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22 February 2009
Barry M. Straube, MD
Director and Chief Clinical Officer
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
Mail Stop S3-02-01
7500 Security Boulevard
Baltimore, MD 21244
Dear Doctor Straube:
We are writing on behalf of the Connecticut Oncology Association (CtOA), the
Hematology Oncology Managers of New York (HOMny), the New York State Society
Medical Oncologists & Hematologists (NYSSMOH) and the Upstate New York Society
of Medical Oncology Hematology (UNYSMOH) to request that the Centers for
Medicare & Medicaid Services and National Government Services (NGS), an A/B
Medicare Administrative Contractor, reconsider and rescind the application of
limitations on use of injectable medications when an oral equivalent is
available in the oncology setting.
While we understand the intent of this policy, the complexity and logistics of
cancer care make a blanket application of this policy both contrary to the
interests of Medicare patients and to national Medicare policy. It also takes
the treatment decision for the individual patient out of the hands of the
attending Oncologist.
Background: On January 13, 2009, NGS posted the following announcement on its
web site:
Use of Injectable Medications When an Oral Equivalent is Available
National Government Services would like to remind providers that the use of
injectable medications when an oral form of the same medication is available
must meet medical necessity requirements for use of the drug, and for the route
of administration. Documentation should indicate that the patient was unable to
tolerate the oral preparation prior to initiation of the intravenous form of the
medication. An example is a failed course of the oral anti-emetic before
starting an intravenous form of the same anti-emetic. Instruction regarding this
topic is from the Centers for Medicare & Medicaid Services (CMS) and is a
national not a local determination.
References Noted by NGS and CMS: The Medicare Benefit Policy Manual, CMS
Publication 100-2, Chapter 15, Section 50.2 & 50.5.4 National Government
Services Local Coverage Determination Supplemental Instruction Article for Drugs
and Biologicals, Coverage of, for Label and Off-Label Uses - Supplemental
Instructions Article (A44930) As noted in the announcement, NGS takes the
position that this policy – under which intravenous drugs, including
anti-emetics will ordinarily not be covered by Medicare – is mandated by
provisions of the Medicare Benefit Policy Manual that were issued in 2005. NGS
cites section 50.5.4 of the Manual, but this section does not support its
position. This provision relates to Part B coverage of oral antiemetics when
they are a “full replacement” for intravenous antiemetics. It provides that,
notwithstanding the “full replacement” requirement, Medicare will cover
supplemental intravenous antiemetics if the oral antiemetics were ineffective.
Section 50.2.A, K of the Manual, also cited by NGS, provides that the route of
administration must be medically reasonable and necessary. It states further
that “if a drug is available in both oral and injectable forms, the injectable
form of the drug must be reasonable and necessary as to using the oral form.” We
do not believe that this language was intended to deny coverage to injectable
drugs whenever an oral version exists. Instead, we believe that his language is
intended to reflect the policy stated in section 50.4.3: Medication given by
injection (parenterally) is not covered if standard medical practice indicates
that the administration of the medication by mouth (orally) is effective and is
an accepted or preferred method of administration for that particular patient.
In the case of antiemetics administered in conjunction with anticancer
chemotherapy, the standard practice is to use IV antiemetics for moderately and
highly emetogenic chemotherapy combinations, although oral antiemetics may
sometimes be used instead. In fact, in Section 50.3 of Chapter 15 of the Claims
Processing Manual states that the weight of whether or not any drug should be
denied by Part B as self-administered is whether ≥ 50% of Medicare beneficiaries
are receiving that Medication in a self-administered form. This is not the case
with almost all antiemetics and cancer drugs where two forms are available.
Early and effective management of nausea and vomiting is critical to a
successful course of treatment. Successful management of these side effects and
symptoms caused by the toxic nature of individual and combination therapies has
helped patients to tolerate more dose dense treatments and contributed to the
decline of cancer death rates. Indeed, the cancer death rate has been steadily
declining since the early 1990s. The American Cancer Society reported in
February 2008 that death rates from all cancers combined peaked in 1990 for men
and 1991 for women. Between1990/1991 and 2004, death rates from cancer decreased
18.4 percent for men and 10.5 percent for women. Coincidentally, during this
same time, the treatment and management of cancer has evolved from the hospital
setting (predominant before DRGs in 1984) into the physician office setting. By
2001, over 80% of all cancer was being treated in the community physician office
setting; in addition the use of IV antiemetics allowed better compliance with
the completion of chemotherapy prescribed.
Clarification Needed: The physician’s standard for care in these offices for
management of nausea and vomiting is determined not only by whether IV or oral
forms of the medications exist, but also is based upon the individual patient’s
tolerance for the treatment and management of the side effects, as well as the
interactions and composition of all the drugs involved in the treatment.
Frequently, failure in management of nausea and vomiting can affect the
patient’s health status and state of mind, especially when embarking upon a
treatment regimen involving multiple cycles. Clarification is needed by CMS as
to whether their intention is to insist upon use of oral when the physician’s
judgment and patient history suggest that use of the infusion version of a given
drug,. This may mean that therapy will be interrupted due to lack of tolerance
by patients, who become dehydrated or have intractable vomiting. This may lead
to higher costs to the Medicare program due to the stopping and starting of
therapies. The following are just some of the examples where an absolute
application of the assumption that a clinically equivalent oral can be readily
substituted for an IV version is likely to cause disruption in the care and
treatment of Medicare patients, and therefore should justify use of appropriate
physician judgment at the time of care delivery. We request clarification of the
intent and application of this policy in the following settings:
• Multiple cycles of therapy – if a patient has failed use of an oral on the
first line of therapy, they will have already experienced the impact that nausea
and vomiting can have on their lives. Common medical practice is to not risk
further disruption of care with additional failures, or even the onset of
anticipatory nausea and vomiting – a common occurrence for cancer patients, and
thus to use IV treatments in subsequent cycles.
• Anticipatory nausea - Shall anticipatory nausea be identified as an
appropriate “medically necessary” justification for use of IV antiemetics?
• Complex combination regimens – many chemotherapy regimens constitute multiple
complex and highly emetogenic drugs and the preparation for these regimens can
also involve multiple supportive care drugs, some of which may have both IV and
oral versions. In a vacuum, it is easy to consider the effect and uptake for a
single isolated drug. However, chemotherapy is not delivered in a vacuum and
many regimens have been built with a standard of care that involves multiple IV
versions of a variety of different drugs. The timing and anticipated uptake of
the effect of these drugs has been carefully developed and balanced for the most
medically effective impact of that regimen.
CMS overstepping authorization – We are concerned that the application of this
policy in the cancer disease state may represent a situation where our local MAC
is entering both into medical decision-making and attempting to circumvent
Medicare law set by Congress by limiting payment for appropriately indicated
Part B drugs administered in a physicians office to the least costly
alternative. No other MAC has a similar policy, nor have any been drafted that
are as sweeping as this one.
A federal court ruling on October 16 has already found that Medicare law does
not authorize CMS or the contractors to redefine payment rates or policy that
have already been set statutorily. There are several compendia approved by
Congress to indicate medically appropriate treatment. Those compendia do not
limit use of drugs to one route of administration over another for drugs with
both IV and oral forms for very valid reasons, linked to the medical judgment of
the physician and each individual patient situation. Even the national oncology
guidelines set forth by the American Society of Clinical Oncology (ASCO) and the
National Comprehensive Cancer Network (NCCN) do not limit use of drugs to one
route of administration over another for cancer patients.
Recommendation and request: It is our recommendation that this policy be
exempted for drugs involved in the treatment and management of cancer. Our local
MAC, NGS, has attempted to create this limitation without regard for the medical
complications of such a policy, and without regard for their authority to create
limitations for covered items and services as determined by Congress.
Because the appropriate use of drugs is clearly defined through FDA indication
as well as the authorized compendia for Medicare coverage, CMS has created a
limitation that is inappropriate, particularly in the treatment of cancer. As
U.S. District Judge Henry H. Kennedy Jr. wrote in the ruling set forth October
16 from the U.S. District Court for the District of Columbia, “It does not make
sense to conclude that Congress, having minutely detailed the reimbursement
rates for covered items and services, intended that the secretary could ignore
these formulas whenever [he or she] determined that the expense of an item or
service was not reasonably necessary…There is no indication that Congress
intended to confer such broad authority.”
Respectfully yours,
For the Connecticut Oncology Association:
Steven C. Lattanzi, MD President,
Dawn Holcombe, Executive Director
Tel: 860-305-4510
Email: dawnho@aol.com
For the Hematology Oncology Managers of New York:
Abe Moshel, President
Patricia A. Kaden, Vice President
Tel: 516-921-5533
Email: PatMedOnc@aol.com
For the New York State Society Medical Oncologists & Hematologists
Abe Mittelman, MD, President ,
Tel: 914-681-0025
Email: mittens4@aol.com
Florence Madonia, Executive Director
For the Upstate New York Society of Medical Oncology Hematology
John Poggi, MD, President
Tel: 315-788-7990
Email: johnpoggi@hotmail.com
Nancy Izzo, Executive Director
Cc: American Society of Clinical Oncology
Community Oncology Alliance
Dr. Paul Deutsch, National Government Services
Nancy Davenport-Ennis, Patient Advocate Foundation
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