Social Security Act §1861

(I)blood clottingfactors, for hemophilia patients competent to use such factors tocontrol bleeding without medical or other supervision, and items relatedto the administration of such factors, subject to utilization controlsdeemed necessary by the Secretary for the efficient use of such factors;(J)prescriptiondrugs used in immunosuppressive therapy furnished, to an individualwho receives an organ transplant for which payment is made under thistitle;(K)(i)services whichwould be physicians services and services described in subsections (ww)(1) and (hhh) if furnished by a physician(as defined in subsection (r)(1))and which are performed by a physician assistant (as defined in subsection (aa)(5)) under the supervisionof a physician (as so defined) and which the physician assistant islegally authorized to perform by the State in which the services areperformed, and such services and supplies furnished as incident tosuch services as would be covered under subparagraph (A) if furnishedincident to a physicians professional service, but only ifno facility or other provider charges or is paid any amounts withrespect to the furnishing of such services,(ii)services whichwould be physicians services and services described in subsections(ww)(1) and (hhh) if furnished by a physician (as defined in subsection(r)(1)) and which are performed by a nurse practitioner or clinicalnurse specialist (as defined in subsection (aa)(5)) working in collaboration(as defined in subsection (aa)(6)) with a physician (as defined in subsection (r)(1)) which the nursepractitioner or clinical nurse specialist is legally authorized toperform by the State in which the services are performed, and suchservices and supplies furnished as an incident to such services aswould be covered under subparagraph (A) if furnished incident to aphysicians professional service, but only if no facility orother provider charges or is paid any amounts with respect to thefurnishing of such services;(L)certifiednurse-midwife services;(M)qualifiedpsychologist services;(N)clinicalsocial worker services (as defined in subsection (hh)(2));(O)erythropoietinfor dialysis patients competent to use such drug without medical orother supervision with respect to the administration of such drug,subject to methods and standards established by the Secretary by regulationfor the safe and effective use of such drug, and items related tothe administration of such drug;(P)prostatecancer screening tests (as defined in subsection (oo));(Q)an oral drug(which is approved by the Federal Food and Drug Administration) prescribedfor use as an anticancer chemotherapeutic agent for a given indication,and containing an active ingredient (or ingredients), which is thesame indication and active ingredient (or ingredients) as a drug whichthe carrier determines would be covered pursuant to subparagraph (A)or (B) if the drug could not be self-administered;(R)colorectalcancer screening tests (as defined in subsection (pp));(S)diabetesoutpatient self-management training services (as defined in subsection(qq));(T)an oral drug(which is approved by the Federal Food and Drug Administration) prescribedfor use as an acute anti-emetic used as part of an anticancer chemotherapeuticregimen if the drug is administered by a physician (or as prescribedby a physician)(i)for use immediatelybefore, at, or within 48 hours after the time of the administrationof the anticancer chemotherapeutic agent; and(ii)as a full replacementfor the anti-emetic therapy which would otherwise be administeredintravenously;(U)screeningfor glaucoma (as defined in subsection (uu)) for individuals determinedto be at high risk for glaucoma, individuals with a family historyof glaucoma and individuals with diabetes;(V)medical nutritiontherapy services (as defined in subsection (vv)(1)) in the case ofa beneficiary with diabetes or a renal disease who(i)has not receiveddiabetes outpatient self-management training services within a timeperiod determined by the Secretary;(ii)is not receivingmaintenance dialysis for which payment is made under section 1881; and(iii)meets suchother criteria determined by the Secretary after consideration ofprotocols established by dietitian or nutrition professional organizations;(W)an initialpreventive physical examination (as defined in subsection (ww));(X)cardiovascularscreening blood tests (as defined in subsection (xx)(1));(Y)diabetesscreening tests (as defined in subsection (yy));(Z)intravenousimmune globulin for the treatment of primary immune deficiency diseasesin the home (as defined in subsection (zz));(AA)ultrasoundscreening for abdominal aortic aneurysm (as defined in subsection(bbb)) for an individual(i)who receivesa referral for such an ultrasound screening as a result of an initialpreventive physical examination (as defined in section 1861(ww)(1));(ii)who has notbeen previously furnished such an ultrasound screening under thistitle; and(iii)who(I)has afamily history of abdominal aortic aneurysm; or(II)manifestsrisk factors included in a beneficiary category recommended for screeningby the United States Preventive Services Task Force regarding abdominalaortic aneurysms; and(BB)additionalpreventive services (described in subsection (ddd)(1));(CC)items andservices furnished under a cardiac rehabilitation program (as definedin subsection (eee)(1)) or under a pulmonary rehabilitation program(as defined in subsection (fff)(1)); and(DD)items andservices furnished under an intensive cardiac rehabilitation program(as defined in subsection (eee)(4));(EE)kidneydisease education services (as defined in subsection (ggg));(FF)personalizedprevention plan services (as defined in subsection (hhh));(GG)home infusiontherapy (as defined in subsection (iii)(1)); and[502](HH) opioid use disorder treatmentservices (as defined in subsection (jjj)).[503](3)diagnostic X-raytests (including tests under the supervision of a physician, furnishedin a place of residence used as the patients home, if the performanceof such tests meets such conditions relating to health and safetyas the Secretary may find necessary and including diagnostic mammographyif conducted by a facility that has a certificate (or provisionalcertificate) issued under section 354 of the Public Health ServiceAct[504]), diagnostic laboratory tests, and other diagnostic tests;(4)X-ray, radium,and radioactive isotope therapy, including materials and servicesof technicians;(5)surgical dressings,and splints, casts, and other devices used for reduction of fracturesand dislocations;(6)durable medicalequipment;(7)ambulance servicewhere the use of other methods of transportation is contraindicatedby the individuals condition, but only to the extent providedin regulations;(8)prosthetic devices(other than dental) which replace all or part of an internal bodyorgan (including colostomy bags and supplies directly related to colostomycare), including replacement of such devices, and including one pairof conventional eyeglasses or contact lenses furnished subsequentto each cataract surgery with insertion of an intraocular lens;(9)leg, arm, back,and neck braces, and artificial legs, arms, and eyes, including replacementsif required because of a change in the patients physical condition;(10)(A)pneumococcalvaccine and its administration and, subject to section 4071(b) ofthe Omnibus Budget Reconciliation Act of 1987[505], influenzavaccine and its administration; and(B)hepatitisB vaccine and its administration, furnished to an individual who isat high or intermediate risk of contracting hepatitis B (as determinedby the Secretary under regulations);(11)services ofa certified registered nurse anesthetist (as defined in subsection(bb));(12)subject to section4072(e) of the Omnibus Budget Reconciliation Act of 1987[506], extra-depth shoes with inserts or custom molded shoeswith inserts for an individual with diabetes, if(A)the physicianwho is managing the individuals diabetic condition (i) documentsthat the individual has peripheral neuropathy with evidence of callusformation, a history of pre-ulcerative calluses, a history of previousulceration, foot deformity, or previous amputation, or poor circulation,and (ii) certifies that the individual needs such shoes under a comprehensiveplan of care related to the individuals diabetic condition;(B)the particulartype of shoes are prescribed by a podiatrist or other qualified physician(as established by the Secretary); and(C)the shoesare fitted and furnished by a podiatrist or other qualified individual(such as a pedorthist or orthotist, as established by the Secretary)who is not the physician described in subparagraph (A) (unless theSecretary finds that the physician is the only such qualified individualin the area);(13)screening mammography(as defined in subsection (jj));(14)screening papsmear and screening pelvic exam; and(15)bone mass measurement(as defined in subsection (rr)).No diagnostic tests performed in any laboratory, including alaboratory that is part of a rural health clinic, or a hospital (which,for purposes of this sentence, means an institution considered a hospitalfor purposes of section 1814(d)) shall be included within paragraph (3) unless suchlaboratory(16)if situatedin any State in which State or applicable local law provides for licensingof establishments of this nature, (A) is licensed pursuant to suchlaw, or (B) is approved, by the agency of such State or locality responsiblefor licensing establishments of this nature, as meeting the standardsestablished for such licensing; and(17)(A)meets thecertification requirements under section 353 of the Public HealthService Act;[507]and(B)meets suchother conditions relating to the health and safety of individualswith respect to whom such tests are performed as the Secretary mayfind necessary.There shall be excluded from the diagnostic services specifiedin paragraph (2)(C) any item or service (except services referredto in paragraph (1)) which would not be included under subsection(b) if it were furnished to an inpatient of a hospital. None of theitems and services referred to in the preceding paragraphs (otherthan paragraphs (1) and (2)(A)) of this subsection which are furnishedto a patient of an institution which meets the definition of a hospitalfor purposes of section 1814(d) shall be included unless such other conditions aremet as the Secretary may find necessary relating to health and safetyof individuals with respect to whom such items and services are furnished.Drugs and Biologicals(t)(1)The term drugs and the term biologicals, except forpurposes of subsection (m)(5) and paragraph (2), include only suchdrugs (including contrast agents) and biologicals, respectively, asare included (or approved for inclusion) in the United States Pharmacopoeia,the National Formulary, or the United States Homeopathic Pharmacopoeia,or in New Drugs or Accepted Dental Remedies (except for any drugsand biologicals unfavorably evaluated therein), or as are approvedby the pharmacy and drug therapeutics committee (or equivalent committee)of the medical staff of the hospital furnishing such drugs and biologicalsfor use in such hospital.(2)(A)For purposesof paragraph (1), the term drugs also includes anydrugs or biologicals used in an anticancer chemotherapeutic regimenfor a medically accepted indication (as described in subparagraph(B)).(B)In subparagraph(A), the term medically accepted indication, with respectto the use of a drug, includes any use which has been approved bythe Food and Drug Administration for the drug, and includes anotheruse of the drug if(i)the drug hasbeen approved by the Food and Drug Administration; and(ii)(I)such useis supported by one or more citations which are included (or approvedfor inclusion) in one or more of the following compendia: the AmericanHospital Formulary Service-Drug Information, the American MedicalAssociation Drug Evaluations, the United States Pharmacopoeia-DrugInformation, and other authoritative compendia as identified by theSecretary, unless the Secretary has determined that the use is notmedically appropriate or the use is identified as not indicated inone or more such compendia, or(II)the carrierinvolved determines, based upon guidance provided by the Secretaryto carriers for determining accepted uses of drugs, that such useis medically accepted based on supportive clinical evidence in peerreviewed m edical literature appearing in publications which havebeen identified for purposes of this subclause by the Secretary.The Secretary may revise the list of compendia in clause (ii)(I)as is appropriate for identifying medically accepted indications fordrugs. On and after January 1, 2010, no compendia may be includedon the list of compendia under this subparagraph unless the compendiahas a publicly transparent process for evaluating therapies and foridentifying potential conflicts of interests.Provider of Services