Medicare Updates Its List Of Recognized Sources To Help Make Coverage Decisions For Anti-Cancer Chemotherapy Drugs
Main Category: Medicare / Medicaid / SCHIPAlso Included In: Cancer / Oncology
Article Date: 06 Jun 2008 - 6:00 PDT
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The Centers for Medicare & Medicaid Services (CMS) announced changes to ensure that the most up-to-date information is used to determine which drugs may be covered under Medicare Part B to treat patients undergoing chemotherapy.
CMS will recognize the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium™ as an additional source of information and cease use of the no longer updated or maintained American Medical Association Drug Evaluations (AMA-DE) compendium. Medicare law directs CMS to consider certain listed compendia when deciding whether or not the use of a drug is medically accepted for the treatment of cancer. The law also allows the agency to revise the list. Both of these revisions will be reflected in CMS' Medicare Benefit Policy Manual.
"We use these compendia to ensure that that Medicare beneficiaries can be assured that the Medicare contractors and their physicians have the most up-to-date drug information and the best available treatment options. This is important because today's ever-expanding industry of drug treatments is dynamic, requiring the constant monitoring and assessment of new interventions," said CMS Acting Administrator Kerry Weems.
A compendium is a comprehensive listing of FDA-approved drugs and biologics. In some cases, compendia specialize in a particular subset of drugs, such as those used for anti-cancer treatment. Compendia include a summary of how each drug works in the body, as well as information for health care practitioners about proper dosing and whether the drug is recommended or endorsed for use in treating a specific disease.
The Medicare local contractors, who process and pay Medicare claims and approve coverage for drugs under Medicare Part B, use compendia as one of several tools to determine whether an anti-cancer drug should be covered under Medicare Part B.
Before approving coverage for a drug, contractors look at whether the drug is FDA approved for use in treating the beneficiary's type of cancer in the beneficiary's specific clinical circumstances. In some instances, however, the medical community may have scientific evidence that supports using a drug to treat a disease even if the drug's FDA approved label does not include those clinical conditions. In these instances, certain drug compendia may recommend uses beyond those included in the FDA approved labels.
Over the years, some compendia have merged with other publications or have discontinued updating their entries. In particular, one of the compendia listed in the law, the AMA-DE Compendium, has not been published since 1995.
To ensure that contractors continue to have access to up-to-date drug compendia to make coverage decisions for anti-cancer drugs, CMS created a process to change its compendia reference list. This process included the recommendations from CMS' Medicare Evidence Development & Coverage Advisory Committee, which advised CMS on the factors the Agency should consider when updating the list of compendia. The process also includes a 30-day public comment period.
Today's decision to recognize the NCCN Drugs & Biologics Compendium™ and discontinue use of the AMA-DE Compendium is CMS' first step in updating its compendia reference listing.
For more information about these compendium decisions, please visit the CMS website.
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Visitor Opinions In Chronological Order (3)
Have Conflicts Of Interest Been Resolved With NCCN's Drugs And Biologics Compendium?
posted by Gregory D. Pawelski on 7 Jun 2008 at 8:54 amThe public knows nothing about the financial relationships between drug companies and the physicians, biostatisticians and other scientists who comprise the fourty-four panels that write clinical practice guidelines and determine which drugs, indications and weight of evidence that are included in its compendium.
NCCN provides a list of all companies that had any relationship with any member of the committee, but the guidelines do not indicate which member that might have been. This non-disclosure fails to meet the standards outlined by MedCAC. Even our nation's leading medical journals are coming around to better standards in "conflicts of interest."
Compendia claims to use evidence-based methods in their evaluation of therapeutic agents, however, cited literature was often neither the most recent nor the most valide in terms of study design. To give cancer patients confidence that the treatments they receive are worth the cost, the compendia used to justify payment for the off-label use of anti-cancer drugs should adhere to the highest standards of clinical evidence and arrive at their conclusions in a fully transparent manner that includes full disclosure of "conflicts of interest."
Sometimes oncologists like to think for themselves. Perhaps they know of cutting-edge technology that has run through the riggers of evidence, but not attached to standards. The self-educated oncologist doesn't like to submit to the status-quo.
According to the chair of the Community Oncology Alliance's QSP Committee, NCCN guidelines may be fine but many practices use other guidelines or develop evidence-based treatment guidelines for their own individual practices or modify guidelines based on evidence which they use as their defined evidence-based standards for their practices.
The best reform to the system is to totally remove the profit incentive from chemotherapy administration. Continuing to do so is egregiously poor scholarship and an egregious disservice to cancer patients.
CMS Gave Oncologists The Okay To Begin Using The NCCN Compendium
posted by Gregory D. Pawelski on 13 Jun 2008 at 4:34 pmThe Center for Medicare and Medicaid Services (CMS) gave oncologists the okay to begin using the NCCN compendium to justify payment for the off-label use of cancer drugs.
Oncologists who administer cancer chemotherapy drugs to their patients in offices or free-standing facilities receive reimbursement for those drugs plus a small profit under Medicare's Part B program.
Reimbursable drugs include those prescribed off-label as long as they are listed in compendia officially designated by CMS, Medicare's parent agency. Most private insurers follow Medicare's lead when setting their cancer drugs reimbursement policy.
In 2006, the Medicare Evidence Development and Coverage Advisory Committee recommended that any new compendia approved by CMS carry public identification of “potential conflicts of interest of the compendia’s parent and sibling organizations, reviewers, and committee members.”
In addition to the NCCN drug registry, CMS may approve Elsevier’s Clinical Pharmacology and Thomson Healthcare’s DrugDex and its companion DrugPoints.
The Elsevier publication relies on in-house scientist-writers who are prohibited from accepting any “gifts or benefits” from the drug industry. Thomson uses outside experts supervised by its Oncology Advisory Board, many of whom have ties to industry that are disclosed on the company’s website.
All three compendia received a scathing review from the Agency for Healthcare Research and Quality’s technology assessment program, which analyzed the compendia's reviews of 14 on- and off-label indications for commonly used anti-cancer drugs. An estimated 60 percent of anti-cancer drugs are used off-label.
Compendia claim to use evidence-based methods in their evaluation of therapeutic agents, but cited literature was often neither the most recent nor the most valid in terms of study design. DrugDex was more likely than the others to list off-label indications, while the NCCN compendium was scored for failing to discuss adverse effects.
There’s an inherent bias in an organization that gets the majority of its funding from pharma. Negative things do not get published. I would not like to see NCCN become an official compendium because of possible bias.
While the change in NCCN's disclosure policy is a victory for transparency, it doesn't change the underlying reality that many of the drug uses listed in the compendium do not have much evidence to back their inclusion.
The evidence for including many of the off-label uses in these compendia is thin. Many, at best, add just a few months of life, often with harsh side effects. Yet they must be taken throughout the final months or even years of the diseases' progress.
For the war on cancer to progress, the public needs better information about the outcomes from the use of these drugs in very sick and dying patients. CMS should consider requiring physicians to electronically report the outcomes of their chemotherapy regimens, especially when they involve the off-label use of drugs.
Independent epidemiologists and biostatisticians could then have a powerful database for analyzing the outcomes from the use of these drugs. While such analyses will not have the same predictive power as controlled clinical trials, it would give researchers and practicing oncologists valuable insights into what really works and what doesn't when it comes to treating the more than 100 forms of this dreaded disease. Patients' health, and the nation's fiscal health, deserves nothing less.
What Use Are Compendiums?
posted by Gregory D. Pawelski on 18 Jul 2008 at 9:53 pmIn the setting of metastatic cancer, if you look at the NCI-recommended treatments, you'll find that all patients in this setting are candidates for clinical trials of some sort.
This is just another way for the NCI to say that there is no single "best regimen" to give to the "average" patient and it is therefore entirely appropriate to consider novel drugs or drug combinations for different types of cancers.
Some new drugs are so expensive that insurance companies are discussing the possibility of not paying for them outside of settings in which they have been shown - in some patients - to have provided some benefit and have received specific FDA approval for use in that setting.
It has been very routine and well-accepted practice to prescribe drugs in cancer types and disease stages outside of those in which the drugs originally received FDA approval.
Generally, however, insurance companies have paid for drugs used outside of FDA-approved settings because the treating physician finds their use in those instances to be "medically necessary."
I would think that having additional support of drug patient-specific activity as determined by extensive laboratory pre-tests could very well bolster an argument to the insurance company in seeking payment for treatments.
One place where the clinician disparity is most obvious is the delivery of cancer benefits, according to Dr. Scott Gottlieb, a former senior official at CMS and a fellow at the American Enterprise Institute.
In a June 24, 2008 Wall Street Journal op-ed piece, he said, "Medicare doesn't have a single oncologist on staff, yet since the year 2000 the program issued, by my count, 165 restrictions and directives on the use of cancer drugs and diagnostic tools."
Medicare has radically expanded its authorization for use of cancer drugs by putting off-label decision making in the hands of compendia writers in the private sector, many of whom are on the payrolls of the companies that make the drugs.
An estimated 60 percent of anti-cancer drugs are used off-label. I'm all for cancer patients, particularly at end-stages, receiving these needed drugs.
However, my personal belief is in having additional support of drug patient-specific activity as determined by these extensive laboratory pre-tests to bolster the clinical justification of the drug(s) chosen, with no economic ties to outside healthcare organizations; recommendations made without financial or scientific prejudice.
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