CONTACTS 

SUBJECTS
Medicare Coverage Kaiser Policy Clinical Trials Routine Care Resolve

3403 -
3403 -    ..
3404 - Summary/Objective
3405 -
340501 - Follow up ref SDS 8 0000, ref SDS 7 0000.
340502 -
340503 -
340504 -
340506 -  ..
3406 -
3407 -
3408 - Progress
3409 -
340901 - Millie received ref DRT 1 0001 from Arlette transmitting internal
340902 - guidance on Kaiser policy for managing clinical trials, and following
340903 - up discussion with Arlette at the Kaiser Oncology Department in Walnut
340904 - Creek, CA last week on 070829. ref SDS 5 EF6J
340906 -         ..
340907 -    1.  [Following up our meeting at Kaiser on September 29, 2007
340908 -        discussing payment for Kaiser referrals to clinical trials] I
340909 -        don't know if this [Medicare Coverage Policy on Clinical
340910 -        Trials] helps explain things or not.
340912 -  ..
340913 - On 070829 Arlette was surprised that Millie was being charged extra
340914 - expense for the clinical trial referral to UCSF. ref SDS 5 EG34
340915 -
340916 -            [On 070907 primary care physician not familiar with
340917 -            Kaiser's guidance on clinical trials. ref SDS 9 N43F
340919 -  ..
340920 - Today she submits an undated document with internal guidance on
340921 - Kaiser's policy managing clinical trials.
340923 -  ..
340924 - Kaiser transmits with Arlette's letter...
340925 -
340926 -    2.  MEDICARE COVERAGE POLICY
340927 -        Clinical Trials.......................... ref DRT 1 R57K
340929 -         ..
340930 -    3.  FOR INTERNAL USE ONLY
340932 -         ..
340933 -    4.  APPLIES TO CALIFORNIA
340935 -         ..
340936 -    5.  Coverage
340938 -         ..
340939 -        Important Note:  Clinical trials and services related to
340940 -        clinical trials are not covered by KPSA [Kaiser Permanente
340941 -        Senior Advantage].  However, original Medicare covers, on a
340942 -        fee-for-service basis, certain benefits related to the routine
340943 -        costs of qualifying clinical trials.  Below is a summary of
340944 -        original Medicare's coverage for routine care associated with
340945 -        clinical trials. ref DRT 1 OS7O
340947 -  ..
340948 - Kaiser's policy guidelines that "clinical trials are not covered by
340949 - for Medicare patients ("Senior Advantage") conflicts with Kaiser's
340950 - policy making referrals for clinical trials, as shown by case study on
340951 - 070830. ref SDS 6 LQ5I  Kaiser's referral to the clinical study for
340952 - Avastin on 040318, ref SDS 1 PU6M, and submitting authorization for
340953 - prescribed treatment was for Kaiser to pay for required treatment, as
340954 - shown in the study on 070130. ref SDS 4 2X6L  Since, as stated by
340955 - Kaiser on 040318, clincial trials are central to oncology care for
340956 - cancer patients, and since the patient pays insurance premiums for
340957 - effective care, there is no rational basis nor public policy purpose
340958 - for Kaiser to bank the money patients pay for health care by forcing
340959 - patients to pay for treatment determined to be effective through
340960 - clinical trials, while not paying for treatments beleived less
340961 - effective.
340962 -
340963 -           [On 070927 Kaiser Senior Advantage EOC section 2 requires
340964 -           the doctor to prescribe necessary treatment for covered
340965 -           services, in this case oncology. ref SDS 11 WS6M
340967 -            ..
340968 -           [On 070927 Kaiser Senior Advantage EOC section 7 calls for
340969 -           patients to pay 20% coinsurance for self-refer participation
340970 -           in clinical trial to advance medical science. ref SDS 11
340971 -           1F67
340973 -            ..
340974 -           [On 071011 Millie requests UCSF explain confusing billings,
340975 -           citing Doctor Rugo's comment that requirements are "very
340976 -           muddy." ref SDS 12 K65V
340978 -            ..
340979 -           [On 071026 UCSF responds, ref SDS 13 K49J, and demands
340980 -           payment of its claim against Millie within 1 week.
340981 -           ref SDS 13 SU5V
340983 -            ..
340984 -           [On 071027 patient requests meeting so UCSF can present
340985 -           claim, and explain charges. ref SDS 14 CG6H
340987 -            ..
340988 -           [On 071029 UCSF refuses to meet; claims suffering from
340989 -           delay "stringing out payments. ref SDS 15 6N6K
340991 -            ..
340992 -           [On 071031 UCSF notice treatment for cancer ordered by
340993 -           Kaiser will be terminated, ref SDS 16 KM8J; further notice
340994 -           UCSF making referral to collection agency for payment of
340995 -           $202.65 on Kaiser referral. ref SDS 16 KK4I
340997 -            ..
340998 -           [On 071128 Kaiser Appeals Committee approved payment for
340999 -           Millie's care on referral to UCSF. ref SDS 17 JZ5R
341001 -  ..
341002 - When Millie signed up for Kaiser Senior Advantage she was told by
341003 - Kaiser that this supplemented coverage provided by Medicare.
341005 -  ..
341006 - Kaiser Medicare Coverage Policy Clinical Trials continues...
341007 -
341008 -    6.  Original Medicare covers the routine care associated with
341009 -        Medicare qualified clinical trials, as well as reasonable and
341010 -        necessary items and services used to diagnose and treat
341011 -        complications arising from participation in clinical trials.
341012 -        As indicated in the Memeber's Evidence of Coverage, KPSA/Cost
341013 -        Members may self-refer to any Medicare qualified trial.  When a
341014 -        KPSA/Cost member self refers to a clinical trial, the clinical
341015 -        trial provider bills Medicare directly for Medicare allowable
341016 -        charges. ref DRT 1 OS8O
341018 -  ..
341019 - This internal policy explanation seems similar to documents received
341020 - from Barbara in Member Services on 070829. ref SDS 5 RA85
341022 -  ..
341023 - Case study on 070830 shows Kaiser reasonably distinguishes between
341024 - patient self-referral to participate in a clinical trial paid by
341025 - Medicare directly and requiring payment of coinsurance, and when
341026 - Kaiser makes referral for medical necessity to discharge Kaiser's
341027 - responsibility to treat the patient with routine oncology practice.
341028 - ref SDS 6 LQ5I
341030 -            ..
341031 -           [On 070907 primary care physician not familiar with Kaiser's
341032 -           guidance on clinical trials. ref SDS 9 N43F
341034 -            ..
341035 -           [On 070909 Arlette's research on clinical trials submitted
341036 -           to Kaiser and UCSF to resolve payment issues. ref SDS 10
341037 -           NW5N
341039 -            ..
341040 -           [On 070927 Kaiser Senior Advantage EOC section 2 requires
341041 -           the doctor to prescribe necessary treatment for covered
341042 -           services, in this case oncology. ref SDS 11 WS6M
341044 -            ..
341045 -           [On 070927 Kaiser Senior Advantage EOC section 7 calls for
341046 -           patients to pay 20% coinsurance for self-refer participation
341047 -           in clinical trial to advance medical science. ref SDS 11
341048 -           1F67
341050 -            ..
341051 -           [On 071011 Millie requests UCSF explain confusing billings,
341052 -           citing Doctor Rugo's comment that requirements are "very
341053 -           muddy." ref SDS 12 K65V
341055 -            ..
341056 -           [On 071026 UCSF responds, ref SDS 13 K49J, and demands
341057 -           payment of its claim against Millie within 1 week.
341058 -           ref SDS 13 SU5V
341060 -            ..
341061 -           [On 071027 patient requests meeting so UCSF can present
341062 -           claim, and explain charges. ref SDS 14 CG6H
341064 -            ..
341065 -           [On 071029 UCSF refuses to meet; claims suffering from
341066 -           delay "stringing out payments. ref SDS 15 6N6K
341068 -            ..
341069 -           [On 071031 UCSF notice treatment for cancer ordered by
341070 -           Kaiser will be terminated, ref SDS 16 KM8J; further notice
341071 -           UCSF making referral to collection agency for payment of
341072 -           $202.65 on Kaiser referral. ref SDS 16 KK4I
341074 -            ..
341075 -           [On 071128 Kaiser Appeals Committee approved payment for
341076 -           Millie's care on referral to UCSF. ref SDS 17 JZ5R
341078 -  ..
341079 - What is Kaiser's responsibility for prescribing needed treatment with
341080 - referral to a clinical trial, rather than the member self-refer?  In
341081 - this case, Kaiser prescribed treatment with referral to the Avastin
341082 - and Taxol clinical trial on 040318, ref SDS 1 PU6M, and Kaiser later
341083 - made another referral prescribing treatment with the cetuximab and
341084 - carboplatin clinical trial on 070105. ref SDS 3 PK7L
341086 -  ..
341087 - On 060809 letter reports Kaiser makes referrals routinely for patients
341088 - who need treatment which Kaiser cannot provide. ref SDS 2 NT9X
341090 -  ..
341091 - Kaiser Medicare Coverage Policy Clinical Trials continues...
341092 -
341093 -    7.  Medicare will cover the routine care if the clinical trial
341094 -        meets the following qualifying criterion:
341095 -
341096 -             •  The purpose of the trial must be the evaulation of an
341097 -                item or service that falls within a Medicare benefit
341098 -                category (e.g., physician's service, durable medical
341099 -                equipment) and is not statuorily excluded from coverage
341100 -                (e.g., cosmetic surgery, hearing aids). ref DRT 1 MU9G
341102 -                 ..
341103 -             •  The trial must not be designed exclusively to test
341104 -                toxicity or desease pathophysiology.  It must have a
341105 -                therapeutic intent. ref DRT 1 OS44
341107 -                 ..
341108 -             •  Trials of therapeutic intervention must enroll patients
341109 -                with diagnosed disease rather than healthy volunteers.
341110 -                Trials of diagnostic interventions may enroll healthy
341111 -                patients in order to have a proper control group.
341112 -                ref DRT 1 OS47
341114 -                 ..
341115 -             •  The trial is automatically deemed as qualified by
341116 -                Medicare.  Examples include but are not limited to
341117 -                trials funded by the NIH, CDC, CMS, VA. ref DRT 1 MU52
341119 -         ..
341120 -    8.  Covered routine care in clinical trials includes:
341121 -
341122 -             •  Items or services that are typically provided absent a
341123 -                clinical trial (e.g., conventional care);, ref DRT 1
341124 -                MU5V;
341125 -
341126 -             •  Items or services required solely for the provision of
341127 -                the investigational item or service (e.g.,
341128 -                administration of a noncovered chemotherapeutic agent),
341129 -                the clinically appropriate monitoring of the effects of
341130 -                the item or service, or the prevention of
341131 -                complications;, ref DRT 1 MU6F; and
341133 -                 ..
341134 -             •  Items or services needed for reasonable and necessary
341135 -                care arising from the provision of an investigational
341136 -                item or service -- in particular, for the diagnosis or
341137 -                treatment of complications. ref DRT 1 MU6W
341139 -         ..
341140 -    9.  Limitations & Exclusions
341141 -
341142 -             •  The investigational item or service, itself, used in
341143 -                the clinical trial. ref DRT 1 MV3T
341144 -
341145 -             •  Items and services provided solely to satisify data
341146 -                collection and analysis needs and that are not used in
341147 -                the direct clinical management of the patient (e.g.,
341148 -                monthly CT scans for a condition usually requiring only
341149 -                a single scan), ref DRT 1 MV40
341151 -                 ..
341152 -             •  Items or services customarily provided by the research
341153 -                sponsors free of charge for any enrollee in the trial.
341154 -                ref DRT 1 MV4U
341156 -                 ..
341157 -             •  Items and services provided solely to determine trial
341158 -                eligibility. ref DRT 1 N64X
341160 -                 ..
341161 -             •  Self-certified trials. ref DRT 1 N650
341163 -                 ..
341164 -             •  Items or services for which payment is statuorily
341165 -                prohibited by Medicare, that are statuorily excluded
341166 -                (e.g., cosmetic surgery, hearing aids), or that fall
341167 -                under a national non-coverage, ref DRT 1 N65H
341169 -         ..
341170 -   10.  Copayments
341171 -
341172 -             •  Members are liable for the coinsurance amounts
341173 -                applicable to services paid under Medicare
341174 -                fee-for-service rules when participating in a qualified
341175 -                clinical trial. ref DRT 1 MV56
341177 -  ..
341178 - How much is coinsurance?  How is it calculated.  Where is this
341179 - specified?
341181 -  ..
341182 - When Kaiser prescribes treatment by clinical trial how does Kaiser
341183 - inform the patient the amount of extra cost for coinsurance in order
341184 - to assess cost/benefits?
341186 -  ..
341187 - Can Kaiser prescribe treatment without disclosing the amount of extra
341188 - cost to the patient?
341190 -  ..
341191 - Kaiser Medicare Coverage Policy Clinical Trials continues...
341192 -
341193 -   11.  Members may obtain more information on Medicare payments for
341194 -        clinical trials and which trials qualify, by viewing or
341195 -        downloading the publication "Medicare and Clinical Trials" at
341196 -        http://www.medicare.gov on the web.  Under "Search Tools,"
341197 -        select "Find a Medicare Publication."  Or, Members may call
341198 -        Medicare directly at 1 800 633 4227) (TTY 1 877 486 2048) 24
341199 -        hours a day, seven days a week. ref DRT 1 MV6S
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3413 -