medicare’s coverage policy relating to organ transplantation medicare’s coverage policy relating...
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Medicare’s Coverage Medicare’s Coverage PolicyPolicy
Relating to Organ Relating to Organ TransplantationTransplantationJohn Whyte, MD, MPHJohn Whyte, MD, MPH
Centers for Medicare and Medicaid Centers for Medicare and Medicaid ServicesServices
Ethics and Policy ConferenceEthics and Policy Conference
July, 2001July, 2001
The Old StructureThe Old Structure
The H ealth C are F inancing Adm inistration
P ress O ffice O ffice of Leg is la tion
O ffice of S tra teg ic P lann ing
C en ter for B en ficia ry S ervices C en ter for H ea lth P lans & P roviders
C en ter for M ed ica id & S ta te O pera tions O ffice of C lin ica l S tandards & Q ua lity
A dm in is tra tor
Centers for Medicare and Centers for Medicare and Medicaid Services (CMS)Medicaid Services (CMS)
P ress O ffice O ffice of Leg is la tion
O ffice of S tra teg ic P lann ing
C en ter for B en ficia ry C hoice C en ter for M ed ica re M anagem en t
C en ter for M ed ica id & S ta te O pera tions O ffice of C lin ica l S tandards & Q ua lity
A dm in is tra torTom S cu lly
New StructureNew Structure
D ivis ion o f O pera tions
D iv is ion o f M edica l/S urg ica l S erv ices
D iv is ion o f M edica l Item s & D evices
C overag e and A nalys is G rou pS ean T u nis , M .D .
Online Access to HCFA
www.hcfa.gov
HCFA’s Authority to Make HCFA’s Authority to Make Coverage DecisionsCoverage Decisions Section 1862(a)(1)(A) of the SSA Section 1862(a)(1)(A) of the SSA
restricts all coverage and payment to restricts all coverage and payment to that which is found “reasonable and that which is found “reasonable and necessary” for the treatment of illness necessary” for the treatment of illness or injuryor injury
The provision gives the Secretary, HHS, The provision gives the Secretary, HHS, acting through HCFA, the authority to acting through HCFA, the authority to determine the coverage of services determine the coverage of services under Medicareunder Medicare
Section 1862 (a)(1)(A)Section 1862 (a)(1)(A)
““. . .no payment may be made . . . . . .no payment may be made . . . For expenses incurred for items or For expenses incurred for items or services . . [which] are not services . . [which] are not reasonable and necessary for the reasonable and necessary for the diagnosis or treatment of illness or diagnosis or treatment of illness or injury or to improve the injury or to improve the functioning of a malformed body functioning of a malformed body member.”member.”
Two General Methods by Two General Methods by which Coverage Decisions which Coverage Decisions are Madeare Made
Medicare contractors may develop coverage Medicare contractors may develop coverage policies, known as Local Medical Review Policies policies, known as Local Medical Review Policies (LMRPs) -- www.lmrp.net --> medicarelcd(LMRPs) -- www.lmrp.net --> medicarelcd
HCFA may develop national coverage policiesHCFA may develop national coverage policies Most new items and services covered by the first Most new items and services covered by the first
process, with about 10% covered by secondprocess, with about 10% covered by second Both rely upon evidence of medical effectivenessBoth rely upon evidence of medical effectiveness
Coverage of Services, Coverage of Services, GeneralGeneral Medicare is a defined benefit Medicare is a defined benefit
programprogram– A service must fall into one of 55 A service must fall into one of 55
statutorily-defined “benefit statutorily-defined “benefit categories” as a first step toward categories” as a first step toward coveragecoverage
Medicare National Coverage Process
45 Days
Submission of Formal Request for Review
Is Submission complete?
HCFA Accepts Request
HCFA Responds to Request
Once HCFA accepts a formal request, it will take 90 days to respond to requestor. HCFA will also announce its decision on the Web.
90 DAYS
HCFA Reviews for Completeness
Return to Requestor
Request Duplicates Pending Request. Requests Combined
NO
YES
60 Days
DECISION
Payment Change Effective
180 Days from 1st day of next calendar quarter
HCFA Issues National Coverage Decision
HCFA Announces Intention to make Decision Via Decision Memorandum
Notify Requestor of Estimated Timeframe
Request Duplicates Earlier Request where Decision Made. Insufficient evidence to reopen
Referral for a Technology Assessment
National Coverage Decision without
Coverage Limitations
National Coverage Decision with
Coverage Limitations
Issue left to Contractor Discretion
National Noncoverage
Decision
60 Days
Referral to MCAC
No benefit category. Unable to consider
Medicare Coverage Medicare Coverage PoliciesPolicies 1976 - Kidney transplants1976 - Kidney transplants 1987 - Heart transplants1987 - Heart transplants 1992 - Liver transplants1992 - Liver transplants 1995 - Lung transplants1995 - Lung transplants 1999 - Liver transplants (expanded)1999 - Liver transplants (expanded) 1999 - Pancreas transplants1999 - Pancreas transplants 2000 - Intestinal transplants2000 - Intestinal transplants
Actuarial DataActuarial Data
1 year actuarial survival standards--1 year actuarial survival standards--– heart 73%heart 73%– liver 77%liver 77%– lung 69%lung 69%
2 year survival standards --2 year survival standards --– hear 65%hear 65%– liver 60%liver 60%– lung 62%lung 62%
Issues Related to Issues Related to MalignanciesMalignancies
