[Federal Register: August 20, 2003 (Volume 68, Number 161)]
[Proposed Rules]
[Page 50427-50452]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20au03-27]
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Part IV
Department of Health and Human Services
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Centers for Medicare and Medicaid Services
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42 CFR Part 405
Medicare Program; Payment Reform for Part B Drugs; Proposed Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 405
[CMS-1229-P]
RIN 0938-AM12
Medicare Program; Payment Reform for Part B Drugs
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This proposed rule would revise, based on one of four
approaches, the current payment methodology for Part B covered drugs
and biologicals that are not paid on a cost or prospective payment
basis. We are seeking comments on which of these proposed approaches we
should implement. This proposed rule would also make changes to
Medicare payment for furnishing or administering certain drugs and
biologicals.
DATES: We will consider comments if we receive them at the appropriate
address, as provided below, no later than 5 p.m. on October 14, 2003.
ADDRESSES: In commenting, please refer to file code CMS-1229-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission or e-mail. Mail written comments (one
original and three copies) to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-1229-P, P.O. Box 8013, Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be timely
received in the event of delivery delays.
If you prefer, you may deliver (by hand or courier) your written
comments (one original and three copies) to one of the following
addresses: Room 445-G, Hubert H. Humphrey Building, 200 Independence
Avenue, SW., Washington, DC 20201, or Room C5-14-03, 7500 Security
Boulevard, Baltimore, MD 21244-1850. (Because access to the interior of
the HHH Building is not readily available to persons without Federal
Government identification, commenters are encouraged to leave their
comments in the CMS drop slots located in the main lobby of the
building. A stamp-in clock is available for persons wishing to retain a
proof of filing by stamping in and retaining an extra copy of the
comments being filed.)
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and could be considered late.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Marjorie Baldo, (410) 786-0548.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: Comments
received timely will be available for public inspection as they are
received, generally beginning approximately 3 weeks after publication
of a document, at the headquarters of the Centers for Medicare &
Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244,
Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule
an appointment to view public comments, please call (410) 786-7197.
Copies: This Federal Register document is available from the
Federal Register online database through GPO Access, a service of the
U.S. Government Printing Office. The Web site address is: http://www.access.gpo.gov/nara/index.html
.
To assist readers in referencing sections contained in this
document, we are providing the following Table of Contents.
Table of Contents
I. Background
A. Covered Drugs and Biologicals
B. Current Medicare Drug Spending
C. History of the Current Payment System
D. List AWP and Widely Available Market Prices
E. Studies and Developments Since the Balanced Budget Act of
1997 (BBA)
F. Implications of GAO and OIG Studies
II. Provisions of the Proposed Rule
A. Approaches to Revising the Current Payment System
1. Comparability Provision
2. Average AWP Discount
3. Market Monitoring
4. Competitive Acquisition Program and Average Sales Prices
B. Increases in Payments Related to the Administrative Costs of
Furnishing Drugs
C. Beneficiary Access
III. Collection of Information Requirements
IV. Response to Public Comments
V. Regulatory Impact Analysis
Addendum A Tables
Addendum B List of Medicare Drug HCPCS Codes
Alphabetical List of Acronyms in the Proposed Rule
AMP Average Manufacturer's Price
APC Ambulatory Payment Classification
ASCO American Society of Clinical Oncology
ASP Average Sale Price
AWP Average Wholesale Price
BBA Balanced Budget Act of 1997
BBRA Balanced Budget Refinement Act of 1999
BIPA Medicare, Medicaid, and SCHIP Benefits Improvement and Protection
Act of 2000
CMS Centers for Medicare & Medicaid Services
DHHS Department of Health and Human Services
DME Durable Medical Equipment
DMERC Durable Medical Equipment Regional Carrier
DOJ Department of Justice
EAC Estimated Acquisition Cost
EPO Erythropoietin
ESRD End-Stage Renal Disease
FSS Federal Supply Schedule
GAO General Accounting Office
MEDPAC Medicare Payment Advisory Commission
NDC National Drug Code
NOC Not Otherwise Classified
OIG Department of Health and Human Services Office of Inspector General
OMB Office of Management and Budget
OPPS Outpatient Prospective Payment System
PPO Preferred Provider Organization
PRA Paperwork Reduction Act of 1995
SDP Single Drug Pricer
VA Department of Veterans Affairs
WAMP Widely Available Market Price
I. Background
A. Covered Drugs and Biologicals
Medicare Part B currently covers a limited number of prescription
drugs. For the purposes of this proposed rule, the term ``drugs'' will
hereafter refer to both drugs and biologicals. Currently covered
Medicare drugs generally fall into three categories: drugs furnished
incident to a physician's service, durable medical equipment (DME)
drugs, and statutorily covered drugs and other drugs.
1. Drugs Furnished Incident to a Physician's Service
These are injectable or intravenous drugs that are administered
incident to a physician's service (section 1861(s)(2) of the Social
Security Act (the Act)). The Act limits coverage to drugs that are not
usually self-administered. Under the ``incident-to'' provision, the
physician must incur a cost for the drug, and must bill for it.
Examples include injectable prostate cancer drugs (lupron acetate for
depot suspension, goserelin acetate implant), injectable drugs used in
connection with treatment of cancer (epoetin alpha), intravenous drugs
used to treat cancer (paclitaxel and docetaxel
[[Page 50429]]
used to treat breast cancer), injectable anti-emetic drugs used to
treat the nausea resulting from chemotherapy, infliximab used to treat
rheumatoid arthritis, and rituximab used to treat non-Hodgkin's
lymphoma.
2. Durable Medical Equipment (DME) Drugs
These are drugs that are administered through a covered item of DME
such as a nebulizer or pump. Two of the most common drugs in this
category are the inhalation drugs albuterol sulfate and ipratropium
bromide.
3. Statutorily Covered Drugs and Other Drugs
Certain drugs are specifically covered by statute including:
immuno[chyph]suppressive drugs; hemophilia blood clotting factor;
certain oral anti-cancer drugs; oral anti-emetic drugs; pneumococcal,
influenza and hepatitis vaccines; antigens; erythropoietin for trained
home dialysis patients; certain other drugs separately billed by end
stage renal disease (ESRD) facilities (for example, iron dextran,
vitamin D injections); and osteoporosis drugs.
4. Types of Providers
Types of providers and suppliers that are paid based on average
wholesale price (AWP) for all or some of the Medicare covered drugs
they furnish include: physicians, pharmacies, DME suppliers, hospital
outpatient departments, and ESRD facilities.
5. Drugs Paid on a Cost or Prospective Payment Basis
Drugs paid on a cost or prospective payment basis that are
generally outside of the scope of this proposed rule include: drugs
furnished during an inpatient hospital stay (except clotting factor);
drugs packaged under the outpatient prospective payment system (OPPS);
drugs furnished by ESRD facilities whose payments are included in
Medicare's composite rate; and drugs furnished by critical access
hospitals, skilled nursing facilities (unless outside of a covered
stay), comprehensive outpatient rehabilitation facilities, rural health
facilities, and federally qualified health centers.
B. Current Medicare Drug Spending
In 2002, the preliminary estimate of allowed charges for the
approximately 450 drugs paid by Medicare carriers is $8.4 billion. The
majority of these expenditures were for drugs administered incident to
a physician's service and drugs furnished in conjunction with DME.
Spending growth for Medicare drugs has been substantial. Medicare
allowed charges for drugs were approximately $3.3 billion in 1998. As
indicated above, we estimate 2002 Medicare spending for drugs at
approximately $8.4 billion or nearly three times the 1998 levels or an
average of 27 percent per year. Because during this time period
Medicare fee-for-service enrollment grew by an average of only 1.4
percent per year, other factors such as price increases and additional
utilization played a greater role in this expenditure growth. More than
77 percent of Medicare spending for drugs goes to oncologists and
urologists for cancer drugs and pharmacies and other medical suppliers
of DME drugs. Medicare spending for drugs billed by oncologists has
more than tripled between 1998 and 2002 growing from $1.2 billion to
$3.8 billion. Between 2001 and 2002, Medicare spending for drugs billed
by oncologists increased by 41 percent. Growth in spending for the two
highest expenditure DME drugs, albuterol and ipratropium bromide, has
increased from $393 million in 1998 to nearly $1.0 billion in 2002.
Much of the current Medicare spending is concentrated in relatively
few of the approximately 450 covered drugs. For example, of the $8.4
billion for carrier paid drugs, 7 drugs account for 49 percent of
spending ($4.0 billion), 19 drugs account for 75 percent of spending
($6.2 billion) and 33 drugs account for 86 percent of spending ($7.1
billion). The top drug code, epoetin alpha (Q0136), accounts for 13 of
carrier spending. Two prostate cancer drugs, lupron acetate for depot
suspension (J9217) and goserelin acetate implant (J9202), combined,
account for 14 of carrier paid drugs. Two generic drugs furnished via a
covered item of DME, albuterol and ipratropium bromide, account for 13
percent of carrier drug spending.
Intermediaries and not carriers process ESRD facility claims for
drugs paid outside the ESRD composite rate. In 2000, allowed charges
for ESRD facilities for these drugs were $1.4 billion for
erythropoietin, $0.1 billion for iron dextran, $0.1 billion for vitamin
D injections, and $0.4 billion for all other separately billed drugs.
Section 1881(b)(11)(B) of the Act provides a statutory formula to
determine the payment amount for erythropoietin separately billed by
ESRD facilities. The other drugs furnished and separately billed by
ESRD facilities are paid 95 percent of the AWP under section 1842(o) of
the Act.
C. History of the Current Payment System
In the June 5, 1991 physician fee schedule proposed rule (56 FR
25792), we proposed that the drug payment limit be based on 85 percent
of the national AWP of the drug. For very high volume drugs, we
proposed that the drug payment limits be based on the estimated
acquisition cost (EAC) of the drugs. The EAC was to be determined from
survey data. We received many comments, primarily from oncologists,
indicating that an 85 percent standard was inappropriate. In response
to these comments, the 1992 physician fee schedule final rule
established a payment limit based on the lower of 100 percent of AWP or
the EAC. However, because of statistical sampling concerns generated by
a lack of information on the variation in acquisition costs between low
and high volume providers, the EAC was never implemented. Various
legislative proposals were submitted to move away from payment based on
100 percent of AWP, including changing the percentage of AWP to a lower
amount. In 1997, the Congress, responding in part to one of these
proposals, amended the Act to limit payment for drugs not paid on a
cost or prospective payment basis to the lower of the actual charge or
95 percent of AWP (section 1842(o)(1) of the Act as added by section
4556 of the Balanced Budget Act of 1997 (BBA 1997) (Pub. L. 105-33)).
The statutory term, average wholesale price, is not defined in law or
regulation. In creating payment limits for Medicare covered drugs,
Medicare currently relies on the list AWP. The term ``list AWP'' will
hereafter refer to the AWP published in commercial compendia such as
Red Book, Price Alert, and Medispan.
D. List AWP and Widely Available Market Prices
Numerous reports by the General Accounting Office (GAO), and the
Office of Inspector General (OIG), as well as data collected by the
Department of Justice (DOJ), discussed below, have indicated that 95
percent of list AWP reflected in published compendia is significantly
higher than the prices that drug manufacturers, wholesalers, physician
supply houses, specialty pharmacies, and similar entities actually
charge to physicians and suppliers purchasing these drugs.
Differences between Medicare's payment based on 95 percent of list
AWP and the widely available market prices creates what has been
referred to as the ``spread''. The presence of a
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substantial ``spread'' or a difference between the price that
physicians and suppliers actually pay to acquire drugs in the market
and Medicare's reimbursement at 95 percent of list AWP, means that the
Medicare program and Medicare beneficiaries often overpay for drugs.
For a few drugs, the ``spread'' is so large that the amount that the
Medicare beneficiary pays the physician or supplier for coinsurance is
greater than the physician or supplier's payment to acquire the drug.
For example, leucovorin calcium (J0640) has a list AWP of $18.44. Based
on GAO and OIG studies, the widely available market price is 15 percent
of the list AWP or $2.77. The Medicare payment is 95 percent of the
list AWP, or $17.52. The beneficiary coinsurance is 20 percent of the
Medicare payment or $3.69. The beneficiary is paying more in
coinsurance ($3.69) than the physician is paying to purchase the drug
($2.77).
E. Studies and Developments Since the Balanced Budget Act of 1997 (BBA)
This section discusses developments since BBA and provides an
overview of some of the relevant studies that have been performed
illustrating the excessive payments that occur under the current
payment methodology.
In September 2000, the Medicare program attempted to allow carriers
to consider data provided by DOJ as another and more accurate data
source than the list AWP in the published compendia. The use of another
data source would allow us to set more accurate AWP payment limits for
certain drugs (Program Memorandum ``An Additional Source of Average
Wholesale Price Data in Pricing Drugs and Biologicals Covered by the
Medicare Program,'' (AB-00-86, (change request 1232),
published September 8, 2000). However, we deferred implementation of
this program memorandum in November 2000 since, although we continued
to believe that the list AWP reported in the published compendia was
inaccurate and inflated, congressional action pending at that time
would have precluded the immediate use of this data. We wanted to avoid
the disruption that would result from a decrease in payment allowances
followed by an immediate increase due to congressional action. In
addition to the payment disruption, we also received numerous public
comments asserting that drug payments for chemotherapy drugs subsidize
payments for services related to the administration of these drugs. The
deferral of the use of the DOJ data was published in our program
memorandum titled, ``Source of Average Wholesale Price Data in Pricing
Drugs and Biologicals Covered by the Medicare Program,'' AB-00-115
(change request 1447) published November 17, 2000.
In December 2000, the Congress enacted the Medicare, Medicaid, and
SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L.
106-554). Section 429(a) of BIPA mandated that the GAO conduct a study
on the payment for drugs under the current Medicare methodology.
Section 429(c) established a moratorium on reductions in Medicare
payments rates for drugs until after the Secretary reviewed the GAO
report. In the study, the GAO was required to--
[sbull] Identify the average prices at which Medicare drugs are
acquired by physicians and other suppliers;
[sbull] Quantify the difference between such average prices and the
Medicare payment amount; and
[sbull] Determine the extent to which Medicare payment is adequate
to compensate physicians, providers of services, or other suppliers of
these drugs for costs incurred related to administrative costs of
furnishing drugs and biologicals.
In addition, BIPA required the GAO to provide specific
recommendations for revised methodologies for payment of drugs and for
related services under the Medicare program. In making these
recommendations, BIPA instructed the GAO to consider--
[sbull] If appropriate, new or adjusted payments for costs incurred
in the administration, handling, or storage of certain categories of
drugs;
[sbull] The method and amount of payment for similar drugs made by
large group health plans;
[sbull] The potential for patients to receive inpatient or
outpatient hospital services in lieu of services in a physician's
office as a result of any revised payment methodology;
[sbull] The effect of any revised payment methodology on the
delivery of drug therapies by hospital outpatient departments; and
[sbull] The results of a previously mandated GAO study (GAO-02-053)
on the adequacy of Medicare's physician payments to oncologists.
Additionally, the Congress required that the GAO, in making their
recommendations, ``shall ensure that any proposed revised payment
methodology be designed to ensure that Medicare beneficiaries continue
to have appropriate access to health care services under the Medicare
program.''
Section 429(b) of BIPA requires us, notwithstanding any other
provision of law, to revise the Medicare payment methodology for drugs
under sections 1842(o) of the Act based on the GAO report to the
Congress. We may, to the extent appropriate, provide new or adjusted
payments for the costs incurred in the administration, handling, and
storage of drugs. However, the estimated aggregate payments for drugs
under the revised system (including additional payments for the
administration, handling, and storage of drugs) cannot exceed payments
as projected by the Secretary under section 1842(o) of the Act.
Prior to the completion of the GAO report, the OIG published a
report in January 2001 titled ``Medicare Reimbursement of Prescription
Drugs'' (OEI-03-00-00310) that revealed excessive payments for Medicare
covered drugs. This study was a follow-up to a prior 1997 OIG Study:
``Excessive Medicare Payments for Prescription Drugs'' (OEI-03-97-
00290) in which the OIG found that payments based on 95 percent of list
AWP were substantially greater than the prices widely available to the
physician community. In this January 2001 study, the OIG compared
calendar year (CY) 1999 Medicare payments for 24 high expenditure drugs
to prices available to the physician and supplier community, the
Department of Veterans Affairs (VA), and Medicaid. In determining the
prices available to the physician supplier community, the OIG reviewed
print and online catalogs from five drug wholesalers and one group
purchasing organization. The report indicated that we would have saved
$761 million a year by paying for drugs based on the actual wholesale
prices available to physicians and suppliers rather than paying 95
percent of list AWP.
In September 2001, the GAO presented its study to the Congress in a
report titled, ``Medicare: Payments for Covered Outpatient Drugs Exceed
Providers' Costs'' (GAO-01-1118). The report contained some significant
findings and also confirmed previous OIG reports on drug payments.
[sbull] Physicians and suppliers are able to obtain Medicare-
covered drugs at prices significantly below 95 percent of list AWP.
(See Table 1 in Appendix A for a reprint of the table from the GAO
report summarizing some of these findings.)
[sbull] For most physician-administered drugs, the average discount
from list AWP ranged from 13 percent to 34 percent; two physician-
administered drugs had discounts of 65 and 86 percent. That is,
physicians paid an average of 66 to 87 percent of the list AWP, and for
two drugs physicians paid 14 percent and 35 percent of the list AWP.
[[Page 50431]]
[sbull] For two high expenditure drugs provided by pharmacies,
ipratropium bromide and albuterol, discounts from list AWP averaged 78
percent and 85 percent, respectively. In other words, suppliers paid 15
and 22 percent of the list AWP.
[sbull] While physician practices that purchase large volumes of
drugs may have access to larger discounts and rebates, low volume
providers can also purchase drugs for markedly less than list AWP, and
often at additional discounts below widely available prices. In
particular, physicians who bill Medicare for low volumes of drugs used
in cancer treatment receive discounted prices for many of these drugs
similar to or greater than widely available discounts. (See Table 2 in
Appendix A for a reprint of the table from the GAO report summarizing
some of these findings.)
[sbull] Private health plans use their drug-purchase and patient
volume to negotiate favorable prices for drugs and the physician and
supplier services related to supplying or delivering the drugs.
[sbull] Public payers, such as the VA, use their purchasing volume
along with information about actual transaction prices from private
payers to lower their drug payments.
Based on its studies, the GAO concluded that our current payment
methodology is flawed because current payment rates (that is, 95
percent of the list AWP) do not reflect market prices. The GAO
recommended that we take the following actions with regard to the
payment for drugs and related services.
[sbull] Establish Medicare payment levels for Part B drugs that are
more closely related to their costs. Payments for drugs should be set
at levels that reflect actual market transaction prices and the likely
acquisition cost to providers.
[sbull] Pay appropriately for drug delivery and administration and
not allow potential overpayments for drugs to subsidize payments for
related services.
[sbull] Examine the benefits and risks of expanding the current
competitive bidding demonstration projects for drugs covered under Part
B.
[sbull] Institute a process to monitor access to Part B covered
drugs to ensure that payment changes do not negatively affect access
for particular drugs or groups of beneficiaries or for certain
geographic areas.
F. Implications of GAO and OIG Studies
Table 4 provides a summary of the reports on Medicare prescription
drugs published by OIG between 1997 through 2001. The 1997 report
indicated that for 22 drugs studied by the OIG, Medicare's allowances
for these drugs exceeded wholesale prices by $447 million in 1996. For
1998 the report indicated that Medicare would have saved $1 billion if
the allowed amounts for the 34 drugs studied were equal to prices
obtained by the VA through the Federal Supply Schedule (FSS).
Additionally, the report indicated that Medicare would have saved $1.6
billion for 24 drugs studied if Medicare had paid for these drugs based
on the FSS. Although the savings estimates vary, for example due to
differences in the particular drugs studied, OIG concluded based on the
reports that the potential savings for Medicare and its beneficiaries
from reforming the current payment policy to a system based on FSS is
substantial.
In table 3, we have combined the findings of the GAO and OIG
reports displaying the prices that they found as a percent of list AWP.
For the GAO report, we used the findings from their widely available
drug prices. We examined but did not use the separate survey of low
volume billers. Although many low volume biller prices were below the
widely available drug prices, they were compiled through a small phone
survey of physicians. The widely available drug prices were based on
price lists from wholesalers and GPOs. We believe that the widely
available drug prices are a better reflection of the prices available
to physicians and suppliers. In addition, there was much more
consistency between the GAO's widely available drug prices and the
OIG's finding.
Table 3 separately presents the findings for brand name drugs and
for generic drugs. The ``spread,'' computed as a percent of Medicare's
payment at 95 percent of list AWP, is also displayed for each drug
based on the average of the GAO and OIG findings. The lower the price
found by GAO or OIG as a percent of list AWP, the larger the spread
between that price and Medicare's current payment. In effect, the
``spread'' is the difference between the Medicare allowed charge (95
percent of the list AWP) and the actual purchase price paid by the
physicians and suppliers. The percent spread is the difference between
the Medicare payment and the market price expressed as a percentage of
the Medicare payment. For example, the list AWP for granisetron hcl
(J1626) is $19.52. The Medicare payment is 95 percent of the list AWP
or $18.54. The average of the GAO and OIG data indicates that the
market price is 71 of the list AWP or $13.86. The 25 percent spread is
calculated as ($18.54 - $13.86) / $18.54 = $4.68 / $18.54 = .25 = 25
percent.
A review of Table 3 shows that in general the ``spread,'' in
percentage terms, is larger for the generic drugs examined in the
studies than for brand drugs. This is consistent with our understanding
that when actual market prices decline with the introduction of generic
competition, the list AWPs do not usually experience a corresponding
decline of the same magnitude. With one exception, among the brand name
drugs studied, physicians and suppliers could obtain these drugs at 71
percent to 87 percent of list AWP, which translates into a spread of 25
percent and 8 percent, respectively. For the generic drugs examined,
there was considerably more variability. For six of the drugs examined,
physicians or suppliers could purchase at a price between 15 percent
and 46 percent of list AWP, translating into a spread of 84 percent and
52 percent, respectively. The other three drugs examined had spreads
more in line with that for brand drugs.
A general conclusion reached in reviewing the GAO and OIG data is
that there is a level of overstatement in the list AWP for all drugs
beyond the 5 percent currently accounted for in Medicare's policy.
Using the average of the GAO and OIG findings, every drug studied was
available at a price not greater than 87 percent of list AWP. Most
drugs could be obtained at an even lower price, sometimes substantially
lower.
If we examine the data in the aggregate, the difference between
Medicare's payment and widely available market prices was $1.5 billion
in 2002 for the 29 drugs where we have GAO and OIG data. That is, if
Medicare had paid widely available market prices instead of 95 percent
of list AWP in 2002 for these 29 drugs, Medicare and its beneficiaries
would have paid nearly $1.5 billion less for drugs or nearly 17 percent
less than total estimated payments of $8.4 billion. Of this amount,
Medicare and its beneficiaries would have paid approximately $475
million less to oncologists and $760 million less to suppliers of DME
drugs. Assuming that widely available market prices were between 80
percent and 90 percent of list AWP for all other drugs, the total
savings to Medicare and its beneficiaries in 2002 from paying in this
way would have been between $1.7 and $2.0 billion.
II. Provisions of the Proposed Rule
A. Approaches to Revising the Current Payment System
Given the serious and well-documented flaws in the current
[[Page 50432]]
Medicare payment system identified by the GAO, OIG, and our own
analyses, we are seeking comments on four different approaches to
revising the Medicare drug payment system: (1) Basing our reform
efforts on the comparability provision in the statute; (2) applying an
average list AWP discount to the list AWPs as of April 1, 2003; (3)
utilizing existing sources of market-based prices and developing
additional sources for market monitoring; and (4) establishing a
competitive acquisition program and Average Sales Price system. We are
proposing to select one of these options.
Option 1--Comparability Provision
One option we are proposing is to base our reform efforts on the
``comparability'' provision in the Act, section 1842(b)(3)(B) of the
Act. Specifically, this provision limits Medicare payment for a drug to
what our contractors pay when the same drug is provided to their
private policyholders and subscribers under comparable circumstances.
As described below, we are proposing additional guidance to our
contractors in identifying comparable circumstances with respect to the
drug payments they make in their private sector business. While
comparability applies to all charge-based services, we are proposing to
focus its application on drugs given the excessive payments by the
Medicare program and our beneficiaries under the current methodology,
as reflected in several OIG and GAO reports.
Section 1842 of the Act authorizes us to enter into contracts with
carriers for the administration of Part B benefits. Section 1842(b)(3)
of the Act mandates that each contract with a carrier provide that the
carrier:
``* * * will take such action as may be necessary to assure
that, where payment under this part for a service is on a charge
basis, such charge will be reasonable and not higher than the charge
applicable, for a comparable service and under comparable
circumstances, to policyholders and subscribers of the carrier * *
*.''
Section 1842 of the Act sets forth general provisions applicable to
part B payment determinations, including drug payments. The
comparability provision requires a carrier to take action, when
necessary, to ensure that Part B charges are reasonable and ``not
higher than the charge applicable for a comparable service in
comparable circumstances'' to its own policyholders. This limitation is
a principle set forth by the Congress at the outset of the Medicare
program, providing that Medicare beneficiaries should not be charged
more than private pay patients for a comparable service provided under
comparable circumstances. To this end, the Congress mandated that,
where payment for a service to a Medicare beneficiary is on a charge
basis, as opposed to a cost basis, the carrier's private plan, if it
has one, should be assessed to determine whether the service in
question and the circumstances under which the service is provided are
``comparable'' to Medicare. If the service is comparable, then the
applicable charge under the carrier's private insurance plan may serve
as a limitation on the amount that we pay. In accordance with these
provisions, we have broad authority to make comparability adjustments
with respect to Part B payment determinations based on charges.
At the time the Congress legislated the current drug payment
methodology, it did not amend our authority to make comparability
adjustments or provide any indication that the other provisions of
section 1842(b) of the Act with respect to Part B payment calculations
were no longer applicable.
Section 1842(b)(3) of the Act requires carriers, including Durable
Medical Equipment Regional Carriers (DMERCs), to limit payment rates
for Medicare covered drugs to the amounts that the carriers pay when
these drugs are provided to their private policyholders and subscribers
under comparable circumstances. We are proposing to issue additional
guidance to our contractors indicating that comparability would exist
with drug payments made in the same geographic area under the carrier's
indemnity health insurance products or broad network preferred provider
organization (PPO) products that do not rely on selective contracting.
We are seeking comments on this proposed guidance.
Consistent with Sec. 405.508(c), the responsibility for
determining that a carrier's indemnity product or PPO product is
comparable would in the first instance fall upon the carrier in
reporting pertinent information about its programs to us. When the
pertinent information has been reported, we will advise the carrier
whether any of its products has comparability. If we determine that a
carrier's lower private payment for a drug has comparability in a given
locality, the lower private payment limit would apply to the Medicare
payment in that locality.
Contractors would inform physicians, suppliers and other impacted
parties about the new lower payment limit through their usual means of
provider education (for example, bulletins, newsletters, Web site
postings.)
As an example of how this approach would apply to a specific drug
using hypothetical data, we will examine docetaxol (J9170). Suppose the
national payment limit for docetaxol in 2004 was $358. If one of our
carriers was paying $325 for docetaxol in one of its localities in its
comparable private side business, the Medicare payment limit for
docetaxol in that locality would be set at $325. This lower payment
amount would only apply in that locality and would not be the national
payment limit. If, however, the carrier was paying $375 for docetaxol
in this locality, the Medicare payment would be based on the current
national limit of $358.
We understand that to the extent private sector drug payments vary
by geographic region, the application of comparability may result in
regional variation in drug payments. We seek comment on this aspect of
the policy.
It is our understanding that historically many private insurers
have focused more on payments for oral drugs and inhalation drugs than
injectable drugs, although this is changing due to the rapid growth in
expenditures for injectable drugs. MedPAC discussed this in their June
2003 report to Congress titled ``Report to the Congress: Variation and
Innovation in Medicare,'' which stated that ``Only as expenditures have
sharply increased in the past few years have payers begun to focus on
more efficient methods of paying for these drugs.'' We are seeking
information on these new methods of paying for injectable drugs and
comments on any implications for Medicare drug payment limits under the
comparability provision.
Option 2--Average AWP Discount
a. Existing Drugs
Another option we are proposing is to apply an average AWP discount
to the AWPs published in commercial compendia as of April 1, 2003.
Specifically, we would lock-in and reduce the AWP published as of April
1, 2003 in the national drug pricing compendia by an average price
discount from AWP. Our analysis of the available data from the GAO and
OIG studies indicates that the majority of drugs examined had a
discount of approximately 10 to 20 percent off of the AWP, with the
remaining drugs having larger discounts. The Medicare payment limit,
therefore, would be set at between 80 percent and 90 percent of the AWP
published as of April 1, 2003. We are seeking comment on the
appropriate uniform reduction to make in this range. This policy would
be effective January 1, 2004. In future years, these prices would be
updated on an annual basis by the increase in the consumer price index
for medical care
[[Page 50433]]
for the 12-month period ending June of the prior year.
As an example of how this approach might apply to a specific drug
assuming an average AWP discount of 15 percent, we will again examine
docetaxol (J9170). The April 1, 2003 AWP published in the commercial
compendia for docetaxol is $377. Applying an average AWP discount of 15
percent, the Medicare 2004 payment limit for J9170 would be $320.
Assuming a 4.0 percent increase in the consumer price index (CPI) for
medical care for the 12-month period ending June 2004, the 2005 payment
limit for J9170 would be $333, regardless of the list AWP at that time.
b. New Drugs and Drugs With Patent Expirations
The reimbursement rate for new drugs and drugs coming off of patent
would be determined for the first year based on our review of
information provided by the manufacturer about the expected widely
available market price for that year. As a condition of obtaining a
HCPCS code for billing purposes (in the case of new drugs) or
continuing to recognize a HCPCS code for billing purposes (in the case
of drugs coming off patent), manufacturers would be required to provide
information on the anticipated widely available market price that a
prudent physician or prudent supplier would pay for the drug and a
rationale for the new price. We expect that drug manufacturers in the
normal course of conducting their business have determined the prices
that physicians and suppliers would pay for the drug when sold through
a distributor or via direct distribution.
If we suspect that a manufacturer has knowingly supplied misleading
pricing information to generate or maintain a ``spread'' between
Medicare payment and the widely available market price, we will refer
the matter to the OIG. As stated by the OIG in their Office of
Inspector General's Compliance Program Guidance for Pharmaceutical
Manufacturers (68 FR 23737) that was published on May 5, 2003:
``If a pharmaceutical manufacturer purposefully manipulates the
AWP to increase its customers' profits by increasing the amount the
federal health care programs reimburse its customers, the anti-
kickback statute is implicated. Unlike bona fide discounts, which
transfer remuneration from a seller to a buyer, manipulation of the
AWP transfers remuneration to a seller's immediate customer from a
subsequent purchaser (the federal or state government). Under the
anti-kickback statute, offering remuneration to a purchaser or
referral source is improper if one purpose is to induce the purchase
or referral of program business. In other words, it is illegal for a
manufacturer knowingly to establish or inappropriately maintain a
particular AWP if one purpose is to manipulate the `spread' to
induce customers to purchase its product.''
During the first year the HCPCS code is used for billing, the
manufacturer would provide updated information to us on the actual
prices that physicians and suppliers are paying to purchase the drug.
Again, we expect manufacturers would collect this information in the
normal course of conducting their business.
We would review this data and other available data sources on the
widely available market price of the drug to determine if an adjustment
to the Medicare payment limit would be required for the second year. In
the absence of a second year adjustment, the first year payment would
be updated by the increase in the medical component of the CPI for the
12-month period ending six months prior to the year. For the third year
and all subsequent years, the Medicare payment limit would be updated
on an annual basis by the increase in the CPI for medical care for the
12-month period ending June of the prior year.
Option 3--Market Monitoring
Another option we are proposing is to utilize existing sources of
market-based prices in developing Medicare payment limits and to
develop additional sources of this information for market monitoring.
Under this option, we would define AWP to be the widely available
market price. Initially, we would use the market analyses available to
us from GAO and OIG studies to transition widely available market
prices into the Medicare payments. As discussed below, over time we may
expand our data sources for these market prices. Although the GAO and
OIG performed market analyses on drugs covering the majority of
Medicare expenditures, they did not study all of the approximately 450
Medicare drugs. As described earlier in section I.B, Medicare drug
spending is concentrated in relatively few drugs; 33 drugs account for
86 percent of the spending. Initially, for those drugs where we do not
have GAO and OIG information on which to base a market price, we would
proceed as in option 2 and base the payment limit on an average AWP
discount off of the list AWP reported to the commercial compendia as of
April 1, 2003.
a. Definition of Average Wholesale Price
In implementing sections 1842(o) of the Act and 429 of BIPA, we
propose to define the AWP of a drug to be the widely available market
price. The widely available market price would be the price that a
prudent physician or prudent supplier would pay when purchasing the
drug from common sources. Common sources that a prudent physician or
supplier might utilize when purchasing a drug include, but are not
limited to, wholesalers, manufacturers, repackagers, physician supply
houses, pharmacies, specialty pharmacies, and group purchasing
organizations. The widely available market price would not be a list
price that is commonly discounted, but would be the purchase price net
of discounts, rebates, and price concessions routinely available to
prudent purchasers.
The widely available market price would reflect prices in programs
where a manufacturer, a manufacturer's subsidiary or related company,
or a repackager sells drugs to physicians and suppliers directly or
through buying groups or other mechanisms. For example, if a drug
manufacturer establishes a buying group easily accessed by prudent
physicians, the lower price offered to the buying group should be
reflected as the widely available market price.
It is not our intent to set the Medicare payment limit below the
widely available market price. Under the current system, the Medicare
allowed charge is the lower of the actual charge and 95 percent of the
AWP. Using the authority granted to the Secretary under section 429(b)
of BIPA, the Medicare allowed charge in a fully phased-in revised
payment methodology would be the lower of the actual charge or the
widely available market price. We would not pay at 95 percent of the
widely available market price since we wish to consider further the
issue of beneficiary access at 95 percent of the widely available
market price. As described in section II.D, we do not expect any
beneficiary access issues with payment at the widely available market
price.
b. Use of existing sources of market based prices
As described earlier in section I.F, both the GAO and OIG have
performed market analyses of the widely available market prices for the
top Medicare drugs in terms of expenditures. While the market analyses
differed in their methodologies, for example the GAO used averages of
drug prices from their data sources and the OIG used medians, in
general the results were consistent for these drugs. To begin to
incorporate this information into the Medicare payment limits for the
drugs that have been studied, we would take the average discount
between the GAO and OIG data for the drug and apply it to the list AWP
reported in the published
[[Page 50434]]
compendia as of April 1, 2003. Although as noted the results of the GAO
and OIG market analyses are generally consistent, we seek comment on
our proposed approach of averaging these two data sources.
For example, one drug studied by both the GAO and OIG is rituximab
(J9310). The April 1, 2003 list AWP published in the commercial
compendia for rituximab is $501.13 for 100 mg. The GAO study indicates
the average market price for rituximab is 81 percent of the list AWP.
The OIG study indicates the average market price for rituximab is 80
percent of AWP. The average of these two data sources rounded to
nearest percent is 81 percent of the list AWP. Under this option, the
Medicare payment limit for J9310 would be $405.92 (that is, 81 percent
of $501.13) effective January 1, 2004.
Clotting factor was the subject of a separate GAO report entitled
``Payment for Blood Clotting Factor Exceeds Providers' Acquisition
Costs'' (GAO-03-184). This report found that the market price for
clotting factor was 59 percent of list AWP for hemophilia treatment
centers and 69 percent of list AWP for homecare companies. We are
proposing to transition these market prices into the Medicare payment
limit for clotting factor at the average of these two figures, 64
percent, with an initial transition amount of 80 percent in 2004. (see
section 3.f. for further discussion on the transition to market
prices). We are requesting comments on the appropriate payment limit
rate. The limit would apply for all clotting factor HCPCS codes,
including both the human and recombinant forms.
c. Drugs Without Market-Based Price Information
Initially, for those drugs where we do not have GAO and OIG
information on which to base a market price, we would proceed as in
option 2 and base the payment limit on the average AWP discount off of
the list AWP reported to the commercial compendia as of April 1, 2003.
As an example of how this approach might apply to a specific drug
assuming an average AWP discount of 15 percent, we will examine
ifosfamide (J9208). The OIG and GAO did not study ifosfamide. The April
1, 2003 list AWP published in the commercial compendia for ifosfamide
is $158. The Medicare payment limit for J9208 would be $135 (that is,
85 percent of $158) effective January 1, 2004.
d. Exceptions Process for First Year Reductions
A manufacturer could seek an exception from the application of
these reductions on January 1, 2004 to one or more of its drugs if it
would furnish us before October 1, 2003 with verifiable data on the
widely available market price, as described earlier in section
II.A.3.a, of the drug as of April 1, 2003 and certify the accuracy of
this data. We will review the data and determine if it should be
incorporated into the Medicare payment limit. Note that all data
submitted as part of comments on this proposed rule would be available
to the public. Also note that we would base any changes to our proposed
payment policy only on data that we could make available to the public.
e. Future Years
As discussed in section 3.f below, we expect to develop additional
sources of market-based prices in future years for the purpose of
market monitoring. We also recognize that the OIG may perform updated
market analyses on drugs previously studied or additional drugs. If the
OIG performs a new market analysis, we expect to incorporate this
information into the Medicare payment limits. As we develop additional
sources of widely available market prices and sufficient new valid
information becomes available from these sources, we expect to
incorporate this information into the Medicare payment limits based on
the methodology described above. In the absence of additional valid
data sources indicating a change in the widely available market price,
the Medicare payment limits would be updated on an annual basis by the
increase in the CPI for medical care for the 12-month period ending
June of the prior year.
f. Transition for Existing Drugs
For existing drugs where the widely available market price based on
the OIG and GAO studies is less than 80 percent of list AWP, we would
transition to the market-based payment in 15 percentage point
increments. This is similar to the approach taken by the Congress in
specifying the incremental payment changes under the inherent
reasonableness authority (section 1842(b)(8) of the Act). For example,
one drug studied by both the GAO and OIG is ipratropium bromide
(J7644). The April 1, 2003 AWP published in the commercial compendia
for ipratropium bromide is $3.52. The GAO study indicates the average
market price for ipratropium bromide is 33 percent of list AWP. The OIG
study indicates the average market price for ipratropium bromide is 34
percent of list AWP. The average of these two data sources rounded to
the nearest percent is 34 percent of AWP. Because this is lower than 80
percent of list AWP, the Medicare payment limit for ipratropium bromide
effective January 1, 2004 would be 80 percent of the list AWP or $2.82.
The Medicare payment limit for ipratropium bromide effective January 1,
2005 would be 65 percent of the list AWP published in the commercial
compendia as of April 1, 2003 updated by the medical CPI. The Medicare
payment limits for CY 2006 and CY 2007 would be 50 percent and 35
percent, respectively, of the April 1, 2003 list AWP updated by the
medical CPI. In 2008, the transition to the widely available market
price would be complete and the payment limit would be 34 percent of
the April 1, 2003 list AWP updated by the medical CPI.
To the extent that the OIG performs a new market analysis or
additional data sources are developed as described in section 3.h, the
target widely available market price might change.
g. New Drugs and Drugs with Patent Expirations
The payment limit for new drugs and drugs coming off of patent
would be determined as described under option 2. The only difference
would be that under the market monitoring approach the out year payment
limit might change to the extent that the OIG performs a market
analysis or additional data sources are developed as described in the
next section.
h. Additional Sources of Market-Based Prices
We are considering additional sources of market-based price
information. These sources could include drug distributors (for
example, wholesalers, physician supply houses, specialty pharmacies,
retail pharmacies, manufacturers, repackagers) physicians, suppliers,
and group purchasing organizations (GPOs). To the extent that payments
by private insurers and health plans reflect widely available market
prices, we are considering inclusion of these sources.
The general approach we will use is to take the median price among
valid available sources of information on widely available market
prices, after making any adjustments required to make the information
comparable. We are considering whether to restrict the median
calculation to those information sources that reflect significant
market share. We are proposing to rely on a single information source
if we determine that the source is representative of the widely
available market price for a drug.
We are considering the acquisition of this market-based price
information through market research firms, contractors, consultants,
the OIG, and/or by directly obtaining such data.
If we obtain additional sources of market-based prices and if we
determine
[[Page 50435]]
these sources are valid for the purposes of determining payment limits
based on widely available prices, we will provide an opportunity for
public comment on the sources.
1. Data from Distributors and Manufacturers
We would seek to acquire data from drug distributors and
manufacturers. Although there may be many distributors for a given
drug, our understanding is that most physicians and suppliers tend to
use the same distributors over a given time period and that the
majority of these purchases, at least for injectable drugs, are
concentrated in a small number of distributors. We are considering
whether to focus our efforts initially on these distributors and we are
seeking comment on this focused approach.
Our market analyses would also include pricing information from
manufacturers' direct distribution programs since, as discussed
earlier, we understand that many of these programs are easily
accessible to physicians and suppliers and that the prices offered in
these programs are often lower than the prices available through other
distribution channels.
2. Data From Physicians and Suppliers
We would also seek to obtain acquisition cost information from
physician and suppliers. Although individual invoice pricing may not
necessarily be reflective of the widely available market price, for
example due to the presence of volume related rebates and price
concessions, this information could be informative in developing the
widely available market price.
While issues have been raised in the past concerning the use of
invoice prices due to the potential presence of volume discounting, we
note that the GAO study found that physicians who billed for low
amounts of chemotherapy drugs were still able to obtain significant
price discounts. We seek comment on this issue.
3. Data from Private Insurers and Health Plans
We are considering obtaining data from private insurers and health
plans, including Medicare carriers' private businesses. As discussed
earlier, it is our understanding that while many private insurers pay
widely available market prices for oral drugs and inhalation drugs,
they have not historically paid widely available market prices for
injectable drugs. Given this, we are considering initially seeking
private business prices for oral and inhalation drugs. For example, we
are considering whether to request our four DMEPOS contractors to
supply us with oral and inhalation drug pricing and related information
from their private side business.
For injectable drugs, as private insurers develop alternative
payment approaches that reflect widely available market prices, we
could seek this information from them. For example, similar to the
approach suggested for oral and inhalation drugs, we are considering
asking our carriers to furnish us with their private business payments
for these drugs.
4. Approaches to Acquiring Market-Based Pricing Information
We are considering the acquisition of this market-based price
information through market research firms, consultants, contractors,
the OIG, and/or directly obtaining such data. It is our understanding
that many manufacturers use market research firms to gather information
on their products. For example, they conduct surveys of physician
practices and compile pricing information. We are considering
contracting with one of these firms to perform a market analysis of
physician practices. We also understand that a few private health plans
have begun to use consultants, at least for injectable drugs, to assist
them in developing market-based payment structures. We are considering
contracting with these consultants. We are considering an attempt to
obtain pricing information directly from distributors using full or
part-time CMS employed or contracted physicians. We are considering the
selection of one or more contractors to acquire this information for us
and maintain updated pricing information. The OIG may also update
market analyses of drugs they have previously studied and examine
additional drugs.
Option 4--Competitive Acquisition Program and Average Sales Prices
A fourth option we are considering is the establishment of a
competitive acquisition program for drugs covered under section 1842(o)
of the Act coupled with the establishment of a process for determining
Average Sales Price (ASP). Under this option, we would establish
competitive acquisition areas and entities would bid to supply drugs to
physicians in one or more of these areas. A physician could choose
annually to acquire drugs from one of these entities and the entity
would be responsible for billing Medicare. Alternatively, a physician
could choose to purchase drugs and bill Medicare. If a physician
elected to purchase drugs, we would pay the physician the ASP for the
drug. Manufacturers would be required to furnish us with the ASP for
each of their drugs quarterly. This option is consistent with the GAO's
recommendation that we evaluate expanding competitive bidding
approaches to obtain lower drug prices (GAO-01 1118, p.5) and is
consistent with our understanding of Congressional intent with respect
to section 429 of BIPA.
Below we describe our proposed competitive acquisition program and
ASP-based payment systems. We seek comment on any additional elements
that need to be considered in the establishment of these payment
systems. We also note that for some drugs, such as those currently
provided directly from the manufacturer to the physician, we may be
potentially introducing an additional distribution level in the form of
the bidding entity. Therefore, we have explicitly identified safeguards
under the competitive acquisition program that are more implicit under
our alternative payment reform proposals. While we believe that section
429 of BIPA contemplates (and section 1842(o) of the Act could be
defined to permit) the use of such a competitive acquisition model,
coupled with the implementation of an ASP setting function described
below, we specifically solicit comments on the extent of the authority
to implement the option set forth below either in its entirety or in a
modified fashion.
A. Competitive Acquisition
1. Categories of Drugs
Under this proposal, we would bid two categories of drugs in each
competitive acquisition area: oncology and non-oncology. The oncology
category would consist of covered drugs typically billed by oncologists
or otherwise used to treat cancer. The non-oncology category would
consist of all other covered drugs with the exception of DME drugs,
clotting factors, drugs furnished to individuals in connection with the
treatment of end stage renal disease, and vaccines. Payment for
excepted drugs would be based on the ASP. We may propose subcategories
of non-oncology drugs in the future. We seek comment on any additional
categories of drugs that may be inappropriate for competitive bidding
due to low utilization, a unique method of delivery, or similar
reasons.
2. Bidding Entity Qualifications
a. Capacity
Bidding entities would be required to demonstrate sufficient
capacity to
[[Page 50436]]
supply the drugs in the drug category in accordance with all applicable
state requirements and pharmacy laws. The entity would need to have
sufficient arrangements to acquire and to deliver drugs within the
category at the bid price for all physicians that may elect such entity
in a competitive acquisition area.
b. Shipment
Bidding entities would be required to have arrangements in effect
for the shipment of drugs at least 5 days each week and for the timely
delivery (including emergency situations) of drugs in the competitive
acquisition area. The shipments would be made to the physician and not
directly to the beneficiary, except under circumstances where a
beneficiary currently receives the drug in the home or other
nonphysician office setting. The contractor would not deliver drugs to
a physician except upon receipt of a prescription.
c. Integrity of the distribution system.
Bidding entities would need to demonstrate that the drugs provided
in the competitive acquisition program would be acquired directly from
the manufacturer or from a distributor that has acquired the drugs
directly from the manufacturer.
d. Inquiries and dispute resolution.
Bidding entities would be required to establish procedures for the
prompt response and resolution of physician and beneficiary inquiries
regarding the shipment of drugs and to establish a grievance process
for the resolution of disputes. For disputes that are not resolved at
the bidding entity, we propose to establish a national ombudsman to
oversee and review complaints under the competitive acquisition
program.
3. Bidding Process
a. Evaluation of bids.
We propose to select one or more winning bidders for each category
based on the bid prices for the drugs, the ability to ensure product
integrity, customer service, and past experience in the distribution of
drugs. We also propose to reject any bid that we estimate would result
in aggregate payments that exceed the payments that would have been
made if the drugs in the category were paid at the ASP.
b. Timing of bidding process.
We expect to have the initial bidding process complete and the
winning entities selected in time for the competitive acquisition
program to be implemented for oncology drugs beginning in 2005 and non-
oncology drugs beginning in 2006. We propose to select subsequent
contractors on a periodic basis and seek comment on the appropriate
time between bidding periods and the appropriate length of the
contracts.
c. Bid prices.
The prices bid by an entity would be the prices in effect and
available for the supply of contracted drugs in the area through the
entity for the entire contract period. The bid price would not vary
within a competitive acquisition area. The bid price would include all
costs related to carrying out the contract provisions, including costs
related to the delivery, dispensing, and shipping of the drug.
d. Bidding on a national or regional basis.
We would propose, but not require, entities to bid for contracts in
more than one competitive acquisition area.
4. Competitive Acquisition Areas
We seek comment on the appropriate geographic regions to establish
for a competitive acquisition program.
5. Billing and Coinsurance Under Competitive Acquisition
We propose that a successful bidder would be responsible for
billing Medicare and collecting coinsurance for the drugs they supply
that are subsequently administered to Medicare beneficiaries.
B. Average Sales Price
Under the competitive acquisition model option, a physician would
make an annual election to obtain drugs in a given category through a
winning bidder or could purchase the drugs and bill Medicare. If a
physician chooses to purchase drugs, they would be paid under the ASP-
based system described below. Manufacturers would be required to report
the ASP to us on a quarterly basis.
1. Definition of Average Sales Price
Under this proposed option we would propose to define the ASP for a
drug for a quarter as a manufacturer's total sales for the quarter less
any sales exempted from the ASP calculation divided by the total number
of units of such drug sold by the manufacturer in such quarter less any
units from sales exempted from the ASP calculation. We seek comment on
this definition as well as on the appropriate categories of sales that
should be exempted from the ASP calculation.
2. Discounts
Under this proposal, in calculating the ASP, the manufacturer would
take into account volume discounts, prompt pay discounts, cash
discounts, the free goods that are contingent on any purchase
requirement, chargebacks, and rebates (other than rebates under section
1927), that result in a reduction of the cost to the purchaser. A
rebate to a payor or other entity that does not take title to a covered
outpatient drug shall not be taken into account in determining such
price unless the manufacturer has an agreement with the payor or other
entity under which the purchaser's price for the drug is reduced as a
consequence of such rebate.
3. Payments.
We propose to pay for multi-source drugs at an appropriate markup
above ASP and seek comment on a markup in the range of 101 to 112
percent of ASP. We propose to pay for single source drugs at the lesser
of an appropriate markup of ASP in the range of 101 to 112 percent or
the Wholesale Acquisition Cost (WAC).
a. Wholesale Acquisition Cost (WAC).
Under this competitive acquisition model option we would propose
defining the WAC as the manufacturer's list price for the drug to
wholesalers and direct purchasers in the United States as reported in
wholesale price guides or other publications of drug pricing data. The
WAC would not include prompt pay or other discounts, rebates or
reductions in price.
B. Increases in Payments Related to the Costs of Furnishing or
Administering Drugs
As described earlier, section 429(b) of BIPA requires us to revise
the Medicare payment methodology for drugs under section 1842(o) of the
Act based on the GAO report to the Congress. Under section 429(b), to
the extent the Secretary determines appropriate, the Secretary may make
adjustments to the practice expense component of the physician fee
schedule for costs incurred in the administration, handling, or storage
of certain categories of such drugs and biologicals. Section 429(b)
also authorizes the Secretary to make proposals for new payments to
providers of services or suppliers for such costs, if appropriate.
However, the estimated aggregate payments for drugs under the revised
system (including additional payments for related costs of furnishing
or administering the drug) cannot exceed payments as projected by the
Secretary under the current system. Below, we discuss payment issues
associated with furnishing or administering Medicare covered drugs. To
the extent appropriate, we are proposing increased payments for the
administration of drugs or new payments to providers or suppliers for
[[Page 50437]]
furnishing Medicare covered drugs and seek comment on the applicability
of these payments under each of our four options for reforming the
current payment system.
1. Proposed Changes in Physician Fee Schedule Payment for the
Administration of Medicare Covered Drugs
a. SMS and Supplemental Survey Data
An important element in calculation of the practice expense
relative value units (RVUs) for all services paid using the physician
fee schedule is specialty-specific practice expenses per hour of
patient care. We use the American Medical Association's (AMA's)
Socioeconomic Monitoring System (SMS) survey of actual aggregate cost
data by specialty as the major source of data for these expenses per
hour. However, not every specialty is included in the SMS data and
several other specialties have commented that the SMS data were not
adequately representative of the costs incurred by their specialty. (63
FR 58824-58826) Section 212 of the Balanced Budget Refinement Act of
1999 (BBRA) directed us to establish a process under which we would
accept and use, to the maximum extent practicable and consistent with
sound data practices, data collected or developed by organizations. In
an interim final rule published on May 3, 2000 (65 FR 25664) we set
forth our criteria for accepting such supplemental surveys. In the
December 31, 2002 Federal Register that contained the 2003 physician
fee schedule final rule (67 FR 79972), in response to comments, we made
some modifications to these criteria. In this year's physician schedule
proposed rule (68 FR 49030), we proposed changes to the deadline for
submitting supplemental survey information to our contractor, the Lewin
Group.
Using the SMS data, we calculated a total practice expense per hour
of $99.30 for oncology. We are currently using this practice expense
per hour for CMS specialty codes 83 (Hematology/Oncology) and 90
(Medical Oncology). However, the American Society of Clinical Oncology
(ASCO) submitted a supplemental survey in 2002 with a practice expense
per hour of $189.00. In the 2003 physician fee schedule final rule (67
FR 79973), we discussed the practice expense survey submitted by the
ASCO. Although the survey met our stated criteria, we did not use it in
the calculation of the 2003 practice expense RVUs because of concerns
about the data. Our contractor, the Lewin Group evaluated the data and
indicated that average compensation (including salaries and fringes)
for clinical and administrative staff reported in the ASCO survey
averaged $71,014 and $87,253 respectively and appear inconsistent with
other available data on wage rates for such staff. Furthermore, the
Lewin Group indicated that the category of ``other professional
expenses'' was 349 percent higher than the SMS survey. The Lewin Group
suggested that we seek an explanation for the high values in the ASCO
survey before incorporating it into the practice expense methodology.
In the December 31, 2002 physician fee schedule final rule we indicated
that we intended to meet with ASCO to discuss our concerns and that we
would consider using the data in the future if our concerns were
addressed. We have subsequently held such discussions with ASCO and
understand that the high values for average compensation for clinical
and administrative staff are largely due to a limited number of
practices with very high values that raise the average values
calculated across all respondents to the survey. At this time, we are
proposing to incorporate the survey into the methodology. Since our
practice has been to use all survey data and not eliminate practices
with high values, we are including all respondents in the supplemental
practice expense per hour.
As we note in more detail below, section 429(b) authorizes the
Secretary to provide for adjustments to payments for the costs incurred
in the administration of certain categories of drugs. While we believe
the provision allows the Secretary to make changes to practice expense
payments in a non-budget neutral manner, we also believe that it
anticipates that the Secretary will make adjustments to payments for
drug administration services at the same time the Secretary revises the
payment methodology for drugs. Otherwise, we would be unable to compare
the aggregate costs of the changes authorized by section 429. We are,
therefore, proposing only to incorporate the oncology survey data into
the practice expense methodology at the same time proposed changes in
Medicare payment for drugs are adopted.
ASCO, the GAO, and OIG have all indicated that Medicare overpays
for drugs and revisions to the payment methodology for drugs should
coincide with increase in practice expense payments for drug
administration services. In testimony before the House Ways and Means
Committee on October 3, 2002, ASCO acknowledged the need for
comprehensive reform of Medicare payment for drugs and physician
practice expenses. ASCO testified:
We do not relish being targets for those who correctly point out
that some drugs are reimbursed by Medicare at a rate that exceeds
the acquisition cost * * * reform must be comprehensive,
encompassing both overpayments for drugs and underpayments for the
costs of administering the drugs.
The GAO echoed this view in testimony before the House Energy and
Commerce Subcommittee on Health Oversight and Investigations on
September 21, 2001 testifying: ``it should be a principle of Medicare
payment policy to pay for each service appropriately.'' OIG testified:
Our reports have shown time after time that Medicare pays too
much for drugs * * * We agree that physicians need to be properly
reimbursed for patient care. However, we do not believe that the
payment of artificially inflated drug prices is an appropriate
mechanism to compensate them.
At the same hearing, Subcommittee Chair James C. Greenwood stated:
We will need to develop a solution that results in Medicare paying
prices for drugs that are closer to the actual prices paid by health
care providers. Similarly we will need to take steps to ensure that
health care providers are sufficiently reimbursed for all of their
services.
Furthermore, we remain concerned about high practice expense per
hour values from the ASCO survey. Even when practices with extremely
high values are eliminated from the calculations, the supplemental
survey practice expense per hour would remain 174 percent higher than
the all physician average and more than 45 percent higher than the next
highest specialty. We will continue investigating why oncology practice
expenses would be so far above other specialties. For the reasons
above, we believe the supplemental survey should only be incorporated
into the practice expense methodology at the same time that Medicare
revises the payment methodology for drugs.
b. Weight Averaging Supplemental Survey and SMS Data
When we use supplemental survey data, we have generally blended the
supplemental data with SMS data for the specialty in order to use the
maximum number of survey responses in calculating a practice expense
per hour. However, the argument has been made that specialty societies
would only undertake a survey because of the belief that the existing
SMS data were not sufficiently representative of the specialty's
practice expenses. According to this argument, blending the
[[Page 50438]]
supplemental data with existing SMS data were not appropriate. We agree
and propose to use supplemental survey data without blending it with
the SMS data.
On only one previous occasion have we used blended data in the
calculation of a specialty's practice expense per hour. In the 1999
physician fee schedule final rule (64 FR 59391), we blended the survey
data from the Society of Thoracic Surgeons (STS) with the older SMS
data for cardiac and thoracic surgery. Consistent with the proposed
change to use supplemental survey data for oncologists' practice
expenses without blending it with the SMS data, we are proposing to
recalculate the practice expense per hour for cardiac and thoracic
surgery using the data from only the STS survey which will result in a
modest increase in their practice expense per hour. We are proposing to
use the following revised data for oncology and cardiac and thoracic
surgery:
Revised Practice Expense Per Hour
[Dollar]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clin. Admin. Office Med. Med.
Specialty staff staff expense supplies equip. Other Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cardiac/Thoracic............................................. 19.5 18.0 17.2 2.1 2.1 14.2 73.1
Oncology..................................................... 53.4 34.7 34.4 16.9 7.4 42.2 189.0
--------------------------------------------------------------------------------------------------------------------------------------------------------
c. Nonphysician Work Pool
The nonphysician work pool is a special methodology that we used to
determine practice expense RVUs for many services that do not have
physician work RVUs. We created the nonphysician work pool as an
interim measure until we could further analyze the effect of the basic
practice expense methodology on Medicare payment for services that do
not have physician work RVUs. While the nonphysician work pool is of
benefit to many of the services that were originally included, we have
allowed specialties to request that their services be removed from the
pool. Because the nonphysician work pool includes a variety of services
performed by many different specialties, we use the ``all physician''
average practice expense per hour in place of a specialty-specific
practice expense per hour.
Oncologists currently receive approximately 23 percent of their
Medicare physician fee schedule revenues from drug administration
services that are in the nonphysician work pool. For drug
administration codes to benefit from the increase in oncology's
practice expense per hour, it would be necessary to remove them from
the nonphysician work pool and use the general top-down methodology to
establish their practice expense RVUs. For this reason, we are
proposing to remove therapeutic and diagnostic infusions (CPT codes
90780 and 90781), therapeutic, prophylactic or diagnostic injections
(CPT codes 90782 through 90788) and chemotherapy administration (CPT
codes 96408 through 96549) from the nonphysician work pool. Practice
expense RVUs for these services will be computed utilizing the standard
practice expense methodology used for computing practice expense RVUs
for other services outside the nonphysician work pool. (CPT code 96400,
chemotherapy injection, is not listed above because it has already been
removed from the nonphysician work pool at the request of the American
Urological Association. See the December 31, 2002 final rule, 67 FR
79981. This service is primarily provided by urologists and increased
in payment by 640 percent between 2002 and 2003 as a result of being
removed from the nonphysician work pool).
As we state above, we use the all physician average practice
expense per hour in calculating the aggregate practice expense pool for
services included in the nonphysician work pool. Once drug
administration services are removed from the nonphysician work pool,
nearly 98 percent of Medicare allowed charges for services affected by
the nonphysician work pool calculations are diagnostic tests provided
by radiologists, cardiologists and internists and therapeutic radiation
oncology services. Because there is a less heterogeneous group of
services remaining in the nonphysician work pool once drug
administration services are removed and to minimize the impact of the
removal of these services, we are proposing to revise the practice
expense per hour based on a weighted average of the specialties that
perform the services affected by its calculations. We are proposing to
use the following revised data in the practice expense methodology for
services remaining in the nonphysician work pool:
Revised Practice Expense Per Hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clin. Admin. Office Med.
Specialty staff staff expense supplies Med. equip Other Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nonphysician Work Pool....................................... $15.8 $17.4 $21.5 $7.9 $4.9 $15.0 $82.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
In the practice expense methodology, the practice expense per hour
for each category of costs is multiplied by the physician time per
procedure and summed to the specialty level to create aggregate cost
pools. By definition, nonphysician work pool services do not involve
the physician and have no physician time. To create the nonphysician
work pool, we have used clinical staff time per procedure in the
computation. In the June 28, 2002 proposed rule (67 FR 43851), we
proposed to use the maximum staff time where multiple staff are
involved in providing the service. By using the maximum staff time, we
are assuming that clinical staff are working concurrently. However, it
is possible that clinical staff are working sequentially and it would
be appropriate to use the total staff time for each service. We believe
the staff time arrangement will likely differ based on the specific
service and it is not possible to adopt a rule that will address every
situation. Nevertheless, we are proposing to use the total staff time
in place of the maximum staff time for developing the 2004 physician
fee schedule. As we stated earlier, the nonphysician work pool was
adopted as an interim step until we could further
[[Page 50439]]
analyze the effect of the top-down methodology on nonphysician work
pool services. We have performed these analyses and are optimistic
about being able to address nonphysician work pool issues as part of
developing the 2005 physician fee schedule. At that time, we will no
longer need to use staff time in the creation of the aggregate cost
pools and this issue will be resolved.
We have modeled the effect of removing drug administration services
from the nonphysician work pool in combination with the change to the
practice expense per hour and clinical staff time changes described
above. These changes will increase the practice expense RVUs for the
nonphysician work pool by approximately 3 percent relative to the
practice expense RVUs shown in the physician fee schedule proposed rule
published on August 15, 2003.
d. Crosswalk Issues
As stated above, we are currently using the oncology practice
expense per hour for CMS specialties 83 (Hematology/Oncology) and 90
(Medical Oncology). We have reviewed 2002 Medicare data for specialty
82 (Hematology). The mix of services provided by physicians billing
under specialty 82 is similar to those of specialties 83 and 90. For
this reason, we are proposing to change the specialty practice expense
per hour crosswalk for specialty 82 from internal medicine to oncology.
e. Issues Related to Budget Neutrality
Section 1848(c)(2)(B)(ii)(II) of the Act requires that the
additional expenditures resulting from changes in RVUs be budget-
neutral. We normally adjust the practice expense RVUs so that the
aggregate amount of expenditures is the same before and after a change
to the methodology or data that are used to develop the practice
expense RVUs. However, section 429(b)(1) of the BIPA indicates that,
``Notwithstanding any other provision of law'' * * *. (emphasis added)
the Secretary is required to revise payments for drugs and is allowed
to provide for adjustments to payment amounts for the practice expense
component of the physician fee schedule (or new payments to providers
or suppliers) for the costs incurred in the administration, handling,
or storage of certain categories of drugs and biologicals). The
additional physician fee schedule payment and the new payments to
providers and suppliers cannot exceed savings from revising payments
for drugs. We believe that BIPA section 429(b) provides authority for
us to increase physician fee schedule expenditures (that is, not apply
the budget-neutrality requirement in section 1848(c)(2)(B)(ii)(II) of
the Act) for adjustments made to the practice expense RVUs for drug
administration. We have modeled all of the changes described above and
determined that payments for the drug administration services will
increase by $190 million ($150 million to oncologists and $40 million
to other specialties that provide drug administration services such as
rheumatology, gastroenterology and infectious disease). Because section
429(b) of BIPA provides authority to increase physician fee schedule
expenditures for the adjustments to the practice expense RVUs for drug
administration services, the proposed adjustments to practice expense
RVUs will increase physician fee schedule allowed charges by $190
million or the amount of increased payments for drug administration
services. In general, the proposed adjustments to practice expense RVUs
will result in increases in payment for those specialties that provide
drug administration services and minimal net payment effects on other
specialties. We believe that BIPA allows us not to apply the physician
fee schedule budget-neutrality requirements in the context of revising
payment rates for drugs and only if the additional expenditures from
these and other changes described below do not exceed savings from
revising prices for drugs. If we increased physician fee schedule
expenditures for the adjustments made to the practice expense RVUs for
drug administration without simultaneously revising payments for drugs,
we would be spending more on Medicare drugs and drug administration
services than we would be in the absence of making the payment changes.
Such a policy is clearly prohibited by BIPA.
As we stated earlier, we believe the statute anticipates that we
would make drug administration payment changes in conjunction with
adopting a revised payment methodology for Medicare drugs. Therefore,
we are also proposing not to make the drug administration payment
changes, even if we were to make them budget neutral under section
1848(c)(2)(B)(ii)(II) of the Act with respect to other physician fee
schedule service unless the drug payment changes are also made. If
these proposed changes are adopted the increased costs will be
reflected in the sustainable growth rate.
f. Multiple Pushes
In the November 25, 1991 Federal Register (56 FR 59541), we
indicated that Medicare will allow CPT code 96408 (Chemotherapy
administration, intravenous; push technique) to be reported only once
per day even if the physician administers multiple drugs. Since this
code is in the nonphysician work pool, its payment amount is
established based on charge-based practice expense RVUs. However,
because we are establishing resource-based practice expense RVUs and
there are additional resources involved in administering each
subsequent drug, we are proposing to change our policy and allow for
96408 to be reported once per day for each drug administered. Using
2002 Medicare utilization data and the payment amounts resulting from
the proposed changes described above, we estimate a $25 million
increase in Medicare allowed charges to oncologists. We will reflect
any increased costs associated with paying for multiple drug
administrations on the same day in the sustainable growth rate.
However, as discussed previously, we do not believe the statute permits
us to adopt this proposal without revising Medicare's payment
methodology for drugs since aggregate payments for drugs and drug
administration services would exceed payments that would be made in the
absence of such changes.
g. Summary of Physician Fee Schedule Proposals
We are proposing to: (1) Use the ASCO survey data without blending
it with existing SMS data to determine practice expenses per hour for
use in the top-down methodology (resulting in increased payment rates
for drug administration codes provided by oncologists, rheumatologists,
gastroenterologists, infectious disease specialties and all other
physicians that provide these services); (2) revise the cardiac/
thoracic surgery practice expense per hour to use supplemental survey
data without blending with SMS data; (3) remove drug administration
codes from the nonphysician work pool and instead use our general top-
down methodology to establish practice expense relative values units
(RVUs); (4) revise the practice expense per hour and clinical staff
time used to determine the nonphysician work pool; (5) change the
specialty practice expense crosswalk for specialty 82 (Hematology) from
internal medicine to oncology; (6) increase physician fee schedule
expenditures for the adjustments made to the practice expense RVUs for
drug administration services (but only if there are accompanying
revisions in payment for drugs discussed elsewhere in this proposed
rule) resulting in minimal net payment effects on any specialty that
does not provide drug administration services; and (7) revise our
policy on payment for multiple pushes.
We have modeled the above proposals as though they were in effect
in 2002 to determine the specialty-level impact on
[[Page 50440]]
Medicare revenues for oncologists. In 2002, oncologists received
approximately $3.8 billion in Medicare revenues for drugs, $1.1 billion
for physician fee schedule services and $0.1 billion for all other
services. Taken together, oncologists received approximately $5.0
billion in 2002 Medicare revenues for all services. Using 2002
utilization, we estimate that total physician fee schedule payments to
oncologists would have increased by $150 million as a result of using
oncology survey data and other changes to the practice expense
methodology. Allowing payment for multiple drug administration by the
push technique would have increased oncology payments another $25
million. The estimated additional payment of $175 million to
oncologists represents a 17 percent increase in their physician fee
schedule revenues and a 58 percent increase in their payments for drug
administration services. If we had adopted one of the proposals
described above to revise drug payments in 2002, Medicare revenues to
oncologists would have increased $80 million or 2 percent from applying
comparability. Medicare revenues to oncologists would have declined by
$570 million or 8 percent from applying an average list AWP discount of
80 percent.
2. Clotting Factor
As mentioned earlier, in January 2003 the GAO issued a report
entitled ``MEDICARE: Payment for Blood Clotting Factor Exceeds
Providers'' Acquisition Costs'' (GAO-03-184). GAO recommended that we
establish Medicare payment levels for clotting factor that are more
closely related to providers' acquisition costs and then establish a
separate payment for the cost of delivering clotting factor to Medicare
beneficiaries by hemophilia treatment centers and homecare companies.
In following the GAO's recommendation, at the same time that we
establish an appropriate price for clotting factor, we plan to
establish a separate payment to hemophilia treatment centers and
homecare companies for the administrative costs associated with
furnishing the clotting factor. GAO estimated that total delivery costs
in 2000 and 2001 ranged from $0.03 to $0.08 per unit of clotting factor
sold by hemophilia treatment centers. GAO did not receive enough data
from homecare companies to estimate their costs. We are proposing to
create a payment of $0.05 per unit of clotting factor provided to
Medicare beneficiaries by hemophilia treatment centers and homecare
companies to appropriately pay for the administrative costs associated
with furnishing the clotting factor. Note that we are not proposing the
creation of separate payment for furnishing the clotting factor for
individuals or entities other than hemophilia treatment centers and
homecare companies, for example hospitals. The administrative costs of
these other individuals or entities associated with furnishing clotting
factor are already paid for in their respective payment systems. We
also note that GAO indicated that providers may also furnish other
services for which they are not separately reimbursed, such as patient
education and community outreach. However, these services are not
Medicare-covered benefits and they are generally targeted to younger
patients who are not Medicare beneficiaries. We are proposing not to
include such non-Medicare covered services in the separate payment that
we plan to establish for furnishing clotting factor. Section 429(b) of
BIPA authorizes the Secretary to establish payment for clotting factor
delivery. Therefore, we plan to assure that the total amount of
Medicare expenditures for both clotting factor and delivery of such
factor does not exceed the amount that Medicare would otherwise spend
for clotting factor in the absence of adjustment in payment for the
drug and establishment of a separate fee for furnishing the drug. We
are seeking public comment and data related to the appropriateness of a
fee for furnishing clotting factor under each of our four options for
revising the current payment methodology.
3. Separately Billable ESRD Drugs
Medicare pays ESRD facilities a prospective payment, the composite
rate, for each hemodialysis treatment furnished. The composite rate is
designed to cover the facility's costs of ESRD services furnished to
beneficiaries. ESRD facilities can also bill Medicare separately for
certain drugs paid outside the composite rate, including
erythropoietin, vitamin D analogue, and calcitrol. By law, Medicare
payment for erythropoietin furnished by ESRD facilities is $10 per
1,000 units. The other separately billable drugs are paid under the
current 95 percent of list AWP methodology.
In its March 2003 report to Congress, MedPAC concludes that after
taking into account the combined payments to ESRD facilities for both
the dialysis treatment and the separately billable drugs, the aggregate
Medicare payments for outpatient dialysis services appear to be
adequate. However, MedPAC found that in 2001, Medicare's composite rate
payment did not cover the costs of providing dialysis services. MedPAC
indicated that the profitability of erythropoietin and other separately
billable drugs is subsidizing the lower margins under the composite
rate. The finding regarding the profitability of the separately
billable drugs is consistent with two earlier studies by the OIG. The
OIG also found that Medicare's payment rates for these drugs were high
relative to providers' costs and the rates paid by the VA and Medicaid
programs.
We believe that it is important to pay appropriately for the
composite rate and separately billable drugs and not have payments for
one cross-subsidize the other. It is our preference for the Congress to
provide explicit authority to increase the composite rate when we
reduce payments for ESRD separately billable drugs. However, we believe
that Congress intended for us to establish additional payments for ESRD
facilities to account for increased costs resulting from revised drug
payment rates. Section 429(b) provides that the Secretary may provide
for additional payments to providers or suppliers for the
administration, handling, and storage of drugs and biologicals. While
the citation in section 429(b) is to a provision of the statute that no
longer exists, we believe that in light of other provisions in section
429, Congress intended the Secretary to provide for additional payments
to ESRD facilities for increased costs related to the administration of
drugs and biologicals to offset revised Part B payments rates if the
Secretary determined it was appropriate. We believe based on the MedPAC
analysis that it is appropriate to increase ESRD payments to offset the
savings that will occur as we reform drug payments under the current
methodology. This would result in the same amount of money being paid
to ESRD facilities in 2004, but with more accurate payment for
separately billable drugs. This would not involve the bundling of
payment for these drugs or the drug savings into the composite rate,
but a separate payment from the composite rate. After we have selected
an AWP reform option, we would determine the average first year savings
from the ESRD separately billable drugs per hemodialysis treatment and
create a separate ESRD facility payment per hemodialysis treatment
equal to this amount. As stated earlier, we would prefer for Congress
to provide explicit authority for us to bundle the savings from
reforming the separately billable ESRD drug payments into the composite
rate.
We are requesting comments from the public on our interpretation of
the BIPA
[[Page 50441]]
provisions as well as our proposal for additional ESRD payments.
4. Inhalation and Home Infusion Drugs
For inhalation drugs furnished in connection with an item of DME,
Medicare currently pays for: (i) The DME itself, (ii) servicing of the
DME, and (iii) the inhalation or infusion drug. For inhalation drugs,
Medicare also pays a dispensing fee.
Inhalation equipment, such as nebulizers and home infusion pumps,
are paid under the DME benefit under the capped rental category. The
supplier furnishes the equipment to a beneficiary and the supplier is
paid 10 percent of the purchase price for the first three months and
7.5 percent of the purchase price for months 4 through 15 (that is, up
to 120 percent) of the purchase price of the equipment. The supplier
furnishes the equipment for as many months as the beneficiary needs it.
The statute also provides for a purchase option for the beneficiary. If
a beneficiary does not purchase the equipment, the supplier retains
title to the equipment and could furnish it to another beneficiary. In
this case, the payment occurs in a similar fashion and the supplier
could be paid up to another 120 percent of the purchase price of the
equipment. Medicare's payment includes delivery of the equipment to the
patient and any necessary setup and training of the beneficiary in its
use.
The statute specifies that Medicare also make payments for
maintenance and servicing the equipment. Such maintenance and servicing
payments cover 6-month periods beginning 7 months after initial use of
the equipment. By statute, Medicare's payment for maintenance and
servicing is equal to the lesser of a reasonable and necessary
maintenance and servicing fee, or 10 percent of the total purchase
price of the equipment.
In their September 2001 report described earlier (GAO-01-1118), the
GAO noted that although there have been no recent analyses of the
adequacy of Medicare DME payments, there are indications that the
payments may be above market rates. We are unaware of any studies
indicating that absent excessive Medicare payments for DME drugs,
payment for the DME itself is inadequate. Nevertheless, we are
interested in receiving convincing and comprehensive data from the
public about any underpayment for inhalation and infusion durable
medical equipment believed to exist and the applicability of that data
under each of our four options revising the current payment
methodology.
We note that it has been suggested that the current excessive
Medicare payments for DME drugs are used to pay for inhalation and
infusion services provided by DME suppliers that are not covered by the
Medicare program. We believe it is inappropriate for excessive drug
payments to subsidize these non-covered services.
5. Oral Drugs Provided by Pharmacies
Medicare makes no separate payment to pharmacies for dispensing
covered Medicare drugs such as oral immunosuppressive and oral anti-
emetic drugs. The GAO report did not make a recommendation with respect
to dispensing fees for pharmacies. We are seeking public comment and
data related to the appropriateness of dispensing fees under each of
our four options for revising the current payment methodology.
C. Beneficiary Access to Drugs
Given our intent to pay appropriately for drugs and our proposed
increases in payments for the costs related to furnishing and
administering drugs, we do not believe that any beneficiaries will
experience drug access issues as a result of our four proposed options.
For the drugs (for example, the inhalation drugs) where we are not
currently proposing changes in payments related to the administrative
costs of furnishing the drugs, we are seeking comments and data
supporting the appropriateness of any payment changes.
Although we do not believe any drug access issues will result from
this proposed rule, we intend to monitor beneficiary access closely and
may propose additional changes to our payment system in the future if
necessary. The data sources we might examine in our access monitoring
effort include claims data, surveys and focus groups, beneficiary
inquiries to the 1-800-Medicare number, and environmental scanning
activities.
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), we are required to
provide 30-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we
solicit comment on the following issues:
[sbull] The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
[sbull] The accuracy of our estimate of the information collection
burden.
[sbull] The quality, utility, and clarity of the information to be
collected.
[sbull] Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Requirement:
Under proposed option 2 and option 3 for this regulation, a
manufacturer of a new drug or a drug coming off patent would have to
submit detailed information and a rationale to us for a new price, in
order to receive a HCPCS code or continue the use of a HCPCS code,
respectively. During the first year, the manufacturer would also have
to provide updated information on the actual prices that Medicare
physicians and supplier pay to purchase the drug.
The burden associated with these requirements is the time involved
in providing us the information the first time and in providing us the
updates. The burden of submitting the data should be minimal, as most
of it will undoubtedly be electronically stored and transmitted.
Submitting information should take no longer than 1 hour; updates would
take no more than 30 minutes per year. Assuming a maximum of 50
Medicare Part B covered drugs per year either new, coming off patent,
or subject to a manufacturer update in the first year based on actual
sales, we expect the maximum aggregate burden per year would not exceed
150 hours. In addition, under option 3 a manufacturer could request an
exception to price reduction in the first year. We believe that it
would take an average of one hour to submit the request and the
necessary data and certification. Given the universe of approximately
450 Medicare drug codes and assuming an average of 10 manufacturers per
drug code, the maximum aggregate burden associated with this activity
would be 4500 hours.
For proposed option 3 for this regulation we would collect, through
various means, market-based price information. This information would
be collected from any of the following: manufacturers, distributors,
physicians and suppliers, and private insurers and health plans.
The burden associated with these requirements is the time involved
in providing us the information. We expect it would take an average of
one hour to provide us with this information. We expect the burden will
not vary significantly regardless of the number of codes requested
since this information
[[Page 50442]]
is predominately stored electronically by these entities. Assuming a
maximum of 1000 of the above entities are requested to provide
information in a given year, the maximum aggregate burden associated
with this information in 1000 hours per year.
Under option 4, bidders would have to submit a bid. They would have
to demonstrate that they have sufficient capacity, that the source of
the drugs is the wholesaler or distributor for the wholesaler, and that
they have arrangements for shipment within a specified time frame. They
would be required to have a procedure for resolving disputes.
The burden associated with the competitive acquisition program
would be the time it would take a bidder to submit the bid and to
document that it has met the requirements. We expect it would take an
average of approximately 40 hours to collect the information for
competitive bidding under option 4. Given that we are seeking comment
on the number of geographic areas to conduct the competitive bidding,
it is not possible to estimate the aggregate burden.
Also under option 4 we are requesting information from
manufacturers on the Average Sales Price of a drug. We believe that it
would take an average of one hour to collect this information. Given
the universe of approximately 450 Medicare drug codes and assuming an
average of 10 manufacturers per drug code, the maximum aggregate burden
associated with this activity would be 4500 hours per quarter.
If you comment on these information collection and record keeping
requirements, please mail copies directly to the following:
Centers for Medicare & Medicaid Services, Office of Strategic
Operations and Regulatory Affairs, DRDI, DRD-B, Attn: Julie Brown, Room
C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn: Brenda Aguilar, CMS Desk Officer.
Comments submitted to OMB may also be emailed to the following
address: email: baguilar@omb.eop.gov; or faxed to OMB at (202) 395-
6974.
IV. Response to Public Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this preamble, and, if we proceed with a subsequent
document, we will respond to the major comments in the preamble to that
document.
V. Regulatory Impact Analysis
We have examined the impact of this rule as required by Executive
Order 12866 (September 1993, Regulatory Planning and Review), the
Regulatory Flexibility Act (RFA) (September 16, 1980, Pub. L. 96-354),
section 1102(b) of the Social Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132.
Executive Order 12866 (as amended by Executive Order 13258, which
reassigns responsibility of duties) directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis must be prepared for final rules with
economically significant effects (that is, a final rule that would have
an annual effect on the economy of $100 million or more in any 1 year,
or would adversely affect in a material way the economy, a sector of
the economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities). As described below, we have simulated the effect of
changes in payment resulting from the implementation of each of the
four options for revising the current drug payment methodology. We have
also simulated the impact of our proposed increase in payments for the
administrative costs related to furnishing drugs.
Since this rule is considered to be a major rule because it is
economically significant, we have prepared a regulatory impact
analysis. The RFA requires that we analyze regulatory options for small
businesses and other entities. We prepare a Regulatory Flexibility
Analysis unless we certify that a rule would not have a significant
economic impact on a substantial number of small entities. The analysis
must include a justification concerning the reason action is being
taken, the kinds and number of small entities the rule affects, and an
explanation of any meaningful options that achieve the objectives with
less significant adverse economic impact on the small entities.
For purposes of the RFA, physicians and non-physician practitioners
are considered small businesses if they generate revenues of $8.5
million or less. Approximately 96 percent of physicians are considered
to be small entities. There are in excess of 20,000 physicians and
other practitioners that receive Medicare payment for drugs. These
physicians are more concentrated in the specialties of oncology,
urology, and rheumatology. Of the physicians in these specialties,
approximately 40 percent are in oncology and 45 percent in urology.
For purposes of the RFA, approximately 98 percent of suppliers of
DME and prosthetic devices are considered small businesses according to
the Small Business Administration's (SBA) size standards. We estimate
that 106,000 entities bill Medicare for DME, prosthetics, orthotics,
surgical dressings, and other equipment and supplies each year. Total
Medicare expenditures for DME are approximately $7 billion per year, of
which approximately $1 billion are for DME drugs.
The impact of this proposed rule on an individual physician or DME
supplier is dependent on the mix of drugs they provide to Medicare
beneficiaries. For example, under the market monitoring option a
physician could: (1) Determine the quantities of drugs that the
physician provides to Medicare beneficiaries; (2) determine the
proposed impact on that physician for drugs which have been studied by
GAO and OIG based on the quantities the physician provides, the
information in Table 3, and our proposed transition as described in
section II.A.3.f; and, (3) determine the proposed impact on that
physician for drugs which have not been studied by GAO and OIG based on
the quantities the physician provides and our proposal to pay 80
percent to 90 percent of AWP as discussed earlier in section II.A.3.c.
Different impacts will result from this calculation depending on the
mix of drugs provided.
Section 1102(b) of the Act requires us to prepare a regulatory
impact analysis for any proposed rule that may have a significant
impact on the operations of a substantial number of small rural
hospitals. This analysis must conform to the provisions of section 603
of the RFA. For purposes of section 1102(b) of the Act, we define a
small rural hospital as a hospital that is located outside a
Metropolitan Statistical Area and has fewer than 100 beds. To the
extent changes in drug payments would have any impact on small rural
hospitals, it would be limited to the few drugs they might furnish with
pass-through status
[[Page 50443]]
under the Outpatient Prospective Payment System.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that may result in expenditures in any 1 year by
State, local, or tribal governments, in the aggregate, or by the
private sector, of $110 million. We have determined that this proposed
rule will have no consequential effect on State, local, or tribal
governments.
We have examined this final rule in accordance with Executive Order
13132 and have determined that this regulation would not have any
significant impact on the rights, roles, or responsibilities of State,
local, or tribal governments.
A. Anticipated Effects
We have prepared the following analysis, related to the assessment
requirements. It explains the rationale for, and purposes of, the rule,
details the costs and benefits of the rule, analyzes alternatives, and
presents the measures we are using to minimize the burden on small
entities. As indicated elsewhere, we are making changes to payments for
drugs and related services in response to the requirements of section
429(b) of BIPA and section 1842(o) of the Act. It is our intent to
revise our drug payment system and pay appropriately for the
administrative costs related to furnishing drugs. We provide
information for each of the policy changes in the relevant sections in
this rule. The provisions of this rule are changing only our payment
rates for drugs and related services. This rule does not impose
reporting, record keeping, and other compliance requirements except as
described in section II.A.2.b New Drugs and Drugs with Patent
Expirations and section II.A.4.b Average Sales Price. We are unaware of
any relevant Federal rules that duplicate, overlap, or conflict with
this rule.
B. Impact of Approaches to Revising the Current Payment System
The proposed approach of basing our reform efforts on the
comparability provision (Option 1) in the statute and issuing
additional guidance to our contractors would result in decreases in
Medicare expenditures for drugs of $4.1 billion over the ten-year
period FY 2004 through 2013. The effect of implementing an average list
AWP discount (Option 2) is dependent on the level of the discount. We
are seeking comment on the appropriate discount in the range of 10
percent to 20 percent. At 10 percent, the impact of this proposal is
$5.1 billion for FY 2004 through 2013. At 20 percent the impact is
$14.3 billion for FY 2004 through 2013. The implementation of market
monitoring (Option 3) is also dependent on the list AWP discount since
the discount impacts the drugs that have not been studied by the OIG
and GAO. At a 10 percent discount for the drugs that have not been
studied, the impact of this proposal is $16.1 billion for FY 2004
through 2013. At 20 percent, the impact is $19.4 billion for FY 2004
through 2013. The proposed approach of basing our reform efforts on the
establishment of a competitive acquisition program and Average Sales
Price system (Option4) is dependent on the ASP markup. At a 1 percent
markup the impact of this proposal for FY 2004 through 2013 is $13.5
billion excluding DME drugs and $27.6 billion including DME drugs. At a
12 percent markup the impact of this proposal for FY 2004 through 2013
is $7.6 billion excluding DME drugs and $21.2 billion including DME
drugs.
C. Impact on Payments Related to Furnishing or Administering Drugs
We have simulated the impact of our proposed increase in payments
for the costs of furnishing or administering drugs. Medicare payments
for physician fee schedule services are estimated to increase by $1.6
billion over the ten-year period FY 2004 through 2013. For ESRD
facility costs related to furnishing separately billable ESRD drugs, we
would set payments budget neutral to the reductions in drug payments.
For DME inhalation, DME home infusion, and oral drugs provided by
pharmacies, we are seeking comment on the appropriateness of any
changes to the payments for the administrative costs of furnishing
these drugs.
D. Alternatives Considered
This proposed rule contains the four alternative approaches to
reforming the current payment methodology that we considered, each of
which has been discussed in detail. We are seeking comment on these
approaches. We expect to select one of these approaches after reviewing
all public comments received on the proposed rule and making any
necessary modifications.
E. Impact on Beneficiaries
We have simulated the effect of changes in beneficiary copayments
for drugs and related changes in beneficiary Part B premium payments
resulting from the implementation of the four options for reforming the
AWP system. The proposed approach of basing our reform efforts on the
comparability provision in the statute and issuing additional guidance
to our contractors would result in decreases in these payments by
beneficiaries of $2.6 billion over the ten-year period FY 2004 through
2013. The effect on beneficiary payments resulting from the
implementation of an average list AWP discount is dependent on the
level of the discount. At 10 percent, the proposal will save
beneficiaries $3.2 billion for FY 2004 through 2013. At 20 percent, the
proposal will save beneficiaries $9.1 billion for FY 2004 through 2013.
The implementation of market monitoring is also dependent on the list
AWP discount since this impacts the drugs that have not been studied by
the OIG and GAO. At a 10 percent discount for the drugs that have not
been studied, the proposal will save beneficiaries $10.3 billion for FY
2004 through 2013. At 20 percent, the proposal will save beneficiaries
$12.3 billion for FY 2004 through 2013. The proposed approach of basing
our reform efforts on the establishment of a competitive acquisition
program and Average Sales Price system is dependent on the ASP markup.
At a 1 percent markup the proposal will save beneficiaries $8.6 billion
excluding DME drugs and $17.6 billion including DME drugs. At a 12
percent markup this proposal will save beneficiaries $4.8 billion
excluding DME drugs and $13.5 billion including DME drugs.
Beneficiaries will pay an additional $1.1 billion in copayments and
related Part B premium increases as a result of the proposed changes to
the Medicare physician fee schedule.
As described in section II.C, we do not believe that any
beneficiaries will experience drug access issues as a result of our
four proposed options. We intend to monitor beneficiary access closely
and may propose additional changes to our payment system in the future
if necessary.
In accordance with the provisions of Executive Order 12866, the
Office of Management and Budget has reviewed this regulation.
(Catalog of Federal Domestic Assistance Program No. 93.774,
Medicare--Supplementary Medical Insurance Program)
Dated: June 27, 2003.
Thomas A. Scully,
Administrator, Centers for Medicare & Medicaid Services.
Approved: August 13, 2003.
Tommy G. Thompson,
Secretary.
Addendum A
[[Page 50444]]
Table 1.--Reprint of ``Table 3: Widely Available Discounts from AWP for Medicare-Covered Drugs Billed Primarily
by Physicians, 2001'' From the GAO Report
----------------------------------------------------------------------------------------------------------------
Average widely
Specialty most frequently available
Drug name billing for drug Average AWP a discount from AWP
(percentage) b
----------------------------------------------------------------------------------------------------------------
Leuprolide acetate (for depot suspension)... urology........................ $618.93 17.6
Rituximab................................... oncology c..................... 478.47 19.2
Goserelin acetate implant................... urology........................ 469.99 21.9
Docetaxel................................... oncology....................... 313.51 22.0
Filgrastim (G-CSF) 480 mcg.................. oncology....................... 300.40 d 18.0
Pamidronate disodium........................ oncology....................... 279.86 16.8
Hylan G-F 20................................ orthopedic surgery............. 225.13 d 17.7
Filgrastim (G-CSF) 300mcg................... oncology....................... 193.62 d 18.4
Paclitaxel.................................. oncology....................... 180.57 19.0
Irinotecan.................................. oncology....................... 141.32 22.9
Carboplatin................................. oncology....................... 120.48 20.3
Gemcitabine HCl............................. oncology....................... 112.34 21.3
Dolasetron mesylate, injection.............. oncology....................... 45.02 d 65.0
Granisetron HCl, injection.................. oncology....................... 19.52 29.3
Leucovorin calcium.......................... oncology....................... 18.44 85.6
Epoetin alpha for non-ESRD use.............. oncology....................... 12.91 15.2
Ondansetron HCl, injection.................. oncology....................... 6.41 12.8
Botulinum toxin type A...................... neurology...................... 4.86 e n/a
Imiglucerase................................ oncology....................... 3.95 e n/a
Dexamethasone sodium phosphate.............. oncology....................... 1.44 14.2
Heparin sodium.............................. oncology....................... 0.43 34.4
----------------------------------------------------------------------------------------------------------------
Source: GAO Report ``Medicare Payments for Covered Outpatient Drugs Exceed Providers' Cost'' (GAO-01-1118)
a ``Average AWP'' is the average of AWP of each NDC for that product adjusted to the HCPCS-defined dosage.
b ``Average widely available discount from AWP'' for each drug was calculated by (1) determining the average
widely available price(s) for each NDC for that drug, (2) determining the percentage difference between the
average widely available price(s) and the AWP for each NDC for that drug, and (3) averaging the percentage
differences for all NDCs for that drug.
c ``Oncology'' specialty includes hematology/oncology and medical oncology.
d ``Average widely available discount from AWP'' in 2001 for this drug is based on a price or prices from a
single wholesaler. For these four drugs, we had 2000 data from two or more sources. Those data showed that the
average widely available discount from AWP in 2000 was 18.8 percent for Filgrastim (G-CSF) 480 mcg, 17.6
percent for Hylan G-F 20, 19.0 percent for Filgrastim (G-CSF) 300mcg, and 42.2 percent for Dolasetron
mesylate, injection.
e We (GAO) were unable to obtain wholesaler or GPO prices for these products.
Source: GAO analysis of data from BESS, the Medical Economics Drug Topics Red Book CD-ROM vol. 21, and
wholesaler and GPO price lists.
Table 2.--Reprint of ``Table 4: Discounts From AWP Obtained by
Physicians Who Billed Medicare for a Low Volume of Selected Drugs,
Compared to Widely Available Discounts, 2001'' From the GAO Report
------------------------------------------------------------------------
Low volume Average widely
billers' average available
Drug name discount from AWP discount from AWP
(percentage) a (percentage)
------------------------------------------------------------------------
Leuprolide acetate (for depot 32.8 17.6
suspension)......................
Rituximab......................... 15.7 19.2
Goserelin acetate implant......... b 22.3 21.9
Docetaxel......................... 22.0 22.0
Filgrastim (G-CSF) (480 mcg)...... 22.4 c 18.0
Pamidronate disodium.............. 18.0 16.8
Filgrastim (G-CSF) (300mcg)....... 21.7 c 18.4
Paclitaxel........................ 25.8 19.0
Irinotecan........................ 27.1 22.9
Carboplatin....................... b 20.0 20.3
Gemcitabine HCl................... 16.1 21.3
Dolasetron mesylate, injection.... 62.0 c 65.0
Granisetron HCl, injection........ 28.1 29.3
Leucovorin calcium................ 90.4 85.6
Epoetin alpha for non-ESRD use.... 22.1 15.2
Ondansetron HCl, injection........ 26.4 12.8
------------------------------------------------------------------------
Source: GAO Report ``Medicare Payments for Covered Outpatient Drugs
Exceed Providers' Cost'' (GAO-01-1118)
a ``Average widely available discount from AWP'' for each drug was
calculated by (1) determining the average widely available price(s)
for each NDC for that drug, (2) determining the percentage difference
between the average widely available price(s) and the AWP for each NDC
for that drug, and (3) averaging the percentage differences for all
NDCs for that drug.
b ``Low-volume billers' average discount from AWP'' for this drug is
based on a price from a single physician.
c ``Average widely available discount from AWP'' for this drug is based
on a price or prices from a single wholesaler.
Notes: Out of our sample of 108 physicians, 14 provided us with
acquisition cost data for 16 of the 18 cancer treatment drugs we
examined. An additional 37 physicians belonged to large, hospital-
based or national chain oncology practices that likely had access to
widely available drug price discounts. Fifty-six physicians could not
be contacted or refused to participate. One physician in the sample
did not purchase drugs.
[[Page 50445]]
Source: GAO telephone survey of a sample of physicians who billed
Medicare for a low volume of cancer drugs in 1999 and AWPs listed in a
contemporaneous wholesaler catalog.
Table 3.--Medicare Part B Drugs in the Most Recent GAO and OIG Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Rank in GAO average
Medicare terms of widely OIG median
allowed medicare available catalogue Average of ``Spread''
Brand drugs (c) HCPCS charges (CY allowed price as a price as a GAO and OIG (j)
'02, run charges percent of percent of data (percent)
thru 2/03) across all AWP (a) AWP (b) (percent)
part B drugs (2001) (2000)
--------------------------------------------------------------------------------------------------------------------------------------------------------
EPOETIN ALFA (PROCRIT).................. Q0136 $928 1 85 89 87 8
LEUPROLIDE ACETATE (LUPRON)............. J9217 627 2 82 80 81 15
GOSERELIN ACETATE (ZOLADEX)............. J9202 441 4 78 80 79 17
RITUXIMAB (RITUXAN)..................... J9310 377 6 81 80 81 15
PACLITAXEL (c) (TAXOL).................. J9265 226 9 81 80 81 15
DOCETAXEL (TAXOTERE).................... J9170 221 10 78 80 79 17
CARBOPLATIN (PARAPLATIN)................ J9045 189 11 80 82 81 15
IRINOTECAN (CAMPTOSAR).................. J9206 170 12 77 80 79 17
GEMCITABINE HCL (GEMZAR)................ J9201 159 13 79 80 80 16
PAMIDRONATE DISODIUM (c) (AREDIA)....... J2430 126 14 83 87 85 11
DOLASETRON MESYLATE (ANZEMET)........... J1260 125 15 d 58 d 53 56 41
FILGRASTIM (NEUPOGEN) 480mcg............ J1441 99 17 d 81 d 80 81 15
HYLAN G-F 20 (SYNVISC).................. J7320 93 18 d82 ............ f 82 14
MYCOPHENOLATE MOFETIL (CELLCEPT)........ J7517 64 20 e 86 ............ 86 9
FILGRASTIM (NEUPOGEN) 300mcg............ J1440 53 26 d 81 d 80 81 15
GRANISETRON HCL (KYTRIL)................ J1626 47 28 71 71 71 25
ONDANSETRON (ZOFRAN).................... J2405 45 29 87 86 87 8
VINORELBINE TARTATE (c) (NAVELBINE)..... J9390 38 33 81 g 81 15
SARGRAMOSTIM (LEUKINE).................. J2820 35 35 80 ............ g 80 16
TOPOTECAN (HYCAMTIM).................... J9350 34 36 ............ 84 g 84 12
Generic Drugs
IPRATROPIUM BROMIDE..................... J7644 550 3 d 33 (d)(i) 34 34 64
ALBUTEROL SULFATE....................... J7619 381 5 15 (i) 18 17 82
IMMUNE GLOBULIN (h)..................... J1561 J1563 105 ............ ............ 72 g72 24
LEUCOVORIN CALCIUM...................... J0640 61 22 14 15 15 84
DOXORUBICIN HCL......................... J9000 29 41 ............ 22 g 22 77
DEXAMETHOSONE SODIUM PHOSPHATE.......... J1100 3 104 86 ............ f 86 9
HEPARIN SODIUM LOCK-FLUSH............... J1642 3 105 66 f 66 ............ 31
CROMOLYN SODIUM......................... J7631 3 106 31 f 31 67
ACETYLCYSTEINE.......................... J7608 2 129 e 28 64 46 52
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sources: GAO, ``Medicare Payments for Covered Outpatient Drugs Exceed Providers' Costs,'' September 2001. OIG, ``Medicare Reimbursement of Prescription
Drugs,'' January 2001. OIG, ``Excessive Medicare Reimbursement for Albuterol,'' March 2002. OIG, ``Excessive Medicare Reimbursement for Ipratromium
Bromide,'' March 2002.
(a) GAO estimated the average widely available discount from AWP. We converted that figure into the average widely available price as percent of AWP by
subtracting the GAO average widely available discount from 100 percent.
(b) The OIG studies report the median Medicare payment amount and the median catalogue price for each HCPCS code. Based on the OIG data, we divided the
OIG Medicare payment amount by 95 percent to estimate AWP and then divided the median catalogue price by the estimated AWP.
(c) PACLITAXEL and PAMIDRONATE DISODIUM became generic drugs in 2002 and VINORELBINE TARTATE became generic in 2003, however, the pricing information in
the GAO and OIG studies covers the time period when they were brand drugs only.
(d) For these drugs, GAO only had data from 1 wholesaler in 2001, but had data from 2 or more sources in 2000. The widely available price as a % of AWP
shown above for these drugs is the 2000 estimate. The figures for 2000 and 2001, respectively, were: DOLASETRON MESYLATE (58% and 35%), FILGRASTIM
480mcg (81% and 82%), HYLAN G-F 20 (82% and 82%) FILGRASTIM 300mcg (81% and 82%), and IPRATROPIUM BROMIDE (33% and 22%).
(e) GAO data are for 2000.
(f) Only based on GAO data.
(g) Only based on OIG data.
(h) Immune globulin was included in the generic category because it is a multisource biologic. OIG collected data on Immune Globulin HCPCs J1562. That
Jcode is no longer in use and now corresponds to Jcodes 1561 and 1563.
(i) The price estimates based on OIG data for ALBUTEROL AND IPRATROPIUM BROMIDE include more than just catalogue prices. OIG conducted special studies
on these two drugs in 2002. The studies provided data on the median Medicare payment amount in 2001, the median wholesale catalogue price in 2001, the
median invoice price (data gathered by OIG reflecting the time period 1998--August 2000), and the median wholesale acquisition cost reported in the
April 2001 Drug Topics Redbook. For these 2 drugs, we calculated the median price across OIG's three data sources, and then divided it by our estimate
of AWP (OIG's Medicare median payment amount divided by 95%).
(j) The ``spread'' is the percent difference between the Medicare reimbursement price (i.e., 95 percent of AWP) and the average GAO/OIG widely available/
catalogue price.
(k) Top 20 w/combined Jcodes.
Table 4.--Summary of OIG Reports on Medicare Prescription Drugs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year of Report 1997 1998 2000 2001 2002
--------------------------------------------------------------------------------------------------------------------------------------------------------
22 34 5 ESRD 24 24 Ipratropium
Drugs reviewed drugs drugs drugs Albuterol drugs Albuterol drugs Bromide
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year Reviewed................................................ 1996 1997 1998 1999 1999 2000 2000 2000
Medicare Expenditures for Reviewed Drugs..................... \3\ \3\ \4\ $379 \4\ $246 \3\ \4\ $296 \3\ \4\ $348
$1.5 $2.1 $3.1 $3.7
Excessive Payments Based On:
VA....................................................... ....... \3\ $1 \4\ $162 \4\ $209 \3\ \4\ $264 \3\ \4\ $279
$1.6 $1.9
Catalogs................................................. \4\ ....... ........... ........... \4\ \4\ $245 \4\ \4\ $262
$447 $761 $887
Medicaid................................................. ....... ....... \4\ $42 \4\ $120 \4\ ........... ....... ..............
$425
Beneficiary Share of Excessive Payments:
VA....................................................... ....... ....... \4\ $32 \4\ $42 \4\ \4\ $53 \4\ \4\ $56
$320 $380
Catalogs................................................. \4\ $89 \4\ ........... ........... \4\ \4\ $49 \4\ \4\ $52
$200 $152 $177
[[Page 50446]]
Medicaid................................................. ....... ....... 4$8 4$24 4$85 ........... .......
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sources:
\1\ OIG, ``Testimony of George F. Grob, Deputy Inspector General for Evaluation and Inspections, HHS Office of Inspector General,'' House Committee on
Energy and Commerce, Subcommittee on Oversight and Investigations and Subcommittee on Health, Joint Hearing September 21, 2001.
\2\ OIG, ``Excessive Reimbursement for Ipratropium Bromide,'' Report Number: OEI-03-01-00411, March 2002.
\3\ Billion.
\4\ Million.
List of Medicare Drug HCPCS Codes
------------------------------------------------------------------------
HCPCS* Description
------------------------------------------------------------------------
90371.................... HEPATITIS B IG, IM
90375.................... RABIES IG, IM/SC
90376.................... RABIES IG, HEAT TREATED
90379.................... RESPIRATORY SYNCYTIAL VIRUS IG, IV
90385.................... RHO(D) IG (RHLG), MINIDOSE, IM
90389.................... TETANUS IG, IM
90585.................... BACILLUS CALMETTE-GUERIN VACCINE,
PERCUTANEOUS
90632.................... HEPATITIS A VACCINE, ADULT IM
90633.................... HEPATITIS A VACCINE, PED/ADOL, 2 DOSE
90634.................... HEPATITIS A VACCINE, PED/ADOL, 3 DOSE
90645.................... HEMOPHILUS INFLUENZA B VACCINE, HBOC, IM
90675.................... RABIES VACCINE, IM
90691.................... TYPHOID VACCINE, IM
90700.................... DIPTHERIA, TETANUS TOXOIDS VACCINE, IM
90703.................... TETANUS VACCINE, IM
90704.................... MUMPS VACCINE, SC
90705.................... MEASLES VACCINE, SC
90706.................... RUBELLA VACCINE, SC
90707.................... MEASLES, MUMPS AND RUBELLA VIRUS VACCINE, SC
90713.................... POLIOVIRUS VACCINE, IPV, SC
90716.................... CHICKEN POX VACCINE, SC
90717.................... YELLOW FEVER VACCINE, SC
90718.................... TETANUS AND DIPTHERIA TOXOIDS VACCINE 7, IM
90721.................... DIPTHERIA, TETANUS TOXOIDS, & ACELLULAR
PERTUSSIS VACCINE & HEMOPHILUS INFLUENZA B
VACCINE, IM
90733.................... MENINGOCOCCAL VACCINE, SC
90740.................... HEPATITIS B VACCINE, DIALYSIS OR
IMMUNOSUPPRESSED PATIENT, 3 DOSE, IM
90743.................... HEPATITIS B VACCINE, ADOL, 2 DOSE, IM
90744.................... HEPATITIS B VACCINE, PED/ADOL 3 DOSE, IM
90746.................... HEPATITIS B VACCINE, ADULT, IM
90747.................... HEPATITIS B VACCINE, DIALYSIS OR
IMMUNOSUPPRESSED PATIENT, 4 DOSE, IM
J0130.................... INJECTION, ABCIXIMAB, 10 MG
J0150.................... INJECTION, ADENOSINE, 6 MG (NOT TO BE USED TO
REPORT ANY ADENOSINE PHOSPHATE)
J0151.................... INJECTION, ADENOSINE, 90 MG (NOT TO BE USED
TO REPORT ANY ADENOSINE PHOSPHATE)
J0170.................... INJECTION, ADRENALIN, EPINEPHRINE, UP TO 1 ML
AMPULE
J0200.................... INJECTION, ALATROFLOXACIN MESYLATE, 100 MG
J0205.................... INJECTION, ALGLUCERASE, PER 10 UNITS
J0207.................... INJECTION, AMIFOSTINE, 500 MG
J0210.................... INJECTION, METHYLDOPATE HCL, UP TO 250 MG
J0256.................... INJECTION, ALPHA 1-PROTEINASE INHIBITOR--
HUMAN, 10 MG
J0280.................... INJECTION, AMINOPHYLLIN, UP TO 250 MG
J0282.................... INJECTION, AMIODARONE HYDROCHLORIDE, 30 MG
J0285.................... INJECTION, AMPHOTERICIN B, 50 MG
J0287.................... INJECTION, AMPHOTERICIN B LIPID COMPLEX, 10
MG
J0288.................... INJECTION, AMPHOTERICIN B CHOLESTERYL SULFATE
COMPLEX, 10 MG
J0289.................... INJECTION, AMPHOTERICIN B LIPOSOME, 10 MG
J0290.................... INJECTION, AMPICILLIN SODIUM, 500 MG
J0295.................... INJECTION, AMPICILLIN SODIUM/SULBACTAM
SODIUM, PER 1.5 GM
J0300.................... INJECTION, AMOBARBITAL, UP TO 125 MG
J0330.................... INJECTION, SUCCINYLCHOLINE CHLORIDE, UP TO 20
MG
J0360.................... INJECTION, HYDRALAZINE HCL, UP TO 20 MG
J0380.................... INJECTION, METARAMINOL BITARTRATE, PER 10 MG
J0390.................... INJECTION, CHLOROQUINE HYDROCHLORIDE, UP TO
250 MG
J0395.................... INJECTION, ARBUTAMINE HCL, 1 MG
J0456.................... INJECTION, AZITHROMYCIN, 500 MG
J0460.................... INJECTION, ATROPINE SULFATE, UP TO 0.3 MG
J0470.................... INJECTION, DIMERCAPROL, PER 100 MG
J0475.................... INJECTION, BACLOFEN, 10 MG
J0476.................... INJECTION, BACLOFEN, 50 MCG FOR INTRATHECAL
TRIAL
J0500.................... INJECTION, DICYCLOMINE HCL, UP TO 20 MG
J0515.................... INJECTION, BENZTROPINE MESYLATE, PER 1 MG
J0520.................... INJECTION, BETHANECHOL CHLORIDE, MYOTONACHOL
OR URECHOLINE, UP TO 5 MG
J0530.................... INJECTION, PENICILLIN G BENZATHINE AND
PENICILLIN G PROCAINE, UP TO 600,000
J0540.................... INJECTION, PENICILLIN G BENZATHINE AND
PENICILLIN G PROCAINE, UP TO 1,200,000
[[Page 50447]]
J0550.................... INJECTION, PENICILLIN G BENZATHINE AND
PENICILLIN G PROCAINE, UP TO 2,400,000
J0560.................... INJECTION, PENICILLIN G BENZATHINE, UP TO
600,000 UNITS
J0570.................... INJECTION, PENICILLIN G BENZATHINE, UP TO
1,200,000 UNITS
J0580.................... INJECTION, PENICILLIN G BENZATHINE, UP TO
2,400,000 UNITS
J0585.................... BOTULINUM TOXIN TYPE A, PER UNIT
J0587.................... BOTULINUM TOXIN TYPE B, PER 100 UNITS
J0592.................... INJECTION, BUPRENORPHINE HYDROCHLORIDE, 0.1
MG
J0600.................... INJECTION, EDETATE CALCIUM DISODIUM, UP TO
1000 MG
J0610.................... INJECTION, CALCIUM GLUCONATE, PER 10 ML
J0620.................... INJECTION, CALCIUM GLYCEROPHOSPHATE AND
CALCIUM LACTATE, PER 10 ML
J0630.................... INJECTION, CALCITONIN SALMON, UP TO 400 UNITS
J0636.................... INJECTION, CALCITRIOL, 0.1 MCG
J0637.................... INJECTION, CASPOFUNGIN ACETATE, 5 MG
J0640.................... INJECTION, LEUCOVORIN CALCIUM, PER 50 MG
J0670.................... INJECTION, MEPIVACAINE HYDROCHLORIDE, PER 10
ML
J0690.................... INJECTION, CEFAZOLIN SODIUM, 500 MG
J0692.................... INJECTION, CEFEPIME HYDROCHLORIDE, 500 MG
J0694.................... INJECTION, CEFOXITIN SODIUM, 1 GM
J0696.................... INJECTION, CEFTRIAXONE SODIUM, PER 250 MG
J0697.................... INJECTION, STERILE CEFUROXIME SODIUM, PER 750
MG
J0698.................... INJECTION, CEFOTAXIME SODIUM, PER GM
J0702.................... INJECTION, BETAMETHASONE ACETATE AND
BETAMETHASONE SODIUM PHOSPHATE, PER 3 MG
J0704.................... INJECTION, BETAMETHASONE SODIUM PHOSPHATE,
PER 4 MG
J0706.................... INJECTION, CAFFEINE CITRATE, 5MG
J0713.................... INJECTION, CEFTAZIDIME, PER 500 MG
J0715.................... INJECTION, CEFTIZOXIME SODIUM, PER 500 MG
J0720.................... INJECTION, CHLORAMPHENICOL SODIUM SUCCINATE,
UP TO 1 GM
J0725.................... INJECTION, CHORIONIC GONADOTROPIN, PER 1,000
USP UNITS
J0735.................... INJECTION, CLONIDINE HYDROCHLORIDE, 1 MG
J0740.................... INJECTION, CIDOFOVIR, 375 MG
J0743.................... INJECTION, CILASTATIN SODIUM; IMIPENEM, PER
250 MG
J0744.................... INJECTION, CIPROFLOXACIN FOR INTRAVENOUS
INFUSION, 200 MG
J0745.................... INJECTION, CODEINE PHOSPHATE, PER 30 MG
J0760.................... INJECTION, COLCHICINE, PER 1 MG
J0770.................... INJECTION, COLISTIMETHATE SODIUM, UP TO 150
MG
J0780.................... INJECTION, PROCHLORPERAZINE, UP TO 10 MG
J0800.................... INJECTION, CORTICOTROPIN, UP TO 40 UNITS
J0835.................... INJECTION, COSYNTROPIN, PER 0.25 MG
J0850.................... INJECTION, CYTOMEGALOVIRUS IMMUNE GLOBULIN
INTRAVENOUS (HUMAN), PER VIAL
J0880.................... INJECTION, DARBEPOETIN ALFA, 5 MCG
J0895.................... INJECTION, DEFEROXAMINE MESYLATE, 500 MG
J0900.................... INJECTION, TESTOSTERONE ENANTHATE AND
ESTRADIOL VALERATE, UP TO 1 CC
J0945.................... INJECTION, BROMPHENIRAMINE MALEATE, PER 10 MG
J0970.................... INJECTION, ESTRADIOL VALERATE, UP TO 40 MG
J1000.................... INJECTION, DEPO-ESTRADIOL CYPIONATE, UP TO 5
MG
J1020.................... INJECTION, METHYLPREDNISOLONE ACETATE, 20 MG
J1030.................... INJECTION, METHYLPREDNISOLONE ACETATE, 40 MG
J1040.................... INJECTION, METHYLPREDNISOLONE ACETATE, 80 MG
J1051.................... INJECTION, MEDROXYPROGESTERONE ACETATE, 50 MG
J1056.................... INJECTION, MEDROXYPROGESTERONE ACETATE/
ESTRADIOL CYPIONATE, 5MG/25MG
J1060.................... INJECTION, TESTOSTERONE CYPIONATE AND
ESTRADIOL CYPIONATE, UP TO 1 ML
J1070.................... INJECTION, TESTOSTERONE CYPIONATE, UP TO 100
MG
J1080.................... INJECTION, TESTOSTERONE CYPIONATE, 1 CC, 200
MG
J1094.................... INJECTION, DEXAMETHASONE ACETATE, 1 MG
J1100.................... INJECTION, DEXAMETHASONE SODIUM PHOSPHATE,
1MG
J1110.................... INJECTION, DIHYDROERGOTAMINE MESYLATE, PER 1
MG
J1120.................... INJECTION, ACETAZOLAMIDE SODIUM, UP TO 500 MG
J1160.................... INJECTION, DIGOXIN, UP TO 0.5 MG
J1165.................... INJECTION, PHENYTOIN SODIUM, PER 50 MG
J1170.................... INJECTION, HYDROMORPHONE, UP TO 4 MG
J1180.................... INJECTION, DYPHYLLINE, UP TO 500 MG
J1190.................... INJECTION, DEXRAZOXANE HYDROCHLORIDE, PER 250
MG
J1200.................... INJECTION, DIPHENHYDRAMINE HCL, UP TO 50 MG
J1205.................... INJECTION, CHLOROTHIAZIDE SODIUM, PER 500 MG
J1212.................... INJECTION, DMSO, DIMETHYL SULFOXIDE, 50
percent, 50 ML
J1230.................... INJECTION, METHADONE HCL, UP TO 10 MG
J1240.................... INJECTION, DIMENHYDRINATE, UP TO 50 MG
J1245.................... INJECTION, DIPYRIDAMOLE, PER 10 MG
J1250.................... INJECTION, DOBUTAMINE HYDROCHLORIDE, PER 250
MG
J1260.................... INJECTION, DOLASETRON MESYLATE, 10 MG
J1270.................... INJECTION, DOXERCALCIFEROL, 1 MCG
J1320.................... INJECTION, AMITRIPTYLINE HCL, UP TO 20 MG
J1325.................... INJECTION, EPOPROSTENOL, 0.5 MG
J1327.................... INJECTION, EPTIFIBATIDE, 5 MG
J1364.................... INJECTION, ERYTHROMYCIN LACTOBIONATE, PER 500
MG
J1380.................... INJECTION, ESTRADIOL VALERATE, UP TO 10 MG
J1390.................... INJECTION, ESTRADIOL VALERATE, UP TO 20 MG
J1410.................... INJECTION, ESTROGEN CONJUGATED, PER 25 MG
J1435.................... INJECTION, ESTRONE, PER 1 MG
J1436.................... INJECTION, ETIDRONATE DISODIUM, PER 300 MG
J1438.................... INJECTION, ETANERCEPT, 25 MG (CODE MAY BE
USED FOR MEDICARE WHEN DRUG
[[Page 50448]]
J1440.................... INJECTION, FILGRASTIM (G-CSF), 300 MCG
J1441.................... INJECTION, FILGRASTIM (G-CSF), 480 MCG
J1450.................... INJECTION FLUCONAZOLE, 200 MG
J1452.................... INJECTION, FOMIVIRSEN SODIUM, INTRAOCULAR,
1.65 MG
J1455.................... INJECTION, FOSCARNET SODIUM, PER 1000 MG
J1460.................... INJECTION, GAMMA GLOBULIN, INTRAMUSCULAR, 1
CC
J1470.................... INJECTION, GAMMA GLOBULIN, INTRAMUSCULAR, 2
CC
J1480.................... INJECTION, GAMMA GLOBULIN, INTRAMUSCULAR, 3
CC
J1490.................... INJECTION, GAMMA GLOBULIN, INTRAMUSCULAR, 4
CC
J1500.................... INJECTION, GAMMA GLOBULIN, INTRAMUSCULAR, 5
CC
J1510.................... INJECTION, GAMMA GLOBULIN, INTRAMUSCULAR, 6
CC
J1520.................... INJECTION, GAMMA GLOBULIN, INTRAMUSCULAR, 7
CC
J1530.................... INJECTION, GAMMA GLOBULIN, INTRAMUSCULAR, 8
CC
J1540.................... INJECTION, GAMMA GLOBULIN, INTRAMUSCULAR, 9
CC
J1550.................... INJECTION, GAMMA GLOBULIN, INTRAMUSCULAR, 10
CC
J1563.................... INJECTION, IMMUNE GLOBULIN, INTRAVENOUS, 1G
J1564.................... INJECTION, IMMUNE GLOBULIN, 10 MG
J1565.................... INJECTION, RESPIRATORY SYNCYTIAL VIRUS IMMUNE
GLOBULIN, INTRAVENOUS, 50 MG
J1570.................... INJECTION, GANCICLOVIR SODIUM, 500 MG
J1580.................... INJECTION, GARAMYCIN, GENTAMICIN, UP TO 80 MG
J1590.................... INJECTION, GATIFLOXACIN, 10MG
J1600.................... INJECTION, GOLD SODIUM THIOMALATE, UP TO 50
MG
J1610.................... INJECTION, GLUCAGON HYDROCHLORIDE, PER 1 MG
J1620.................... INJECTION, GONADORELIN HYDROCHLORIDE, PER 100
MCG
J1626.................... INJECTION, GRANISETRON HYDROCHLORIDE, 100 MCG
J1630.................... INJECTION, HALOPERIDOL, UP TO 5 MG
J1631.................... INJECTION, HALOPERIDOL DECANOATE, PER 50 MG
J1642.................... INJECTION, HEPARIN SODIUM, (HEPARIN LOCK
FLUSH), PER 10 UNITS
J1644.................... INJECTION, HEPARIN SODIUM, PER 1000 UNITS
J1645.................... INJECTION, DALTEPARIN SODIUM, PER 2500 IU
J1650.................... INJECTION, ENOXAPARIN SODIUM, 10 MG
J1652.................... INJECTION, FONDAPARINUX SODIUM, 0.5 MG
J1655.................... INJECTION, TINZAPARIN SODIUM, 1000 IU
J1670.................... INJECTION, TETANUS IMMUNE GLOBULIN, HUMAN, UP
TO 250 UNITS
J1700.................... INJECTION, HYDROCORTISONE ACETATE, UP TO 25
MG
J1710.................... INJECTION, HYDROCORTISONE SODIUM PHOSPHATE,
UP TO 50 MG
J1720.................... INJECTION, HYDROCORTISONE SODIUM SUCCINATE,
UP TO 100 MG
J1730.................... INJECTION, DIAZOXIDE, UP TO 300 MG
J1742.................... INJECTION, IBUTILIDE FUMARATE, 1 MG
J1745.................... INJECTION, INFLIXIMAB, 10 MG
J1750.................... INJECTION, IRON DEXTRAN, 50 MG
J1756.................... INJECTION, IRON SUCROSE, 1 MG
J1785.................... INJECTION, IMIGLUCERASE, PER UNIT
J1790.................... INJECTION, DROPERIDOL, UP TO 5 MG
J1800.................... INJECTION, PROPRANOLOL HCL, UP TO 1 MG
J1810.................... INJECTION, DROPERIDOL AND FENTANYL CITRATE,
UP TO 2 ML AMPULE
J1815.................... INJECTION, INSULIN, PER 5 UNITS
J1835.................... INJECTION, ITRACONAZOLE, 50 MG
J1840.................... INJECTION, KANAMYCIN SULFATE, UP TO 500 MG
J1850.................... INJECTION, KANAMYCIN SULFATE, UP TO 75 MG
J1885.................... INJECTION, KETOROLAC TROMETHAMINE, PER 15 MG
J1890.................... INJECTION, CEPHALOTHIN SODIUM, UP TO 1 GRAM
J1910.................... INJECTION, KUTAPRESSIN, UP TO 2 ML
J1940.................... INJECTION, FUROSEMIDE, UP TO 20 MG
J1950.................... INJECTION, LEUPROLIDE ACETATE (FOR DEPOT
SUSPENSION), PER 3.75 MG
J1955.................... INJECTION, LEVOCARNITINE, PER 1 GM
J1956.................... INJECTION, LEVOFLOXACIN, 250 MG
J1960.................... INJECTION, LEVORPHANOL TARTRATE, UP TO 2 MG
J1980.................... INJECTION, HYOSCYAMINE SULFATE, UP TO 0.25 MG
J1990.................... INJECTION, CHLORDIAZEPOXIDE HCL, UP TO 100 MG
J2000.................... INJECTION, LIDOCAINE HCL, 50 CC
J2010.................... INJECTION, LINCOMYCIN HCL, UP TO 300 MG
J2020.................... INJECTION, LINEZOLID, 200MG
J2060.................... INJECTION, LORAZEPAM, 2 MG
J2150.................... INJECTION, MANNITOL, 25 percent IN 50 ML
J2175.................... INJECTION, MEPERIDINE HYDROCHLORIDE, PER 100
MG
J2180.................... INJECTION, MEPERIDINE AND PROMETHAZINE HCL,
UP TO 50 MG
J2210.................... INJECTION, METHYLERGONOVINE MALEATE, UP TO
0.2 MG
J2250.................... INJECTION, MIDAZOLAM HYDROCHLORIDE, PER 1 MG
J2260.................... INJECTION, MILRINONE LACTATE, 5 MG
J2270.................... INJECTION, MORPHINE SULFATE, UP TO 10 MG
J2271.................... INJECTION, MORPHINE SULFATE, 100MG
J2275.................... INJECTION, MORPHINE SULFATE (PRESERVATIVE-
FREE STERILE SOLUTION), PER 10 MG
J2300.................... INJECTION, NALBUPHINE HYDROCHLORIDE, PER 10
MG
J2310.................... INJECTION, NALOXONE HYDROCHLORIDE, PER 1 MG
J2320.................... INJECTION, NANDROLONE DECANOATE, UP TO 50 MG
J2321.................... INJECTION, NANDROLONE DECANOATE, UP TO 100 MG
J2322.................... INJECTION, NANDROLONE DECANOATE, UP TO 200 MG
J2324.................... INJECTION, NESIRITIDE, 0.5 MG
J2355.................... INJECTION, OPRELVEKIN, 5 MG
J2360.................... INJECTION, ORPHENADRINE CITRATE, UP TO 60 MG
[[Page 50449]]
J2370.................... INJECTION, PHENYLEPHRINE HCL, UP TO 1 ML
J2400.................... INJECTION, CHLOROPROCAINE HYDROCHLORIDE, PER
30 ML
J2405.................... INJECTION, ONDANSETRON HYDROCHLORIDE, PER 1
MG
J2410.................... INJECTION, OXYMORPHONE HCL, UP TO 1 MG
J2430.................... INJECTION, PAMIDRONATE DISODIUM, PER 30 MG
J2440.................... INJECTION, PAPAVERINE HCL, UP TO 60 MG
J2460.................... INJECTION, OXYTETRACYCLINE HCL, UP TO 50 MG
J2501.................... INJECTION, PARICALCITOL, 1 MCG
J2510.................... INJECTION, PENICILLIN G PROCAINE, AQUEOUS, UP
TO 600,000 UNITS
J2515.................... INJECTION, PENTOBARBITAL SODIUM, PER 50 MG
J2540.................... INJECTION, PENICILLIN G POTASSIUM, UP TO
600,000 UNITS
J2543.................... INJECTION, PIPERACILLIN SODIUM/TAZOBACTAM
SODIUM, 1 GRAM/0.125 GRAMS (1.125)
J2545.................... PENTAMIDINE ISETHIONATE, INHALATION SOLUTION,
PER 300 MG, ADMINISTERED THROUGH
J2550.................... INJECTION, PROMETHAZINE HCL, UP TO 50 MG
J2560.................... INJECTION, PHENOBARBITAL SODIUM, UP TO 120 MG
J2590.................... INJECTION, OXYTOCIN, UP TO 10 UNITS
J2597.................... INJECTION, DESMOPRESSIN ACETATE, PER 1 MCG
J2650.................... INJECTION, PREDNISOLONE ACETATE, UP TO 1 ML
J2670.................... INJECTION, TOLAZOLINE HCL, UP TO 25 MG
J2675.................... INJECTION, PROGESTERONE, PER 50 MG
J2680.................... INJECTION, FLUPHENAZINE DECANOATE, UP TO 25
MG
J2690.................... INJECTION, PROCAINAMIDE HCL, UP TO 1 GM
J2700.................... INJECTION, OXACILLIN SODIUM, UP TO 250 MG
J2710.................... INJECTION, NEOSTIGMINE METHYLSULFATE, UP TO
0.5 MG
J2720.................... INJECTION, PROTAMINE SULFATE, PER 10 MG
J2725.................... INJECTION, PROTIRELIN, PER 250 MCG
J2730.................... INJECTION, PRALIDOXIME CHLORIDE, UP TO 1 GM
J2760.................... INJECTION, PHENTOLAMINE MESYLATE, UP TO 5 MG
J2765.................... INJECTION, METOCLOPRAMIDE HCL, UP TO 10 MG
J2770.................... INJECTION, QUINUPRISTIN/DALFOPRISTIN, 500 MG
(150/350)
J2780.................... INJECTION, RANITIDINE HYDROCHLORIDE, 25 MG
J2788.................... INJECTION, RHO D IMMUNE GLOBULIN, HUMAN,
MINIDOSE, 50 MCG
J2790.................... INJECTION, RHO D IMMUNE GLOBULIN, HUMAN, FULL
DOSE, 300 MCG
J2792.................... INJECTION, RHO D IMMUNE GLOBULIN,
INTRAVENOUS, HUMAN, SOLVENT DETERGENT, 100
IU
J2795.................... INJECTION, ROPIVACAINE HYDROCHLORIDE, 1 MG
J2800.................... INJECTION, METHOCARBAMOL, UP TO 10 ML
J2820.................... INJECTION, SARGRAMOSTIM (GM-CSF), 50 MCG
J2910.................... INJECTION, AUROTHIOGLUCOSE, UP TO 50 MG
J2912.................... INJECTION, SODIUM CHLORIDE, 0.9 percent, PER
2 ML
J2916.................... INJECTION, SODIUM FERRIC GLUCONATE COMPLEX IN
SUCROSE INJECTION, 12.5 MG
J2920.................... INJECTION, METHYLPREDNISOLONE SODIUM
SUCCINATE, UP TO 40 MG
J2930.................... INJECTION, METHYLPREDNISOLONE SODIUM
SUCCINATE, UP TO 125 MG
J2940.................... INJECTION, SOMATREM, 1 MG
J2941.................... INJECTION, SOMATROPIN, 1 MG
J2950.................... INJECTION, PROMAZINE HCL, UP TO 25 MG
J2993.................... INJECTION, RETEPLASE, 18.1 MG
J2995.................... INJECTION, STREPTOKINASE, PER 250,000 IU
J2997.................... INJECTION, ALTEPLASE RECOMBINANT, 1 MG
J3000.................... INJECTION, STREPTOMYCIN, UP TO 1 GM
J3010.................... INJECTION, FENTANYL CITRATE, 0.1 MG
J3030.................... INJECTION, SUMATRIPTAN SUCCINATE, 6 MG (CODE
MAY BE USED FOR MEDICARE WHEN DRUG)
J3070.................... INJECTION, PENTAZOCINE, 30 MG
J3100.................... INJECTION, TENECTEPLASE, 50MG
J3105.................... INJECTION, TERBUTALINE SULFATE, UP TO 1 MG
J3120.................... INJECTION, TESTOSTERONE ENANTHATE, UP TO 100
MG
J3130.................... INJECTION, TESTOSTERONE ENANTHATE, UP TO 200
MG
J3140.................... INJECTION, TESTOSTERONE SUSPENSION, UP TO 50
MG
J3150.................... INJECTION, TESTOSTERONE PROPIONATE, UP TO 100
MG
J3230.................... INJECTION, CHLORPROMAZINE HCL, UP TO 50 MG
J3240.................... INJECTION, THYROTROPIN ALPHA, 0.9 MG,
PROVIDED IN 1.1 MG VIAL
J3245.................... INJECTION, TIROFIBAN HYDROCHLORIDE, 12.5 MG
J3250.................... INJECTION, TRIMETHOBENZAMIDE HCL, UP TO 200
MG
J3260.................... INJECTION, TOBRAMYCIN SULFATE, UP TO 80 MG
J3265.................... INJECTION, TORSEMIDE, 10 MG/ML
J3280.................... INJECTION, THIETHYLPERAZINE MALEATE, UP TO 10
MG
J3301.................... INJECTION, TRIAMCINOLONE ACETONIDE, PER 10 MG
J3302.................... INJECTION, TRIAMCINOLONE DIACETATE, PER 5 MG
J3303.................... INJECTION, TRIAMCINOLONE HEXACETONIDE, PER 5
MG
J3305.................... INJECTION, TRIMETREXATE GLUCURONATE, PER 25
MG
J3315.................... INJECTION, TRIPTORELIN PAMOATE, 3.75 MG
J3320.................... INJECTION, SPECTINOMYCIN DIHYDROCHLORIDE, UP
TO 2 GM
J3360.................... INJECTION, DIAZEPAM, UP TO 5 MG
J3364.................... INJECTION, UROKINASE, 5000 I.U. VIAL
J3365.................... INJECTION, IV, UROKINASE, 250,000 I.U. VIAL
J3370.................... INJECTION, VANCOMYCIN HCL, 500 MG
J3395.................... INJECTION, VERTEPORFIN, 15 MG
J3410.................... INJECTION, HYDROXYZINE HCL, UP TO 25 MG
J3420.................... INJECTION, VITAMIN B-12 CYANOCOBALAMIN, UP TO
1000 MCG
J3430.................... INJECTION, PHYTONADIONE (VITAMIN K), PER 1 MG
J3475.................... INJECTION, MAGNESIUM SULFATE, PER 500 MG
J3480.................... INJECTION, POTASSIUM CHLORIDE, PER 2 MEQ
[[Page 50450]]
J3485.................... INJECTION, ZIDOVUDINE, 10 MG
J3487.................... INJECTION, ZOLEDRONIC ACID, 1 MG
J7030.................... INFUSION, NORMAL SALINE SOLUTION , 1000 CC
J7040.................... INFUSION, NORMAL SALINE SOLUTION, STERILE
(500 ML=1 UNIT)
J7042.................... 5 percent DEXTROSE/NORMAL SALINE (500 ML = 1
UNIT)
J7050.................... INFUSION, NORMAL SALINE SOLUTION, 250 CC
J7051.................... STERILE SALINE OR WATER, UP TO 5 CC
J7060.................... 5 percent DEXTROSE/WATER (500 ML = 1 UNIT)
J7070.................... INFUSION, D5W, 1000 CC
J7100.................... INFUSION, DEXTRAN 40, 500 ML
J7110.................... INFUSION, DEXTRAN 75, 500 ML
J7120.................... RINGERS LACTATE INFUSION, UP TO 1000 CC
J7130.................... HYPERTONIC SALINE SOLUTION, 50 OR 100 MEQ, 20
CC VIAL
J7190.................... FACTOR VIII (ANTIHEMOPHILIC FACTOR, HUMAN)
PER I.U.
J7191.................... FACTOR VIII (ANTIHEMOPHILIC FACTOR
(PORCINE)), PER I.U.
J7192.................... FACTOR VIII (ANTIHEMOPHILIC FACTOR,
RECOMBINANT) PER I.U.
J7193.................... FACTOR IX (ANTIHEMOPHILIC FACTOR, PURIFIED,
NON-RECOMBINANT) PER I.U.
J7194.................... FACTOR IX, COMPLEX, PER I.U.
J7195.................... FACTOR IX (ANTIHEMOPHILIC FACTOR,
RECOMBINANT) PER I.U.
J7197.................... ANTITHROMBIN III (HUMAN), PER I.U.
J7198.................... ANTI-INHIBITOR, PER I.U.
J7310.................... GANCICLOVIR, 4.5 MG, LONG-ACTING IMPLANT
J7317.................... SODIUM HYALURONATE, PER 20 TO 25 MG DOSE FOR
INTRA-ARTICULAR INJECTION
J7320.................... HYLAN G-F 20, 16 MG, FOR INTRA ARTICULAR
INJECTION
J7330.................... AUTOLOGOUS CULTURED CHONDROCYTES, IMPLANT
J7340.................... DERMAL AND EPIDERMAL TISSUE OF HUMAN ORIGIN,
WITH OR WITHOUT BIOENGINEERED OR
J7342.................... DERMAL TISSUE, OF HUMAN ORIGIN, WITH OR
WITHOUT OTHER BIOENGINEERED OR
J7500.................... AZATHIOPRINE, ORAL, 50 MG
J7501.................... AZATHIOPRINE, PARENTERAL, 100 MG
J7502.................... CYCLOSPORINE, ORAL, 100 MG
J7504.................... LYMPHOCYTE IMMUNE GLOBULIN, ANTITHYMOCYTE
GLOBULIN, EQUINE, PARENTERAL, 250 MG
J7505.................... MUROMONAB-CD3, PARENTERAL, 5 MG
J7506.................... PREDNISONE, ORAL, PER 5 MG
J7507.................... TACROLIMUS, ORAL, PER 1 MG
J7508.................... TACROLIMUS, ORAL, PER 5 MG
J7509.................... METHYLPREDNISOLONE ORAL, PER 4 MG
J7510.................... PREDNISOLONE ORAL, PER 5 MG
J7511.................... LYMPHOCYTE IMMUNE GLOBULIN, ANTITHYMOCYTE
GLOBULIN, RABBIT, PARENTERAL, 25 MG
J7513.................... DACLIZUMAB, PARENTERAL, 25 MG
J7515.................... CYCLOSPORINE, ORAL, 25 MG
J7516.................... CYCLOSPORIN, PARENTERAL, 250 MG
J7517.................... MYCOPHENOLATE MOFETIL, ORAL, 250 MG
J7520.................... SIROLIMUS, ORAL, 1 MG
J7525.................... TACROLIMUS, PARENTERAL, 5 MG
J7599.................... IMMUNOSUPPRESSIVE DRUG, NOT OTHERWISE
CLASSIFIED
J7608.................... ACETYLCYSTEINE, INHALATION SOLUTION
ADMINISTERED THROUGH DME, UNIT DOSE FORM,
PER GRAM
J7618.................... ALBUTEROL, ALL FORMULATIONS INCLUDING
SEPARATED ISOMERS, INHALATION SOLUTION
ADMINISTERED THROUGH DME, CONCENTRATED FORM,
PER 1 MG (ALBUTEROL) OR PER 0.5 MG
(LEVALBUTEROL)
J7619.................... ALBUTEROL, ALL FORMULATIONS INCLUDING
SEPARATED ISOMERS, INHALATION SOLUTION
ADMINISTERED THROUGH DME, UNIT DOSE, PER 1
MG (ALBUTEROL) OR PER 0.5 MG (LEVALBUTEROL)
J7626.................... BUDESONIDE INHALATION SOLUTION, ADMINISTERED
THROUGH DME, UNIT DOSE FORM, 0.25 TO 0.50 MG
J7628.................... BITOLTEROL MESYLATE, INHALATION SOLUTION
ADMINISTERED THROUGH DME, CONCENTRATED FORM,
PER MILLIGRAM
J7631.................... CROMOLYN SODIUM, INHALATION SOLUTION
ADMINISTERED THROUGH DME, UNIT DOSE FORM,
PER 10 MILLIGRAMS
J7639.................... DORNASE ALPHA, INHALATION SOLUTION
ADMINISTERED THROUGH DME, UNIT DOSE FORM,
PER MILLIGRAM
J7644.................... IPRATROPIUM BROMIDE, INHALATION SOLUTION
ADMINISTERED THROUGH DME, UNIT DOSE FORM,
PER MILLIGRAM
J7648.................... ISOETHARINE HCL, INHALATION SOLUTION
ADMINISTERED THROUGH DME, CONCENTRATED FORM,
PER MILLIGRAM
J7649.................... ISOETHARINE HCL, INHALATION SOLUTION
ADMINISTERED THROUGH DME, UNIT DOSE FORM,
PER MILLIGRAM
J7668.................... METAPROTERENOL SULFATE, INHALATION SOLUTION
ADMINISTERED THROUGH DME, CONCENTRATED FORM,
PER 10 MILLIGRAMS
J7669.................... METAPROTERENOL SULFATE, INHALATION SOLUTION
ADMINISTERED THROUGH DME, UNIT DOSE FORM,
PER 10 MILLIGRAMS
J7682.................... TOBRAMYCIN, UNIT DOSE FORM, 300 MG,
INHALATION SOLUTION, ADMINISTERED THROUGH
DME
J7699.................... NOC DRUGS, INHALATION SOLUTION ADMINISTERED
THROUGH DME
J8499.................... PRESCRIPTION DRUG, ORAL, NON
CHEMOTHERAPEUTIC, NOS
J8510.................... BUSULFAN; ORAL, 2 MG
J8520.................... CAPECITABINE, ORAL, 150 MG
J8521.................... CAPECITABINE, ORAL, 500 MG
J8530.................... CYCLOPHOSPHAMIDE; ORAL, 25 MG
J8560.................... ETOPOSIDE; ORAL, 50 MG
J8600.................... MELPHALAN; ORAL, 2 MG
J8610.................... METHOTREXATE; ORAL, 2.5 MG
J8700.................... TEMOZOLMIDE, ORAL, 5 MG
J8999.................... PRESCRIPTION DRUG, ORAL, CHEMOTHERAPEUTIC,
NOS
J9000.................... DOXORUBICIN HCL, 10 MG
J9001.................... DOXORUBICIN HYDROCHLORIDE, ALL LIPID
FORMULATIONS, 10 MG
J9010.................... ALEMTUZUMAB, 10 MG
J9015.................... ALDESLEUKIN, PER SINGLE USE VIAL
J9017.................... ARSENIC TRIOXIDE, 1MG
J9020.................... ASPARAGINASE, 10,000 UNITS
J9031.................... BCG (INTRAVESICAL) PER INSTILLATION
J9040.................... BLEOMYCIN SULFATE, 15 UNITS
J9045.................... CARBOPLATIN, 50 MG
[[Page 50451]]
J9050.................... CARMUSTINE, 100 MG
J9060.................... CISPLATIN, POWDER OR S0LUTION, PER 10 MG
J9062.................... CISPLATIN, 50 MG
J9065.................... INJECTION, CLADRIBINE, PER 1 MG
J9070.................... CYCLOPHOSPHAMIDE, 100 MG
J9080.................... CYCLOPHOSPHAMIDE, 200 MG
J9090.................... CYCLOPHOSPHAMIDE, 500 MG
J9091.................... CYCLOPHOSPHAMIDE, 1.0 GRAM
J9092.................... CYCLOPHOSPHAMIDE, 2.0 GRAM
J9093.................... CYCLOPHOSPHAMIDE, LYOPHILIZED, 100 MG
J9094.................... CYCLOPHOSPHAMIDE, LYOPHILIZED, 200 MG
J9095.................... CYCLOPHOSPHAMIDE, LYOPHILIZED, 500 MG
J9096.................... CYCLOPHOSPHAMIDE, LYOPHILIZED, 1.0 GRAM
J9097.................... CYCLOPHOSPHAMIDE, LYOPHILIZED, 2.0 GRAM
J9100.................... CYTARABINE, 100 MG
J9110.................... CYTARABINE, 500 MG
J9120.................... DACTINOMYCIN, 0.5 MG
J9130.................... DACARBAZINE, 100 MG
J9140.................... DACARBAZINE, 200 MG
J9150.................... DAUNORUBICIN, 10 MG
J9151.................... DAUNORUBICIN CITRATE, LIPOSOMAL FORMULATION,
10 MG
J9160.................... DENILEUKIN DIFTITOX, 300 MCG
J9165.................... DIETHYLSTILBESTROL DIPHOSPHATE, 250 MG
J9170.................... DOCETAXEL, 20 MG
J9180.................... EPIRUBICIN HYDROCHLORIDE, 50 MG
J9181.................... ETOPOSIDE, 10 MG
J9182.................... ETOPOSIDE, 100 MG
J9185.................... FLUDARABINE PHOSPHATE, 50 MG
J9190.................... FLUOROURACIL, 500 MG
J9200.................... FLOXURIDINE, 500 MG
J9201.................... GEMCITABINE HCL, 200 MG
J9202.................... GOSERELIN ACETATE IMPLANT, PER 3.6 MG
J9206.................... IRINOTECAN, 20 MG
J9208.................... IFOSFAMIDE, 1 GM
J9209.................... MESNA, 200 MG
J9211.................... IDARUBICIN HYDROCHLORIDE, 5 MG
J9212.................... INJECTION, INTERFERON ALFACON-1, RECOMBINANT,
1 MCG
J9213.................... INTERFERON, ALFA-2A, RECOMBINANT, 3 MILLION
UNITS
J9214.................... INTERFERON, ALFA-2B, RECOMBINANT, 1 MILLION
UNITS
J9215.................... INTERFERON, ALFA-N3, (HUMAN LEUKOCYTE
DERIVED), 250,000 IU
J9216.................... INTERFERON, GAMMA 1-B, 3 MILLION UNITS
J9217.................... LEUPROLIDE ACETATE (FOR DEPOT SUSPENSION),
7.5 MG
J9218.................... LEUPROLIDE ACETATE, PER 1 MG
J9219.................... LEUPROLIDE ACETATE IMPLANT, 65 MG
J9230.................... MECHLORETHAMINE HYDROCHLORIDE, (NITROGEN
MUSTARD), 10 MG
J9245.................... INJECTION, MELPHALAN HYDROCHLORIDE, 50 MG
J9250.................... METHOTREXATE SODIUM, 5 MG
J9260.................... METHOTREXATE SODIUM, 50 MG
J9265.................... PACLITAXEL, 30 MG
J9266.................... PEGASPARGASE, PER SINGLE DOSE VIAL
J9268.................... PENTOSTATIN, PER 10 MG
J9270.................... PLICAMYCIN, 2.5 MG
J9280.................... MITOMYCIN, 5 MG
J9290.................... MITOMYCIN, 20 MG
J9291.................... MITOMYCIN, 40 MG
J9293.................... INJECTION, MITOXANTRONE HYDROCHLORIDE, PER 5
MG
J9300.................... GEMTUZUMAB OZOGAMICIN, 5MG
J9310.................... RITUXIMAB, 100 MG
J9320.................... STREPTOZOCIN, 1 GM
J9340.................... THIOTEPA, 15 MG
J9350.................... TOPOTECAN, 4 MG
J9355.................... TRASTUZUMAB, 10 MG
J9357.................... VALRUBICIN, INTRAVESICAL, 200 MG
J9360.................... VINBLASTINE SULFATE, 1 MG
J9370.................... VINCRISTINE SULFATE, 1 MG
J9375.................... VINCRISTINE SULFATE, 2 MG
J9380.................... VINCRISTINE SULFATE, 5 MG
J9390.................... VINORELBINE TARTRATE, PER 10 MG
J9600.................... PORFIMER SODIUM, 75 MG
P9041.................... INFUSION, ALBUMIN (HUMAN), 5percent, 50 ML
P9043.................... INFUSION, PLASMA PROTEIN FRACTION (HUMAN),
5percent, 50 ML
P9045.................... INFUSION, ALBUMIN (HUMAN), 5percent, 250 ML
P9046.................... INFUSION, ALBUMIN (HUMAN), 25percent, 20 ML
P9047.................... INFUSION, ALBUMIN (HUMAN), 25percent, 50 ML
P9048.................... INFUSION, PLASMA PROTEIN FRACTION (HUMAN),
5percent, 250ML
Q0136.................... INJECTION, EPOETIN ALPHA, (FOR NON ESRD USE),
PER 1000 UNITS
Q0163.................... DIPHENHYDRAMINE HYDROCHLORIDE, 50 MG, ORAL,
FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR
USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR
AN IV ANTI-EMETIC AT TIME OF CHEMOTHERAPY
TREATMENT NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0164.................... PROCHLORPERAZINE MALEATE, 5 MG, ORAL, FDA
APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE
AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN
IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
[[Page 50452]]
Q0165.................... PROCHLORPERAZINE MALEATE, 10 MG, ORAL, FDA
APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE
AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN
IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0166.................... GRANISETRON HYDROCHLORIDE, 1 MG, ORAL, FDA
APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE
AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN
IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 24 HOUR DOSAGE
REGIMEN
Q0167.................... DRONABINOL, 2.5 MG, ORAL, FDA APPROVED
PRESCRIPTION ANTI-EMETIC, FOR USE AS A
COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV
ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0168.................... DRONABINOL, 5 MG, ORAL, FDA APPROVED
PRESCRIPTION ANTI-EMETIC, FOR USE AS A
COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV
ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0169.................... PROMETHAZINE HYDROCHLORIDE, 12.5 MG, ORAL,
FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR
USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR
AN IV ANTI-EMETIC AT THE TIME OF
CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48
HOUR DOSAGE REGIMEN
Q0170.................... PROMETHAZINE HYDROCHLORIDE, 25 MG, ORAL, FDA
APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE
AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN
IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0171.................... CHLORPROMAZINE HYDROCHLORIDE, 10 MG, ORAL,
FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR
USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR
AN IV ANTI-EMETIC AT THE TIME OF
CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48
HOUR DOSAGE REGIMEN
Q0172.................... CHLORPROMAZINE HYDROCHLORIDE, 25 MG, ORAL,
FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR
USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR
AN IV ANTI-EMETIC AT THE TIME OF
CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48
HOUR DOSAGE REGIMEN
Q0173.................... TRIMETHOBENZAMIDE HYDROCHLORIDE, 250 MG,
ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC,
FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE
FOR AN IV ANTI-EMETIC AT THE TIME OF
CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 48
HOUR DOSAGE REGIMEN
Q0174.................... THIETHYLPERAZINE MALEATE, 10 MG, ORAL, FDA
APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE
AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN
IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0175.................... PERPHENAZINE, 4 MG, ORAL, FDA APPROVED
PRESCRIPTION ANTI-EMETIC, FOR USE AS A
COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV
ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0176.................... PERPHENAZINE, 8MG, ORAL, FDA APPROVED
PRESCRIPTION ANTI-EMETIC, FOR USE AS A
COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV
ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0177.................... HYDROXYZINE PAMOATE, 25 MG, ORAL, FDA
APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE
AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN
IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0178.................... HYDROXYZINE PAMOATE, 50 MG, ORAL, FDA
APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE
AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN
IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0179.................... ONDANSETRON HYDROCHLORIDE 8 MG, ORAL, FDA
APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE
AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN
IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0180.................... DOLASETRON MESYLATE, 100 MG, ORAL, FDA
APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE
AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN
IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 24 HOUR DOSAGE
REGIMEN
Q0181.................... UNSPECIFIED ORAL DOSAGE FORM, FDA APPROVED
PRESCRIPTION ANTI-EMETIC, FOR USE AS A
COMPLETE THERAPEUTIC SUBSTITUTE FOR A IV
ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY
TREATMENT, NOT TO EXCEED A 48 HOUR DOSAGE
REGIMEN
Q0183.................... DERMAL TISSUE, OF HUMAN ORIGIN, WITH AND
WITHOUT OTHER BIOENGINEERED OR
Q0187.................... FACTOR VIIA (COAGULATION FACTOR, RECOMBINANT)
PER 1.2 MG
Q2022.................... VON WILLEBRAND FACTOR COMPLEX, HUMAN, PER IU
Q3025.................... INJECTION, INTERFERON BETA-1A, 11 MCG FOR
INTRAMUSCULAR USE
Q4052.................... INJECTION, OCTREOTIDE, DEPOT FORM FOR
INTRAMUSCULAR INJECTION, 1 MG
Q4053.................... INJECTION, PEGFILGRASTIM, PER 1 MG
Q9920.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 20 OR LESS
Q9921.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 21
Q9922.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 22
Q9923.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 23
Q9924.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 24
Q9925.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 25
Q9926.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 26
Q9927.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 27
Q9928.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 28
Q9929.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 29
Q9930.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 30
Q9931.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 31
Q9932.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 32
Q9933.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 33
Q9934.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 34
Q9935.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 35
Q9936.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 36
Q9937.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 37
Q9938.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 38
Q9939.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 39
Q9940.................... INJECTION OF EPO, PER 1000 UNITS, AT PATIENT
HCT OF 40 OR ABOVE
------------------------------------------------------------------------
* Under HIPAA, pharmacies must use NDC codes, not HCPCS codes, to bill
for drugs effective October 16, 2003.
[FR Doc. 03-21308 Filed 8-15-03; 1:35 pm]
BILLING CODE 4120-01-P