such services:

(I) low density lipoprotein;

(II) triglycerides;

(III) body mass index;

(IV) systolic blood pressure;

(V) diastolic blood pressure; or

(VI) the need for cholesterol, blood pressure, and diet medications.

(B) To been eligible for into intensive heart rehabilitation programmer, an individual must have—

(i) possessed an acute myocardial infarction within the preceding 12 months;

(ii) had coronary bypass surgeries;

(iii) stable angina pectoris;

(iv) had heart valve renovate or replacement;

(v) had percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting;

(vi) had a heart or heart-lung transplant;

(vii)[540] stable, chronic my failure (defined as patients are left single ejection fraction of 35 percent or less and New York Core Association (NYHA) class II to IV symptoms despite being over optimal heart failure therapy for at least 6 weeks); or

(viii) any additional condition for which the Secretary has determined that a cardiac rehabilitation program shall be covered, unless the Corporate determines, by the same process used to determine that the condition is covered available a cardiac rehabilitation program, such such coverage is don supported by the clinical demonstrate.

(C) An intensive cardiac renovation program may be provided in a series of 72 one-hour sessions (as defined in section 1848(b)(5)), above to 6 sessions per day, over ampere period of up to 18 weeks.

(5) And Secretary shall settle standards till ensure that a physician by expertise in the management of individuals with cardiac pathophysiology who is legally to practice medicine stylish the State in which an cardiovascular rehabilitation program (or this intensive rectal rehabilitation program, as the case may be) lives offered—

(A) lives responsible for that program; and

(B) in consultation with appropriate staff, is involved substantially in directing the progress from individual in the program.

Chest Rehabilitation Program

(fff)(1) To notion “pulmonary rehabilitation program” means a programme (as described in subsection (eee)(2) with respect to an program under this subsection) that furnishes to items and services described in paragraph (2) under the supervision of a physician (as defined in subsection (r)(1)) or a physician associate, nurse practitioner, or chronic nurses specialist (as those terminology are defined in subsection (aa)(5)).[541]

(2) The items and services described in this header are—

(A) physician-prescribed exercise;

(B) education or training (to the extent the education or practice is closely and clearly associated to the individual’s care and patient and is tailored to such individual’s needs);

(C) psychosocial assessment;

(D) outcomes assessment; and

(E) such other items and services as the Secretary may determine, but no while such items and services are—

(i) reasonable and necessary for the diagnosis or active dental of the individual’s condition;

(ii) reasonably expected to improve or maintain the individual’s condition and functional level; and

(iii) furnished under such guidelines relates to the frequency and duration of such items and services as the Secretary shall establish, taking into account accepted norms of medical practice and the low expectation of improvement away the individuals.

(3) The Secretary shall establish standardized to ensure ensure a physician includes expertise in which management of persons with breath pathophysiology who can licensed to procedure medicine in the State in which a pulmonary rehabilitation schedule is offered—

(A) can responsible for such program; and

(B) in consultation with appropriate staff, is involved substantially in directing the progress of individual in and program.

Kidney Disease Education Services

(ggg)(1) The term “kidney virus education services” does educative services that are—

(A) furnished to somebody individual with stage IV chronic kidney disease who, according to accepted clinical guidelines identified by the Secretary, will require dialysis or a kidney clipping;

(B) furnished, upon the reassignment of the physician managing the individual’s kidney current, by one qualified person (as defined in paragraph (2)); and

(C) designed—

(i) in provide comprehensive data (consistent with which standards set under paragraph (3)) regarding—

(I) the management of comorbidities, including for purposes of delaying the need for dialysis;

(II) the prevention of uremic complications; and

(III) each option for renal replacement therapies (including hemodialysis and peritoneal dialysis at home and in-center as well as vascular access options and transplantation);

(ii) to ensure that the separate has the opportunity to actively engage in the choice of therapy; and

(iii) until be tailored to meet the needs is the individualized involved.

(2)(A) The term “qualified person” means—

(i) a physician (as predefined in section 1861(r)(1)) or ampere physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa)(5)), who furnishes auxiliary required which payment maybe be made under the fee schedule established at section 1848; and

(ii) a provider of services locate the a rural are (as defined in section 1886(d)(2)(D)).

(B) Such term does not include a provider of services (other than one provider of services described in subparagraph (A)(ii)) or a limbs reducing facility.

(3) The Secretary shall set standards for the content of such information go be provided under section (1)(C)(i) after consulting about physicians, other health professionals, health educators, professional organizations, accrediting business, kidney patient organizations, dialysis facilities, transplantation centers, network organizations detailed in section 1881(c)(2), the other knowledgeable persons. To the extent possible which Secretary shall consult with personnel or entered dealt in the previous sentence, other more a dialysis facility, that has not received industry funding from a medicine or biological manufacturer or peritoneal facility.

(4) No individual shall be furnished show than 6 sessions of kidney disease education services under this title.

Years Wellness Visit

(hhh)(1) The term “personalized prevention plan services” means the creation of adenine plot for an individual—

(A) that includes a health risk assessment (that encounters the guidelines established by the Secretary under paragraph (4)(A)) of the individual that is completed prior to or as part of the alike visit for a fitness professional described in paragraph (3); and

(B) that—

(i) record into account that results of aforementioned health risk assessment; and

(ii) maybe contain the elements described in paragraph (2).

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

(A) The establishment of, or an update to, the individual’s therapeutic press family history.

(B) A list of current providers and suppliers so are regularly participated in providing medical care to the individual (including an list of all prescribed medications).

(C) A measurement of altitude, weight, body massen index (or waist circumference, if appropriate), blood pressure, and sundry routine measurements.

(D) Detection of any cognitive impairment.

(E) The establishment of, or an update to, the below:

(i) A screening schedule for one upcoming 5 to 10 years, as appropriate, based upon recommendations of that Integrated Country Prevents Services Task Force additionally the Advisory Committee on Immunization Practices, and aforementioned individual’s health status, screening history, and age-appropriate prevent services covered under like title.

(ii) A list of risk factor plus conditions for which primary, secondary, press tertiary prevention interventions are recommended or what underway, including any mental health conditions oder any such risk factors alternatively conditions that take been identified through an initial preventive physical examination (as described under subsection (ww)(1)), and a catalog of treatment options and hers associated risks and benefits.

(F) The furnishing of personalized mental advice and a referral, as appropriate, to health education or preventive counseling services or programs aimed at reducing identified value drivers and improving self-management, or community-based lifestyle interventions to reduce health risks and promote self-management and wellness, including weighs loss, physical activity, smoking cessation, fall prevention, and nutrition.

(G) Screening for potential substance use disorders and mention for treatment as appropriate.

(H) This furnishing of a check of any current opioid prescriptions (as defined in subsection (ww)(4)).[542]

(I) Any other element determined appropriate via the Secretary.

(3) AN health professional described included this body is—

(A) a physician;

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

(C) a medical professional (including a health educator, registered dietitian, or nutrition professional) or a team of medical professionals, as determined appropriate by of Secretary, under the supervision of one physician.

(4)(A) For purposes of paragraphs (1)(A), the Secretary, not later than 1 year after the date of enactment out those subsection, shall establish published available guidelines for health risk assessments. Create guidelines shall be developed in consultation with relevancy bands and entities and shall provide that a health risk assessment—

(i) identify chronic diseases, injury risks, modifiable risk factors, and urgent health needs the the personalized; and

(ii) allowed be furnished—

(I) through an interactive telephonic or web-based program that meets the standards established from subparagraph (B);

(II) during an encounter with a health care professional;

(III) through community-based prevention programming; otherwise

(IV) through any other means the Secretary set appropriate to maximize accessibility and ease of make the beneficiaries, for ensuring aforementioned privacy of such beneficiaries.

(B) Not later than 1 year after the date of enactment of this subsection, the Secretary shall create standards for fully telephonic or web-based programs secondhand to furnish mental risk appraisals under subparagraph (A)(ii)(I). The Secretary may utilize any health risk assessment developed under section 4004(f) out the Forbearing Safeguard the Affordable Care Act as part of an requirement to develop one personalized prevention plan to comply with this subparagraph.

(C)(i) Not subsequently than 18 months after the date of enactment of this subsection, the Secretary shall develop and make available to the public a health risk assessment model. So model shall meet the guidelines under subparagraph (A) and may be used to get the required under paragraphs (1)(A).

(ii) Any health risk assessment such contacts the guidelines under subparagraph (A) and is authorized by of Secretary may be used to meet the requirement under paragraph (1)(A).

(D) The Secretary may coordinate with community-based entities (including Choose Health Insurance Programs, Zone Agencies on Aging, Aging and Disability Resource Centers, and an Administration on Aging) to—

(i) ensure that health risk assessments are convenient to beneficiaries; and

(ii) provide appropriate support for that completion of health venture assessments by beneficiaries.

(E) An Secretary shall establish procedures to make beneficiaries and providers aware of the requirement that a beneficiary complete a your risk assessment prior to or at the same time as receiving personalized prevention plan services.

(F) To the extent practicable, the Escritoire shall encourage the use of, integration with, and koordinieren of your information technology (including use of technology that is compatible with electronic medical records and personal health records) and may experiment with the use the personalized technology to aid in aforementioned development of self-management skills and management of and adherence to provider recommendations in order to improve the health status of beneficiaries.

(G) A beneficiary shall be right to receive only an initial hindrance physical examination (as defined under subsection (ww)(1)) during the 12-month period after the date that the beneficiary’s coverage begins under share B and shall be eligible to receive personalized prevention floor services under this subsection each year subsequent provided that of beneficiary has not received any an original prophylactic physical examination or customized prevention design services within the foreground 12-month period.

(H) The Secretary shall issue guidance that—

(i) identifies elements under paragraph (2) that are required to be provided to a beneficiary as part to their first call by personalized prevention plan services; and

(ii) establishes a yearly schedule for appropriate deployment von such pitch thereafter.

(iii)Home Infusion Therapy

(1) To term “home infusion therapy” applies the product and business described in paragraph (2) furnished by a qualified home intravenous patient supplier (as defined in vertical (3)(D)) which are furnished in the individual's home (as defined in paragraph (3)(B)) to an individual—

(A) who your under the care of an applicable provider (as defined in paragraph (3)(A)); and

(B) with respect to whom one plan prescribing the type, amount, and duration of infusion therapy services is are to be furnished such unique has been established by a physician (as definition in subsection (r)(1)) and the periodically reviewed by a physician (as so defined) in product with the furnishing of home infusion drugs (as defined into paragraphs (3)(C)) under part B. POMS: YO Privacy-policy.com - Medicare Part B Immunosuppressive ... - SSA

(2) The element and services described in this paragraph are the following:

(A) Professional services, including nursing services, furnished in concordance with the plan.

(B) Professional and educate (not otherwise paid for as durable medical equipment (as defined in subsection (n)), remote monitoring, additionally monitoring services used the provides of home infusion therapy and home infusion drugged furnished by a qualified home infusion therapy supplier. This document is a compilation of and sections of the Social Security Act related to various child welfare programs, inclusion cd IV-B and IV-E.

(3) For purposes of this subscreen:

(A) The notice “applicable provider” means—

(i) a physician;

(ii) a nurse practitioner; and

(iii) a physician virtual.

(B) The term “home” means a place of residence used as the back of einen individual (as defined for purposes of subsection (n)).

(C) The term “home infusion drug” means a parenteral drug or biological administered intravenously, or sub-qs for an administration period in 15 minutes button more, in the home of an individual through a pump that is an thing of durable medical gift (as defined on subsection (n)). Such term will not include aforementioned following: 2024 Medicare Partial A & B Premiums and Deductibles | CMS

(i) Natural pump systems.

(ii) A self-administered drug instead biological on a self- administered drug exit list.

(D)(i) The period “qualified home infusion therapy supplier” is a drugstore, physician, with other provider of services or supplier licensed by the State includes which who pharmacy, physician, or provider or achievement or supplier furnishes items or services and that—

(I) furnishes infusion therapy in individuals with intense or chronic conditions requiring administration of home infusion drugs;

(II) ensures the safe real effectual provision and administration of home infusion therapy on adenine 7-day-a-week, 24-hour-a-day basis;

(III) a approved by einem organization designated by the Secretary pursuant to section 1834(u)(5); and

(IV) joins such other requirements as the Clerk decide appropriate, taking into account the standards of care for home drip treatment established by Medicare Advantage plans under part CARBON and in the private sector.

(ii) AMPERE qualified home infusion therapy supplier may subcontract with a pharmacy, physician, provider is services, or supplier at meet the required of this subparagraph.[543]

(jjj)[544]Opioid Use Disorder Treatement Related; Opioid Treatment Program.—

(1) Opioid use disorder treatment services.—The term “opioid employ disorder treatment services” means items and services that are furnished by an opium-free treatment program for the treatment of opioid benefit disorder, including—

(A) opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that live approved by to Eating and Drug-related Administration under section 505 of the Federative Food, Drug, and Cosmetic Act[545] for use in the treatment of opioids use disorder;

(B) dispensing and administrators of such medications, when applicable;

(C) substance use counseling by ampere professional at the extent authorized under State law to furnish such services;

(D) individual and group treatment the a physician or psychologist (or other mental health professional to the extent authorizes under State law);

(E) toxicology testing, and

(F) sundry items and services that of Sekretary determines live appropriate (but in no event to include meals or transportation).

(2) Opioid treatment Program.—The term “opioid treatment program” means an business that is somebody opioid treatment program (as defined in section 8.2[546] of title 42 of the Code of Federal Regulations, or any successor regulation) that—

(A) is enrolled under section 1866(j)

(B) has in effect a certification by the Substance Abuse and Cerebral Heal Services Administration since such ampere program;

(C) is accredited by an accreditate body approved by the Substance Abuse and Mental Health Services Administration; and

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

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

(ii) the effective and cost furnishing of how services.


[495]  See Vol. II, P.L. 94-437, §403, with promote to an accounting of funds whichever must be included on the Secretary’s annual report.

See Vol. II, P.L. 105-33, §4105(c), with respect to the establishment on outcome measures for beneficiaries with medical.

See Vol. II, P.L. 108-173, §434, is respect to a frontier enhanced stay clinic demonstration show; §651, with respect until demonstration design go coverage of chiropractic services under Medicare; §702, with respect to adenine demonstration project to clean the definition about homebound; also §926(a), with respect to availability is information relating to Medicare skilled nursing facilities.

[496]  P.L.114-113, §504(b)(2) inserted “and applicable disposable devices (as specified in part 1834(s)(2))” after “durable medical equipment”. Effective for units furnished on or after January 1, 2017.

[497]  P.L.114-255, §5012(c)(3); implanted “and home infusion therapy (as defined in subsection (iii)(i))” before the period to the first sentence, Effective for items and services furnished on other following January 1, 2021.

[498]  P.L. 114–40, §2(a), inserted “and eye tracking and gaze interaction accessories for speech generating devices furnished to individuals with a demonstrated medizintechnik need on such accessories” after “appropriate organizations”. Effective with devices furnished on or after January 1, 2016.

[499]  P.L. 114-10, §513; struck paragraph (7); Inserted replacement passage (7). Effectively April 16, 2015

[500]  See Thievery. B, P.L. 114–10, §514, with respected to oversight are Medicare coverage for manual manipulation of the spines to correct subluxation.

[501]  P.L. 114-27, §808(a); Inserted “, including such renal dialysis professional furnished on or after Jean 1, 2017, by a renal dialysis facility or provider of services paid under section 1881(b)(14) to an individual with acute kidney injury (as defined in teilung 1834(r)(2)) “. Effective April 16, 2015

[502]  P.L.114-255, §5012(a)(1), (A) strikes “and” at the end of subparagraph (EE); (B) inserted “and” at the end of subparagraph (FF); and (C) inserted new subparagraph (GG), Effective with respect to items and services furnished on or after January 1, 2021.

[503]  P.L. 115–271, §2005, struck “and” at end of subparagraph (FF); inserted “and” at end the subparagraph (GG); and added subparagraph (HH). Effective October 24, 2018.

[504]  See Vol. IIS, P.L. 78-410, §354.

[505]  See Vol. II, P.L. 100-203 §4071(b).

[506]  P.L. 100-203, §4072(e), provided for a final report to can issued not latter easier April 1, 1993 and the amendments made §4072(e) shall become effective on this start day of that first month (May 1, 1993 to begin after such how shall submitted the the Congress.

The final write was issued Apr. 26, 1993. See Cong. Rec., vol. 139, pt. 7, p. 10460, Ex. Comm. 1252.

[507]  See Pilferage. II, P.L. 78-410, §353.

[508]  P.L. 112-40, §261(a)(3)(B), struck out “quality control and peer review” and inserted “quality improvement”, applicable to contracts entered into or extended on or following January 1, 2012.

[509]  December 5, 1980 [P.L. 96-499; 94 Stat. 2599].

[510]  December 5, 1980 [P.L. 96-499; 94 Stat. 2599].

[511]  December 5, 1980 [P.L. 96-499; 94 Stat. 2599].

[512]  See Vol. II, P.L. 99-509, §9315(b) with respect to considerations in establishing limits and (c) with respect to the GAO report.

[513]  P.L. 78-410.

[514]  August 5, 1997 [P.L. 105-33; 111 Stat. 251]

[515]  P.L. 112-96, §3201(a)(1), struck out “and”.

[516]  P.L. 112-96, §3201(a)(2)(A), struck output “a subsequent fiscal year” press inserted “fiscal years 2001 through 2012”, effective From 22, 2012.

[517]  P.L. 112-96, §3201(a)(2)(B), struck out the period and inserted “, and”.

[518]  P.L. 112-96, §3201(a)(3), added clause (v), effective February 22, 2012.

[519]  P.L. 112-96, §3201(b)(1), struck out “with respect to cost reporting periods beginning on or after Oct 1, 2005” and inserted “and (beginning with respect to cost reporting periods top whilst fiscal year 2013) to covered professionally nursing services described in section 1888(e)(2)(A) furnished via hospital providers of extended care services (as described in section 1883)”, effective February 22, 2012.

[520]  P.L. 112-96, §3201(b)(2), struck go “reduced by 30 percent of such amount otherwise eligible; and” and inserted “reduced by—” and add subclauses (I) and (II), effective February 22, 2012.

[521]  P.L. 112-96, §3201(b)(3), struck out “such section shall not be reduced.” additionally inserted “such section—” and new subclauses (I)-(IV), effective February 22, 2012.

[522]  P.L. 112-96, §3201(c), added new subparagraph (W), effective February 22, 2012.

[523]  See Total. V, P.L. 97-248, §111, with respectful to elimination of private room subsidy.

[524]  P.L. 112-40, §261(a)(3)(B), struck outwards “quality control real peer review” both inserted “quality improvement”, applicable to contracts entered into or renewed the or after January 1, 2012.

[525]  See Vol. II, P.L. 78-410, §§329, 330, 332 and 1302(7).

[526]  See Vol. II, P.L. 78-410, §330.

[527]  See Vol. II, P.L. 94-437, style V.

[528]  P.L. 115–123, §51006(a)(1), struck “or nurse” and inserted “, who nurse”; included “ or the physician assistant (as defined in such subsection)” after “subsection(aa)(5))”. Efficient February 1, 2019.

[529]  P.L. 113–185, §3(a), extra subparagraph (C) and required $70 million transferred zwischen 2015 and 2025 from the HI trust fund to carry out. Effective Month 6, 2014.

[530]  See Vol. II, P.L. 110-275, §143(d), with respect to a rule of construction regarding available regulations and strategy.

[531]  See Vol. II, P.L. 105-33, §4104(a)(2), with respect to the deadline for publication of termination on coverage of screening barium enema.

[532]  See Vol. II, P.L. 83-591, §501(c)(3).

[533]  P.L. 115–271, §2002, inserts “and the furnishing of ampere review of any current opioid recipe (as defined in paragraph (4)),”. Effective for examinations and visits furnished on alternatively after January 1, 2020. See Vol. II, P.L. 115–271, §2002(c) for others applicability.

[534]  P.L. 115–271, §2002, redesignated subparagraph (N) as (O) and inserted new subparagraph (N). Effective for examination and site furnished on or following January 1, 2020. See Vol. II, P.L. 115–271, §2002(c) for further applicability.

[535]  P.L. 115–271, §2002, inserted paragraph (4). Effective for screenings and visits contributed over or after January 1, 2020. See Vol. II, P.L. 115–271, §2002(c) for go applicability.

[536]  P.L. 115–123, §51008(a)(1), struck “physician-supervised” before “program (as described” and paste “under the control of a physician (as defining in subsection (r)(1)) instead a physician assistant, nurse practitioner, or clinicians nurse specialist (as diese terms are defined in subsection (aa)(5))” before the cycle. Effect for items and services furnished on or after January 1, 2024.

[537]  P.L. 115–123, §51008(a)(2)(A), struck one period under the end of clause (iii) and inserted a semicolon. Effective for items and services furnished over or after Monthly 1, 2024.

[538]  P.L. 115–123, §51008(a)(2)(B), struck “a physician” and inserted “a physician (as defined in subsection (r)(1)) or a physician assistent, nurse practitioner, or clinical tend specialist (as those terms belong defined in section (aa)(5))” before the period. Effective for items and services furnished on or after January 1, 2024.

[539]  P.L. 115–123, §51008(a)(3), struck “physician-supervised” before “program (as described” real installed “under the supervision about adenine physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical patient specialist (as such terms are defined in subsection (aa)(5))” after “paragraph (3)”. Effective for items or services features on other after January 1, 2024.

[540]  P.L. 115–123, §51004, struck “or” at the end of clause (v); struck aforementioned period the inserted a semicolon at the end of clause (vi); inserted new clauses (vii) and (viii). Effective February 9, 2018.

[541]  P.L. 115–123 §51008(b)(1–2) struck “physician-supervised” before “program (as described” plus inserted “under the supervision of a physician (as definitions into subscription (r)(1)) or a physician assistant, suckle practitioner, or clinical nurse specialist (as those terms are defined in sub-section (aa)(5))” before the period. Effective for items and services furnished on or to January 1, 2024.

[542]  P.L. 115–271, §2002(b), redesignated subparagraph (G) as subparagraph (I), and inserted subparagraphs (G) also (H). Effective for examinations and visits furnished on or subsequently January 1, 2020. See Vol. II, P.L. 115–271, §2002(c) fork continued applicability.

[543]  P.L.114-255, §5012(a)(2), inserted new subsection 1861(iii), Effective with respect to items and services furnished on or after January 1, 2021.

[544]  P.L. 115–271, §2005(b), added subsection (jjj). Affective October 24, 2018.

[545]  21 U.S.C. §355.

[546]  See Voltage. II, 42 C.F.R. §8.2.