Presenters: Marge Gustas, Staff Paralegal, NY PAAT Project, Buffalo, NY

1. Anatomy of a SuccessfulMedicare Local CoverageDetermination ChallengeOctober 22, 2009Hilton Garden Inn, Austin, TexasSponsored by the National AT Advocacy Project, Project of Neighborhood Legal Services, Inc.Advocacy, Inc., Austin, TX Presenters: Marge Gustas, Staff Paralegal, NY PAAT Project, Buffalo, NY James R. Sheldon, Jr., Esq. National AT Advocacy Project, Buffalo, NY

2. This Session Will … • Describe the Local Coverage Determination (LCD) Review Process • Describe successful LCD review in the Fink case More detailed information available: • Spring-Summer 2009 issue of AT Advocate • Available at www.nls.org/av/summer09.pdf

3. Terminology National Coverage Determination (NCD) • Published by Center for Medicare and Medicaid Services (CMS) • Binding on all decisions through Departmental Appeal Board Local Coverage Determination (LCD) • Published by Durable Medical Equipment-Medical Administrative Contractor (DME-MAC) • Binding on all decisions made by DME-MAC, Managed Care Agency, and Medicare, Managed Care and PACE Reconsideration Project • Contain only “reasonable and necessary” information

4. Terminology (cont.) Local Medical Review Policies (LMRP) • Can contain benefit categories and statutory exclusions • Were converted to LCDs and Policy Articles in 2004 Policy Articles (PA) • Interpretive policies not related to medical need

5. Terminology (cont.) Aggrieved Party (AP) • Medicare beneficiary or estate • is entitled to benefits • has documentation of need from treating physician • was denied based on applicable LCD Contractor (DME-MAC) • Regional carrier – responsible for DME decisions and policy in multi-state region • Publishes LCDs, governing regional decisions

6. What is an LCD Review? • A means to challenge a DME exclusion contained in an LCD • Available only to “an aggrieved party” • Proceeds through administrative process • More similar to litigation than administrative hearing • However, can culminate in administrative hearing

7. The Reasonableness Standard ”… the adjudicator must uphold a challenged policy (or a provision of a challenged policy) if the findings of fact, interpretation of law, and application of fact to law by the contractor or CMS are reasonable based on the LCD . . . and the relevant record developed before the ALJ or the Board.” 42 CFR 426.110

8. The LCD Review – Getting Started Information you want to know – • Does Medicare Act or federal regulations say anything regarding this request? • For example, hearing aids are specifically excluded from coverage by the Act. • What does NCD 280-1 say about requested device? • Does it refer you to any other NCD? • Does it address the issue? • Have there been any other previous LCD challenges?

9. Obligations of the Aggrieved Party • Is the only party allowed to initiate the LCD review • Must file an acceptable complaint • Bears the burden of proof and the burden of persuasion by a preponderance of the evidence.

10. The Complaint An acceptable complaint is • Timely • Filed within 6 months of issuance of a written statement from the treating practitioner. or • Filed within 120 days of the initial denial notice. 42 CFR 426.400 (b)

11. An Acceptable Complaint - Has specific components that are controlled by law, including but not limited to: • Identifying beneficiary and representative information • Written treating practitioner and aggrieved party statement • LCD - identifying information and issue at hand • Clinical or scientific information 42 CFR 426.400 (c)

12. Docketing the Complaint • The complaint is assigned a docket number. • A determination is made to see if this is the first challenge or a related challenge. • It is assigned to an ALJ. 42 CFR 426.410

13. Obligations of the ALJ ALJ determines if complaint is acceptable. • Is it submitted by the aggrieved party? • Does it include the components of 42 CFR 426.400? • Assure that the complaint is not challenging anything listed under 42 CFR 426.325 • E.g., drafts of, or retired LCDs. Unacceptable complaints have one chance to be amended.

14. Once the ALJ Determines that Complaint is Acceptable The ALJ must: • Notify the aggrieved party of docket # and deadline for contractor to produce LCD record. • Send the complaint and supporting evidence to the contractor and CMS. CMS or the contractor must: • Send the LCD record to ALJ and all parties for review within 30 days of receiving complaint and the evidence.

15. The LCD Record Consists of … Any document or material the contractor considered during the development of the LCD including, but not limited to: • The LCD being challenged • Any medical evidence such as: • scientific articles, technology assessments • clinical guidelines, statements from clinical experts • text books • claims data or other indications of a medical standard of practice • A summary of comments and responses 42 CFR 426.418

16. Steven Fink’s LCD Review Background • Diagnosis of progressive multiple sclerosis • Sought ceiling track lift for his home • Denied by Medicare HMO Traditional Appeal • Mr. F took appeal and lost at ALJ level. • This did not preclude the LCD review.

17. Fink Case - The LCD Record Record produced by contractor: • The history of the preceding LMRP, and • A summary of one set of comments, responding to proposed LMRP The contractor’s position was: • No record needed for an LMRP. • The requested device was addressed in a Policy Article (PA) and no record needed for a PA. The ALJ deemed the PA to be a constructive LCD.

18. Discovery “ If the ALJ determines that the LCD record is not complete and adequate to support the validity of the LCD the ALJ permits discovery and the taking of evidence . . . “ • The ALJ must set a reasonable time frame. • Discovery is strictly limited to a request for the production of documents and/or 10 written interrogatory questions relating to the LCD under review. • The ALJ must notify all parties when discovery is closed. 42 CFR 426.432

19. Protective Orders The ALJ can grant a protective order: • For evidence that is irrelevant, repetitive, costly or burdensome, or • If it delays the proceeding.

20. Subpoenas • Must file a motion for subpoena • The motion must designate the witness, specify any evidence to be produced, and sufficiently describe the address and location where the witness will be found. • The motion must also, “state the pertinent facts that the party expects to establish by the witnesses or documents and whether other evidence may establish without the use of a subpoena.” 42 CFR 426.435

21. Subpoenas (cont.) • Within 15 days of the written motion requesting the issuance of the subpoena, “any party may file an opposition to the motion or other response.” • If the ALJ grants the motion, it must be issued in the ALJ’s name, include the docket # and the LCD title.

22. Retiring or Revising an LCD or an LCD Provision The retired LCD has the same effect as a hearing decision. • The contractor must notify the ALJ within 48 hours that the LCD has been retired. • If the LCD is retired before the ALJ issues a decision the ALJ must: • Dismiss the complaint • Inform the aggrieved party they have the right to an individual claim review under the new LCD 42 CFR 426.420

23. Mandatory Provisions of an ALJ Decision The ALJ must do one of the following: • Determine that a provision of the LCD is either valid or not valid under the reasonableness standard. • Issue a statement dismissing the complaint and the reason why. • Determine that the LCD record “is complete and adequate to support the provisions of the LCD under the reasonableness standard.” 42 CFR 426.450

24. Issuance and Notification of ALJ’s Decision Within 90 days of closing the record, the ALJ must: • Issue a written decision including appeal rights, or • Notify the parties in writing of an approximate decision date. 42 CFR 426.447

25. The ALJ’s Decision and Its Effect • ALJ decision must be implemented in 30 days. • Policy changes apply prospectively “to requests for service or claims filed with dates of service after the implementation of the ALJ decision.” • No retroactive relief, even for claims pending between the time the LCD is retired, revised or its record deemed inadequate and the ALJ decision.

26. What the ALJ’s Decision Cannot Order The ALJ’s decision cannot order any of the following: • It cannot order CMS or the contractor to add any language to the LCD. • It cannot order payment of a specific claim. • It cannot order time limits to establish a new or revised LCD.

27. What the ALJ’s Decision Cannot Order (cont.) • It cannot order specific payment, coding or systems changes or deadlines for implementing changes. • It cannot order how a contractor must implement an LCD. • Nor can the decision review an LCD other than the one under review. 42 CFR 426.455

28. Conclusion This process highly favors the regional contractor and CMS. Consider the following: • Definition of the reasonableness standard, i.e., if the findings of fact and the interpretation of law are reasonable based on the relevant LCD record. • Evidentiary threshold - Preponderance versus substantial evidence • Burden of persuasion rests with aggrieved party • Formalized subpoenas that can be challenged by any party

29. Conclusion (cont.) • Claims that are pending while awaiting the ALJ’s written decision will be considered retroactive (i.e., not covered by any resulting policy change). • This might not be a problem with managed care and a prior approval process, • But consider the consequence to recipients under traditional Medicare direct pay. • Formalized proceedings do not encourage the participation of the pro se appellant. • If the LCD is revised, the appellant has only two options, withdrawing the review request or attempting to challenge the revision and the supplemental record.