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Volume VI Issue 2 April/May 2001 |
Copyright 2001 Neighborhood Legal Services, Inc.
In this issue......
NEW CRITERIA WILL ALLOW FOR MEDICARE FUNDING OF AAC DEVICES, WITHOUT THE NEED
TO APPEAL
THE HISTORICAL BARRIER TO AAC DEVICE COVERAGE: NCD60-9
Policy changes issued by hcfa and the dmercs
Medicare drops the computer-based device exclusion
SPECIAL FEATURES:
Medicare Work Group: A National Forum to Discuss at Funding Issues
The Rerc website: A wealth of information on Medicare Funding of AAC devices
2001 medicare premiums and deductibles
Text of ncd 60-23 available on hcfas website
NEW CRITERIA WILL ALLOW FOR MEDICARE FUNDING
OF AAC DEVICES, WITHOUT THE NEED TO APPEAL
This article was guest authored, in large part, by Lewis
Golinker, Esq., the Director of the Assistive Technology Law Center in Ithaca, New York.
Lews dedication and tireless efforts in pursuit of policy change regarding Medicare
funding of AAC devices has been a major catalyst for the changes in policy that are
described below.
INTRODUCTION
For years, the only way to obtain Medicare funding for an augmentative and alternative communication (AAC) device was to take an appeal to an administrative law judge (ALJ). To date, every known appeal that went to an ALJ resulted in an award of funding (approximately 10 winning decisions as of the end of 2000). That reality created at least three problems: first, without a prior approval system for most Medicare recipients, many individuals were not able to purchase the device (or have a vendor provide the device and accept assignment) in order to start the application and appeal process; second, even if the individual was able to appeal, there were few advocates or attorneys, nationally, who were willing to handle these cases; and third, exhaustion of appeals to get to the ALJ level and obtain an ALJ decision often took two years or more.
This article will describe the basis for this historical problem in obtaining funding for AAC devices. It will then describe how recent policy changes within the Health Care Financing Administration (HCFA) have addressed this problem through issuance of a new National Coverage Decision. Finally, the article will describe a computer-based device exclusion that appears in the revised policy and HCFAs decision to drop that exclusion.
THE HISTORICAL BARRIER TO AAC
DEVICE COVERAGE: NCD 60-9
HCFA, which oversees Medicare, has published numerous National Coverage Decisions (NCDs) over the years. The NCDs have been used to articulate agency policy governing Medicare funding of durable medical equipment (DME). For both traditional Medicare and managed care Medicare, the NCDs are binding at all decision making levels prior to the administrative law judge (ALJ) hearing (see box on p. 221, outlining the Medicare decision making and appeals process). Some NCDs, not relevant to this article, are also binding at the ALJ level.
NCD 60-9 had, until recently, listed AAC devices as not eligible for coverage under Medicare's durable medical equipment (DME) category. This created a very practical problem for the majority of Medicare recipients who are enrolled in the traditional (i.e., non managed care) Medicare program. Since a prior approval decision was not available to them, they could not even obtain an initial decision until they took delivery of the AAC device, by either agreeing to pay for it or by having a vendor agree to accept assignment (i.e., agree to accept what Medicare approved as payment, less a 20 percent recipient co-payment). This explains why so few cases ever made it the ALJ hearing level, where the success rate was 100 percent (of cases known to have gone that far). Even the successful cases took two to four years to go through all appeals, reach the ALJ level, and receive a favorable ALJ decision.
Our National Assistive Technology (AT) Advocacy Project, in collaboration with Lew Golinker, went to great lengths to publicize the ability to obtain Medicare funding for AAC devices if one persisted to the ALJ level. To that end, our two booklets, covering Medicare funding of AAC devices in the traditional and managed care programs, were distributed to thousands of readers nationally. In fact, most of the favorable ALJ decisions involved Lew Golinker or various Protection and Advocacy (P&A) programs.
At the same time that many P&As were pursuing their "one case at a time"; strategy, a separate collaboration of advocates and professionals filed a well-documented formal request with HCFA, seeking a review and change to its AAC device policy. That request resulted in the policy changes which are described below.
POLICY CHANGES ISSUED BY HCFA
AND THE DMERCs
On April 26, 2000, HCFA rescinded the non-coverage policy that appeared in NCD 60-9 and determined that AAC devices are DME. See April-May 2000 issue of AT Advocate. Then, on November 30, 2000, HFCA issued new NCD 60-23, establishing that AAC devices are, effective January 1, 2001, considered to fall within the DME benefit category as "Speech Generating Devices." The new NCD, as written, covered many of the AAC devices on the market and promised to open the door to approval of funding without the need to appeal. However, the new NCD 60-23 precluded coverage of "non-dedicated device" (e.g., devices such as laptop computers that are simultaneously capable of also running software for purposes other than speech generation).
On a separate, but related track, on October 24, 2000, the four Durable Medical Equipment Regional Carriers (DMERCs) joined in issuing a draft policy to establish criteria under which AAC devices would be approved as DME. (The DMERCs are private entities that have been given the authority to make decisions on behalf of Medicare regarding the funding of DME.) The DMERCs have recently issued a final policy for coverage of AAC devices, i.e., "speech generating devices." The policy is identical for all four DMERCs and will be effective July 1, 2001. For the full text of the DMERC policy, see www.palmettogba.com (then, search for "speech generating device.") (For copies of the new NCD or DMERC policy, contact Jim Sheldon at the National AT Advocacy Project.)
MEDICARE DROPS THE COMPUTER-BASED DEVICE EXCLUSION
This section contains the commentary of Lew Golinker related to the recent policy change activities.
Last October, Medicares long awaited AAC device coverage guidance was published, but with an unanticipated limitation: Medicare would cover only "dedicated speech-generating devices." Dedicated devices, as described by Medicare, are not "capable of running software for purposes other than speech generation, e.g., devices that cannot also run a word processing package, an accounting program, or perform other non-medical functions." Stated more succinctly, a dedicated device is one that will not be "useful to someone without severe speech impairment." In addition, the Medicare guidance expressly excluded "laptop computers, desktop computers and PDAs [personal digital assistants], which may be programmed to perform the same function as a speech generating device."
By adopting this exclusion, Medicare was limiting the range of choices for individuals who needed the highest functioning AAC devices. People with ALS, in particular, were predicted to be directly and adversely affected. The Freedom 2000, for example, an AAC device chosen by many people with ALS and the device used by Stephen Hawking, will not be covered by Medicare.
Competing Strategies Emerge
Two alternatives were quickly identified as possible responses to this Medicare limitation. One was a political/legal strategy. It consisted of a direct effort to convince Medicare to drop the dedicated based limitation for AAC devices. The other was a two-step engineering and advocacy strategy that consisted of adapting computer- and PDA-based AAC devices so that they are "dedicated," and then trying to convince Medicare that once the devices "function" in the same manner, they all should be covered.
Convincing Medicare to drop the dedicated device limitation had the strongest factual arguments in its favor, but also had the weakest legal-political foundation. Among its many advantages was that it would not require any technology change by the AAC device manufacturers, and therefore, could be implemented as soon as the policy change was adopted. In addition:
it would allow all currently available devices to be considered as part of the Medicare assessment and recommendation process;
it would bring Medicare coverage into line with Medicaid programs, which almost without exception, do not focus on how AAC devices are assembled;
it would reflect the reality of AAC device need and AAC device use: the primary, if not exclusive purpose for and use of all AAC devices is for communication. That the devices are multi-functional is not really relevant, based on why they are recommended or how they are used;
the devices themselves are not just computers plus software, but instead are communication devices that have unique software and hardware and thus, they differ significantly from off-the-shelf computers available from electronics stores, or other outlets; and
all AAC devices have similar components or sub-assemblies. Focusing on computer-based vs. dedicated devices focuses more on appearance than on substantive differences in the devices themselves.
However, this strategy faced significant legal and political obstacles. Historically, Medicare has excluded so-called dual-purpose equipment, i.e., equipment that for some people or in some circumstances can be used to serve a medical purpose, but which for other users or in other circumstances, can be used for non-medical purposes. Medicare guidance is clear that these devices are not durable medical equipment, and hence, are not covered. [Medicare Carriers Manual, § 2100.1, reprinted in CCH Medicare & Medicaid Guide, ¶ 3144.] In other words, this was not an exclusion created just for AAC devices. In addition:
The exclusion of dual-purpose devices was a conclusion based on Medicare staffs interpretation of its legal authority, not on their belief that these devices provide no benefits. Thus, Medicare staff can defer the issue to Congress, saying the solution lies here, not with the agency.
Because this issue was based on a legal interpretation and not on a speech-language pathology principle, speech language pathologists (SLPs) and advocates have no special expertise on which decision makers will rely.
The alternative strategy: to make existing devices dedicated and then convince Medicare to eliminate the computer-based exclusion, appeared to present equally daunting obstacles. The key to this strategy is technology-change. Were the required changes even possible? Could the devices lock out other, non-speech generating functions? Even if possible, would the AAC device manufacturers -- or could they afford to -- make those changes? And, finally, when could new devices, based on those changes be ready to market?
If those changes could be made, both dedicated and computer-based devices would be functionally identical. But then, would Medicare be willing to focus on the functionality of the devices? Would Medicare be willing to declare that this is sufficient and allow these devices to be covered? And, to the extent this Medicare limitation on dedicated devices was allowed to remain, what, if any impact would that policy have on other programs, such as Medicaid, that covered multi-functional computer based devices?
Who Decides?
There was an additional issue raised by the dedicated device/computer exclusion that had not previously been present in the effort to persuade Medicare to cover AAC devices: who decides? Initially, Medicare policy reform was pursued by a work group of SLPs, advocates and Medicare consultants sponsored by Dynavox Systems and Sunrise Medical. Decisions were made by consensus among the work groups participants.
Who decides was now of particular importance because one of the strategies was openly opposed. Some SLPs and advocates objected to a strategy that would cause a decrease in the functionality of AAC devices, and possibly force people with disabilities to pay more for devices that would do less. To them, this approach was inappropriate and undesirable. It was a compromise strategy that they did not support; to them, eliminating the dedicated device limitation was the only option.
In addition, even to explore a strategy to address the dedicated device limitation/computer-exclusion required new voices to be heard: notably, the affected AAC device manufacturers which had previously not been involved with Medicare policy reform. How to bring them into the discussion, what role they were to play, and how to resolve differences when everyone did not agree all had to be addressed.
By mid-January, 2001, a clear choice existed between the alternative strategies: the AAC device manufacturers reported they could readily change their devices and software to lock out non speech-generating functions. By contrast, the coalition of interests necessary to apply political pressure to Medicare and to Congress to eliminate the dedicated device limitation was not yet formed.
Thus, the choice was whether to proceed with what was clearly a compromise approach to the issue, or to wait for the ability to challenge the dedicated device limitation. Because no one could predict when or even whether the necessary resources will be assembled to challenge the dedicated device limitation on its face, the decision was made to proceed with the compromise strategy. Prototypes of dedicated-computer and dedicated-PDA-based AAC devices were produced, and prototype product literature was written.
In total, five dedicated device prototypes were constructed from existing multi-functional AAC devices:
| Manufacturer | Multi-Functional Model | Dedicated Model |
| Assistive Technology | Freestyle | Freestyle II |
| Enkidu Research | Portable Impact | Portable Impact-D |
| Saltillo | Chat PC | Portable Chat |
| Words Plus | Freedom 2000 | Freedom 2001-E |
| Zygo | Optimist II | Dialog |
These devices have been modified to run only AAC software. Each will proceed directly to the AAC software when turned on, and there is no way to exit the AAC program short of turning off the machine. Also, there is no way to load other software. Functionally, these devices are all indistinguishable from a Dynavox, a dedicated AAC device.
The Problem is Resolved
On March 26, 2001, Iris Fishman, M.S., C.C.C.-S.L.P., Director, Kornreich Assistive Technology Center, National Center for Disability Services, Steve White, Ph.D., Director, Health Care Economics and Advocacy, ASHA, and Lew Golinker met with Medicare officials to demonstrate these devices, compare them to their multi-functional twins, and to discuss whether they met Medicares expectations and will now be covered. The Medicare staff agreed that as long as the devices were functionally dedicated, they had no further concern about whether they were built into a computer or PDA platform. The final language of the DMERCs policy suggests that they will follow a similar approach for AAC device approval.
Implications for Medicare and Other Programs
Medicare will soon publish changes to its AAC guidance that will state more clearly that the computer-exclusion has been eliminated. In the future, any AAC device is covered, as long as it is a dedicated speech generating device. This information will then be sent to the DMERCs and Medicare + Choice (Medicare managed care) providers, so that claims for these devices can be approved.
For Medicare beneficiaries, this policy change will allow access to the full range of currently available AAC devices. In addition to having more devices covered by Medicare, all of these devices will be available to Medicare beneficiaries. Availability of equipment within the Medicare program is tied to whether manufacturers and suppliers will accept or take assignment, the effect of which is to significantly reduce beneficiaries outlays for the equipment. The manufacturers of the dedicated-computer and dedicated-PDA-based devices have stated they will accept Medicare assignment.
The expansion of the range of AAC devices will be of benefit to Medicare beneficiaries, particularly to people with ALS. In December 2000, Congress granted people with ALS a special benefit. Typically there is a 24 month waiting period after onset of disability before a person becomes Medicare eligible. For people with ALS, Congress has waived that requirement, effective July 2001. Thus, Congress has made it possible for people with ALS to become Medicare eligible sooner, and at the same time, Medicare has changed its policy to cover AAC devices. Now that the computer-exclusion also has been eliminated, people with ALS will be able to select from the full range of device choices, including the Freedom 2001-E, the dedicated twin to the Freedom 2000.
That Medicare has made these policy changes may create an issue for other funding programs. Typically, Medicaid programs and insurers will follow Medicares lead on device coverage policy. For AAC devices, however, there has been very little attention paid to how Medicare covered AAC devices, or, whether a device was dedicated vs. computer based. Nonetheless, it is reasonable to anticipate that some states will try to narrow their coverage policies to cover only dedicated or non-computer-based devices.
If this occurs, numerous responses exist. The most obvious is that just as Medicaid covered AAC devices and ignored Medicares convenience item guidance, there is no duty on Medicaids part to follow Medicare when Medicare decides to cover an item or service.
Second, as compared to their multi-functional twins, all of the dedicated devices will cost more. This is a clear deterrent for Medicaid to adopt Medicare criteria: Medicaid is a program which requires consideration of least costly equally effective alternatives. The multi-functional devices had been accepted because they are less expensive than many of the other dedicated devices to which they can be compared; if the multi-functional devices will remain the less expensive alternative, why should Medicaid even consider changing its policy?
Third, for all states for children, under the Early and Periodic Screening, Diagnosis and Treatment program, and for one quarter of the states for adults, Medicaid coverage of AAC devices is based on the prosthetic device or SLP services category, which provides no basis to focus on how the device is assembled. Only those states that cover AAC devices as durable medical equipment have a potential issue, and at least seven of them (Delaware, Indiana, Louisiana, Maine, New Hampshire, New York and Ohio) expressly state in AAC coverage policy that computer-based devices are covered.
Other distinctions also can be presented.
CONCLUSION
Following HCFAs decision to rescind the NCD 60-9 limitation on AAC device coverage, there still remained a problem regarding coverage of non-dedicated devices. This problem was confronted and, in the five months since the issue first arose, Medicares computer-based and PDA-based AAC device exclusions were eliminated. In doing so, the existing coalition of SLPs and advocates recruited and mobilized the affected AAC device manufacturers, persuaded them to make the appropriate changes to their devices and software, and then persuaded Medicare that these changes were sufficient to allow these devices to be covered.
In addition, efforts are ongoing to generate interest in eliminating the dedicated device limitation on its face. In the interim, for individuals with AAC device needs, Medicares acceptance of the compromise strategy means that there will be no break in access to the full range of AAC devices.
Medicare beneficiaries, advocates and SLPs
with questions about the scope of or details related to Medicare coverage of AAC devices
should first check www.aac-rerc.com, where
all information about Medicare will be posted and updated regularly. If the information
posted there does not address the question, please contact Lew Golinker at lgolinker@aol.com or 607-277-7286. As always,
you can also contact Jim Sheldon at the National AT Advocacy Project at
jsheldon@nls.org or 716-847-0650.
MEDICARE WORK GROUP
A National Forum to Discuss AT Funding Issues
Since 1997, the National AT Advocacy Project has hosted periodic meetings (about four times per year) by telephone conference to discuss a range of Medicare issues related to funding of AT. Since the group was first formed to focus on the barrier to funding of AAC devices, that remains a focus. The meetings are an opportunity to: present the cases you are working on and receive input from the group; report on cases you have won; and get the latest report on legislative or policy developments. If you would like to join us, even for one meeting on a trial basis, contact Jim Sheldon at the AT Advocacy Project (716-847-0650 ext. 262, jsheldon@nls.org).
THE RERC WEBSITE:
A Wealth of Information on Medicare Funding
of AAC Devices
The website of the Rehabilitation Engineering Research Center on Communication (RERC), www.aac-rerc.com, should be checked on a regular basis to obtain the most up-to-date information about Medicare funding of AAC devices. Its many sources of useful information include: a section on frequently asked questions; application and assessment protocols; sample reports; checklists for speech-language pathologists; and AAC device coverage guidance. If you are involved in Medicare funding of AAC devices, this site should be on your favorites list.
2001 MEDICARE PREMIUMS AND DEDUCTIBLES
Part A: (Hospital Insurance) Premium
Part A Deductible
Part A Coinsurance
Part B: (Medical Insurance) Premium
Part B: (Medical Insurance) Deductible
Source of information: www.medicare.gov/basics/amounts2001.asp
TEXT OF NCD 60-23 AVAILABLE ON HCFAS WEBSITE
If you want to view the full text of the new National Coverage Decision, NCD 60-23,
which was issued on November 30, 2000, here is the direct link to that document: www.hcfa.gov/coverage/8b-s.htm.
This takes you to a site where you can link to the tracking sheet, the Decision Memorandum
of April 26, 2000, or the actual Coverage Issues Manual containing NCD 60-23 (www.hcfa.gov/pubforms/06_cim/ci60.htm#_60_23).
Yes, these are very long URLs, but will save you the time consuming task of trying to
finding these documents using a search tool on the Health Care Financing
Administrations (HCFAs) site. Keep in mind that this
version of the new policy contains the dedicated device limitation which has since been
revised as described in the feature article.
For a wide range of Medicare-related information, check out HCFAs Medicare website at www.medicare.gov.
| TIMELINES AND MONETARY THRESHOLDS FOR MEDICARE DECISION MAKING & APPEALS PROCESS FOR AAC DEVICES (NON-HMO PARTICIPANTS) |
| Decision
Making Level & Decision Maker |
Time Limit for Request | Time Limit for Decision | Monetary Threshold in Dispute |
| Initial Determination [DMERC] | --- |
60 days | --- |
| Reconsideration [DMERC] | 6 months after
Initial Determination |
45 days | --- |
| Carrier Hearing [DMERC] | 6 months after Reconsideration decision |
60-120 days | $100 or more |
| ALJ Hearing [Administrative Law Judge] |
60 days after
Carrier Hearing decision |
no time limit, expect about 2-3 months | $500 or more |
| Departmental Appeal Board | 60 days after
ALJ decision |
no time limit, expect about 6-9 months or longer | $500 or more |
| Judicial Review [Federal Court Judge] | 60 days after Departmental Appeal Board decision | none | $1,000 or more |
| MEDICARE DECISION MAKING & APPEALS PROCESS FOR AAC DEVICES
Health Maintenance Organization [HMO] And Other Medicare+Choice [M+C] Plan Participants Governed By 42 C.F.R. PART 422 |
| Time Limits and Monetary Thresholds | |||
| Decision
Making Level & Decision Maker |
Time Limit for Request | Time Limit for Decision | Monetary Threshold in Dispute |
| Initial
Determination [HMO, M+C Organization] |
--- |
14 days | --- |
| Reconsideration [HMO, M+C Organization] |
60 days after
Initial Determination |
30 days | --- |
| Reconsideration [Center for Health Dispute Resolution - CHDR] | Review is
automatic. No need to request reconsideration |
30 days | --- |
| ALJ Hearing [Administrative Law Judge] |
60 days after CHDR decision |
no time limit, expect about 2-3 months after hearing | $100 or more |
| Departmental Appeal Board | 60 days after ALJ decision | no time limit,expect about 6-9 months or longer | $100 or more |
| Judicial Review [Federal Court Judge] |
60 days after Departmental Appeal Board decision | none | $1,000 or more |
| MEDICARE DECISION MAKING & APPEALS PROCESS FOR AAC DEVICES
(MANAGED CARE ORGANIZATIONS GOVERNED BY 42 C.F.R. PART 417) |
| Time Limits and Monetary Thresholds | |||
| Decision
Making Level & Decision Maker |
Time Limit for Request | Time Limit for Decision | Monetary
Threshold in Dispute |
| Initial
Determination [Managed Care Organization] |
--- |
60 days | --- |
| Reconsideration [Managed Care Org.] |
60 days after
Initial Determination |
60 days | --- |
| Reconsideration [Center for Health Dispute Resolution] | Review is
automatic No need to request reconsideration |
30 days | --- |
| ALJ Hearing [Administrative Law Judge] |
60 days after CHDR decision |
no time limit, expect about 2-3 months after hearing | $100 or more |
| Departmental Appeal Board | 60 days after ALJ decision | no time limit, expect about 6-9 months or longer | $100 or more |
| Judicial Review [Federal Court Judge] |
60 days after
Departmental Appeal Board decision |
none | $1,000 or more |
A Name Change for HCFA
As this article was going to press (early June), a name change was announced for the Health Care Financing Administration (HCFA). The new name is the Centers for Medicare and Medicaid Services (CMS).
Update on The National Assistive Technology
Resource Library
Please send information to:
Attn.: Jim Sheldon TEL: (716) 847-0650
Neighborhood Legal Services, Inc. FAX: (716) 847-0227
Ellicott Square Building TDD: (716) 847-1322
295 Main Street, Rm 495 e-mail: atproject@nls.org
Buffalo, NY 14203 Web Page: www.nls.org
The AT Advocacy Project will provide nationwide services to PAAT projects including technical assistance to advocates wanting to access funding for assistive technology for individuals with disabilities.
In our next issue...
The U.S. Supreme Court: Golf Carts and Attorneys Fees
Medicaid and Section 1983: The Westside Mothers Case
NOTE: The AT Advocate is now issued bi-monthly
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