Social Security Act §1862

(D)Report to congress.Not later thanNovember 15 before each year, the Secretary shall submit to the Congressa report on the single threshold amount for settlements, judgments,awards, or other payments for conditional payment obligations arisingfrom liability insurance (including self-insurance) and alleged incidentsdescribed in subparagraph (A) for that year and on the establishmentand application of similar thresholds for such payments for conditionalpayment obligations arising from worker compensation cases and fromno fault insurance cases subject to this section for the year. Foreach such report, the Secretary shall(i)calculate thethreshold amount by using the methodology applicable to certain liabilityclaims described in subparagraph (B); and(ii)include a summaryof the methodology and data used in calculating each threshold amountand the amount of estimated savings under this title achieved by theSecretary implementing each such threshold.(c)No payment maybe made under part B for any expenses incurred for(1)a drug product(A)which isdescribed in section 107(c)(3) of the Drug Amendments of 1962[572],(B)which maybe dispensed only upon prescription,(C)for whichthe Secretary has issued a notice of an opportunity for a hearingunder subsection (e) of section 505 of the Federal Food, Drug, andCosmetic Act[573]on a proposed order of the Secretary to withdraw approvalof an application for such drug product under such section becausethe Secretary has determined that the drug is less than effectivefor all conditions of use prescribed, recommended, or suggested inits labeling, and(D)for whichthe Secretary has not determined there is a compelling justificationfor its medical need; and(2)any other drugproduct(A)which isidentical, related, or similar (as determined in accordance with section310.6 of title 21 of the Code of Federal Regulations[574]) to a drug productdescribed in paragraph (1), and(B)for whichthe Secretary has not determined there is a compelling justificationfor its medical need,until such time as the Secretary withdraws such proposed order.(d)For purposes ofsubsection (a)(1)(A), in the case of any item or service that is requiredto be provided pursuant to section 1867  to an individual who is entitledto benefits under this title, determinations as to whether the itemor service is reasonable and necessary shall be made on the basisof the information available to the treating physician or practitioner(including the patients presenting symptoms or complaint) atthe time the item or service was ordered or furnished by the physicianor practitioner (and not on the patients principal diagnosis).When making such determinations with respect to such an item or service,the Secretary shall not consider the frequency with which the itemor service was provided to the patient before or after the time ofthe admission or visit.(e)(1)No payment maybe made under this title with respect to any item or service (otherthan an emergency item or service, not including items or servicesfurnished in an emergency room of a hospital) furnished(A)by an individualor entity during the period when such individual or entity is excludedpursuant to section 1128, 1128A, 1156 or 1842(j)(2) fromparticipation in the program under this title; or(B)at the medicaldirection or on the prescription of a physician during the periodwhen he is excluded pursuant to section 1128, 1128A, 1156 or 1842(j)(2) from participation in theprogram under this title and when the person furnishing such itemor service knew or had reason to know of the exclusion (after a reasonabletime period after reasonable notice has been furnished to the person).(2)Where an individualeligible for benefits under this title submits a claim for paymentfor items or services furnished by an individual or entity excludedfrom participation in the programs under this title, pursuant to section 1128, 1128A, 1156, 1160 (as in effect on September2, 1982), 1842(j)(2), 1862(d) (as in effect on the date ofthe enactment of the Medicare and Medicaid Patient and Program ProtectionAct of 1987[575]), or 1866, and such beneficiary did not know or have reason to know that suchindividual or entity was so excluded, then, to the extent permittedby this title, and notwithstanding such exclusion, payment shall bemade for such items or services. In each such case the Secretary shallnotify the beneficiary of the exclusion of the individual or entityfurnishing the items or services. Payment shall not be made for itemsor services furnished by an excluded individual or entity to a beneficiaryafter a reasonable time (as determined by the Secretary in regulations)after the Secretary has notified the beneficiary of the exclusionof that individual or entity.(f)The Secretary shallestablish utilization guidelines for the determination of whetheror not payment may be made, consistent with paragraph (1)(A) of subsection(a), under part A or part B for expenses incurred with respect tothe provision of home health services, and shall provide for the implementationof such guidelines through a process of selective postpayment coveragereview by intermediaries or otherwise.(g)The Secretary shall,in making the determinations under paragraphs (1) and (9) of subsection(a), and for the purposes of promoting the effective, efficient, andeconomical delivery of health care services, and of promoting thequality of services of the type for which payment may be made underthis title, enter into contracts with quality improvement[576]organizations pursuantto part B of title XI of this Act.(h)(1)TheSecretary.(A)shall waivethe application of subsection (a)(22) in cases in which(i)there is no methodavailable for the submission of claims in an electronic form; or(ii)the entitysubmitting the claim is a small provider of services or supplier;and(B)may waivethe application of such subsection in such unusual cases as the Secretaryfinds appropriate.(2)For purposes ofthis subsection, the term small provider of services or supplier means(A)a providerof services with fewer than 25 full-time equivalent employees; or(B)a physician,practitioner, facility, or supplier (other than provider of services)with fewer than 10 full-time equivalent employees.(i)In order to supplementthe activities of the Medicare Payment Advisory Commission under section 1886(e)in assessingthe safety, efficacy, and cost-effectiveness of new and existing medicalprocedures, the Secretary may carry out, or award grants or contractsfor, original research and experimentation of the type described inclause (ii) of section 1886(e)(6)(E)  with respect to sucha procedure if the Secretary finds that(1)such procedureis not of sufficient commercial value to justify research and experimentationby a commerical organization;(2)research and experimentationwith respect to such procedure is not of a type that may appropriatelybe carried out by an institute, division, or bureau of the NationalInstitutes of Health; and(3)such procedurehas the potential to be more cost-effective in the treatment of acondition than procedures currently in use with respect to such condition.(j)(1)Any advisory committeeappointed under to advise the Secretary on matters relating to theinterpretation, application, or implementation of subsection (a)(1)shall assure the full participation of a nonvoting member in the deliberationsof the advisory committee, and shall provide such nonvoting memberaccess to all information and data made available to voting membersof the advisory committee, other than information that(A)is exemptfrom disclosure pursuant to subsection (a) of section 552 of title5, United States Code[577], by reason of subsection (b)(4) of such section (relatingto trade secrets); or(B)the Secretarydetermines would present a conflict of interest relating to such nonvotingmember.(2)If an advisorycommittee described in paragraph (1) organizes into panels of expertsaccording to types of items or services considered by the advisorycommittee, any such panel of experts may report any recommendationwith respect to such items or services directly to the Secretary withoutthe prior approval of the advisory committee or an executive committeethereof.(k)(1)Subject to paragraph(2), a group health plan (as defined in subsection (a)(1)(A)(v)) providingsupplemental or secondary coverage to individuals also entitled toservices under this title shall not require a Medicare claims determinationunder this title for dental benefits specifically excluded under subsection(a)(12) as a condition of making a claims determination for such benefitsunder the group health plan.(2)A group healthplan may require a claims determination under this title in casesinvolving or appearing to involve inpatient dental hospital servicesor dental services expressly covered under this title pursuant toactions taken by the Secretary.(l)Nationaland Local Coverage Determination Process.(1)Factorsand evidence used in making national coverage determinations.The Secretary shall make available to the public the factorsconsidered in making national coverage determinations of whether anitem or service is reasonable and necessary. The Secretary shall developguidance documents to carry out this paragraph in a manner similarto the development of guidance documents under section 701(h) of theFederal Food, Drug, and Cosmetic Act[578](21 U.S.C. 371(h)).(2)Timeframefor decisions on requests for national coverage determinations.In the case of a request for a national coverage determinationthat(A)does notrequire a technology assessment from an outside entity or deliberationfrom the Medicare Coverage Advisory Committee, the decision on therequest shall be made not later than 6 months after the date of therequest; or(B)requiressuch an assessment or deliberation and in which a clinical trial isnot requested, the decision on the request shall be made not laterthan 9 months after the date of the request.(3)Processfor public comment in national coverage determinations.(A)Period for proposed decision.Not laterthan the end of the 6-month period (or 9-month period for requestsdescribed in paragraph (2)(B)) that begins on the date a request fora national coverage determination is made, the Secretary shall makea draft of proposed decision on the request available to the publicthrough the Internet website of the Centers for Medicare and MedicaidServices or other appropriate means.(B)30-day period for public comment.Beginningon the date the Secretary makes a draft of the proposed decision availableunder subparagraph (A), the Secretary shall provide a 30-day periodfor public comment on such draft.(C)60-day period for final decision.Notlater than 60 days after the conclusion of the 30-day period referredto under subparagraph (B), the Secretary shall(i)make a finaldecision on the request;(ii)include insuch final decision summaries of the public comments received andresponses to such comments;(iii)make availableto the public the clinical evidence and other data used in makingsuch a decision when the decision differs from the recommendationsof the Medicare Coverage Advisory Committee; and(iv)in the caseof a final decision under clause (i) to grant the request for thenational coverage determination, the Secretary shall assign a temporaryor permanent code (whether existing or unclassified) and implementthe coding change.(4)Consultationwith outside experts in certain national coverage determinations.With respect to a request for a national coverage determinationfor which there is not a review by the Medicare Coverage AdvisoryCommittee, the Secretary shall consult with appropriate outside clinicalexperts.(5)Localcoverage determination process.(A)Plan to promote consistency of coverage determinations.The Secretary shall develop a plan to evaluate new local coveragedeterminations to determine which determinations should be adoptednationally and to what extent greater consistency can be achievedamong local coverage determinations.(B)Consultation.The Secretary shall requirethe fiscal intermediaries or carriers providing services within thesame area to consult on all new local coverage determinations withinthe area.(C)Dissemination of information.The Secretaryshould serve as a center to disseminate information on local coveragedeterminations among fiscal intermediaries and carriers to reduceduplication of effort.(D)Local coverage determinationsThe Secretary shall require each Medicare administrative contractorthat develops a local coverage determination to make available onthe Internet website of such contractor and on the Medicare Internetwebsite, at least 45 days before the effective date of such determination,the following information:(i) Such determination in its entirety.(ii) Where and when the proposed determinationwas first made public.(iii) Hyperlinks to the proposed determinationand a response to comments submitted to the contractor with respectto such proposed determination.(iv) A summary of evidence that was consideredby the contractor during the development of such determination anda list of the sources of such evidence.(v) An explanation of the rationale thatsupports such determination.[579](6)Nationaland local coverage determination defined.For purposes of this subsection(A)National coverage determination.Theterm national coverage determination means a determinationby the Secretary with respect to whether or not a particular itemor service is covered nationally under this title.(B)