American Bar Association Health Law Section and Commission on Women in the Profession Present... Legal Advocacy for Women with Breast Cancer Medicare Issues Marisa Schroder,, Frost Brown Todd LLC, Cincinnati, OH 1
Medicare Federal Program that provides health insurance, which covers nearly 40 million Americans Administered by the Centers for Medicare & Medicaid Services (CMS) Applies to: People 65 and older Some disabled people under age 65 People of all ages with End-Stage Renal Disease (permanent kidney failure treated with dialysis or a transplant). 2
Medicare Plans Original Medicare Plan (Medicare Parts A & B) A fee-for for-service program Medicare enrollees have free choice of providers Providers bill and are reimbursed by Medicare for treatment of covered services Medicare Managed Care Plans (Medicare Part C) Includes Medicare Advantage (MA) plans, such as HMOs, PPOs,, or Private Fee-for for-service Plans Medicare services are covered through the plans, and are not paid for under Original Medicare Medicare Prescription Drug Plans (Medicare Part D) A stand-alone alone drug plan Offered by insurers and other private companies to beneficiaries 3
Issues for Receiving Coverage for Services & Items Coverage for items and services that are "reasonable and necessary. See 42 U.S.C. 1395y(a)(1)(A). Determining what is reasonable and necessary What is considered experimental Expensive treatment 4
Medicare Preventive Services Breast Cancer Screening (Mammograms) Covered: Every 12 months For Whom: All women covered by Medicare age 40 and Older Also get one baseline mammogram between ages 35 and 39 Costs in the Original Medicare Plan: You pay 20% of the Medicare-approved approved amount with no Part B deductible Clinical Breast Exam Provides 80% coverage for a clinical breast exam once every 24 months, without Part B deductible 5
Medicare Coverage of Cancer Clinical Trials Research studies to find better ways to treat cancer Medicare will pay for most cancer clinical trials that are funded by: The National Cancer Institute (NCI) Another part of the Federal Government The purpose or subject of the trial must be within a Medicare benefit category Example: clinical trials focused on the diagnosis and treatment of cancer are Medicare benefits Cancer prevention trials are not currently covered. 6
Medicare Coverage of Cancer Clinical Trials Medicare will pay for all routine costs that are part of a clinical trial Routine tests, procedures and doctor visits hospital stay(s) ) or surgery if needed Tests and treatment for side effects Medicare will not cover: Investigational drugs, items or services being tested in a trial Items or services used solely for the data collection needs of the trial Anything being provided free by the sponsor of the trial Any coinsurance and deductibles 7
Medicare Secondary Payer Rules Client covered by Medicare and another group health plan (e.g., employer plan) Medicare Secondary Payer Rules determine whether employer plan or Medicare pays first when a participant files a claim 8
On Medicare Because 65+ If coverage through employer plan and retired or on COBRA, Medicare will pay primary and employer plan is secondary Same result if coverage is through spouse s s plan and spouse is retired If still working (or spouse is still working), employer plan pays primary and Medicare pays secondary 9
On Medicare Because Disabled For active employee (not retired or on COBRA), the employer plan must pay primary if the employer sponsoring the plan has at least 100 employees Same result if coverage through spouse that is an active employee If employer has less than 100 employees, Medicare will pay primary If retired or on COBRA, Medicare will pay primary 10
On Medicare Because Suffering from End Stage Renal Disease For the first 30 months of the individual s s Medicare eligibility, the employer plan must pay primary After 30 months, Medicare will pay primary 11
Denial of Coverage What to do when enrollee s s coverage is denied Depends on which Medicare Plan Client has 1. Original Medicare Plan ( Fee( Fee-for- Service ) 2. Medicare Managed Care Plans 3. Medicare Prescription Drug Plan 12
Appeals Procedures for Original Medicare Plan ( Fee( Fee-for-Service ) Appeal when think Medicare should have paid for or did not pay enough for an item or service received under Medicare Part A or Medicare Part B Initial Determination (42 C.F.R 405.920 405.920-.928).928) Made by Fiscal Intermediaries (FIs( FIs) ) (Part A) and Carriers (Part B) FIs and Carries must provide written notice why bill not paid and the appeal steps that can be taken 5 levels of appeal 13
Original Medicare Plan Level One: Redetermination (42 C.F.R. 405.940 405.940-.958).958) Request for an examination of claim by a different FI or Carrier personnel Must be filed within 120 days from receipt of notice of initial determination On Form CMS-20027 or in writing Should attach applicable evidence Decision for Redetermination must be made by FI or Carrier within 60 days 14
Original Medicare Plan Level Two: Reconsideration (42 C.F.R. 405.960 405.960-.978).978) A Qualified Independent Contractor (QIC) will conduct the reconsideration Must be filed within 180 days from receipt of a Redetermination decision Follow instructions on Redetermination Notice on how to request a reconsideration Made on Form CMS-20033 or in writing Should attach all relevant evidence QICs are required to issue decision within 60 days 15
Original Medicare Plan Level Three: ALJ Hearings (42 C.F.R. 405.1000 405.1000-.1054).1054) At least $120 remains in controversy Must request ALJ hearing within 60 days of receipt of reconsideration decision To request ALJ hearing, refer to reconsideration decision letter from QIC Form CMS-20034 A/B may be used to file a request for an ALJ hearing ALJ hearing usually held by video-teleconference or by telephone (may request an in-person hearing) CMS or its contractors may become a party to or participate in the hearing ALJ will generally issue a decision within 90 days 16
Original Medicare Plan Level Four: Medicare Appeals Council Review (42 C.F.R. 405.1100 405.1100-.1134).1134) Must file within 60 days of receipt of ALJ s decision Must be in writing and must specify issues and findings being contested No amount in controversy requirement Refer to ALJ decision for details regarding the procedures to follow Medicare Appeals Council has 90 days to issue a decision 17
Original Medicare Plan Level Five: Judicial Review (42 C.F.R. 405.1100 405.1100-.1134).1134) Request a Federal District Court hearing within 60 days of receipt of the Medicare Appeals Council s s decision $1,220 or more is still in controversy The Medicare Appeals Council s s decision will contain information about the procedures for requesting judicial review 18
Appeal Rights under Medicare Managed Care Plans Includes Medicare Advantage (MA) plans such as HMOs and PPOs Organization Determination (42 C.F.R. 422.566-.568).568) Make a request for services or for payment Plan must notify enrollee of its determination within 14 days for request for services and within 30 days for requests for payment Notice of any denial by Plan must state reasons for denial and must provide information on rights to appeal denial 19
Medicare Managed Care Plans Expedited Requests Expedited Request Request for a fast track decision by enrollee if believe waiting for a decision could seriously harm enrollee's health If request made or supported by physician, then Plan must provide an expedited determination Plan must notify enrollee of its organizational decision within 72 hours for expedited requests 20
Medicare Managed Care Plans Reconsideration 42 C.F.R. 422.578-.590.590 Appeal decision to the plan by requesting reconsideration Must be filed within 60 days from date of notice of the organization determination Usually in writing unless plan accepts oral requests Standard requests: 30 days for services requests or 60 days for payment requests Expedited reconsideration: 72 hours 21
Medicare Managed Care Plans Reconsideration by Independent Review Entity (IRE) 42 C.F.R. 422.592-.596.596 If plan upholds adverse organization determination then automatic review by IRE MAXIMUS Federal Services is the Medicare Advantage IRE Standard Review: Within 30 days for requests for services and 60 days for requests for payment Expedited Review: Within 72 hours 22
Medicare Managed Care Plans Additional Levels of Appeal Hearing by ALJ (42 C.F.R. 422.600-.602).602) File hearing request within 60 days of IRE s determination Request must be in writing Amount in controversy is at least $120 Office of Medicare Hearings and Appeals (OMHA) is responsible for administering an ALJ hearing Medicare Appeals Council (42 C.F.R. 422.608) Request must be filed within 60 days of ALJ decision May use Appeal Form DAB-101 to request review Federal District Court Review (42 C.F.R. 422.608) File request for review within 60 days of Medicare Appeals Council s s decision Amount in controversy must be at least $1,220 23
Appeal Rights Under Medicare Prescription Drug Plans If Plan won t t cover a prescription drug the enrollee needs Request coverage determination from Plan (See 42 C.F.R. 423.566) Plan has 72 hours (for a standard request) or 24 hours (for an expedited request) to notify enrollee of its decision 24
Medicare Prescription Drug Plans Exceptions 42 C.F.R. 423.578 For some types of coverage determinations (called exceptions ), need a supporting statement from a doctor explaining why enrollee needs the requested drug Applies if requesting that the Plan cover a drug that is not on Plan s list of covered drugs (formulary) or if want the Plan to cover a nonpreferred drug at the preferred drug cost 25
Appeal Rights Under Medicare Prescription Drug Plans If the Plan decides against enrollee, can appeal the decision Five levels of Appeal 1. Redetermination (42 C.F.R. 423.580) 423.580)- appeal through the plan Must request within 60 days from the Coverage Determination. File standard request in writing unless plan accepts requests by telephone. Plan has 7 days from receiving standard request and 72 hours from receiving expedited request to notify enrollee of its decision 26
Appeal Rights Under Medicare Prescription Drug Plans 2. Reconsideration (42 C.F.R. 423.600) 423.600)- review by an Independent Review Entity (IRE) make a standard or expedited request within 60 days from the date of the Redetermination IRE has 7 days for a standard request or 72 hours for an expedited request to notify Client of its decision 27
Appeal Rights Under Medicare Prescription Drug Plans 3. Hearing with an Administrative Law Judge (42 C.F.R. 423.610) 423.610)- Request a hearing with ALJ within 60 days from the date of the notice of the IRE decision You must send your request to the entity specified in the IRE s Reconsideration Notice To receive an ALJ hearing, the amount in controversy must be at least $120 IRE s decision will include this amount There is not a statutory time limit for the ALJ to process the claim 28
Appeal Rights Under Medicare Prescription Drug Plans 4. Review by the Medicare Appeals Council (42 C.F.R. 423.620) Request a review by the Medicare Appeals Council in writing, within 60 days from ALJ s decision There is not a statutory time limit for the Medicare Appeals Council to process the claim 5. Review by a Federal Court (42 C.F.R. 42 C.F.R. 423.630) Request a review by a Federal court within 60 days from the date of the notice of the Medicare Appeals Council s decision To receive a review by a Federal court, the amount in controversy must be at least $1,220 29
Tips for Representing Breast Cancer Patient Understand the Problem Client s s precise health condition (e.g., early-stage breast cancer, first time or recurrent) Whether Client has health coverage from one or more sources Review Client s s plan to determine coverage Reason being denied benefits Client s s resources, goals and priorities Understand the Law and Appeals Process (e.g., Federal laws that establish the rules for Medicare) Most important thing Client can do is to document everything Have Client document everything related to his or her health care May be too late depending on what stage you begin representing Client Obtain Copies of Client s s medical records 30
TIPS for Representing Breast Cancer Patient Try to plead Case in person Personalize written case (e.g., photographs and letters from family and friends) Ask Client s s Physician to advocate for Client s treatment Ask Client s s physician to write a supportive letter or request a notarized statement why the treatment was essential for Client s s health and how it meets the Plan s s criteria for medical necessity Ask physician to include peer-reviewed reviewed research regarding the Client s s condition or treatment If possible, include this information with first written appeal Exhaust Remedies 31
Exhaust Administrative Remedies Masey v. Humana, Inc. Daryl L. Masey,, an enrollee in Humana Inc. s s Medicare Advantage health care plan, was treated for breast cancer in 2006 with chemotherapy. Masey contended that her chemotherapy drugs should have been covered under Medicare Part B, which covers 100 percent of the costs c of the drugs, but that Humana incorrectly characterized the drugs s as covered by Medicare Part D. Masey further alleged that Humana had an incentive to classify the drugs as Medicare Part D instead of Medicare Part B because Humana is reimbursed for nearly full retail costs of the medicine when the drugs are classified as Medicare Part B. Masey sued Humana in the U.S. District Court for the Middle District of Florida alleging breach of contract and breach of fiduciary duty. d Masey contended that she fully pursued the administrative remedies prescribed by Medicare by making numerous calls to Humana s s help line. The court, however, concluded that Masey did not exhaust her administrative remedies by attempting to make numerous calls to Humana s s help line. See Masey v. Humana, Inc., No. 8:06-cv cv-1713-t-24-eaj, 2007 U.S. Dist. LEXIS 70464 (M.D. Fla. Sept. 24, 2007) 32
Dardinger v. Anthem Blue Cross & Blue Shield An insurance bad faith case involving the way a health insurer and a its parent company handled a request for the treatment of brain cancer by a terminally ill forty-nine nine-year-old woman, Esther Dardinger. In October 1996, Mrs. Dardinger was diagnosed with metastatic brain tumors that had spread from her breasts. Radiation therapy did not shrink the tumors. In March 1997, Mrs. Dardinger began a treatment called intra-arterial arterial chemotherapy (IAC) that was shrinking her brain tumors and giving her a decent quality of life. Mrs. Dardinger had three of her twelve scheduled IAC treatments, which her insurer, Anthem Blue Cross and Blue Shield (Anthem), approved and paid for. Days before her fourth treatment, a professional consultant and oncologist hired by Anthem reviewed Mrs. Dardinger s initial request for approval for ten minutes and recommended that Anthem decline payment for the treatment as experimental. The consultant did not n inquire about the success of the first three treatments when he recommended denial of payment. Mrs. Dardinger and her doctor appealed the denial. Over the next four months, the grounds on which Mrs. Dardinger was told the IAC treatment was denied changed from Anthem s s perception that IAC was an experimental procedure to Anthem s s claim that it did not have all of the requisite medical records to make a determination. 33
Dardinger v. Anthem Blue Cross & Blue Shield After waiting three months, Mrs. Dardinger opted to try conventional intravenous chemotherapy, which Anthem would pay for, to treat her h tumors. Anthem finally sent the appeal to its parent company, Anthem A Insurance Companies, Inc. (AICI), in Indianapolis. The reviewing g doctor did not receive from Anthem the medical literature Mrs. Dardinger s doctor had submitted describing the use of IAC for treatment of mestastic brain tumors, nor did he have Mrs. Dardinger s medical records showing her response to the initial IAC treatment. After r a review of less than 30 minutes, the reviewing doctor determined that the treatment was experimental. Mrs. Dardinger died on November 7, 1997. One day after her funeral, the letter from Anthem denying the appeal of its decision arrived d at the Dardinger house. Her widower sued Anthem and AICI for breach of contract, breach of fiduciary duty and breach of duty of good faith. The jury returned a verdict of $51.5 million, including $49 million ion in punitive damages against Anthem and AICI. The Ohio Supreme Court reduced the punitive damages award to $30 million. See Dardinger v. Anthem Blue Cross & Blue Shield, 781 N.E.2d 121 (Ohio 34 2002).
Thank You Thomas D. Anthony Frost Brown Todd LLC Cincinnati, OH tanthony@fbtlaw.com (513) 651-6191 6191 1960993 v1 35