|
Title XVIII of the
Social Security Act, Section 1862 (a)(1)(A). This
section allows coverage and payment for only those services considered
medically reasonable and necessary.
Title XVIII of the Social Security Act, Section 1833 (e). This section
prohibits Medicare payment for any claim which lacks the necessary
information to process the claim.
CMS Pub 100-2, 15-§50, 17-§10. This section is specific to the coverage of
drugs and biologicals.
CMS Pub 100-2, 15-§50. This section is specific to services and supplies.
CMS Pub 100-4, 17-§20 is specific to reasonable charges for injections.
Medicare Program Integrity Manual, Chapter 13 Section 5.4, discusses FI use
of the LCA.
Medicare Claims Processing Manual, Pub. 100-04. Transmittal 197.
|
|
CMS National Coverage Policy References
Title XVIII of the Social Security Act, Section 1862 (a)(1)(A).
This section allows coverage and payment for only those services
considered medically reasonable and necessary.
Title XVIII of the Social Security Act, Section 1833 (e). This section
prohibits Medicare payment for any claim which lacks the necessary information
to process the claim.
CMS Pub 100-2, 15-§50, 17-§10. This section is specific to the coverage
of drugs and biologicals.
CMS Pub 100-2, 15-§50. This section is specific to services and supplies.
CMS Pub 100-4, 17-§20 is specific to reasonable charges for injections.
Medicare Program Integrity Manual, Chapter 13 Section 5.4, discusses FI
use of the LCA.
|
Erythropoietin Analogs include those FDA approved drugs that are used for
the treatment of anemia under situations comparable to the indications for
erythropoietin (epoetin). Erythropoietin is produced in the kidney and
released into the bloodstream in response to hypoxia. It binds to the erythropoetin receptor on the cell surface of erythroid
progenitor cells and stimulates the proliferation and differentiation of
red blood cell precursors in the bone marrow and prolongs their survival by
inhibiting apoptosis. This activity increases the blood hemoglobin
concentration, correcting anemia.
This policy contains a latent Least Costly Alternative clause that will be
activated if and only if the cost of a therapeutically equivalent analog
significantly exceeds the cost of epoetin. Erythropoietin analogs will be
covered in their entirety as long as the weighted average per patient cost
of treatment with the analog does not exceed the cost of comparable
treatment with epoetin by 15% or more. If activated, the mechanism for
capping analog cost will be based on average equivalency data. It will
limit coverage of the analog to a fixed percentage of each dose based on
adjusted equivalent costs of the two drugs. The specific algorithm will be
updated annually using the most recently available clinical equivalency
data and current costs. This will be posted as a Comment in that section of
the policy and revised (as an administrative update without notice and
comment) annually. This LCA clause will have one window of activation per
year (January), following a 90 day notice period.
Triggering the Least Costly Alternative Clause
In September of each year Riverbend may evaluate the claims data for
Riverbend primary service areas that cover the most recent available 12
month period (typically Sept thru Aug):
1. All individually reimbursed Epoetin and analog claims will be selected
(i.e. costs that are bundled into a prospective global payment of any type
will be excluded).
2. All claims for each drug will be arranged in rank order by administered
dose per month to create a dose distribution curve.
3. The terminal 10% of each end of each curve will be excluded to remove
outliers.
4. The dose range from the 10th percentile to the 90th percentile will be
linearly divided for each drug to create four cohorts (low, low normal,
high normal, high).
5. A mean cost per beneficiary per month will be determined for each drug
cohort (sum of units x Medicare cost per unit / number of beneficiaries).
6. A weighted average cost per beneficiary per month will be determined for
each drug based on the relative population sizes of the four cohorts
(average of across
all four cohorts).
7. Epoetin costs will be buffered (inflated) by 15% to avoid triggering the
policy for inconsequential differences and to accommodate for individual
variance in dose equivalency.
8. A relative cost ratio will be determined for each analog by dividing the
weighted cost per beneficiary per month by the buffered weighted cost of
epoetin. If the relative cost exceeds 1 (i.e. true relative costs exceed
115%), the policy may be triggered.
9. If Riverbend decides to trigger the policy, that announcement MUST come
at the start of October with a ninety day notice period prior to its
implementation on the first of the calendar year. If Riverbend elects not
to implement the LCA at that time, the LCA will not be eligible for
implementation until the following year. Thus there will only be one
potential implementation annually.
Physician and Beneficiary Impact of the Least Costly Alternative Clause
The LCA clause will only go into effect if a significant disparity develops
in the cost of two comparable products. Physicians and beneficiaries will
have 90 days notice before the clause is implemented, and need only be
aware of a possible implementation at the start of each calendar year.
This LCA clause does not prohibit payment for the more expensive option.
Rather it reflects the thinking of IDE coverage and covers all costs up to
the cost of the least costly alternative--i.e., what Medicare would have
paid if the other option had been chosen.
The Limitation for Cost Coverage will be published annually as part of the
notice. The Limitation for Cost Coverage will equal 1/relative cost ratio
for each analog, rounded to the nearest percent.(Example: Aranesp weighted
average monthly cost / epoetin (true) weighted average monthly cost = 1.27,
then the relative cost ratio (buffered) equals 1.27/1.15 and the Limitation
of Cost Coverage will be published as its reciprocal, 90%.
For any given dose once the limitation of coverage has gone into effect,
Medicare will only cover costs up to the Limitation of Cost Coverage.
Additional costs will be denied as not medically necessary because
treatment with the alternative would not generate those costs. This should
be reflected on the claim by non-coverage of whatever percentage of units
of the analog is excluded by the LCC. (Example: LCC=90%, so 10% of units
are non-covered. Claims should reflect 90% of units as covered and 10% of
units as noncovered.)
If new evidence comes to light demonstrating that a given analog is not
equivalent to epoetin for a specific sub-group, that indication or subgroup
will be removed from Limitation of Cost Coverage restrictions.
At the time of the release of this policy there is no significant
discrepancy between the cost of epoetin and its analogs. Therefore, the LCA
restriction is NOT immediately applicable. Comparable costs will be
re-evaluated in September 2003 (and each September thereafter) based on
costs for the preceding 12 month period. If the 15% threshold is reached,
the LCA clause will be triggered to be effective, after a 90 day notice
period, on 1 January of the following year (January 2004 and each January
thereafter).
Because this is a medical necessity denial, an ABN would be appropriate. It
should indicate that a given percent of the cost will be non-covered due to
the existence of the less costly medically equivalent alternative.
If, after receiving an approriately worded ABN,
the patient continues to receive the analog, the patient will be
responsible for the uncovered fraction of the dose (cost).
Aranesp
Aranesp stimulates erythropoiesis by the same mechanism as endogenous
erythropoietin. It has an approximately 3-fold longer half-life than
Epoetin Alfa when administered by either the IV or SC route. This allows
less frequent dosing than other anemia treatments. Some patients have been
treated successfully with a SC dose of Aranesp administered once every 2
weeks. With once weekly dosing, steady state serum levels are achieved
within 4 weeks.
The recommended starting dose is 0.45mcg/kg administered intravenously or
subcutaneously once weekly. Pre-dialysis patients, in particular, may
require lower maintenance doses. Increased hemoglobin levels are not
generally observed until 2 to 6 weeks after initiating treatment with
Aranesp.
Please note that alternative dosing regimens specified in the package
insert for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies are also acceptable.
Other Analogs
This policy covers all non-epoetin erythropoietin analogs. Descriptions of
other analogs will be added to this policy as an editorial clarification
whenever new drugs are released.
|
Indications Summary
Erythropoetin analogs, including Aranesp and
any future analogs, will be covered for any
labeled or off-label indication for a given drug provided that epoetin is
also covered for that indication. This LCD is subordinate to Epoetin LCD
such that coverage, utilization and coding guidelines in that LCD apply
equally to erythropoetin analogs.
The elements of the Epoetin LCD that should be particularly referenced
include:
- indications for initiation of therapy
- ESRD: Hct < 33 (on dialysis)
- Chronic Renal Failure: Hct <= 30
(pre-dialysis)
- Non-renal indications: Hct <=30 with
significant symptoms
- indications for continuation of therapy
- reporting requirements for HCT/HGB
(Value Code 49)
- utilization limitations based on average
hematocrit
- target hematocrit 33-36
- payment limitation when rolling
hematocrit is maintained above 37.5
- exception to 37.5 rolling Hct limit for
dialysis facilities with > 80% subcutaneous usage
- payment limitation when peak Hct is
maintained above 40.5
|
Erythropoietin Analogs include those FDA approved drugs that are used for
the treatment of anemia under situations comparable to the indications for
erythropoietin (epoetin). Erythropoietin is produced in the kidney and
released into the bloodstream in response to hypoxia. It binds to the erythropoetin receptor on the cell surface of erythroid
progenitor cells and stimulates the proliferation and differentiation of
red blood cell precursors in the bone marrow and prolongs their survival by
inhibiting apoptosis. This activity increases the blood hemoglobin
concentration, correcting anemia.
Erythropoetin analogs are covered only when:
- Used for a labeled or off-label indication
of the specific drug in accordance with the USPDI, AND
- Used subject to all the conditions and
limitations of this LCD, AND
- Used subject to all the conditions and
limitations of Riverbend Local Coverage Decision on
"Epoetin" unless specifically excepted
by this LCD. This includes all the pertinent epoetin coverage
conditions for the applicable indication as well as all filing and
reimbursement restrictions, particularly:
- Indications for initiation of therapy
- Indications for continuation of therapy
- Reporting requirements for HCT/HGB
- Utilization limitations based on average
hematocrit
Thus, Epoetin LCD is a parent (controlling) LCD to this one such that all
elements of that LCD should be considered applicable to epoetin analogs.
This LCD is a child (subordinate) policy, in that it starts with the
characteristics of the parent LCD and selectively modifies them as needed
for the specific subset of services it covers.
Aranesp
Aranesp is indicated for the treatment of anemia in:
- Chronic Renal Failure patients on dialysis
and
- Chronic Renal Failure patients not on
dialysis and
- Chemotherapy induced anemia and
- Any future Aranesp indications in
accordance with the USPDI, effective as of the date of listing, that
are also covered indications for epoetin.
Aranesp should usually be administered once a week if a patient was
receiving epoetin 2 to 3 times weekly, and should usually be administered
once every 2 weeks if a patient was receiving epoetin once per week. As a
general rule, the Aranesp dosage should be adjusted for each patient to
achieve and maintain a target hemoglobin level not to exceed 12g/dL.
Please note that alternative dosing regimens specified in the package
insert for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies are also acceptable.
Estimated
Aranesp Starting Doses (mcg/week) Based on Previous Epoetin Alfa Dose
(units/week)
|
Previous Weekly
Epoetin Alfa Dose (units/week)
|
Weekly Aranesp Dose
(mcg/week)
|
|
<2,500
|
6.25
|
|
2,500 to 4,999
|
12.5
|
|
5,000 to 10,999
|
25
|
|
11,000 to 17,999
|
40
|
|
18,000 to 33,999
|
60
|
|
34,000 to 89,999
|
100
|
|
> 90,000
|
200
|
All reasons for Denial noted in Epoetin LCD are applicable. Payment for the
drug and associated services will be denied as not medically necessary when
they are used for conditions other than labeled and off-label conditions
for the specific drug in question.
When administered prior to the FDA approval date (for a labeled indication)
or prior to the date of inclusion in the USPDI (for off-label uses), the
service will be denied.
This policy contains a latent Least Costly Alternative clause that will be
activated if and only if the cost of a therapeutically equivalent analog
significantly exceeds the cost of epoetin. If the LCA clause is triggered,
excess costs (percentage of units administered) will be denied as not
medically necessary.
|