The Micromedex DrugDex ® Compendium is a drug discovery system.

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American Medical Association Drug Evaluations (AMA-DE), United States Pharmacopoeia-Drug Information (USP-DI) or its successor publication are recognized by the Social Security Act Section 1861(t)(2)(B)(ii)(I).The only compendium currently in publication is AFHS-DI.

The Thomson Micromedex compendium DrugDex ® was added to the list of compendia for use in the Medicare program.DrugDex ® can be used in the determination of a medically-accepted indication of an off-label drug.

Thomson Micromedex View Requestor Letter

The formal addition of DrugDex ® to the list of compendia used by the Medicare program was requested by Thomson Micromedex.The public comment period ends after 30 days.The addition of DrugDex ® to this list of compendia is of particular interest to the Centers for Medicare and Medicaid Services.

The highlighted “comment” link at the top of the page is where formal public comments can be submitted.

There are instructions on how to submit a request to revise the list of compendia.

Section 1861(t)(2)(B)(ii)(I) of the Social Security Act was amended by the Deficit Reduction Act of 2005.The American Medical Association Drug Evaluations (AMA-DE), United States Pharmacopoeia- Drug Information (USP-DI) and American Hospital Formulary Service-Drug Information are authoritative sources for use.

The AMA- DE and the USP-DI are no longer published due to changes in the pharmaceutical reference industry.The stakeholder community requested a process to revise the list of compendia.The process for revising the list of compendia was established in the final rule of the Physician Fee Schedule.There is a reg.There are 66222, 66303, and 66408.Under 42 C.F.R.

A compendium is defined as a comprehensive listing of FDA-approved drugs and biologicals or a list of a specific subset of drugs.Refer to 42 C.F.R.414.930(a); 72 Fed.There is a reg.66222, 66408.

A list of desirable compendium characteristics outlined by the Medicare Evidence Development and Coverage Advisory Committee was used as a criteria for decision-making.The list of desirable compendium characteristics was developed during a public session.The purpose of this session was to review the evidence and advise the Centers for Medicare and Medicaid Services on the desirable characteristics of compendia for use in the determination of medically-accepted indications of drugs and biologicals in anti-cancer therapy.This meeting resulted in the creation of a list of desirable characteristics.

Relative weights were not assigned to these characteristics.None of the characteristics were identified as optional requirements, as we believe that all are necessary to fulfill the purpose for which this designation is made.There are additional reasonable factors that can be considered in the decision of the Centers for Medicare and Medicaid Services.See 72 Fed.There is a reg.It is at 66306.

Drugs and biologicals used in the treatment of cancer are not benign agents.In many classes of agents, there is a special FDA regulatory requirement called a “black box” warning.When appropriate uses of these agents are supported by Medicare payment, the interests of Medicare beneficiaries who have cancer are safeguarded as well.The identification of indications that are not medically accepted is more important than the identification that is.

The public should have access to such materials in order to determine if a compendium’s actions are in line with its stated policies.Medicare beneficiaries who have cancer have the greatest personal stake in this issue, and we believe that public access is less meaningful if it is not provided broadly.Broad access of the compendia to the general public is an additional reasonable factor.See 72 Fed.There is a reg.It is at 66306.

Thomson Micromedex DrugDex ® was added to the list of compendia for the identification of a medically accepted indication for off-label uses of drugs and biologicals in a cancer therapy regimen.

The application Thomson healthcare submitted was required to include a detailed description of how it believes its compendium meets the criteria of a compendium and each of the MedCAC desirable characteristics.

It is required under 42 C.F.R.The public comment period on the addition of Thomson Micromedex DrugDex ® to the list of compendia began when the request was posted.

A request to add publication to the list of compendia for the identification of a medically accepted indication for off-label uses of drugs and biologicals was supported by the Biotechnology Industry Organization.The content of each compendium varies in publication schedules, priorities, review processes, local practices and methods of describing the evidence.The addition of these compendia is critical to the improvement of Medicare beneficiaries access to time-sensitive cancer treatment options.

There was a public comment against the addition of Thomson Micromedex DrugDex ® to the list of compendia.The addition of DrugDex ® to the list of compendia is not supported by the American Society of Health-System Pharmacists.The Wall Street Journal article that discusses DrugDex ® connections with the pharmaceutical industry is supported by ASHP.We tried to contact Dr. Angell to find out if this is an accurate representation of her position.The ASHP questioned the authority of the CMS to recognize DrugDex ® during the sub-regulatory compendia review process because of a request from Thomson.

The Senate Finance Committee signed the letter.Conflicts of interest on the part of authors who contribute to the compendia were noted by the Senators.

Thomson healthcare responded to the transparency and conflict of interest issues raised by ASHP.Thomson states that its conflict of interest policy is consistent with industry standards and can be easily reviewed on its website.Thomson healthcare outlines the disclosure and disqualification requirements for individuals involved with literature evaluation and content development to address the concerns of ASHP that these individuals are not influenced by financial conflicts of interest.According to Thomson healthcare, Medicare Part A references were only included in its compendia request to complete its application, not for recognition by the Centers for Medicare and Medicaid Services.

The compendium under review would be available to subscribers of the compendium.During the entire review process, CMS was given unlimited access to the Thomson Micromedex DrugDex ® in order to assess its infrastructure and content.

Thomson Micromedex DrugDex ® addresses each of the MedCAC identified desirable characteristics.

There was only one public comment that was specific to DrugDex ® and it opposed the request and mentioned that the compendia review process is only applicable to Medicare Part B.Section 1861(t) of the Act does not restrict the scope of determinations under Medicare Part B.The objection is not relevant to the question at hand.An authoritative compendium for the identification of a medically accepted indication for off-label uses of drugs and biologicals is published by the ASHP.

There are potential conflict of interest and transparency issues pertinent to DrugDex ®.We weren’t provided with primary evidence.The authors of the newspaper article may have considered material from the book.We were not able to confirm that the opinion of Dr. Angell was an accurate representation of her current opinion.We assign less weight to those materials than to systematic technology assessments.The 2006 MedCAC, which considered technology assessment as well as broad public input, expressed overall confidence that DrugDex ® has adequately stated evidence based criteria and that it has processes in making recommendations.

If additional evidence is provided, we would consider removing DrugDex ® from the list.The current body of evidence does not support the denial of Thomson’s request.

Thomson Micromedex DrugDex ® met the definition of a compendium as defined by 42 C.F.R.414.930(a); 72 Fed.There is a reg.All of the criteria created by the MedCAC are referenced in regulation.

Thomson Micromedex DrugDex ® is an authoritative compendium for purposes outlined in 42 C.F.R.414.930(a); 72 Fed.There is a reg.66222, 66408.Thomson Micromedex DrugDex ® will be added to the list of compendia for the determination of a “medically-accepted indication” of drugs and biologicals used off-label.

DrugDex ® recommends and/or efficacy will be considered medically accepted indications for the purposes of determining coverage policy.

DrugDex ® does not list medically accepted indications for the purposes of determining coverage policy.

There are indications listed in the compendia that are not supported or identified as not indicated.We don’t know if the compendia citations are medically accepted indications within the meaning of that section.The situations are most appropriately addressed under 1861(t)(2)(B)(ii)(II)

Thomson Micromedex DrugDex ® addresses each of the MedCAC identified desirable characteristics.

There are potential conflict of interest and transparency issues pertinent to DrugDex ®.We weren’t provided with primary evidence.The authors of the newspaper article may have considered material from the book.We were not able to confirm that the opinion of Dr. Angell was an accurate representation of her current opinion.We assign less weight to those materials than to systematic technology assessments.The 2006 MedCAC, which considered technology assessment as well as broad public input, expressed overall confidence that DrugDex ® has adequately stated evidence based criteria and that it has processes in making recommendations.

If additional evidence is provided, we would consider removing DrugDex ® from the list.The current body of evidence does not support the denial of Thomson’s request.

Thomson Micromedex DrugDex ® met the definition of a compendium as defined by 42 C.F.R.414.930(a); 72 Fed.There is a reg.All of the criteria created by the MedCAC are referenced in regulation.

Thomson Micromedex DrugDex ® is an authoritative compendium for purposes outlined in 42 C.F.R.414.930(a); 72 Fed.There is a reg.66222, 66408.Thomson Micromedex DrugDex ® will be added to the list of compendia for the determination of a “medically-accepted indication” of drugs and biologicals used off-label.

DrugDex ® recommends and/or efficacy will be considered medically accepted indications for the purposes of determining coverage policy.

DrugDex ® does not list medically accepted indications for the purposes of determining coverage policy.