Social Security Act §1862

(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)Local coverage determination.The term local coverage determination has the meaning given that insection 1869(f)(2)(B).(m)Coverageof Routine Costs Associated With Certain Clinical Trials of CategoryA Devices.(1)In general.In the case of an individual entitled to benefits under partA, or enrolled under part B, or both who participates in a categoryA clinical trial, the Secretary shall not exclude under subsection(a)(1) payment for coverage of routine costs of care (as defined bythe Secretary) furnished to such individual in the trial.(2)Categorya clinical trial.For purposes of paragraph(1), a category A clinical trial means a trial of amedical device if(A)the trialis of an experimental/investigational (category A) medical device(as defined in regulations under section 405.201(b) of title 42, Codeof Federal Regulations (as in effect as of September 1, 2003));(B)the trialmeets criteria established by the Secretary to ensure that the trialconforms to appropriate scientific and ethical standards; and(C)in the caseof a trial initiated before January 1, 2010, the device involved inthe trial has been determined by the Secretary to be intended foruse in the diagnosis, monitoring, or treatment of an immediately life-threateningdisease or condition.(n)Requirementof a Surety Bond for Certain Providers of Services and Suppliers.(1)In general.The Secretary may require a provider of services or supplierdescribed in paragraph (2) to provide the Secretary on a continuingbasis with a surety bond in a form specified by the Secretary in anamount (not less than $50,000) that the Secretary determines is commensuratewith the volume of the billing of the provider of services or supplier.The Secretary may waive the requirement of a bond under the precedingsentence in the case of a provider of services or supplier that providesa comparable surety bond under State law.(2)Providerof services or supplier described.Aprovider of services or supplier described in this paragraph is aprovider of services or supplier the Secretary determines appropriatebased on the level of risk involved with respect to the provider ofservices or supplier, and consistent with the surety bond requirementsunder sections 1834(a)(16)(B) and 1861(o)(7)(C).(o)Suspensionof Payments Pending Investigation of Credible Allegations of Fraud.(1)In general.The Secretary may suspend payments to a provider of servicesor supplier under this title pending an investigation of a credibleallegation of fraud against the provider of services or supplier,unless the Secretary determines there is good cause not to suspendsuch payments.(2)Consultation.The Secretary shall consult with the Inspector General of theDepartment of Health and Human Services in determining whether thereis a credible allegation of fraud against a provider of services orsupplier.(3)Promulgationof regulations.The Secretary shall promulgateregulations to carry out this subsection, section 1860D12(b)(7) (includingas applied pursuant to section 1857(f)(3)(D)),[580]and section 1903(i)(2)(C).(4)[581]Credible allegation of fraud.In carrying out this subsection, section 1860D12(b)(7) (includingas applied pursuant to section 1857(f)(3)(D)), and section 1903(i)(2)(C), a fraud hotline tip (as defined by the Secretary) without furtherevidence shall not be treated as sufficient evidence for a credibleallegation of fraud.