concerns the medicare program which provides health insurance for the elderly and disabled in particular concerns local coverage rules that restrict services covered by medicare these rules are exhausted by the private insurance compan that contract with medicare to administer the medicare program in states across the country there are now more than one thousand local coverage rules of this sort the defense secretary requires its contractors to adopt local coverage and only provide for those services if they fall into those categories not to be covered if they are not reasonable and necessary that's the language in the statute it's the language in the regulations that exist certainly are not procedural because they actually have nothing to do with procedures they ourselves are rules concerning substantive matters under your position are you saying that the secretary should have promulgated these regulation is just the criteria for the rules that are spelled out now in the manual there you know that the rules themselves are very long complex it would be a terrible administrative burden but the criteria are not  something they're not aware of yes that is the heart of the argument we feel that these criteria are so important place such and such a role that there should public notice and comment about them criteria for coverage of medicare services it hung around for ten years without anything happening although it was critically received by the public and by the provider community then the secretary withdrew the proposed rule but decided in two thousand and yes they is the provision that says the secretary shall publish in the federal register not less frequently every three months a list of all manual instructions interpret the rules statements of policy and whether they were based on the unacceptable standards if they were i mean certainly it could be easily remedied if the agency does what it's trying to do several times in the past anyway and dr regulation what difference will not be able to do that the public comment as we said before has been very negative towards these standards and i believe i different set of standards will be adopted more in line with the provi the briefs that section five point one in what was section five point four you know those sections of the manual constitute legislative rules subject to notice and comment even though the secretary has expressly not relied on his delegated legislative rules we're talking about him provisions l c d status to the local medical community the providers and the beneficiaries these items and services either are or are not covered under this particular refer you to the program integrity manual it's an excerpt of record getting it page one twenty nine that's chapter thirteen section seven there hocks about how the local coverage determinations themselves are developed it strike me as being a private institution they publish might have a certain separate impact compared to something that's on an official government website you saying that these are also on the web the website  medicare part of the of h h s and yes your honor that is my understanding and furthermore as a result of the settlement entered into in this case with respect to claims that are not before the court when the beneficiaries claim involved both because they're the ones who are really going to know about it most likely and of course because they are the medical experts and they are going to provide medical advice and comment on these proposed rules as to whether or not particular know a blue cross blue shield in a particular area to take advantage of the expertise that these private contractors had for the establishment medicare and to take account of the variations in the way medicine is practiced in this country what might be reasonable judicial review of individual l c d s meaning that today if an individual beneficiary such as mr turner has a claim denied based on what an l c the he has two avenues of recourse expenses secretary's interpretation of that language as set forth in the manual is persuasive the provisions would be entitled to some deference under skidmore but they're not entitled to shop around deference because they don't have  secretary has no obligation to promulgating these particular criteria as legislative regulations having the fourth course and the fact of law well let me ask you about this thirteen ninety five h h i would suspect an l c d would either be an interpretive rule or a general guideline and i honestly don't know whether or not a list of l c d s are where they might be found is or is not published in the federal register but again the claim before the court is not about any l c d only claim before the court is that section five point one and five point four of the program integrity manual constitute legislative rules that they are invalid because they weren't r what's your response your honor i'm not quite sure what miss hart is referring to and the one hand she seems to be referring to the use of l c d's is a general matter of fact contractors rather than reviewing all of the millions of medicare claims and a claim by claim basis can adopt these local coverage determination so that some of the claims can be automatically granted or denied in that respect she claims that that was a change in policy in one thousand nine hundred four i think it's not quite so simple my understanding is that medicare was using something called hewlett station screens before that grew into l  really relevant to the question before the court even if it were a change in policies to use these local coverage determination so what the agency is certainly allowed as a matter of its own internal operations to state rather than determining these millions of claims on a case by case basis we're going to determine them using these local rules that tell us in certain circumstances that claims will or will not be granted or harm  many comments and the secretaries chosen not to do so today and should this court rule for the secretary of course could choose not to do so in the future the result i submit would not be a benefit to plaintiff clients or to the public because the secretary could say you know what i don't want to publish criteria pursuant to not this kind of comment that's too administratively burdensome i will delete those provisions from the program integrity manual and i will have contractors do one of two things consistency in the l c d s in a contractor in among contractor you have less transparency to the whole system because reasonable and necessary tells the community that's commenting and also he's a little less than the criteria set forth in the ma drive agencies into an ad hoc decision making process and exactly what the secretary might decide to do here let's determine these millions of claims on a case by case basis without any interpretive criteria that means you have less noticed than you quote the legislative power of the united states is vested in the congress and the exercise of quasi legislative authority by governmental departments and agencies must be rooted in a grant of such power by the congress and it is for that reason that the focus on whether a rule authority or congress expressly or implicitly requires that it says we're going to establish a medicare program and provide people coverage and we're going to tell the secretary to decide the criteria by which he or she will determine whether claims are covered well absent some criteria there's no legislative basis for deciding claims that in any rule the secretary would issue would be an exercise of the delegated legislative authority from congress that's not what happened here o delegated legislative powers and the secretary here has that power congress has that you can make whatever regulations use deem appropriate in that circumstance the secretary could choose to push through notice and comment rule making he could have promulgated these criteria you know i'm not exercising delegated legislative authority and today if a cleaning appeals a denial benefits to a court the court has to ask are this claim for reasonable and necessary items or services doesn't apply the criteria  criteria are the medicare statute broadly spells out a list of health services that are covered and these are call in title and in the medicare statute hospital services home health services physician services that's it that's what's in the statute it's also what's in the regulation and why my colleague doesn't believe it is applicable and if he's right i think it is applicable the regulations concerning claims terminations you then call back and practice furnished in a setting appropriate to the patient's needs ordered or furnished by qualified medical personnel neat but to not exceed the patient's medical need at least as beneficial as medically appropriate alternative and particularly out of this is the most clearly offensive provision the secretary has a least costly alternative quire meant that applies mandatorily to durable medical equipment and at the option of the private contractor to all other services if the contractor believes that there is an alternative treatments the one at the physician has described the carrier can contract or can choose to simply reimburse at that lower rate rather than other words a service has to be proven to meet these criteria rather than be proven not to meet the criteria they clearly and enormous restrictions to coverage that go far beyond the not reason why necessary exclusion  of appeal and unfortunately very very few medicare beneficiaries as you can understand even their condition are actually pursue a medicare claim that far so they are down by the rules in the actual reality