Dedicated to Lymphedema Patients and the Therapists Who Treat Them
Dedicated to Lymphedema Patients and the Therapists Who Treat Them
Comments to Proposed Rule Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures
Qualifications to Comment
I am a retired aerospace systems engineer with a Bachelor of Mechanical Engineering degree from City College of New York and a Master of Science degree from the University of California at Los Angeles.
I retired in 1996 from my 41-year employment as aerospace systems engineer and manager to learn about lymphedema and its treatment and to find informed medical care for my wife Pearl, then a 5-year survivor of breast cancer with lymphedema. I became a patient advocate to help Pearl, wending my way through the medical and insurance wilderness where lymphedema was a condition that was mostly unknown, mis-diagnosed, under-treated and under-insured. I used the knowledge I gained to become a lymphedema patient advocate and activist and continue to provide assistance to hundreds of cancer survivors and others with this chronic condition.
I completed 80 hours of lymphedema therapy training with the Dr. Vodder School of North America (2003), am a graduate of the National Breast Cancer Coalition Project LEAD (2004) and Quality Care LEAD (2007), and the National Lymphedema Network Lymph Science Advocacy Program. I am the dedicatee of Lymphedema Caregiver's Guide Kearse, McMahon & Ehrlich, San Francisco, CA (2009), and have been designated Adjunct Courtesy Faculty, University of Missouri Sinclair School of Nursing (2011-2012).
I am a past member of a Cochrane Collaboration Breast Cancer Group panel performing a systematic review of manual therapy for lymphedema following cancer treatment, Co-Chair of the American Lymphedema Framework Project Insurance and Health Policy Committee and a member of its Steering Committee, and a member of the Advisory Board of the Circle of Hope Lymphedema Foundation. I write for eLymphNotes, StepUp—SpeakOut, many on-line lymphedema lists and Facebook lymphedema groups and lecture at lymphedema conferences on incidence and prevalence of lymphedema, breast lymphedema, cost-efficacy of lymphedema treatment, insurance, reimbursement and legislation. I have been selected as a "PCORI Merit Reviewer" for the Patient-Centered Outcomes Research Institute.
My peer-reviewed publications relating to lymphedema treatment include:
Most relevant to my qualifications to comment on the proposed changes to the Medicare appeal rules: for the last 20 years I have been representing Medicare Beneficiaries appealing denials of lymphedema treatment at Administrative Law Judge (ALJ) hearings, and have developed an alternative interpretation of the Social Security Act which shows that lymphedema compression bandages, garments and items meet the Medicare requirements for prosthetic devices, and should be covered by Medicare (See http://www.lymphactivist.org/prosthetic_devices-insert.pdf) This logic has been used in over 50 ALJ appeals and has resulted in over 30 ALJ reversals of Medicare denials. I have assisted in the drafting and passage of lymphedema treatment laws in California, Connecticut, Georgia, Massachusetts, New York and Virginia, and wrote the Lymphedema Diagnosis and Treatment Cost-Saving Acts of 2010 and 2011 [H.R. 4662 and H.R. 2499] and have analyzed annual changes in Medicare law and how they affect lymphedema patients and therapists. See for example http://www.lymphactivist.org/medicare_101-insert.pdf
In the last twenty years I have assisted Medicare beneficiaries with their appeals of over 100 denials of compression garments used in the daily care of their lymphedema. Our denial reversal rate exceeds 50%. Resolution times through the appeal system runs 2-4 years, with patients having to wait for reimbursement and some forced to have 3-6 appeals running simultaneously since these medical items need to be purchased every 6-8 months. But what is worse is that most of these denials are based on a faulty understanding of Medicare law and CMS policy by the DME MACs, who never read the evidence submitted with the redetermination, and by the QICs who ignore the case record and issue rubber stamp affirmations of the DME MAC denials. These all contribute to the enormous backlog in ALJ cases.
Reductions in the appeal system backlogs and stemming the flow of appeals cannot be accomplished by simply adding attorney adjudicators. In this person's opinion the key is to reduce the number of denials that are currently based on faulty logic and interpretation of Medicare statutes and CMS policy by educating the DME MACs and QICs and insure that they adhere to their statutory and contractual responsibilities.
The quality of the ALJs is also somewhat spotty in my experience, with too many ALJs not understanding the statutory concept of "benefit categories" and cutting corners by not using the evidence submitted by the appellant and using Wikipedia in lieu of consulting medical experts. The record is even worse with decisions of the Council, and the prospect of granting new "precedential" powers to the Council and to the Secretary is a fearsome prospect from this patient advocate's experience.
The following comments are submitted in the spirit of improving the operation of the Medicare appeals system, and with the hope that CMS will, in addition, better educate their contractors in Medicare law and medical issues that will make them less likely to chose non-relevant NCDs and LCDs on which to base their denials.
Precedential Final Decisions of the Secretary
The prospect of granting the Medicare Appeals Council Medicare precedential authority [§405.968(b)(1), §405.1063(c), and §423.2063(c)] is misguided, and will only serve to deny appeal rights to thousands of Medicare beneficiaries who have been diagnosed with lymphedema. This is not an ethical means of reducing Medicare appeal system work load—on the backs of its beneficiaries. In my 20-year experience with Medicare in the limited field of lymphedema compression garment coverage, I have found that the Medicare Appeals Council has less of an understanding of Medicare law and statutes and the unique medical aspects of lymphedema than does the average ALJ. And for this reason I would not trust the Council with medical policy-making powers that would potentially deprive Medicare beneficiaries with the medical items they require for daily treatment of their lymphedema, and deny them of the right to appeal demonstrably-faulty denials by Medicare contractors.
In my experience with 12 Council appeals, I have found the following problems are common:
Lack of understanding of the concept of "benefit categories" and the application of this concept to the traceability of policy documentation back to the Social Security Act;
Failure to determine statutory benefit category, thereby allowing use of NCDs, LCDs or Coverage Articles applicable to the wrong benefit category, allowing an inappropriate coverage criteria to be applied;
Decision based on outside (and sometimes irrelevant) information instead of the case record;
Decision not based on the preponderance of evidence in the record;
Lack of de novo analysis per §405.1000(d), but instead dependence on lower-level denials;
Sometimes key facts are not factual;
Citations to relevant statutes missing;
Misunderstanding of the pathophysiology of lymphedema and the physical action of compression in treating lymphedema. Expert medical help is available to AAJs but to my knowledge never used; Errors of law.
Traceability of requirements back to the authorizing source is necessary in any legal system, and this principle is aptly demonstrated in the discussions concerning "Application of part 405 rules to other parts". But this same principle seems to be regularly ignored in the administration of the reimbursement and appeal system by the DME MACS, the QICs and some ALJs and AAJs.
The proposal to define an "attorney adjudicator" in §405.902 as a licensed attorney employed by OMHA with knowledge of Medicare coverage and payment laws and guidance may or may not end up reducing the burden of ALJs and alleviate appeal backlog. But who will assure that the knowledge of Medicare coverage and payment laws will not just be an extension of the mis-knowledge that is currently rampant. We need an improvement in the quality, not the quantity of our Medicare adjudicators. This may not happen if "attorney adjudicators would receive the same training as OMHA ALJs." As for unburdening the ALJs from their administrative duties, is there not already a large paralegal staff that already performs these duties under the direction of the ALJ? What new functions are being proposed for the attorney adjudicators at higher cost?
In retaining the requirement to identify the beneficiary's Medicare HICN when the beneficiary is the party appointing a representative, is it clear whether the entire HICN is required for a valid appointment, or whether an abbreviated HICN (e.g. the last 4-5 characters) is adequate? I have seen appointments go both ways.
When the appointed representative files an appeal, is it statutorily required to send a copy of the Appointment of Representative form to the other parties, or is it sufficient to include it in the copy of the appeal sent to the DME MAC, QIC, ALJ or adjudicator?
Amount in Controversy Required for an ALJ Hearing
In the case of a beneficiary who is not represented by a provider, supplier, or Medicaid State agency, the amount in controversy should include any set-up, handling or freight charges incurred in delivering the item to the beneficiary. In the case of Medicare-covered items listed on a DMEPOS schedule, the Medicare allowable amount already includes these services. But in the case that a beneficiary received or may be entitled to a refund of the amount the beneficiary previously paid to the provider or supplier for the items or services in the disputed claim under applicable statutory or regulatory authorities, the basis for the amount in controversy would be the actual amount originally charged to the beneficiary for the items or services in the disputed claim as delivered to the beneficiary.
When CMS or its Contractors may Participate in the Proceedings on a Request for an ALJ Hearing
Please consider adding the requirement for CMS's or its contractor's mandatory attendance when one of the issues in the hearing concerns CMS or one of its contractors' violation or non-compliance with existing statute or CMS policy. The request for an ALJ hearing would identify that this would be an issue for discussion, and the ALJ could "invite" CMS or its contractor to the hearing. Otherwise CMS contractors have no way of recognizing that they may be in violation, with no chance of correcting the situation.
Where and When to File a Request For Hearing or Review of a QIC or IRE Dismissal
In discussions of misrouting of requests for hearings by a party, would the same requirements apply to misrouting caused by an incorrect address provided to the appellant by the CMS contractor (e.g. because the contractor was changed or the contractor moved its appeals operation after the old address was provided)?
There appears to be a problem with the proposed rewrite on submitting evidence. "we are proposing in §405.1018(a) to provide that parties must submit all written or other evidence they wish to have considered with the request for hearing, by the date specified in the request for hearing in accordance with proposed §405.1014(a)(2), or if a hearing is scheduled, within 10 calendar days of receiving the notice of hearing." The appellant is instructed to send the request for hearing to the OMHA Central Operations in Cleveland for assignment to an ALJ, not knowing when or where the hearing will be scheduled. The IMPORTANT INFORMATION ABOUT YOUR APPEAL RIGHTS which is sent by the QIC states "Please do not attach evidence to your hearing request. If you have evidence to submit, please submit the evidence directly to the ALJ when your case is assigned." Your proposed change is not in consonance with these instructions.
Time and Place for a Hearing Before an ALJ
The proposed §405.1020(c) Notice of hearing. (1) A notice of hearing is sent to all parties that filed an appeal or participated in the reconsideration, any party who was found liable for the services at issue subsequent to the initial determination or may be found liable based on a review of the record, the QIC that issued the reconsideration, and CMS or a contractor that the ALJ believes would be beneficial to the hearing, advising them of the proposed time and place of the hearing. In addition, CMS or a contractor should be invited when an issue in contention involves non-adherence to or violation of a Medicare statute or policy by the CMS or a contractor to be made aware of the appellant's concern and to be able to answer any allegations.
Notice of a Hearing before an ALJ and Objections to the Issue
When a Notice of Hearing contains a mistake, (e.g. wrong Appellant Type box "x'ed" , error in appeal number, mis-spelled beneficiary's name, etc.) and the mistake is corrected by the recipient on the RESPONSE TO NOTICE OF HEARING, does the corrected form have to be re-sent to all parties who received the initial notice?
Disqualification of the ALJ or Attorney Adjudicator
With respect to §405.1026(b) objections to the assigned ALJ, what recourse is offered the appellant when the assigned ALJ has demonstrated in prior identical hearings an inability to understand the medical arguments, an unwillingness to review the submitted evidence and expert testimony, use of non-relevant evidence not in the record to support a decision, a proclivity to side with Medicare regardless of the evidence that shows that the decision was wrong or had no basis in fact, misstates "facts in evidence", omits relevant references, etc.? Should there be a "peremptory challenge" to the ALJ without explanation as to the reason for requesting that he withdraw?
ALJ Hearing Procedures
In the proposed new §405.1030(b)(2) The ALJ may limit testimony and/or argument at the hearing that are not relevant to an issue before the ALJ, or that address an issue before the ALJ for which the ALJ determines he or she has sufficient information or on which the ALJ has already ruled. Limiting appellant testimony and argument by the ALJ on the basis that "the ALJ believes he or she has sufficient information" is a dangerous precedent, potentially interrupting the logical flow of an argument, precluding the appellant from knowing what the ALJ understands and preventing the appellant from being able to build a rational case upon a common knowledge base. An understanding of the lymphatic system, its pathophysiology and treatment are essential to be able to rule on whether and how compression garments used in the treatment of lymphedema meet the coverage requirements for prosthetic devices. In the last 5-10 years our knowledge in lymphology has burgeoned, and many lymphology textbooks and certainly the popular information sources still present old discredited information. It is essential, in creating a logical and accurate argument, that the old information be replaced with the more accurate modern knowledge. An ALJ seldom comes into the hearing with sufficient information in this field with which to make a logical analysis. A case in point was the ALJ who, after receiving testimony on the lymphatic system from one of the leading lymphedema MDs in the country about lymphedema being a failure of the lymphangions to collect and transport fluid, made his decision on the basis of two Wikipedia articles on the lymph nodes and on venous insufficiency—two irrelevant topics. Let the appellant or his/her medical expert set the groundwork for a coverage decision based on the evidence in the record, whether or not the ALJ thinks he/she has sufficient information. Otherwise the updated information is precluded from entering the record through the hearing recording. Limiting testimony on the basis that the ALJ feels he/she has sufficient information is not the same as dealing with an uncooperative, disruptive, or abusive party, and should not be written into law.
Deciding a Case Without a Hearing Before an ALJ
In proposed added section §405.1038(c) providing new authority for a stipulated decision, it is not sufficient from an appellant's perspective to close a case on the basis of a written or oral statement indicating that the item or service should be covered or paid unless the amount of the payment is disclosed and the appellant is given the opportunity to accept or reject the payment. CMS or a contractor sometimes bases its reimbursement on a scheduled payment for a standard off the shelf compression garment while the lymphedema patient has paid for a medically necessary custom garment that costs many times the cost of the standard item. A stipulated decision in favor of the appellant for a graduated compression stocking which has been arbitrarily assigned by the CMS contractor an HCPCS code A6531 would pay the appellant approximately $48 less 20% co-pay instead of the $144 less 20% co-pay retail cost of a custom flat knit garment paid by the beneficiary.
Pre-hearing and Post-hearing Conferences
In the proposed changes to §405.1040(c)(2) it is required that an audio recording be made of the conference because audio recording is the most administratively efficient way to make a record of the conference. However, there are many different formats for audio recordings in current use and although the audio recording may be an administratively efficient way to make a record, it may not be compatible with the playback equipment used by an appellant. Furthermore, transcriptions from audio files to written form can be prohibitively expensive. The format and medium of the recorded file needs to be somewhat restricted and a typed transcription must be offered on request if the file is not compatible with a party's equipment.
The Administrative Record
There are no requirements for the detail in the "index of the administrative record" (AKA "exhibit list"). They are sometimes minimal top-level titles such as "Procedural Documents", "Medical Records/Evidence", "Request for ALJ Hearing" and "OMHA Proceedings". A party who may wish to request only a part of the record per §405.1042(b) is almost forced to request the entire record because the list is not detailed enough to request only the part needed.
What form must the "consent from the individual" take? Is there a CMS or HHS form or is a simple authorization letter adequate? Is it sent directly to the OMHA or the ALJ or attorney adjudicator for inclusion in the administrative file?
In the proposed changes to §405.1044 a consolidated hearing may be held if one or more of the issues to be considered at the hearing are the same issues that are involved in one or more other appeals pending before the same ALJ. In the case that two or more Claims/Requests for ALJ Hearings are consolidated by OMHA prior to being assigned to an ALJ, and the claims involve different disputed items, different bases for denial, and different issues, can the consolidation decision be appealed? To whom and when (prior to, during, or after the hearing)?
These questions are based on an actual case currently awaiting hearing. In the case at hand, three claims were combined by OMHA Operations into one on the basis that they all had the same appellant. They were renumbered and assigned to an ALJ who then gave the consolidated case a single new ALJ Appeal Number. There currently is no traceability from the consolidated case number back to the original ALJ Appeal Numbers either in the hearing notice, in the individual exhibit lists, or in the exhibits themselves. A letter sent to the ALJ Team requesting this information is not found in any of the three case files, nor in the combined file. The OMHA recipient apparently didn't know where to file it. The proposed changes to §405.1044 go a long way in defining how to handle the record(s), but there must be rules for the renumbering of the cases that will allow traceability and subsequent appeal of one or more of the individual claims, and rules for filing the administrative record files that allow further action on a part of the consolidated case.
Notice of Decision and Effect of an ALJ's or Attorney Adjudicator's Decision
The contents of the notice, 405.1046(a)(2) should also include reasons for not accepting any evidence with which the ALJ disagreed or did not accept, especially when and if contradictory evidence is absent from the record.
Deletion of the requirement to send a copy of the decision to the contractor that made the initial determination should be revisited. The copy of the decision that is sent to the CMS contractor to effectuate the decision does not necessarily go to their quality assurance or quality improvement organizations. Notification of the contractor of a reversal of their claim decision and the reasons for the determination can assist the contractor to "identify non-conformance and deficiency in the quality of services performed" and to "…implement corrective action." [From Attachment J-01 – Statement of Work (SOW) Procurement of DME MAC].
Content of Request for Review
Is there any substantive difference in the Standard of Review between a Council review of an ALJ's action [§405.1110] and a party's request for review [§405.1112]? Both are appropriate for an ALJ's actions that may be inconsistent with Medicare statute, regulation, ruling etc. but only the statutory wording for the CMS referral includes "abuse of discretion of the ALJ, decision not consistent with the preponderance of the evidence of record, or there is a broad policy or procedural issue that may affect the general public interest." Are the latter issues also appropriate bases for appellant request for Council review?
Submitting a Request for a Hearing
Is there an inconsistency in calculating the time for transport of mail between notices mailed to the appellant from the QIO VS appeals mailed from the appellant to OMHA? Five days are allowed for transport from the date on the QIO notice (not the date the notice was mailed) while zero days are allowed on top of the statutory 60-day filing period for transport from the appellant to OMHA.
Timeframe for Filing a Request for a Reconsideration §405.962(a)
Is there an inconsistency in calculating the time for transport of mail between notices mailed from the QIC to the appellant VS appeals mailed from the appellant to the QIC? Five days are allowed for transport from the date on the QIC notice (not the date the notice was mailed) [§405.962(a)(1)] while zero days are allowed on top of the statutory 180-day filing period for transport from the appellant to the QIC [§405.962(a)(2)]. This is more than an academic problem. In a recent case the QIC dismissed as non-timely an appeal that was posted 7 days prior to the required receipt date, but was not received by the QIC until 10 days later because the QIC had moved from the address on the redetermination notice to another state, and it took five days for the USPS to forward to the new QIC address. This case has generated one more unnecessary ALJ Hearing Request.