The following article was posted in the Wall Street Journal and includes quotes by NYSSMOH past president Seymour M. Cohen, MD
Doctors from across the country were invited to the White House on Oct. 5, but the president did most of the talking. Medical professionals are being ignored or vilified more often than consulted in the current health-care reform debate. To broaden the discussion, the Committee to Reduce Infection Deaths invited 16 highly regarded physicians to convene at the Grand Hyatt in New York City on Oct. 19 to reflect on the current legislative proposals. Here's what they had to say on four key issues.
OCTOBER 28, 2009, 7:34 P.M. EDoctors on Health-Care Reform 'Government is in the process of duplicating everything that managed care did for the last 15 years that was reviled by everybody.'By BETSY MCCAUGHEY
Government-Imposed Treatment GuidelinesDr. Jeffrey Borer, cardiologist, named to Castle Connolly's "America's Top Doctors": "What's the impact of guidelines on the doctor-patient relationship? Guidelines step in between the doctor and the patient. If it's necessary to respond to guidelines rather than what you see, feel and hear when you're evaluating a person, then perhaps you're going to do something that isn't really the right thing. There really isn't an average patient. Every person that you see with a medical problem has some unusual or unique characteristic and this often has to be considered in dealing with the problem."
Dr. David Fields, obstetrician and gynecologist, Lenox Hill Hospital, New York: "They tend to forbid better-than-average medical care; guidelines are always average medical care . . . they tend to cramp the physician who can do better than average."
Dr. Borer: "One of the more common problems that people have as they get older is a disease called aortic stenosis. . . . [W]e can relieve that aortic stenosis with an operation with really very acceptable safety, low mortality rates . . . if that 85-year-old cannot walk down the street because he or she is too breathless to do so . . . or feels light-headed or could faint and break a hip . . . then there is really a very good justification for offering the therapy."
Dr. Richard Amerling, nephrologist, Beth Israel Medical Center, New York: "The example that you give of valve surgery in an 85-year-old is just not going to happen under [White House health care adviser] Ezekiel Emanuel. He's going to just say that that's a nonstarter. That person has outlived their useful years, no matter how long they could live beyond that."
Dr. Borer: "What we're hearing from the president's medical advisers is that what we have is good enough and we really shouldn't be wanting or expecting any more."
Dr. Seymour Cohen, oncologist, named to "America's Top Doctors": "When we went to medical school, people used to die at 66, 67 and 68. Medicare paid for two or three years. Social Security paid for two or three years. We're the bad guys. We're responsible for keeping people alive to 85. So we're now going to try to change health care because people are living too long. It just doesn't make very good sense to me."
Shifting Resources From Specialty to Primary CareDr. Cohen: "Let's talk about specialization for a moment. . . . We don't go to our general attorney when we have a patent problem, but they're telling us to do this now in medicine. We have different types of engineers, even journalists. There's a financial writer, there's a sportswriter . . . . Now in health care we're telling everybody, 'you just go to the guy who's your general doc. He's going to know everything and maybe we'll find a specialist for you if the panel decides maybe you're sick enough to need a specialist.' It really doesn't make sense at all."
Dr. Jeffrey Moses, interventional cardiologist, named to "America's Top Doctors": "If you have heart failure or heart attack or coronaries in general in the hospital you need to be treated by a cardiologist. Study after study shows that . . . when you have an illness and you want to have an accurate diagnosis and the most up-to-date and accurate treatment, you want a specialist."
Patient PrivacyDr. Samuel Guillory, ophthalmologist, refractive and orbital surgery, named to Castle Connolly's "New York's Top Doctors": "We're being asked by the executive branch . . . to break the code with patients and deliver all their records into electronic medical records . . . ."
Cost-Cutting MethodsDr. Fields: "Government is in the process of duplicating everything that managed care did for the last 15 years that was reviled by everybody and which we fought very hard to overcome, The courts finally said 'You can't have withholds, you can't pay people to deny care. You can't have gag rules.' The government is in the process of doing all that. Massachusetts is about to establish capitation [a fixed payment remitted at regular intervals to a medical provider] as the rule of the state. Capitation was the wort thing that ever happened to medical care."
Dr. Joel Kassimir, dermatologist, Mt. Sinai Hospital, New York: "We're now being told by physicians advising the president that we take the Hippocratic Oath too seriously."
Dr. Tracy Pfeifer, plastic surgeon, president, New York Regional Society of Plastic Surgeons: "When physicians graduate from medical school we take an oath, the Hippocratic Oath, to do no harm to our patients. It's a very important philosophy to us and we uphold it and hold it very dear to our hearts. Plato, another philosopher, used to say things like 'Those with a poor physical constitution should be allowed to die. The weak and the ill-constituted shall perish.' These government programs that are being proposed I think are very scary in the sense that physicians could be induced to violate the Hippocratic Oath.
"There's a limit to how much of a financial penalty each individual practitioner is going to be able to bear. . . . If the patient is sitting in the examination room with us and they're wondering, 'Is the doctor not ordering a test for me because he's going to get penalized if he does it?' This is a major, major problem for patients and physicians alike."
Ms. McCaughey is chairman of the Committee to Reduce Infection Deaths and a former Lt. Governor of New York State. For a complete transcript of the physicians' meetings, visit www.defendyourhealthcare.us.
New Incyte Drug for Treatment
I thought you would be interested to learn that we have the new Incyte drug for the treatment of patients with large spleens in primary myelofibrosis. This is a randomized trial between the drug and a placebo. You can refer patients to any of us including Gail Roboz, Eric Feldman, Ellen Ritchie, Usuma Georgis, or me. The contact number is (212) 746-2098.
Best regards,
Richard T. Silver, M.D.
Professor of MedicineWeill Cornell Medical College
Past President, NYSSMOH
Best regards,
Richard T. Silver, M.D.
Professor of MedicineWeill Cornell Medical College
Past President, NYSSMOH
"The War on Specialists" -Wall Street Journal
In President Obama's Washington, medical specialists are slightly more popular than the H1N1 virus. Compared to bread-and-butter primary care doctors, specialists cost more to train and make more use of expensive procedures and technology—and therefore cost the government more money. Even so, the quiet war Democrats are waging on specialists is astonishing.
From Senate Finance Chairman Max Baucus's health-care bill to changes the Administration is pushing in Medicare, Democrats are systematically attacking specific medical fields like cardiology and oncology. With almost no scrutiny, they're trying to engineer a "cheaper" system so that government can afford to buy health care for all—even if the price is fewer and less innovative ways of extending and improving lives.
FOR THE FULL ARTICLE LINK BELOW
http://online.wsj.com/article_email/SB10001424052748704471504574443472658898710-lMyQjAxMDA5MDAwOTEwNDkyWj.html
From Senate Finance Chairman Max Baucus's health-care bill to changes the Administration is pushing in Medicare, Democrats are systematically attacking specific medical fields like cardiology and oncology. With almost no scrutiny, they're trying to engineer a "cheaper" system so that government can afford to buy health care for all—even if the price is fewer and less innovative ways of extending and improving lives.
FOR THE FULL ARTICLE LINK BELOW
http://online.wsj.com/article_email/SB10001424052748704471504574443472658898710-lMyQjAxMDA5MDAwOTEwNDkyWj.html
Phase II study Evaluating Tamibarotene
July 16, 2009
Dear Colleagues:
NorthShore University Hospital is participating in a Phase II study for adult patients with relapsed or refractory acute promyelocytic leukemia (APL) who have been previously treated with ATRA & Arsenic Trioxide. The trial is evaluating Tamibarotene, an orally administered synthetic retinoid. In vitro studies show that Tamibarotene does not substantially bind to CRABP, suggesting possible therapeutic efficacy in patients with ATRA-resistant APL.
If you have any patients that might benefit from this study or would like further information, please call my office at 516-734-8959.
Sincerely,
Steven L. Allen
Associate Chief, Division of Hematology
NorthShoreUniversityHospital
MonterCancerCenter
Dear Colleagues:
NorthShore University Hospital is participating in a Phase II study for adult patients with relapsed or refractory acute promyelocytic leukemia (APL) who have been previously treated with ATRA & Arsenic Trioxide. The trial is evaluating Tamibarotene, an orally administered synthetic retinoid. In vitro studies show that Tamibarotene does not substantially bind to CRABP, suggesting possible therapeutic efficacy in patients with ATRA-resistant APL.
If you have any patients that might benefit from this study or would like further information, please call my office at 516-734-8959.
Sincerely,
Steven L. Allen
Associate Chief, Division of Hematology
NorthShoreUniversityHospital
MonterCancerCenter
**URGENT Immediate Action Needed!**
Urgent! Immediate Action Needed!
NYSSMOH strongly urges all members to complete the Community Oncology Alliance (COA) Components of Care Study.
CMS has released the 2010 Medicare Physician Fee Schedule. It contains the 21.5% cut to all physician-related payments. It eliminates consultation codes. And the real surprise is a 6% additional cut to medical oncology.
That’s correct — an additional cut of 6% to medical oncology.
The oncologists own (AMA) data was used by CMS to arrive at these cuts. Every practice should complete and return the Components of Care Survey so we have data to refute this. We need to send out the results of the Components of Care Survey to the Congress, Administration, and the press.
Additionally, this is not a final rule — we have a comment period. In short, we need accurate, realistic data or your practice is facing large cuts next year effective 1/1/10.
The link below will direct you to the COA website.
Components of Care Study
Again, NYSSMOH strongly urges all members to complete the Components of Care Survey and forward this email on to your colleagues.
NYSSMOH strongly urges all members to complete the Community Oncology Alliance (COA) Components of Care Study.
CMS has released the 2010 Medicare Physician Fee Schedule. It contains the 21.5% cut to all physician-related payments. It eliminates consultation codes. And the real surprise is a 6% additional cut to medical oncology.
That’s correct — an additional cut of 6% to medical oncology.
The oncologists own (AMA) data was used by CMS to arrive at these cuts. Every practice should complete and return the Components of Care Survey so we have data to refute this. We need to send out the results of the Components of Care Survey to the Congress, Administration, and the press.
Additionally, this is not a final rule — we have a comment period. In short, we need accurate, realistic data or your practice is facing large cuts next year effective 1/1/10.
The link below will direct you to the COA website.
Components of Care Study
Again, NYSSMOH strongly urges all members to complete the Components of Care Survey and forward this email on to your colleagues.
Intravenous Vs Oral Drug Questions & Answers
Disclaimer: The answers to these questions were prepared by National Government Services, to assist the provider community in understanding the coverage and reimbursement for oral and parenteral drugs. These responses reflect NGS’s understanding and implementation of CMS’ instructions, and may or may not reflect the interpretations of other contractors or agencies reviewing claims.
We have received many questions regarding CMS’ policy on the medical necessity and payment for intravenous (IV) preparations of drugs when an oral preparation of the same drug is available and in common use. The following Q&As may provide guidance for correct billing in situations when both preparations of a drug are available.
Q:If an oral anti-emetic drug fails to prevent intra- or post-treatment chemotherapy induced nausea and vomiting (CINV), would an intravenous anti-emetic drug administered at the time of the next treatment session be considered medically necessary?
A:If the oral anti-emetic drug was chosen appropriately and administered in an adequate dosage and failed, we would allow the intravenous form during subsequent treatments. Such claims may be subject to medical review.
Q:Would reimbursement be contingent upon the response to the intravenous anti-emetic medication as compared to the response to the previous oral anti-emetic therapy?
A:No, the reimbursement is not dependent on the result. However, future use of the intravenous medication would require at least a better response to the intravenous anti-emetic than was achieved with the oral formulation.
Q:Would subsequent intravenous treatments be covered based upon a poor initial response to the oral formulation and an improved subsequent response to the intravenous formulation? That is, does the provider need to re-establish that the oral anti-emetic is still ineffective after the initial failure and before each start of the intravenous drug?
A:The patient does not need to fail the oral form with each course of therapy. Subsequent IV courses would be covered.
Q:If a patient has a positive response to intravenous treatment after failure of the oral preparation, does that support medical necessity of the intravenous formulation for that patient only, or for all similar patients?
A:Medical necessity is supported only for the individual patient. Because the intravenous form was necessary in one patient, that does not provide clinical evidence that the IV form will be necessary in all such patients.
Q:If a patient has taken oral anti-emetics prior to presenting for treatment and still experiences pre-treatment nausea, would the provider be reimbursed for intravenous administration of additional anti-emetics at that time?
A:Yes, if the nausea prevented the administration of the additional dose in the oral form. The inability to take oral medication at the time of treatment is considered a medically necessary reason to administer intravenous preparations.
Q:If the IV form of an anti-emetic is medically necessary, would concomitant prophylactic Benadryl and Decadron also be covered if administered intravenously?
A:No, not necessarily. The parenteral administration of any particular drug in place of its oral formulation would not be covered unless it was medically necessary. If the patient were on intravenous anti-emetics without concomitant nausea and/or vomiting, and there was no other medically necessary indication for the use of parenteral Benadryl or Decadron, then the parenteral form of Benadryl and Decadron would not be covered.
Q:Can IV Benadryl be covered in the absence of nausea/vomiting?
A:The IV form can be covered only if the oral form was unable to be ingested or was medically contraindicated for some other reason, or if needed to treat an acute allergic reaction, or recommended in the FDA labeling for the chemotherapy drug, or the scientific medical literature for the administered chemotherapy drug documents that intravenous administration is preferred or required.
Q:Can IV Decadron be covered in the absence of nausea/vomiting?
A:The IV form can be covered only if the oral form was unable to be ingested or was medically contraindicated for some other reason, or if needed to treat an acute allergic reaction, or recommended in the FDA labeling for the chemotherapy drug, or the scientific medical literature for the administered chemotherapy drug documents that intravenous administration is preferred or required.
Q:Under which specific circumstances, other than inability to ingest or swallow oral medications (e.g., physical obstruction of the esophagus or active nausea or vomiting) at the time of, or prior to, chemotherapy treatment can anti-emetics, antihistamines, steroids, or other medications be covered when administered intravenously? Please identify the specific conditions that would be considered “medically necessary.”
A:It is impractical to list every possible medical reason that IV medication would be necessary. It is expected that the attending clinician would be able to determine whether the reason for IV administration is medically necessary rather than for convenience, patient preference, or for financial considerations.
Q: If a patient fails on an oral anti-emetic drug, can the provider be reimbursed if a patient is administered intravenous drugs or must another, different oral drug be tried?
A:The provider may be reimbursed for using the intravenous formulation of the same drug. However, if the provider wishes to use the intravenous formulation of a different drug, then the oral formulation of that different drug must be shown to be ineffective or contraindicated before the IV form is covered.
Q: Will scientific studies of chemotherapy regimens utilizing only intravenous formulations be sufficient to document the medical necessity for IV forms of chemotherapy drugs that exist in both oral and intravenous forms?
A:If studies of chemotherapy treatment regimens were performed using only IV forms of the chemotherapy drug, then the IV form would be covered, since the oral form had not been proven to be effective. However, if studies show that both oral and IV forms are effective, then the IV vs. oral rules would apply.
Q: If the patient develops CINV after administration of an oral anti-emetic (other than Emend), can they receive IV Emend at the next treatment without having first tried oral Emend?
A:No, oral Emend may be more effective in a particular instance than other oral anti-emetics, so the oral formulation of the Emend must be tried before using the intravenous formulation.
We have received many questions regarding CMS’ policy on the medical necessity and payment for intravenous (IV) preparations of drugs when an oral preparation of the same drug is available and in common use. The following Q&As may provide guidance for correct billing in situations when both preparations of a drug are available.
Q:If an oral anti-emetic drug fails to prevent intra- or post-treatment chemotherapy induced nausea and vomiting (CINV), would an intravenous anti-emetic drug administered at the time of the next treatment session be considered medically necessary?
A:If the oral anti-emetic drug was chosen appropriately and administered in an adequate dosage and failed, we would allow the intravenous form during subsequent treatments. Such claims may be subject to medical review.
Q:Would reimbursement be contingent upon the response to the intravenous anti-emetic medication as compared to the response to the previous oral anti-emetic therapy?
A:No, the reimbursement is not dependent on the result. However, future use of the intravenous medication would require at least a better response to the intravenous anti-emetic than was achieved with the oral formulation.
Q:Would subsequent intravenous treatments be covered based upon a poor initial response to the oral formulation and an improved subsequent response to the intravenous formulation? That is, does the provider need to re-establish that the oral anti-emetic is still ineffective after the initial failure and before each start of the intravenous drug?
A:The patient does not need to fail the oral form with each course of therapy. Subsequent IV courses would be covered.
Q:If a patient has a positive response to intravenous treatment after failure of the oral preparation, does that support medical necessity of the intravenous formulation for that patient only, or for all similar patients?
A:Medical necessity is supported only for the individual patient. Because the intravenous form was necessary in one patient, that does not provide clinical evidence that the IV form will be necessary in all such patients.
Q:If a patient has taken oral anti-emetics prior to presenting for treatment and still experiences pre-treatment nausea, would the provider be reimbursed for intravenous administration of additional anti-emetics at that time?
A:Yes, if the nausea prevented the administration of the additional dose in the oral form. The inability to take oral medication at the time of treatment is considered a medically necessary reason to administer intravenous preparations.
Q:If the IV form of an anti-emetic is medically necessary, would concomitant prophylactic Benadryl and Decadron also be covered if administered intravenously?
A:No, not necessarily. The parenteral administration of any particular drug in place of its oral formulation would not be covered unless it was medically necessary. If the patient were on intravenous anti-emetics without concomitant nausea and/or vomiting, and there was no other medically necessary indication for the use of parenteral Benadryl or Decadron, then the parenteral form of Benadryl and Decadron would not be covered.
Q:Can IV Benadryl be covered in the absence of nausea/vomiting?
A:The IV form can be covered only if the oral form was unable to be ingested or was medically contraindicated for some other reason, or if needed to treat an acute allergic reaction, or recommended in the FDA labeling for the chemotherapy drug, or the scientific medical literature for the administered chemotherapy drug documents that intravenous administration is preferred or required.
Q:Can IV Decadron be covered in the absence of nausea/vomiting?
A:The IV form can be covered only if the oral form was unable to be ingested or was medically contraindicated for some other reason, or if needed to treat an acute allergic reaction, or recommended in the FDA labeling for the chemotherapy drug, or the scientific medical literature for the administered chemotherapy drug documents that intravenous administration is preferred or required.
Q:Under which specific circumstances, other than inability to ingest or swallow oral medications (e.g., physical obstruction of the esophagus or active nausea or vomiting) at the time of, or prior to, chemotherapy treatment can anti-emetics, antihistamines, steroids, or other medications be covered when administered intravenously? Please identify the specific conditions that would be considered “medically necessary.”
A:It is impractical to list every possible medical reason that IV medication would be necessary. It is expected that the attending clinician would be able to determine whether the reason for IV administration is medically necessary rather than for convenience, patient preference, or for financial considerations.
Q: If a patient fails on an oral anti-emetic drug, can the provider be reimbursed if a patient is administered intravenous drugs or must another, different oral drug be tried?
A:The provider may be reimbursed for using the intravenous formulation of the same drug. However, if the provider wishes to use the intravenous formulation of a different drug, then the oral formulation of that different drug must be shown to be ineffective or contraindicated before the IV form is covered.
Q: Will scientific studies of chemotherapy regimens utilizing only intravenous formulations be sufficient to document the medical necessity for IV forms of chemotherapy drugs that exist in both oral and intravenous forms?
A:If studies of chemotherapy treatment regimens were performed using only IV forms of the chemotherapy drug, then the IV form would be covered, since the oral form had not been proven to be effective. However, if studies show that both oral and IV forms are effective, then the IV vs. oral rules would apply.
Q: If the patient develops CINV after administration of an oral anti-emetic (other than Emend), can they receive IV Emend at the next treatment without having first tried oral Emend?
A:No, oral Emend may be more effective in a particular instance than other oral anti-emetics, so the oral formulation of the Emend must be tried before using the intravenous formulation.
June 17th, 2009 Message from former President
June 17, 2009Message from former President Richard T. Silver, MD
Dear Colleagues:
I wish to tell you of a very interesting opportunity for your patients that we are conducting at Cornell. Wyeth is sponsoring a drug trial comparing imatinib to their new drug bosutinib in untreated patients with chronic myeloid leukemia. Both drugs will be provided free. This may be of some importance for those patients who have a 10% or 20% deduction or a donor. Bosutinib has been thought to be equally or more effective than imatinib with less toxicity. It has already been used in imatinib-resistant patients with success. If you have such patients, please call 212-746-2098 for anyone in our group in the Leukemia/Myeloproliferative Disease section who are all well-qualified to see such patients.I send my best regards.
Sincerely,
Richard T. Silver, M.D.
Attending PhysicianProfessor of MedicineDirector, Leukemia and Myeloproliferative Center
Dear Colleagues:
I wish to tell you of a very interesting opportunity for your patients that we are conducting at Cornell. Wyeth is sponsoring a drug trial comparing imatinib to their new drug bosutinib in untreated patients with chronic myeloid leukemia. Both drugs will be provided free. This may be of some importance for those patients who have a 10% or 20% deduction or a donor. Bosutinib has been thought to be equally or more effective than imatinib with less toxicity. It has already been used in imatinib-resistant patients with success. If you have such patients, please call 212-746-2098 for anyone in our group in the Leukemia/Myeloproliferative Disease section who are all well-qualified to see such patients.I send my best regards.
Sincerely,
Richard T. Silver, M.D.
Attending PhysicianProfessor of MedicineDirector, Leukemia and Myeloproliferative Center
Providers Beware - Recent Identity Theft Schemes
Protect Your Identity!
If you have recently received a phone call or fax from an alleged contractor employee asking for a “CMS File Update,” please contact the provider enrollment department immediately for verification. If you have responded to an employment opportunity which, in retrospect seems suspicious, again contact the provider enrollment department so the information may be forwarded to the Program Safeguard contractor(PSC). Remember, it takes all of us working together to protect the Medicare Trust Fund.
Common Sense Tips!
1. Perform rigorous research regarding opportunities presented toyou when making application for joint venture opportunities of companies unknown to you.
2. Remove any unnecessary personal identifying information from outgoing correspondence.
3. Do not post your resume on line, especially if it contains any confidential personal identifying information.
4. Remember, no one from Medicare will contact you to verify your Medicare numbers. They already have this information.
5. Don’t leave laptops or other gateways into your personal information unattended.
6. Cancel computer access immediately when anyone leaves your employment.
7. Perform rigorous research regarding the company you intend to work for when applying for employment prior to sharing any personalinformation.
8. Check with your carrier to see what practice locations theyhave listed for you.
9. Contact the OIG Hotline if you suspect you are the victim ofprovider identity theft:
Phone:1-800-HHS-TIPS (1-800-447-8477)
Fax:1-800-223-8164TTY:1-800-377-4950
E-Mail:HHSTips@oig.hhs.gov
Mail:
Office of Inspector GeneralDepartment of Health and Human Services
Attn: HOTLINE
P.O. Box 23489
Washington, DC 20026
If you have recently received a phone call or fax from an alleged contractor employee asking for a “CMS File Update,” please contact the provider enrollment department immediately for verification. If you have responded to an employment opportunity which, in retrospect seems suspicious, again contact the provider enrollment department so the information may be forwarded to the Program Safeguard contractor(PSC). Remember, it takes all of us working together to protect the Medicare Trust Fund.
Common Sense Tips!
1. Perform rigorous research regarding opportunities presented toyou when making application for joint venture opportunities of companies unknown to you.
2. Remove any unnecessary personal identifying information from outgoing correspondence.
3. Do not post your resume on line, especially if it contains any confidential personal identifying information.
4. Remember, no one from Medicare will contact you to verify your Medicare numbers. They already have this information.
5. Don’t leave laptops or other gateways into your personal information unattended.
6. Cancel computer access immediately when anyone leaves your employment.
7. Perform rigorous research regarding the company you intend to work for when applying for employment prior to sharing any personalinformation.
8. Check with your carrier to see what practice locations theyhave listed for you.
9. Contact the OIG Hotline if you suspect you are the victim ofprovider identity theft:
Phone:1-800-HHS-TIPS (1-800-447-8477)
Fax:1-800-223-8164TTY:1-800-377-4950
E-Mail:HHSTips@oig.hhs.gov
Mail:
Office of Inspector GeneralDepartment of Health and Human Services
Attn: HOTLINE
P.O. Box 23489
Washington, DC 20026
"Out Reach" Program 2008-09 We Want To Hear From You!
We want to hear from the practicing Oncologist!
ASCO created the State Affiliate Grant Program in 2005 to provide financial support to its State/Regional Affiliates as they seek to enhance the scope of their activities.
NYSSMOH is a 2008-2009 Grant Recipient . Our project goal is to restructure NYSSMOH to meet the individual needs of our members, their patients, and address the impact of the current economic crisis relative to their geographic area. By evaluating data from your completed questionnaires and discussion at our focus group meetings NYSSMOH can develop, implement and promote a restructuring plan that will focus on providing members with meaningful support.
Our purpose for this grant will be to meet the needs of the practicing Oncologist in 2009. An "Out-Reach" project is being developed and will be promoted to focus on current and ongoing issues related to members specific geographical areas.
Our "Out-Reach program will begin by dividing our localities into three sections.
These sections will be
1. Bronx , Brooklyn, Manhattan
2. Queens, Long Island, Staten Island
3. Rockland County, & Westchester County
Our "Out-Reach program will begin by dividing our localities into three sections.
These sections will be
1. Bronx , Brooklyn, Manhattan
2. Queens, Long Island, Staten Island
3. Rockland County, & Westchester County
The "Out Reach" meetings will be held in September!..
....
Please make sure to check your emails & participate!!
Letter to CMS on March 1st Anti-Emetic Policy
On February 22nd NYSSMOH along with UNYSMOH, HOMny and Connecticut Oncology Association sent a letter to CMS on behalf of all members to address the March 1st Anti-Emetic Policy
22 February 2009
Barry M. Straube, MDDirector 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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