THE WELCH COMPANY
440 Davis Court #1602
San Francisco, CA 94111-2496
415 781 5700
rodwelch@pacbell.net


S U M M A R Y


DIARY: September 27, 2007 01:11 PM Thursday; Rod Welch

CMS called on Kaiser Senior Advantage coinsurance clinical trials.

1...Summary/Objective
2...CMS Medicare Kaiser Cannot Transfer Costs Prescribed Care to Patient
3...Managed Care Pays for Prescribed Treatment in Clinical Trials
4...Kaiser Senior Advantage Transmittal to Customers
5...EOC Evidence of Coverage Kaiser Benefits Clinical Trials Medigap
6...Evidence of Coverage EOC Kaiser Benefits Clinical Trials Medigap
....1...Kaiser Permanente Senior Advantage Scope of Services
....1...Welcome to Kaiser Permanente Senior Advantage
........Medigap Supplemental Coverage Excluded Senior Advantage
........Supplemental Medigap Coverage Excluded Senior Advantage
....5...About Kaiser Permanente
....7...Please tell us how we are doing
........Section 2
7...Kaiser HMO Managed Care Not Medigap Supplemental Medicare Coverage
8...Primary Care Physician Single Point of Contact Case Management
9...Insurance Premiums Require Kaiser to Pay for Prescribed Care
10...Kaiser Must Prescribe Necessary Treatment for Covered Services
........Section 2
........Getting Care from your primary care Plan Physician
....Section 7
....Hospital care, Skilled Nursing Facility care, and other Services
....1...Participating in a clinical trial
11...Medicare Pays Lab Costs for Clinical Trials
12...Laboratory Blood Tests Paid by Medicare No Coinsurance
13...Coinsurance 20% Patient Pays Clinical Trials Advance Medical Science
14...Clinical Trial Service Provider Must Explain Charges Prior to Services
........Self-referral for Clinical Trials Without Doctor Authorization
15...16 Issues presented in Kaiser's Referral Dispute with UCSF
16...Kaiser Must Prescribe Needed Care for Oncology Services EOC 2
17...Patient Relied on Doctor Point of Contact with Kaiser EOC Sec 2


..............
Click here to comment!

CONTACTS 

SUBJECTS
Default Null Subject Account for Blank Record

0503 -
0503 -    ..
0504 - Summary/Objective
0505 -
050501 - Follow up ref SDS 26 O492, ref SDS 25 SS4I.
050502 -
050503 -
050504 -
050505 -
050506 -
050507 -
050509 -  ..
0506 -
0507 -
0508 - Progress
0509 -
050901 - CMS Medicare Kaiser Cannot Transfer Costs Prescribed Care to Patient
050902 - Managed Care Pays for Prescribed Treatment in Clinical Trials
050903 -
050904 - Last week on 070917 Catherine Windfield Jones with CMS Operations
050905 - Group was listed on the Internet as a contact for policy issues on
050906 - Medigap...
050908 -                     ..
050909 -                    410 786 6674
050911 -  ..
050912 - At that time on 070917 left a message for Cathy to ask about Kaiser
050913 - senior advantage paying coinsurance expense for treatment Kaiser
050914 - prescribed in a clinical trial. ref SDS 25 SY6K
050916 -  ..
050917 - A few days ago, Cathy called back and said she referred the matter to
050918 - a Kaiser specialist.  Her feeling seemed to be that Kaiser should pay
050919 - for Millie's treatment on clincial trial prescribed by the doctor, per
050920 - Medicare guidance reported on 070917, ref SDS 25 WQ3G, and Kaiser's
050921 - notice to members they should cancel their Medigap coverage after
050922 - receiving verification that Kaiser Senior Advantage becomes effective.
050923 - ref SDS 25 EZ56
050924 -
050925 -     [On 071003 called Cathy; she was traveling, her voice mail
050926 -     referred calls to James Mayhew. ref SDS 28 KA5J
050928 -      ..
050929 -     [On 071003 called James Mayhew at CMS, and he requested a letter
050930 -     to review public issues in Millie's case. ref SDS 28 0E4K
050932 -  ..
050933 - When we returned today from UCSF for Millie's weekly treatment, there
050934 - was a message from....
050935 -
050936 -                         Julyann???
050937 -
050938 -                         415 744 3617
050940 -  ..
050941 - Called the number and talked to Lee Faleafine.
050942 -
050943 -        [On 071003 Jullin called back and is working on Millie's case.
050944 -        ref SDS 28 7G5G
050946 -  ..
050947 - Asked Lee about CMS Medicare regulations encouraging patients to
050948 - particiapte in clinical trials that advance medical science.  Can
050949 - managed care service providers (HMO's) who prescribe treatments
050950 - patients need with therapies provided in clinical trials, called out
050951 - in Kaiser's Senior Advantage EOC section 2, reviewed below,
050952 - ref SDS 0 RY5H, transfer their duty to pay for covered oncology
050953 - services to Medicare 80% and patient coinsurance 20%, as reviewed
050954 - below? ref SDS 0 WV5G
050956 -  ..
050957 - Lee asked about Millie's case.
050959 -  ..
050960 - Millie is 72 years old and stage IV cancer patient, being treated for
050961 - 3rd relapse of IBC at UCSF Medical Center on clinical trial with
050962 - cetuximab on referral from Kaiser in Walnut Creek, CA.
050964 -  ..
050965 - Background on referral is shown in a case study on 070130. ref SDS 17
050966 - 2X6L  On 061230 the doctor said Kaiser would pay any costs not covered
050967 - by the trial. ref SDS 13 3X6K  Documentation on referral is listed in a
050968 - case study on 070830. ref SDS 20 LQ5I
050970 -  ..
050971 - Six months or so later, Millie began getting invoices from UCSF
050972 - seeking recovery for extra expenses, initially totaling about $10K per
050973 - year, which is about 56% of Medicare approved payments, contrary to
050974 - agreement on 061230 for Kaiser to pay costs of the work, and further
050975 - conflicting with review on 070917 showing coinsurance should be a
050976 - percentage above 20% minimum. ref SDS 25 SS4I  Meeting with UCSF
050977 - revealed about $2K of the extra cost is for "coinsurance," reported on
050978 - 070830. ref SDS 20 W06L
050980 -  ..
050981 - On 070917 Millie received a letter from UCSF dated 070912 that
050982 - indicated UCSF eliminated some charges, and revised the bill to about
050983 - $2K per year. ref SDS 25 WP5I  Since then Millie continues to get
050984 - invoices that seem much higher, and refuses to state the amount of
050985 - charges until after work is performed, which prevents the patient from
050986 - approving the work, and budgeting for payments.  Additionally, charges
050987 - exceed terms of agreement with Kaiser, in that Kaiser seeks to
050988 - transfer all costs not paid by Medicare to the patient, per below.
050989 - ref SDS 0 WV5G
050991 -  ..
050992 - UCSF's letter cited CMS regulation 69.9 to justification overcharging
050993 - Millie for medical services which Kaiser agreed to pay, also, reviewed
050994 - on 070917. ref SDS 25 596Q
050996 -  ..
050997 - Lee suggested sending a letter to CMS email address...
050998 -
050999 -                rosfodhpp@cms.hhs.gov
051000 -
051001 - ...for review of issues presented by the record in Millie's case, per
051002 - below. ref SDS 0 WU6M
051003 -
051004 -        [On 071002 submitted letter to Lee explaining issues for CMS to
051005 -        address in Millie's case. ref SDS 27 KA5J
051006 -
051007 -
051008 -
051009 -
0511 -

SUBJECTS
Kaiser Senior Advantage Individual Plan Membership Agreement and Dis

2103 -
210401 -  ..
210402 - Kaiser Senior Advantage Transmittal to Customers
210403 -
210404 - Millie found a document today which she received from Kaiser in
210405 - December or January.  There is a transmittal letter with an
210406 - inconclusive date of January 2007.
210407 -
210408 -        [On 071006 Paula checking for changes in EOC from 2004 to
210409 -        2007. ref SDS 30 453G
210411 -  ..
210412 - Millie does not know when the document was received, either in
210413 - November or December of 2007 so that customers have time to inquire
210414 - and make arrangements in the event of disagreement with proposed
210415 - terms, or in January, February, March 2007.  The document has no
210416 - received date markings, stamp, etc.
210417 -
210418 -    1.  Kaiser Permanente Senior Advantage
210419 -        Kaiser Foundation Health Plan, Inc.
210420 -        393 East Walnut Street
210421 -        Pasadena, CA  91188
210423 -         ..
210424 -    2.  January 2007
210426 -         ..
210427 -    3.  Dear Kaiser Permanente Member:
210429 -  ..
210430 - EOC Evidence of Coverage Kaiser Benefits Clinical Trials Medigap
210431 - Evidence of Coverage EOC Kaiser Benefits Clinical Trials Medigap
210432 -
210433 -
210434 -        Thank you for your continued membership in Kaiser Pemmanente
210435 -        Senior Advantage.  The enclosed Disclosure for and Evidence of
210436 -        Coverage (DF/EOC) describes your coverage for 2007.  Please
210437 -        read this DF/EOC completely so that you can take full advantage
210438 -        of your health plan benefits.
210440 -         ..
210441 -    4.  If you have any questions about this information please call
210442 -        our Member Service Call Center.  Our Representatives are
210443 -        available toll free at 1 800 443 0815 (TTY 1 800 777 1730),
210444 -        seven days a week 8 am to 8 pm.
210446 -         ..
210447 -    5.  Sincerely,
210448 -
210449 -        Denise Hanson
210450 -        Vice President, Medicare & State Programs
210452 -         ..
210453 -    6.  Kaiser Permanente is a Medicare Advantage Organization with a
210454 -        Medicare contract.
210456 -         ..
210457 -        The next page says...
210458 -
210459 -
210460 -
210461 -    1.  Kaiser Permanente Senior Advantage Scope of Services
210462 -
210463 -        2007 Individual Plan Membership Agreement and Disclosure Form
210464 -        and Evidence of Coverage (DF/EOC)
210466 -         ..
210467 -        January 1, 2007 through December 31, 2007
210469 -  ..
210470 - Kaiser Senior Advantage Page i says in part...
210471 -
210472 -    1.  Welcome to Kaiser Permanente Senior Advantage
210473 -
210474 -        We are pleased that you are enrolled (or are considering
210475 -        enrollment) in Kaiser Permanente Senior Advantage (Senior
210476 -        Advantage), a Medicare Advantage Plan for people with Medicare.
210478 -         ..
210479 -    2.  When you enroll in Senior Advantage, you are getting your care
210480 -        through the Kaiser Permanente Medical Care Program (Kaiser
210481 -        Permanente).  Kaiser Permanente is comprised of Kaiser
210482 -        Foundation Health Plan, Inc. (Health Plan), Kaiser Foundation
210483 -        Hospitals, and The Permanente Medical Group, Inc.
210484 -
210485 -
210486 -
2105 -

SUBJECTS
Medigap Supplemental Coverage Medicare Excluded Kaiser Senior Advant

4003 -
400401 -         ..
400402 -        Medigap Supplemental Coverage Excluded Senior Advantage
400403 -        Supplemental Medigap Coverage Excluded Senior Advantage
400404 -
400405 -
400406 - Kaiser Senior Advantage Page i continues...
400407 -
400408 -    3.  Health Plan, a Health Maintenance Organization (HMO) and a
400409 -        Medicare Advantage Organization, offers Senior Advantage, a
400410 -        Medicare Advantage Plan for people with Medicare.  Senior
400411 -        Advantage is not a Medigap or supplemental Medicare insurance
400412 -        policy; it is a Medicare Advantage Plan.
400414 -  ..
400415 - Kaiser's disclaimer of supplemental coverage is stated again in
400416 - section 2 page 4, ref SDS 0 1F6L, reviewed below in relation to
400417 - Millie's patient history. ref SDS 0 4A9J
400418 -
400419 -            [On 071006 Paula with Kaiser MCRC unit checking for changes
400420 -            in EOC from 2004 to 2007. ref SDS 30 453G
400422 -             ..
400423 -            [On 071215 article SF Chronicle reports challenges getting
400424 -            treatment clinical trials at Kaiser. ref SDS 41 E75J
400426 -  ..
400427 - An issue for legal review is whether this disclaimer has been obviated
400428 - by Kaiser's conduct, ref SDS 0 MS3K, including Kaiser sales rep
400429 - telling the patient Kaiser would provide continuing care for a
400430 - continuing condition, per below, ref SDS 0 H75F, and including public
400431 - notices that attract customers by saying to cancel Medigap coverage
400432 - after signing up with Senior Advantage? ref SDS 0 WX6K
400433 -
400434 -
400435 -
400436 -
400437 -
400438 -
400439 -
4005 -

SUBJECTS
Default Null Subject Account for Blank Record

4103 -
410401 -  ..
410402 - Kaiser Senior Advantage Page i continues...
410403 -
410404 -    4.  This DF/EOC explains how to get your Medicare Services through
410405 -        Senior Advantage (except for hospice care for Members with
410406 -        Medicare Parts A and B and qualifying clinical trials, which
410407 -        are covered directly by Original Medicare as described in
410408 -        Section 7).
410410 -         ..
410411 -    5.  About Kaiser Permanente
410413 -         ..
410414 -        Kaiser Permanente provides Services directly to our Members
410415 -        through an integrated medical care program.  Health Plan, Plan
410416 -        Hospitals, and the Medical Group work together to provide our
410417 -        Members with quality care.  Our medical care program gives you
410418 -        access to all of the covered Services you may need, such as
410419 -        routine care with your own personal Plan Physician, hospital
410420 -        care, laboratory and pharmacy Services, Emergency Care, Urgent
410421 -        Care, and other benefits.  Plus, our preventive care programs
410422 -        and healthy living (health education) classes offer you great
410423 -        ways to protect and improve your health.
410425 -         ..
410426 -    6.  We provide covered Services to Members using Plan Providers
410427 -        located in our Service Area, which is described in Section 2.
410428 -        You must receive all covered care from Plan Providers inside
410429 -        our Service Area, except as otherwise described in this DF/EOC.
410431 -  ..
410432 - Kaiser Senior Advantage Page ii says in part...
410433 -
410434 -        Please read this DF/EOC so that you will know from whom or what
410435 -        group of providers you may get health care.  It is important to
410436 -        familiarize yourself with your coverage by reading this DF/EOC
410437 -        completely, so that you can take full advantage of your Health
410438 -        Plan benefits.  Also, if you have special health care needs,
410439 -        please carefully read the sections that apply to you.
410440 -
410442 -         ..
410443 -    7.  Please tell us how we are doing
410444 -
410445 -        We want to hear from you about how we are doing as your health
410446 -        plan.  Your comments are always welcome.  You can call or write
410447 -        to us at any time (Section 1 of this DF/EOC tells how to
410448 -        contact us).  From time to time, we do surveys that ask our
410449 -        Members to tell about their experiences with Kaiser Permanente.
410450 -        If you are contacted, we hop you will participate in a Member
410451 -        satisfaction survey.  Your answer to the survey questions will
410452 -        help us know what we are doing well and where we need to
410453 -        improve.
410454 -
410456 -  ..
410457 - Kaiser Senior Advantage section 2 Page 4 says in part...
410458 -
410459 -        Section 2
410460 -
410461 -    1.  What is Kaiser Permanente Senior Advantage
410462 -
410463 -        Senior Advantage provides Services covered by Medicare
410464 -        (including Medicare Part D prescription drug coverage described
410465 -        in Section 6), except for hospice care for Members with
410466 -        Medicare Parts A and B and qualifying clinical trials, which
410467 -        are covered directly by Medicare as described in Section 7.
410468 -        ref SDS 0 1F92  Senior Advantage is for Members entitled to
410469 -        Medicare, providing the advantages of combined Medicare and
410470 -        Health Plan benefits.  Enrollment in Senior Advantage means
410471 -        that you are automatically enrolled in Medicare Part D.
410472 -
410473 -
410474 -
4105 -

SUBJECTS
Medigap Supplemental Coverage Medicare Excluded Kaiser Senior Advant

6203 -
620401 -  ..
620402 - Kaiser HMO Managed Care Not Medigap Supplemental Medicare Coverage
620403 -
620404 -
620405 -    2.  Senior Advantage is a Medicare Advantage Plan offered by Health
620406 -        Plan (an HMO) and a Medicare Advantage Organization) to people
620407 -        with Medicare.  As a Senior Advantage Member, you are getting
620408 -        your Medicare benefits through Kaiser Permanente (except for
620409 -        hospice are for Members with Medicare Parts A and B and
620410 -        qualifying clinical trials, which are covered directly by
620411 -        Original Medicare as described in Section 7, ref SDS 0 1F92).
620412 -        The Medicare program pays us to manage health care for people
620413 -        with Medicare who are Senior Advantage Members.  Senior
620414 -        Advantage is not a Medicare supplement policy.  Medicare
620415 -        supplement policies are sometimes called "Medigap" insurance
620416 -        policies (see Section 15 for definition of Medicare Supplement
620417 -        policy).  Kaiser Permanente provides medical care through
620418 -        Medicare-certified Plan Facilities.  In addition, our Plan
620419 -        Providers are in compliance with Medicare credentialing
620420 -        standards.
620422 -  ..
620423 - Restates notice on page i, per above. ref SDS 0 1E91
620425 -  ..
620426 - An issue for legal review apart from whether Kaiser is obligated to
620427 - pay for referral under Section 2, ref SDS 0 WU6M, is whether Kaiser's
620428 - EOC disclaimer of Medigap coverage has been obviated by Kaiser's
620429 - conduct (see issue #14, below, ref SDS 0 MS3K), including public
620430 - notices telling customers to cancel Medigap coverage after signing up
620431 - with Senior Advantage? ref SDS 0 WX6K
620432 -
620433 -            [On 071006 Paula with Kaiser MCRC unit checking for changes
620434 -            in EOC from 2004 to 2007. ref SDS 30 453G
620436 -             ..
620437 -            [On 071018 AARP article reports widespread confusion about
620438 -            differences between Medigap supplemental Medicare policies
620439 -            and HMO insurance coverage due to misrepresentations
620440 -            selling managed care insurance cause beneficiaries to incur
620441 -            significant extra charges. ref SDS 35 CR6T
620443 -  ..
620444 - For approximately, 20 years prior to 2004, Millie was treated by
620445 - Kaiser through employer paid health care.  She turned 65 in 2001, and
620446 - signed up for social security.  She was told social security deducts
620447 - monthly payments for Medicare, and that she should get supplemental
620448 - coverage.  At the time, this was not siginficant, because her full
620449 - coverage at work continued.  In 2004, her employer dropped coverage
620450 - for Kaiser.  Millie was given a choice to leave Kaiser and join
620451 - another health plan fully paid by her employer, or the employer would
620452 - pay additional amounts for Millie to buy insurance, including continue
620453 - with Kaiser.
620455 -  ..
620456 - In 2002 Millie was diagnosed with breast cancer.  Her condition
620457 - worsened considerably in 2004 with diagnosis of rare, aggressive form
620458 - of secondary cancer, reported on 040517, ref SDS 4 Y16I, and at the
620459 - time when the change in insurance occurred.
620461 -  ..
620462 - Millie was told by Kaiser sales representative in 2004 that Senior
620463 - Advantage supplements Medicare, and that she did not need Medigap nor
620464 - nor any further insurance in order to maintain continuity of care for
620465 - the past 30 years, including treatment for cancer begun by Kaiser in
620466 - 2002, and that all of her doctors, medical history, procedures, and
620467 - treatments would remain intact by making a 2nd insurance payment to
620468 - Kaiser.
620470 -             ..
620471 -            [On 071018 AARP article reports widespread confusion about
620472 -            differences between Medigap supplemental Medicare policies
620473 -            and HMO insurance coverage due to misrepresentations
620474 -            selling managed care insurance cause beneficiaries to incur
620475 -            significant extra charges. ref SDS 35 CR6T
620477 -  ..
620478 - As a result, she was never aware of distinctions Kaiser presents on
620479 - page 4, per above, between Senior advantage and supplemental "Medigap"
620480 - coverage. ref SDS 0 1F6L
620482 -  ..
620483 - Kaiser's presentation on page 4 is masked by pressures, emotions, and
620484 - shock of illness that prevent awareness by a panicked cancer patient,
620485 - who is oriented to accept assurances of sales people that payment to
620486 - Medicare, and making a 2nd insurance payment to Kaiser supplements
620487 - Medicare to continue providing essential treatments. (see for example
620488 - the meeting at Kaiser on 040318, when the doctor enrolled her in a
620489 - clinical trial, and all costs were paid by Kaiser without coinsurance.
620490 - ref SDS 3 PU6M)
620492 -  ..
620493 - The fact that none of the professionals at Kaiser nor at UCSF had ever
620494 - heard of coinsurance, nor that patients referred by Kaiser for
620495 - treatment in a clinical trial would be billed extra charges of any
620496 - kind demonstrates Millie was justified in relying on Kaiser's conduct
620497 - in numerous clinical trial referrals to establish that Kaiser paid all
620498 - costs not covered by the trial. (see for example doctor's
620499 - correspondence on 061230, ref SDS 13 3X6K; meeting on 070829 with
620500 - oncology department staff manager, ref SDS 19 EG34; meeting with Member
620501 - Services also on 070829. ref SDS 19 SF52
620503 -  ..
620504 - Reliance on Kaiser's assurance of care for cancer that supplements
620505 - Medicare reflects Kaiser's public position that patients can cancel
620506 - Medigap coverage after signing up for Senior Advantage, reviewed on
620507 - 070917. ref SDS 25 EZ56
620508 -
620509 -            [On 071018 AARP article reports widespread confusion about
620510 -            differences between Medigap supplemental Medicare policies
620511 -            and HMO insurance coverage due to misrepresentations
620512 -            selling managed care insurance cause beneficiaries to incur
620513 -            significant extra charges. ref SDS 35 CR6T
620515 -  ..
620516 - At no time did Kaiser notify Millie that coverage for health care
620517 - would require paying for a 3rd insurance policy when Kaiser prescribes
620518 - treatments by clincial trial, as explained by the doctor on 040318.
620519 - ref SDS 3 PU6M
620521 -  ..
620522 - Kaiser Senior Advantage Page 4 continues and says in part...
620523 -
620524 -    3.  This DF/EOC explains your benefits and Services, what you have
620525 -        to pay, and the rules you must follow to get your care.  Senior
620526 -        Advantage gives you all the Medicare benefits and Services that
620527 -        Medicare covers for everyone (except for hospice care for
620528 -        Members with Medicare Parts A and B and qualifying clinical
620529 -        trials, which are covered directly by Medicare as described in
620530 -        Section 7.
620531 -
620532 -
620533 -
6206 -

SUBJECTS
Medigap Supplemental Coverage Medicare Excluded Kaiser Senior Advant

8103 -
810401 -  ..
810402 - Primary Care Physician Single Point of Contact Case Management
810403 - Insurance Premiums Require Kaiser to Pay for Prescribed Care
810404 - Kaiser Must Prescribe Necessary Treatment for Covered Services
810405 -
810406 -
810407 - Kaiser Senior Advantage Page 9 Section 2 says in part...
810409 -         ..
810410 -        Section 2
810411 -        Getting Care from your primary care Plan Physician
810413 -         ..
810414 -        Your primary care Plan Physician will provide most of your
810415 -        primary care and will help arrange or coordinate other covered
810416 -        Services you get as a Senior Advantage Member (for example,
810417 -        X-rays, laboratory test, theapies, care from Plan Physicians
810418 -        who are specialists, hospital admissions, and follow-up care).
810420 -         ..
810421 -        "Coordinating" your Services includes checking or consulting
810422 -        with other Plan Providers about your care and how it is going.
810423 -        If you need certain types of covered Services, your primary
810424 -        care Plan Physician must prescribe or authorize the Services
810425 -        (for example, some care requires a referral from a Plan
810426 -        Physician for certain types of speciality care).
810428 -  ..
810429 - EOC Section 2 requiring Kaiser to prescribe needed treatment for
810430 - covered Services, like oncology, aligns with traditional medical
810431 - practice that patients rely on the doctor to prescribe care.  This
810432 - complies with HHS Publication No. 00-PO38 issued by the Agency for
810433 - Healthcare Research and Quaity (AHRQ) requiring a single doctor to be
810434 - in charge of case management to insulate fragile patients from delays
810435 - coordinating complex arrangements among multiple health care
810436 - providers, reviewed on 041113. ref SDS 5 JH3Q
810438 -  ..
810439 - In this case, Millie requires "therapy" called out in Section 2,
810440 - ref SDS 0 GN3N, for cancer, commonly called "chemotherapy," which is
810441 - the core component of oncology Services covered by Kaiser insurance
810442 - based on pattern and practice the past 6 years.  Kaiser has used
810443 - clinical trials as part of the doctor's "tool kit" for routine care in
810444 - oncology practice, explained by the doctor on 040318, ref SDS 3 PU6M,
810445 - and cited in the case study on using clinical trials for Millie's care
810446 - shown on 070830. ref SDS 20 LQ5I
810448 -  ..
810449 - On 070917 research found CMS guidance for clinical trial service
810450 - providers to bill Medicare under EOC Section 7, when patients
810451 - self-refer, ref SDS 0 OU84, does not apply to clinical trials
810452 - prescribed by the doctor for treatment of oncology services covered
810453 - under EOC section 2, since Medicare is not billed. ref SDS 25 F28H
810454 - Prescribed treatments are paid from insurance revenues. ref SDS 25
810455 - O45K
810457 -  ..
810458 - Kaiser notified Millie on 020321 that her oncology doctor was assigned
810459 - to be the primary care physician, ref SDS 1 MA3F, for a single point
810460 - of contact providing Millie's treatment in accordance with terms of
810461 - the EOC, similar to a project manager role coordinating work that
810462 - implements contract requirements. ref SDS 1 425M  Millie had no duty
810463 - to read the EOC and tell the doctor what to prescribe.
810465 -             ..
810466 -            [On 071006 Paula with Kaiser MCRC unit checking for changes
810467 -            in EOC from 2004 to 2007. ref SDS 30 453G
810469 -             ..
810470 -            [On 071128 Kaiser Appeals Committee approved payment for
810471 -            Millie's care on referral to UCSF. ref SDS 40 JZ5R
810473 -             ..
810474 -            [On 081112 Kaiser's representative in the Expedited Claims
810475 -            Department advised that Kaiser is lawfully required to
810476 -            implement doctor's orders for patient care. ref SDS 42 PR35
810478 -             ..
810479 -            [On 090521 2006 Doctor Johnson's letter to Millie without
810480 -            copy to medical team refuses to prescribe treatment and
810481 -            tells Millie she can "choose" any treatment she wants,
810482 -            because no treatment is superior for Millie's patient
810483 -            profile, ref SDS 43 9Q9H; Doctor Johnson warns Millie that
810484 -            she needs treatment by the end of the week, which is 12
810485 -            hours because her cancer is progressing rapidly,
810486 -            ref SDS 43 HC8O, and Kaiser tells Millie to call Medicare
810487 -            for a prescription to recover from 8th relapse of cancer.
810488 -            ref SDS 43 9Q9H
810490 -  ..
810491 - Kaiser Senior Advantage Page 9 Section 2 continues...
810492 -
810493 -        In some cases, your primary care Plan Physician will need to
810494 -        get prior authorization (prior approval) as described in the
810495 -        Medical Group authorization procedures for certain referrals in
810496 -        this Section 2.  Since your primary care Plan Physician will
810497 -        provide and coordinate your medical care, you should have all
810498 -        of your past medical records sent to your primary care Plan
810499 -        Physician.  Section 9 tells how we will protect the privacy of
810500 -        your medical records and personal health information.
810502 -  ..
810503 - In this case, on 070105 the primary care physician prescribed
810504 - treatment for breast cancer with cetuximab that was needed by the
810505 - patient, but was not available at Kaiser, ref SDS 14 PK7L, and reported
810506 - have coordinated to arrange for treatment at UCSF, ref SDS 14 PK68, as
810507 - called out in this part of EOC.
810509 -  ..
810510 - Treatment began on 070201, and the next day the primary care physician
810511 - performed required coordination and oversight by meeting with the
810512 - patient, ref SDS 18 0001, and has continued to perform this role.
810514 -  ..
810515 - Kaiser describes "covered Services," ref SDS 0 WS6M, which evidently
810516 - includes oncology care services, since Millie has been getting this
810517 - care since 2002.
810518 -
810519 -
810520 -
810521 -
810522 -
8106 -

SUBJECTS
Clinical Trials Patients Participate Advance Medical Science Doctors

A003 -
A00401 -  ..
A00402 - Kaiser Senior Advantage Page 68 Section 7 says in part...
A00404 -     ..
A00405 -    Section 7
A00406 -    Hospital care, Skilled Nursing Facility care, and other Services
A00407 -
A00408 - Five (5) pages below the main heading, Kaiser says...
A00409 -
A00410 -    1.  Participating in a clinical trial
A00411 -
A00412 -        A "clinical trial" is a way of testing new types of medical
A00413 -        care, like how well a new cancer drug works.  Clinical trials
A00414 -        are one of the final stages of a research process to find
A00415 -        better ways to prevent, diagnose, or treat diseases.  The
A00416 -        trials help doctors and researchers see if a new approach works
A00417 -        and if it is safe.
A00419 -  ..
A00420 - Millie at no time has ever requested treatment in a clinical trial to
A00421 - test drugs, assist research, or for any reason other than for Kaiser
A00422 - to perform its duty of care in section 2, ref SDS 0 WS6M, explained by
A00423 - Kaiser on 040318, ref SDS 3 DG4J, and again in Kaiser's letter on
A00424 - 060809, explaining Kaiser's reputation for providing good care
A00425 - routinely making referrals for needed treatments. ref SDS 10 NT9X
A00426 -
A00427 -        [On 071128 Kaiser Appeals Committee approved payment for
A00428 -        Millie's care on referral to UCSF. ref SDS 40 JZ5R
A00430 -  ..
A00431 - Research on 070917 shows CMS guidance on service providers billing
A00432 - Medicare for patients who self-refer to participate in clinical
A00433 - trials, ref SDS 25 F28H, and does not apply in Millie's case because
A00434 - the doctor prescribed treatment in a clinical trial for covered
A00435 - oncology services under EOC section 2, per above. ref SDS 0 WS6M
A00437 -  ..
A00438 - Millie has been treated in clinical trials only for prescribed care
A00439 - based on the doctor's professional advice that treatment was already
A00440 - proven safe and effective, as shown in the meeting at Kaiser on
A00441 - 040318, ref SDS 3 DG6H, and cited in analysis of CMS section 69.9
A00442 - submitted by UCSF on 070917, ref SDS 25 596Q, and which does not
A00443 - justify charging Millie for coinsurance in this case. ref SDS 25 OH9I
A00444 -
A00445 -            [On 071006 Paula with Kaiser MCRC unit checking for changes
A00446 -            in EOC from 2004 to 2007. ref SDS 30 453G
A00448 -  ..
A00449 - On 041130, Millie resisted treatment with another clinical trial
A00450 - because delay imperiled recovery.  Kaiser persisted in prescribing
A00451 - treatment by clinical trial as the best course of care which Kaiser
A00452 - was duty bound to provide, ref SDS 6 028N, shown by Kaiser's letter on
A00453 - 060809 explaining practice of prescribing treatment on referral to
A00454 - provide the best care. ref SDS 10 NT9X
A00456 -  ..
A00457 - On 041230, Kaiser prescribed conventional treatment only for the
A00458 - purpose of qualifying Millie for another clinical trial. ref SDS 7
A00459 - XQ41  This record of persistently prescribing treatment by referral to
A00460 - clinical trials, which recently on 070921 was reported to save Kaiser
A00461 - money on drug costs, ref SDS 26 QY58, cannot be turned into $10K per
A00462 - year extra charges to the patient, nearly 5 times annual insurance
A00463 - premiums, shown by review of UCSF invoices on 070830. ref SDS 20 W05N
A00465 -  ..
A00466 - Medicare intent to encourage participation in clinical trials in order
A00467 - to reduce costs and save lives of future patients, cannot be misused
A00468 - by managed care enterprises to transfer obligations for reasonable and
A00469 - necessary costs of care from insurance premium coverage to open ended
A00470 - coinsurance out-of-pocket expenses to the patient, especially without
A00471 - notice.  We need statutory authority and analysis that justifies
A00472 - transferring costs to patients under the guise of clinical trial
A00473 - coinsurance, noted in Millie's letter to UCSF on 070904. ref SDS 21
A00474 - 6R3X
A00476 -  ..
A00477 - Kaiser Senior Advantage Page 68 Section 7 continues,...
A00478 -
A00479 -    2.  Medicare pays for routine costs if you take part in a clinical
A00480 -        trial that meets Medicare requirements.  Routine costs include
A00481 -        costs like room and board for a hospital stay that Medicare
A00482 -        would pay for even if you weren't in a trial, and operation to
A00483 -        implant an item that is being tested, and items and Services to
A00484 -        treat side effects and complications arising from the new care.
A00485 -        Generally, Medicare will not cover the costs of experimental
A00486 -        care, such as the drugs or devices being tested in a clinical
A00487 -        trial.
A00489 -         ..
A00490 -    3.  There are certain requirements for Medicare coverage of
A00491 -        clinical trials.  If you participate as a patient in a clinical
A00492 -        trial that meets Medicare requiremetns, Original Medicare (and
A00493 -        not Senior Advantage) pays for the clinical trial doctors and
A00494 -        other providers for the covered services you receive that are
A00495 -        related to the clinical trial.  When you are in a clinical
A00496 -        trial, you may stay enrolled in Senior Advantage and continue
A00497 -        to get the rest of your care that is unrelated to the clinical
A00498 -        trial through Senior Advantage.
A00499 -
A00500 -
A00501 -
A006 -

SUBJECTS
Coinsurance 20% Clinical Trials Patient Responsibility Medicare Pays

AL03 -
AL0401 -  ..
AL0402 - Medicare Pays Lab Costs for Clinical Trials
AL0403 - Laboratory Blood Tests Paid by Medicare No Coinsurance
AL0404 - Coinsurance 20% Patient Pays Clinical Trials Advance Medical Science
AL0405 - Clinical Trial Service Provider Must Explain Charges Prior to Services
AL0406 -
AL0407 -
AL0408 -    4.  You will have to pay Original Medicare coinsurance for the
AL0409 -        Services you receive when participating in a qualifying
AL0410 -        clinical trial.  You do not have to pay the Original Medicare
AL0411 -        Part A or Part B deductibles, because you are enrolled in
AL0412 -        Senior Advantage.  For instance, you will be responsible for
AL0413 -        Part B coinsurance, generally 20% of the Medicare approved
AL0414 -        amount for most doctor Services and most other outpatient
AL0415 -        Services.  However, there is no coinsurance for Medicare
AL0416 -        covered clinical laboratory Services related to the clinical
AL0417 -        trial.
AL0419 -  ..
AL0420 - This language Section 7 for EOC dated 070101 that patients "have to
AL0421 - pay coinsurance" is clarified by Kaiser's documentation received from
AL0422 - Member Services on 070829 saying coinsurance "may apply" to clinical
AL0423 - trials, ref SDS 19 SF4I, when patients self-refer, per below,
AL0424 - ref SDS 0 1G4O, since EOC Section 2 requires Kaiser to pay costs of
AL0425 - prescribed treatment, which Kaiser must perform for covered oncology
AL0426 - services, per above? ref SDS 0 WS6M
AL0428 -  ..
AL0429 - Section 7 of Kaiser's EOC saying patients are liable for 20%
AL0430 - coinsurance aligns somewhat with authority received from UCSF on
AL0431 - 070917 that cites CMS Medicare Claims Processing Manual Publication
AL0432 - 100-04, Chapter 32 Section 69.9. ref SDS 25 4P4I  Review at that time
AL0433 - indicated Millie is not liable for costs of implementing this part of
AL0434 - Medicare regulations. ref SDS 25 OH9I
AL0436 -             ..
AL0437 -            [On 071006 Paula with Kaiser MCRC unit checking for changes
AL0438 -            in EOC from 2004 to 2007. ref SDS 30 453G
AL0440 -  ..
AL0441 - Kaiser's documents received from Member Services on 070829 say that
AL0442 - clinical trial service provider must explain charges in advance of
AL0443 - starting services. ref SDS 19 SF52
AL0445 -  ..
AL0446 - Research on 070917 supports Kaiser's requirements for clinical trial
AL0447 - provider to explain charges. ref SDS 25 416K  This conflicts with the
AL0448 - record on 070105; Kaiser failed to disclose charges to the patient.
AL0449 - ref SDS 14 PK68  Similarly, on 070130 UCSF failed to disclose extra
AL0450 - costs for treatment in the clinical trial. ref SDS 16 LY9H
AL0451 - Additionally, on 070906 Doctor Rugo disclosed having no knowledge of
AL0452 - billing charges to patients. ref SDS 22 UK5M  The next day on 070907,
AL0453 - the primary care physician at Kaiser also has no knowledge of billing
AL0454 - charges for clinical trials. ref SDS 24 XH5H
AL0455 -
AL0456 -            [On 071011 Millie requests UCSF explain confusing billings,
AL0457 -            citing Doctor Rugo's comment that requirements are "very
AL0458 -            muddy." ref SDS 33 K65V
AL0460 -             ..
AL0461 -            [On 071026 UCSF responds, ref SDS 36 K49J, and demands
AL0462 -            payment of its claim against Millie within 1 week.
AL0463 -            ref SDS 36 SU5V
AL0465 -             ..
AL0466 -            [On 071027 patient requests meeting so UCSF can present
AL0467 -            claim, and explain charges. ref SDS 37 CG6H
AL0469 -             ..
AL0470 -            [On 071029 UCSF refuses to meet; claims suffering from
AL0471 -            delay by patient "stringing out payments. ref SDS 38 6N6K
AL0473 -             ..
AL0474 -            [On 071128 Kaiser Appeals Committee approved payment for
AL0475 -            Millie's care on referral to UCSF. ref SDS 40 JZ5R
AL0477 -  ..
AL0478 - Senior Advantage requirement for patient payment of 20% coinsurance to
AL0479 - participate in clinical trials for advancing medical insurance under
AL0480 - section 7, does not relieve Kaiser from responsibility to prescribe
AL0481 - and pay with insurance premium revenue costs of needed care under
AL0482 - section 2, since in this case chemotherapy is an oncology covered
AL0483 - Service. ref SDS 0 WT37
AL0485 -  ..
AL0486 - EOC section 7 aligns with internal memo received from Kaiser on 070906
AL0487 - telling doctors that Kaiser cannot prescribe treatment through
AL0488 - clinical trials for Senior Advantage beneficiaries, ref SDS 23 WC5P,
AL0489 - and conflicts with Kaiser's practice to use clinical trials to expand
AL0490 - treatment options for patients. ref SDS 23 HD3K
AL0492 -  ..
AL0493 - Kaiser's notice that Senior Advantage requires payment of coinsurance
AL0494 - for clinical insurance was at all times masked by Kaiser's conduct
AL0495 - repeatedly referring Millie for treatament in clinical trials for
AL0496 - routine oncology practice, and never charging for coinsurance, as
AL0497 - shown in case study on 070830. ref SDS 20 LQ5I  Kaiser's conduct
AL0498 - obviated any requirement for Millie to have taken time away from
AL0499 - health care activities to study Kaiser documentation.
AL0501 -  ..
AL0502 - Kaiser's guidance indicating Medicare pays the full cost of laboratory
AL0503 - services for blood tests, aligns with documentation from Kaiser Member
AL0504 - Services received on 070829. ref SDS 19 695L  As a result, there is no
AL0505 - coinsurance for laboratory services required for standard of care in
AL0506 - clinical trials.  This representation seems to conflict with Bob
AL0507 - Schwartz's report on 070830 that Kaiser billed the patient for blood
AL0508 - tests. ref SDS 20 T149  The sample UCSF invoice approved by Kaiser has
AL0509 - extensive charges for blood test work performed by laboratory
AL0510 - Services. ref SDS 20 4P8K
AL0512 -  ..
AL0513 - May raise questions of billing irregularities, shown in issue #13
AL0514 - below. ref SDS 0 WW4O
AL0515 -
AL0516 -            [On 071010 UCSF letter seems to say Millie is not charged
AL0517 -            coinsurance on blood tests; refusal to submit details
AL0518 -            showing how charges are calculated, raises questions of
AL0519 -            billing irregularities. ref SDS 32 T64J
AL0521 -  ..
AL0522 - Kaiser Senior Advantage Page 68 Section 7 continues,...
AL0523 -
AL0524 -    5.  The Medicare program has written a booklet that includes
AL0525 -        information on Original Medicare coinsurance rules, called
AL0526 -        "Medicare & You."  To get a free copy, please call 1 800 633
AL0527 -        4227 or visit http://www.medicare.gov on the web.  Also the
AL0528 -        Medicare program has written a booklet aobut Medicare and
AL0529 -        Clinical Trials."  To obtain a free copy, please call 1 800 633
AL0530 -        4227 or visit http://www.medicare.gov on the web.  Section 1
AL0531 -        tells more about how to contact the Medicare program and about
AL0532 -        Medicare's website.
AL0533 -
AL0535 -         ..
AL0536 -        Self-referral for Clinical Trials Without Doctor Authorization
AL0537 -
AL0538 -
AL0539 -    6.  You should continue to come to Plan Providers for all covered
AL0540 -        Services that are not part of the clinical trial.  Original
AL0541 -        Medicare does not require that you get a referral from a Plan
AL0542 -        Physician to join a qualifying clinical trial.  However, you
AL0543 -        should tell us before you join a clinical trial outside of
AL0544 -        Kaiesr Permanente so we can keep track of your Services.
AL0546 -  ..
AL0547 - Kaiser's policy on clinical trials for patients volunteering to
AL0548 - support medical research, per above, ref SDS 0 1F92, calls for
AL0549 - coinsurance when patients "self-refer" for treatment in a clinical
AL0550 - trial. ref SDS 23 WC6S  Review at that time shows Kaiser made the
AL0551 - referral in order to provide prescribed treatment, ref SDS 23 OQ6K,
AL0552 - and citing case study on 070830. ref SDS 20 LQ5I
AL0553 -
AL0554 -
AL0555 -
AL06 -

SUBJECTS
Clinical Trials Dispute Coinsurance 20% 16 Issues Presented Kaiser S

B803 -
B80401 -  ..
B80402 - 16 Issues presented in Kaiser's Referral Dispute with UCSF
B80403 - Kaiser Must Prescribe Needed Care for Oncology Services EOC 2
B80404 - Patient Relied on Doctor Point of Contact with Kaiser EOC Sec 2
B80405 -
B80406 - This case presents at least 16 issues involving patient health,
B80407 - Medicare law and regulation, CMS contract management, medical
B80408 - practice, ethics and standards for oncology care using clinical
B80409 - trials, cost containment, and billing procedures.  At stake is whether
B80410 - Kaiser can transfer 100% of cost for patient care to others simply by
B80411 - prescribing treatment in clinical trials?
B80413 -  ..
B80414 - Goals for resolution of dispute are listed on 070830. ref SDS 20 T94H
B80415 -
B80416 -            [On 071002 letter to CMS asks if Medicare law prohibits
B80417 -            Kaiser (HMO) from paying for prescribed treatment in
B80418 -            clinical trials? ref SDS 27 OY4Q
B80420 -             ..
B80421 -            [On 071003 James Mayhew requested submission of issues for
B80422 -            public policy review at CMS. ref SDS 28 I34O
B80424 -             ..
B80425 -            [On 071003 Jullin Kwok manages Medicare contract with
B80426 -            Kaiser for Senior Advantage, and noted complexity of
B80427 -            Millie's case. ref SDS 28 BZ40
B80429 -             ..
B80430 -            [On 071006 Paula McPhail called and advised Kaiser received
B80431 -            50 pages of documents via fax from CMS, and converted this
B80432 -            into an appeal on Millie's behalf for Kaiser to pay for
B80433 -            prescribed treatments at UCSF. ref SDS 30 Z87L
B80435 -             ..
B80436 -            [On 071009 Jullin Kwok called and advised the letter dated
B80437 -            071002 to CMS along with 50 pages of citations was printed
B80438 -            and submitted for research; does not mention faxing 50
B80439 -            pages to Kaiser. ref SDS 31 EX5J
B80441 -             ..
B80442 -            [On 071128 Kaiser Appeals Committee approved payment for
B80443 -            Millie's care on referral to UCSF. ref SDS 40 JZ5R
B80445 -         ..
B80446 -    1.  What is Kaiser's duty of care; can the patient rely on the
B80447 -        doctor to prescribe treatment?
B80449 -         ..
B80450 -        Kaiser Senior Advantage EOC Section 2
B80451 -        Getting care from your primary care Plan Physician
B80452 -
B80453 -        ...says in part...
B80454 -
B80455 -            "If you need certain types of covered Services, your
B80456 -            primary care Plan Physician must prescribe or authorize the
B80457 -            Services (for example, some care requires a referral from a
B80458 -            Plan Physician for certain types of speciality care)."
B80459 -            ref SDS 0 WT37
B80461 -         ..
B80462 -        In this case, on 070105 the doctor determined Millie needed
B80463 -        oncology care with cetuximab. ref SDS 14 PK7L  Kaiser was faced
B80464 -        with a choice of buying the drug and administering treatment at
B80465 -        Kaiser (which would be expensive for Kaiser, reported recently
B80466 -        on 070921, ref SDS 26 QY58), or making referral to UCSF where
B80467 -        the drug would be paid by a clinical trial.  What was done?
B80468 -        The doctor prescribed the cost effective solution of treatment
B80469 -        at UCSF.  The doctor performed Kaiser's duty of care by
B80470 -        coordinating and making arrangements with UCSF so that Millie
B80471 -        was treated, as called out in Kaiser's EOC section 2,
B80472 -        ref SDS 0 WS6M, shown by Kaiser correspondence with UCSF on
B80473 -        061230, ref SDS 13 3X6K, and confirmed by the doctor's letter
B80474 -        to Millie on 070119 stating auhorization was submitted for
B80475 -        treatment on referral to the clinical trial at UCSF.
B80476 -        ref SDS 15 4R4M
B80478 -             ..
B80479 -            [On 071004 Medicare policy questions submitted to
B80480 -            James Mayhew at CMS for review. ref SDS 29 P74W
B80482 -         ..
B80483 -        The doctor's decision on 070105 has resulted in significantly
B80484 -        improved health for Millie, and significant savings for Kaiser
B80485 -        by avoiding the cost of the drug, and, also, the cost of
B80486 -        laboratory blood tests, which Kaiser would otherwise pay with
B80487 -        insurance preimum revenues but for treatment in the clinical
B80488 -        trial.  The doctor's decision has been a stunning success.
B80490 -         ..
B80491 -        In performing Kaiser's duties under EOC Section 2, can the
B80492 -        patient rely on the doctor as the single point of contact to
B80493 -        provide necessary research and coordination to arrange for
B80494 -        treatments according to requirements of the EOC, ref SDS 0
B80495 -        WS6M, including payments for coinsurance, if applicable, under
B80496 -        section 7? ref SDS 0 OU8P  In the absence of notice by Kaiser
B80497 -        of extra costs, as occurred here, can the patient rely on past
B80498 -        pattern and practice of Kaiser prescribing clinical trials for
B80499 -        oncology treatment without extra cost as notice of continuing
B80500 -        practice, explained by the doctor at Kaiser on 040318,
B80501 -        ref SDS 3 PU6M, and further shown by case study on 070830 that
B80502 -        Kaiser has consistently relied on referrals and clinical trials
B80503 -        for performing EOC covered services for oncology. ref SDS 20
B80504 -        LQ5I
B80505 -
B80506 -           [On 071128 Kaiser Appeals Committee approved payment for
B80507 -           Millie's care on referral to UCSF. ref SDS 40 JZ5R
B80509 -         ..
B80510 -        Or, must the patient review the insurance policy EOC to assess
B80511 -        every doctor order for added charges, and must Kaiser provide
B80512 -        additional people in the examination room to guide
B80513 -        determinination of costs and benefits balancing obtuse
B80514 -        provisions in lengthy insurance contracts, and in order to
B80515 -        prescribe treatment for routine care?  If the patient cannot
B80516 -        rely on good faith, expertise, and experience of the doctor, as
B80517 -        the single point of contact, called out in section 2,
B80518 -        ref SDS 0 WS6M, how can medical practice survive with multiple
B80519 -        conflicting instructions?
B80521 -         ..
B80522 -    2.  Double dipping.. save on drug costs and avoid other costs...
B80523 -
B80524 -        Section 7 in Kaiser's EOC says Kaiser avoids costs of drugs,
B80525 -        because the clinical trial sponsor pays for chemotherpay drugs,
B80526 -        ref SDS 0 1F4K; it also appears Medicare pays the full cost of
B80527 -        laboratory services (blood tests) for clinical trials.
B80528 -        ref SDS 0 1F67
B80530 -         ..
B80531 -        Having saved the cost of drugs and labs in this case, can
B80532 -        Kaiser transfer responsibility for payment of all other costs
B80533 -        for prescribed oncology care to others:  roughly 80% to
B80534 -        Medicare and 20% to the patient through the simple expedient of
B80535 -        prescribing treatment in a clinical trial?  What benefit is the
B80536 -        patient deriving in exchange for payment of insurance premiums,
B80537 -        if Kaiser avoids all costs of care for covered oncology
B80538 -        Services under section 2, ref SDS 0 WS6M, merely by prescribing
B80539 -        treatment in a clinical trial under section 7? ref SDS 0 OU84
B80540 -
B80541 -           [On 071128 Kaiser Appeals Committee approved payment for
B80542 -           Millie's care on referral to UCSF. ref SDS 40 JZ5R
B80544 -         ..
B80545 -    3.  Can Kaiser avoid its duty to prescribe necessary care for
B80546 -        covered oncology Services specified in section 2, ref SDS 0
B80547 -        WS6M, on grounds that oncology practice requires treatment in
B80548 -        clinical trials, noted by the doctor on 040318, ref SDS 3 PU6M,
B80549 -        but participation in clinical trials are not covered Services,
B80550 -        when patients self-refer to advance medical science, set out in
B80551 -        section 7? ref SDS 0 OU84
B80553 -         ..
B80554 -    4.  Can Kaiser avoid its duty to prescribe needed care for oncology
B80555 -        services under Section 2 of the EOC, ref SDS 0 WS6M, in light
B80556 -        of 2nd opinions from accredited cancer center specialists (see
B80557 -        Doctor Benz UCSF opinion received from Kaiser on 060929,
B80558 -        ref SDS 11 UI9K) recommending such treatment, which the doctor
B80559 -        determines is essential to sustain the health of the patient,
B80560 -        who necessarily is alwyas running out of limited treatments for
B80561 -        cancer available to front-line doctors at Kaiser, noted by
B80562 -        Millie's doctor on 040318, ref SDS 3 DG4J, and again during the
B80563 -        meeting on 041130? ref SDS 6 028N (see also discussion on
B80564 -        limited drugs at Kaiser, ref SDS 6 763L)
B80566 -         ..
B80567 -    5.  Can Kaiser avoid its duty to pay costs of covered Services for
B80568 -        oncology care, set out in Section 2 of the EOC, ref SDS 0 WS6M,
B80569 -        by prescribing treatment in a clinical trial on grounds that an
B80570 -        EOC implements Medicare policy to empower patients to
B80571 -        "self-refer" in order to advance medical scieince? ref SDS 0
B80572 -        OU84  What is Kaiser's legal duty to prescribe care?
B80574 -         ..
B80575 -    6.  Can patients disregard Kaiser's prescribed treatment under
B80576 -        Section 2, ref SDS 0 WS6M, to seek treatment from a service
B80577 -        provider outside Kaiser's Health Plan in a clinical trial for
B80578 -        the purpose of advancing medical science, under section 7,
B80579 -        ref SDS 0 OU84, and in that case Kaiser avoids costs and
B80580 -        responsiblity of self-referral by the patient (see review of
B80581 -        Kaiser's "self-referal" theory on 070830, ref SDS 20 T259),
B80582 -        which is not what occurred in this case, and is not the intent
B80583 -        of the patient, as further shown in the record on 070830?
B80584 -        ref SDS 20 QX5K
B80586 -         ..
B80587 -    7.  Can Kasiser implement Medicare policy to encourage
B80588 -        participation in clinical trials by paying for essential
B80589 -        prescribed treatment under section 2, and charging the patient
B80590 -        20% coinsurance only when the patient self-refers to advance
B80591 -        medical science under section 7? ref SDS 0 OU84
B80593 -         ..
B80594 -    8.  Kaiser cost transfer scheme "cut loose" the patient to fend for
B80595 -        herself conflicts with duty of care and accountability for
B80596 -        performance?
B80598 -         ..
B80599 -        Can Kaiser benefit from public policy (Medicare) to encourage
B80600 -        participation in clincial trials for advancing medical science,
B80601 -        shown in Kaiser's documentation reviewed on 070829, ref SDS 19
B80602 -        SF4I, and also stated in EOC section 7, ref SDS 0 OU84, by
B80603 -        cutting the patient loose to fend for herself in order to avoid
B80604 -        all costs of care from diverting payment for 80% to Medicare,
B80605 -        and converting a patient's legal right to "self-refer" paying
B80606 -        20% of costs, into a cost transfer scheme that shields Kaiser
B80607 -        from its duty to prescribe needed care and retain responsbility
B80608 -        for covered oncology services and to pay for that care with
B80609 -        revenues from insurance premiums, and can Kaiser additionally
B80610 -        be absolved from responsibility and accountability for standard
B80611 -        of care required by EOC section 2? ref SDS 0 WS6M (see prior
B80612 -        analysis on 070830, reporting patient intent for Kaiser to
B80613 -        retain responsibility for patient care. ref SDS 20 QX5K)
B80614 -
B80615 -              [On 071018 Doctor Rugo reported understandings that
B80616 -              Millie was "cut loose" by Kaiser to fend for herself
B80617 -              working with UCSF for treatment prescribed by Kaiser.
B80618 -              ref SDS 34 W23I
B80620 -         ..
B80621 -    9.  Did Kaiser change its EOC policy in section 7 published at the
B80622 -        beginning of 2007 and stating that patients "have to pay" for
B80623 -        coinsurance in the amount generally of 20%, ref SDS 0 1F67,
B80624 -        when Kaiser's public documents advertise that patients "may
B80625 -        have to pay" for coinsurance to self-refer for treatment that
B80626 -        advances medical science, reported on 070829 by Kaiser Member
B80627 -        Services? ref SDS 19 SF4I  Should not Kaiser retain
B80628 -        responsibility for costs of prescribed and necessary treatment
B80629 -        for covered oncology services, under Section 2? ref SDS 0 WS6M
B80631 -         ..
B80632 -   10.  If Kaiser's clinical trial EOC provisions prevent Kaiser from
B80633 -        prescribing needed treatment, did Kaiser's conduct in this case
B80634 -        modify the EOC agreement between Kaiser and the patient to
B80635 -        require that Kaiser pay for costs of clinical trial at UCSF,
B80636 -        as had been done previously...
B80637 -
B80638 -            a.  Pattern and practice for 6 years (mostly in 2004)
B80639 -                Kaiser prescribing and insisting on treatment in
B80640 -                clinical trials as essential component of professional
B80641 -                oncology practice and paying for all costs, without
B80642 -                charging the patient coinsurance, shown by case study
B80643 -                on 070830? ref SDS 20 LQ5I
B80645 -                 ..
B80646 -            b.  Kaiser coordinated and arranged for treatment in this
B80647 -                case with UCSF and agreed to pay any costs not covered
B80648 -                by clinical trial, reported in Kaiser correspondence on
B80649 -                061230? ref SDS 13 3X6K
B80651 -                 ..
B80652 -            c.  Kaiser never notified the patient of an interpretation
B80653 -                that Kaiser's referral by the doctor for treatment at
B80654 -                UCSF in a clinical trial was actually a "self-referral"
B80655 -                under Section 7 that required the patient to pay 20% of
B80656 -                costs for coinsurance, necessary to overcome logical
B80657 -                inference from Kaiser's prior conduct, and express
B80658 -                represention in this particular case that Kaiser paid
B80659 -                all costs not covered by the clinical trial.  Kaiser's
B80660 -                duty under EOC Section 2 required providing a single
B80661 -                point of contact for coordinating and arranging for
B80662 -                patient care. ref SDS 0 WS6M  Kaiser never told the
B80663 -                patient the order of magnituge of coinsurance would be
B80664 -                $10K above annual insurance premiums, and 56% of
B80665 -                clinical trial costs approved by medicare, shown by
B80666 -                UCSF charges presented during a meeting at UCSF on
B80667 -                070830. ref SDS 20 QW8M
B80669 -         ..
B80670 -   11.  Notice requirements were not met by Kaiser.
B80671 -
B80672 -        If Kaiser's clinical trial EOC provisions prevent Kaiser from
B80673 -        prescribing needed treatment, and require the patient to pay
B80674 -        20% coinsurance covering costs for prescribed treatment in
B80675 -        addition to insurance premiums, did Kaiser meet its duty of
B80676 -        notice performing case management specified in EOC section 2,
B80677 -        ref SDS 0 WS6M, by failing to present to the patient language
B80678 -        in section 7 on page 68, and in light of Kaiser's
B80679 -        representations to the customer in 2004 at the time of signing
B80680 -        up for Kaiser Senior Advantage that this would continue care
B80681 -        for a continuing condition of cancer, ref SDS 0 H75F, and
B80682 -        further telling the patient that Kaiser would pay any costs not
B80683 -        covered by the clinical trial, reported in Kaiser
B80684 -        correspondence on 061230? ref SDS 13 3X6K
B80686 -         ..
B80687 -        Did the patient have a duty to take notice of (i.e., read and
B80688 -        understand) Kaiser's EOC, when Kaiser's conduct at all times
B80689 -        showed Kaiser paid all costs of referrals and other costs of
B80690 -        care for continuing condition?
B80692 -         ..
B80693 -   12.  Age discrimination - does Kaiser policy to pay for referrals
B80694 -        that provide prescribed treatment needed by customers under age
B80695 -        65 discriminate by withholding the same prescribed treatment
B80696 -        needed for patients 65 and older?  On 030606 Millie asked
B80697 -        Kaiser if treatment was being withheld in order to favor
B80698 -        younger patients?  At that time, the doctor assured that
B80699 -        withholding needed treatment on the basis of age is against the
B80700 -        law? ref SDS 2 XR7I  Can Kaiser circumvent policy against age
B80701 -        discrimination by forcing older patients on fixed retirement
B80702 -        incomes to pay 20% higher prices for cancer care as a
B80703 -        "self-referral" to advance medical science, under section 7,
B80704 -        ref SDS 0 OU84, when Kaiser does not charge the same 20%
B80705 -        premium to younger patients with active incomes, when both
B80706 -        classes of patients require treatment for covered oncology
B80707 -        services?
B80709 -         ..
B80710 -   13.  Administration - compounding emotional, medical trauma.
B80711 -
B80712 -        Medical care, management, coordination, and billings are
B80713 -        complex and so stressful for medical professionals, shown by
B80714 -        example of UCSF invoice on 070830. ref SDS 20 4P8K  Millie's
B80715 -        case is especially complicated, noted by case study on 061020.
B80716 -        ref SDS 12 T25H  Cancer patients are necessarily handicapped
B80717 -        and so dependent on the doctor to simplify complexity to a
B80718 -        level that enables knowing judgements and decisions, noted by
B80719 -        Millie's doctor at Kaiser on 070921. ref SDS 26 CU58
B80721 -         ..
B80722 -        On 070921 the primary care physician reported Millie suffering
B80723 -        stress and trauma from dealing with unexpected medical bills
B80724 -        for clinical trial prescribed and arranged by Kaiser.
B80725 -        ref SDS 26 QY9V  Kaiser's failure to perform arrangements made
B80726 -        with UCSF on 061230, as called out in section 2 of the EOC,
B80727 -        ref SDS 0 WS6M, to pay any costs not covered by the clinical
B80728 -        trial, ref SDS 13 3X6K, "cut loose" a 72 year old enfeebled
B80729 -        cancer patient to assume the duties of the primary care
B80730 -        physician and Kaiser's team of medical financial experts to
B80731 -        manage treatment and billing activities at UCSF, required by
B80732 -        EOC Section 2. ref SDS 0 WS6M
B80734 -               ..
B80735 -              [On 071018 UCSF reports Kaiser advised UCSF in January
B80736 -              that the patient was "cut loose" to fend for herself
B80737 -              through self-referral clinical trial treatment which
B80738 -              Kaiser had prescribed. ref SDS 34 W23I
B80740 -         ..
B80741 -        Kaiser's failure to perform required support resulted in Millie
B80742 -        receiving over 100 pages of invoices with thousands of charges
B80743 -        that require review and audit for compliance with terms and
B80744 -        conditions negotiated by Kaiser, and in which the patient had
B80745 -        no hand, and no inkling of obligation for 6 months.  Initially,
B80746 -        patients must withstand trauma from the shock of getting
B80747 -        endless billings that demand payment for charges that cannot be
B80748 -        verified, illustrated by UCSF's invoice reviewed at UCSF during
B80749 -        a meeting on 070830, ref SDS 20 4P8K, and yet face devestating
B80750 -        threat of being denied essential treatment, all in the wake of
B80751 -        experience never having received even a single invoice from
B80752 -        Kaiser for 6 years of prior treatment.  This presents an easy,
B80753 -        inviting target for opportunists to overcharge, even if by
B80754 -        inadvertance, reported on 070830. ref SDS 20 RV6F
B80755 -
B80756 -            [On 071031 Millie receives notice dated 071026 UCSF plans
B80757 -            referral to collection agency for payment of $202.65 on
B80758 -            Kaiser referral account 12493370, ref SDS 39 KK4I, revised
B80759 -            070830, ref SDS 20 4P8K, and revised again on 070917,
B80760 -            ref SDS 25 MK4H; no indication of UCSF collection efforts
B80761 -            against Kaiser; separate notice dated 071027 and also
B80762 -            received 071031 UCSF says Millie's treatment for cancer
B80763 -            ordered by Kaiser will be terminated if UCSF does not
B80764 -            receive payment of $202.65. ref SDS 39 KM8J
B80766 -         ..
B80767 -        Cutting the patient loose from Kaiser payment support forces
B80768 -        patients to learn complex accounting practices in order to
B80769 -        understand delphic claims which even the claimant (here UCSF)
B80770 -        cannot explain, reported on 070830. ref SDS 20 WU5N  The
B80771 -        patient must futher become an expert in Medicare law for
B80772 -        determining correct application of entitlement and calculation
B80773 -        of quantum, illustrated by the record on 070917. ref SDS 25
B80774 -        596Q  Does Kaiser really intend for senior citizens fighting to
B80775 -        survive and remain productive to perform medical coordination
B80776 -        duties specified in section 2 of the EOC for the primary care
B80777 -        physician, ref SDS 0 WS6M, backed up by legions of trained and
B80778 -        experienced legal and financial personnel?  Shouldn't Kaiser
B80779 -        and UCSF staff be negotiating sensible, efficient billing
B80780 -        processes for routine payments and audits rather than place
B80781 -        this Hurculean task on the patient?  If Kaiser pays for costs
B80782 -        as originally promised and required by EOC section 2 (see
B80783 -        above, ref SDS 0 WS6M), and as performed on prior trials (see
B80784 -        case study on 070830, ref SDS 20 LQ5I), and as provided for
B80785 -        younger patients, would not Kaiser and UCSF professionals
B80786 -        working with Medicare bring order and efficiency to the billing
B80787 -        process?  Would this not reduce overbilling enfeebled,
B80788 -        frightened senior citizen as inviting targets of opportunity
B80789 -        for "financial engineering" to "harvest" extra revenues,
B80790 -        illustrated by the record on 070917? ref SDS 25 595P
B80791 -
B80792 -            [On 071006 billing irregularities arising from complex
B80793 -            calculation procedures, ref SDS 30 454M, cause duplication
B80794 -            and overcharging concerns that conflict with public policy
B80795 -            to simplify procedures and reduce emotional and financial
B80796 -            costs of care for seniors. ref SDS 30 PRWW
B80798 -             ..
B80799 -            [On 071010 Millie requests explanation of UCSF evident
B80800 -            duplicate charges for medical services, ref SDS 32 HZ6S,
B80801 -            reported on 071006. ref SDS 30 PRWW
B80803 -             ..
B80804 -            [On 071010 UCSF refuses to explain charges in complex
B80805 -            billings; refers patient to 3rd part. ref SDS 32 OH7R
B80807 -             ..
B80808 -            [On 071010 UCSF letter seems to say Millie is not charged
B80809 -            coinsurance on blood tests; refusal to submit details
B80810 -            showing how charges are calculated, raises questions of
B80811 -            billing irregularities. ref SDS 32 T64J
B80813 -             ..
B80814 -            [On 071018 Doctor Rugo reports understandings from Kaiser
B80815 -            in January that Millie was "cut loose" to fend for herself
B80816 -            getting treatment at UCSF. ref SDS 34 W23I
B80818 -         ..
B80819 -   14.  Kaiser told Millie she did not need additional insurance.
B80820 -
B80821 -        If Kaiser's view is correct that Millie "self-referred,"
B80822 -        despite the fact that Kaiser made all referral arrangements,
B80823 -        then did Kaiser's assurance that signing up for Kaiser Senior
B80824 -        Advantage would continue prior benefits for treating continuing
B80825 -        condition defeat any provisions that the EOC is not sufficient
B80826 -        to maintain her prior coverage that paid for treatment of a
B80827 -        continuing condition in clinical trials without charging 20%
B80828 -        for coinsurance, and did this reasonably mislead and prevent
B80829 -        Millie from obtaining additional Medigap coverage which Kaiser
B80830 -        maintains is not part of Senior Advantage, per section 1,
B80831 -        ref SDS 0 1F6L, and which Medicare law intends to encourage
B80832 -        patients to purchase as supplemental coverage to pay for
B80833 -        coinsurance charges?
B80834 -
B80835 -           [On 071006 Millie received billings from UCSF in the amount
B80836 -           of $15K - $20K per year for coinsurance. ref SDS 30 PRWW
B80838 -            ..
B80839 -           [On 071018 AARP article reports widespread confusion about
B80840 -           differences between Medigap supplemental Medicare policies
B80841 -           and HMO insurance coverage due to misrepresentations
B80842 -           selling managed care insurance cause beneficiaries to incur
B80843 -           significant extra charges. ref SDS 35 CR6T
B80845 -            ..
B80846 -           [On 071128 Kaiser Appeals Committee approved payment for
B80847 -           Millie's care on referral to UCSF. ref SDS 40 JZ5R
B80849 -         ..
B80850 -   15.  Do Kaiser's public statments that customers who purchase Kaiser
B80851 -        Senior Advantage may consider cancelling their Medigap policy
B80852 -        coverage demonstrate that Kaiser either recognizes
B80853 -        responsibility for Medigap scope, or misled customers in order
B80854 -        to increase sales by conveying promise of coverage that is
B80855 -        expressly denied in the EOC, reported on 070917? ref SDS 25
B80856 -        EZ56
B80857 -
B80858 -           [On 071018 AARP article reports widespread confusion about
B80859 -           differences between Medigap supplemental Medicare policies
B80860 -           and HMO insurance coverage due to misrepresentations
B80861 -           selling managed care insurance cause beneficiaries to incur
B80862 -           significant extra charges. ref SDS 35 CR6T
B80864 -         ..
B80865 -   16.  If Kaiser misdiagnosed and delayed treatment during 2003 due to
B80866 -        errors and omissions that allowed cancer to reach sustaining
B80867 -        strength (see case study on 040517, ref SDS 4 S66O), can Kaiser
B80868 -        under Medicare law pay for continuing treatment through
B80869 -        clinical trials for routine oncology practice, as Kaiser
B80870 -        explained on 040318, ref SDS 3 PU6M, and for the purpose of
B80871 -        mitigating damages?  If Kaiser then further delayed treatment
B80872 -        at the end of 2004 after removing the patient from treatment in
B80873 -        a clinical trial that caused pulmonary embolism, and such delay
B80874 -        in resuming treatment allowed cancer to spread beyond a point
B80875 -        that could be treated by surgery, reported by the surgeon on
B80876 -        050104, ref SDS 8 IS5N, and particularly explained further at
B80877 -        that time, ref SDS 8 UM6I, while Kaiser searched, against
B80878 -        patient request, for further clinical trial treatment to
B80879 -        prescribe, which at that time saved Kaiser money by reducing
B80880 -        the cost of drugs, reported on 041230, ref SDS 7 2V85, with the
B80881 -        result that surgery on 051021 failed on 060711, requiring
B80882 -        further systemic treatment with chemotherapy to the present
B80883 -        day, ref SDS 9 QK7H, can Kaiser now contort it's own conduct to
B80884 -        prescribe clinical trial treatments to mitigate damages from
B80885 -        errors and omissions in medical practice into patient
B80886 -        "self-referral" for the purpose of avoiding accountability for
B80887 -        all costs of care?  Does Medicare law prevent Kaiser from
B80888 -        fixing their mistake by paying for needed treatment on clinical
B80889 -        trial at this time?  Did Kaiser breach its duty of care by
B80890 -        "cutting the patient loose" to fend for herself and without
B80891 -        notice rather than provide continuing care of a continuing
B80892 -        condition, which was compounded by Kaiser searching for
B80893 -        clinical trials to meet obligations under section 2 of the EOC?
B80894 -        ref SDS 0 WS6M
B80896 -               ..
B80897 -              [On 071018 UCSF reports Kaiser advised in January that
B80898 -              the patient was "cut loose" to fend for herself through
B80899 -              self-referral process for treatment Kaiser prescribed in
B80900 -              clinical trial. ref SDS 34 W23I
B80902 -               ..
B80903 -              [On 071128 Kaiser Appeals Committee approved payment for
B80904 -              Millie's care on referral to UCSF. ref SDS 40 JZ5R
B80905 -
B80906 -
B80907 -
B80908 -
B80909 -
B80910 -
B80911 -
B80912 -
B810 -