DEPART.\IE::'>!T OF HE:\LTH AND HC~viA;\ SERVICES 

OFFICE OF INSPECTOR GENERAL 

OCT 3 0 2014 

TO: 	 Marilyn Tavenner 

Administrator 

Centers for Medicare & Medicaid Services 

FR0 M: Suzall-tre l¥fuHN:l' 

Deputy luspeetor. General 

for EValuation and Inspections 

SUBJECT: 	 OIG Memorandum Report: Drug Compendia Publishers Maintain Transparent 

Processes for Evaluating Anticancer Drug Therapies and Identifj;ing Potential 

Conflicts, OEI-07-13-00220 

This memorandum report provides information regarding drug compendia publishers' 

(publishers) compliance with Federal law that mandates transparency in their criteria for 

evaluating anticancer drug therapies and identifying potential conflicts of interest on the part of 

their staff. Medicare Parts Band D cover anticancer drugs for indications not approved by the 

Food and Drug Administration (FDA) only ifthe drugs are supported by one or more of the four 

authorized compendia. Conflicts of interest on the part of compendia staff might result in 

anticancer drugs being included in the compendia that otherwise might not have been included. 

To assess publishers' compliance as of October 2013 with Federal law related to transparency, 

we (I) reviewed publishers' policies and procedures-as posted on their Web sites-for 

evaluating anticancer drug therapies and for identifying potential conflicts of interest, 

(2) interviewed each of the publishers' staff, and (3) interviewed Centers for Medicare & 

Medicaid (CMS) staff. 

SUMMARY 

We found that the four publishers of each of the authorized compendia complied with Federal 

laws for maintaining a transparent process for evaluating anticancer drug therapies and 

identifying potential conflicts of interest. Specifically, publishers made the following available 

on their Web sites: the criteria they used to evaluate requests for inclusion of a therapy, the 

evidentiary materials they reviewed, a listing of all individuals who participated in reviews, and 

the minutes from meetings in which they discussed requests. Additionally, all four publishers 

included on their Web sites their definitions ofpotential conflicts of interest and their policies for 

identifying potential conflicts related to anticancer drug therapies. 
 

 

 

 

 

 

 

 

 

Page 2 – Marilyn Tavenner 

BACKGROUND 

For drugs to qualify for Medicare coverage, their use must meet several criteria. These criteria 

are outlined in the Social Security Act (the Act) and applicable CMS Manuals. In most 

circumstances, the drugs must be approved by FDA.1, 2 Medicare generally covers drugs for 

indications not approved by FDA (i.e., for “off-label” indications) if the drugs are supported by 

one or more authorized compendia. 

Under Medicare Parts B and D, there are four compendia recognized as authorized sources for 

the determination of medically accepted indications for anticancer drugs.3 These compendia are 

American Hospital Formulary Service-Drug Information (AHFS-DI), Micromedex DrugDEX 

(DrugDEX), National Comprehensive Cancer Network (NCCN) Drugs and Biologics 

Compendium, and Clinical Pharmacology. 

A compendium summarizes evidence of the effectiveness of drugs for given indications.4 The 

publisher of each compendium evaluates scientific evidence from research literature for various 

uses of drugs and—on the basis of this literature—publishes its own recommendations for use.5 

Potential conflicts of interest might affect publishers’ recommendations. For example, a 

compendium staff member who has a relationship with a pharmaceutical manufacturer may 

benefit financially if the recommendation regarding the use of a drug is favorable toward that 

manufacturer. 

Federal Law Related to Evaluating Anticancer Drug Therapies and Identifying Potential 

Conflicts of Interest 

Section 1861 of the Act mandates that the publishers that evaluate anticancer drug therapies 

maintain publicly transparent processes for (1) evaluating these therapies and (2) identifying 

potential conflicts of interest related to inclusion of these therapies in the compendia.6 

Evaluating Anticancer Drug Therapies. A compendium’s process for evaluating anticancer drug 

therapies is considered to be transparent if the publisher makes the following information 

1 See generally the Act §§ 1861(t), 1860D-2(e)(1)(A), and 1927(k)(2); CMS, Medicare Benefit Policy Manual 

(Internet-only manual), Pub. No. 100-02, ch. 1, § 30 and ch. 15, § 50; CMS, Medicare Prescription Drug Manual 

(Internet-only manual), Pub. No. 100-18, ch. 6, § 10. 

2

 The Act §§ 1861(t), 1860D-2(e)(1)(A), and 1927(k)(2); CMS, Medicare Benefit Policy Manual (Internet-only 

manual), Pub. No. 100-02, ch. 1, § 30 and ch. 15, § 50; CMS, Medicare Prescription Drug Manual (Internet-only 

manual), Pub. No. 100-18, ch. 6, § 10. 

3

 The Act, §§ 1861(t)(2)(B)(ii)(I) and 1860D-2(e)(4)(A)(i) (regarding anticancer drugs under Medicare Parts B 

and D, respectively). The Medicare Improvements for Patients and Providers Act amended the Part D statute to add 

a new definition for “medically accepted indication” for Part D anticancer drugs. Specifically, it extended the 

applicability of the four compendia under Part B to the anticancer drugs covered under Part D. See P. L. 

No. 110-275 § 182 (July 15, 2008). 

4

 Ross McKinney, et al. White Paper: Potential Conflict of Interest in the Production of Drug Compendia. 

(Prepared by the Duke Evidence Based Practice Center under Contract HHSA 290 2007 10066 1). Agency for 

Healthcare Research and Quality. April 2009. 

5

 Ibid. The term “publisher” refers broadly to the organization that publishes each compendium. Publishers are not 

employed by the Federal Government, nor are they entitled to Federal funds for purposes related to publishing the 

compendia. 

6 The Act, § 1861(t)(2)(B), as amended by P.L. No. 110-275 § 182(b), July 15, 2008. 

Drug Compendia Publishers Maintained Transparent Processes (OEI-07-13-00220) 
 

Page 3 – Marilyn Tavenner 

publicly available: (1) the criteria that it used to evaluate the request for inclusion of a therapy; 

(2) all the evidentiary materials that it reviewed or considered pursuant to the request; (3) a 

listing of all individuals who substantively participated in the review and disposition of the 

request; and (4) the minutes and voting records of meetings for the review and disposition of the 

request.7 Federal law does not explicitly stipulate how a publisher must implement its 

transparent process for evaluating anticancer drug therapies. As a result, each publisher has 

flexibility in implementing its transparent process for evaluating anticancer drug therapies. 

Identifying Potential Conflicts Related to Inclusion of Anticancer Drug Therapies in the 

Compendia. A compendium’s process for evaluating anticancer drug therapies is considered to 

be transparent if the publisher makes available (in response to a public request) information 

related to “direct or indirect financial relationships” and “ownership or investment interests ... 

between individuals or the spouse or minor child of individuals who have substantively 

participated in the development or disposition of compendia recommendations and the 

manufacturer or seller of the drug or biological being reviewed by the compendium.”8 Federal 

law does not explicitly stipulate what constitutes a potential conflict of interest. As a result, each 

publisher has discretion to determine what constitutes a potential conflict of interest. 

METHODOLOGY 

This study included: (1) a review of each publisher’s policies and procedures—as posted on its 

Web site—for evaluating anticancer drug therapies and for identifying potential conflicts of 

interest; (2) interviews with publishers’ staff who were knowledgeable as to how potential 

conflicts were managed; and (3) an interview with CMS staff. Our review took place in 

September and October of 2013. See Table 1 below for a listing of the four publishers and their 

corresponding compendia. 

Table 1: Publishers and Their Corresponding Compendia 

Publisher Corresponding 

Compendium 

American Society of Health-System Pharmacists (ASHP) AHFS-DI 

Truven Health Analytics DrugDEX 

National Comprehensive Cancer Network (NCCN) NCCN Drugs and 

Biologics Compendium 

Elsevier/Gold Standard Clinical Pharmacology 

Source: Office of Inspector General (OIG) legal analysis, 2014. 

When interviewed, all four publishers reported that there were no public requests for information 

related to potential conflicts of interest in 2013. Thus, our assessment of publishers’ compliance 

with Federal law for transparency as it relates to potential conflicts was limited to reviewing 

publishers’ policies and procedures and reviewing their respective Web sites. 

We interviewed CMS staff about how they ensure that publishers comply with Federal law 

related to transparency. 

7

 42 CFR § 414.930. 

8

 Ibid. 

Drug Compendia Publishers Maintained Transparent Processes (OEI-07-13-00220) 
Page 4 – Marilyn Tavenner 

This study was conducted in accordance with the Quality Standards for Inspection and 

Evaluation issued by the Council of the Inspectors General on Integrity and Efficiency. 

RESULTS 

Publishers complied with Federal law related to transparency 

As of October 2013, all four publishers maintained a transparent process for evaluating 

anticancer drug therapies. All four publishers maintained the following information on their 

publicly available Web sites: (1) the criteria that the compendium used to evaluate the request 

for inclusion of a therapy; (2) all the evidentiary materials that the compendium reviewed or 

considered pursuant to the request; (3) a listing of all individuals who substantively participated 

in the review and disposition of the request; and (4) the minutes and voting records of meetings 

for the review and disposition of the request. 

All four publishers maintained a transparent process for identifying potential conflicts. All 

included on their Web sites their policies for identifying potential conflicts related to anticancer 

drug therapies. These publicly available policies required that staff assigned to work on off-label 

uses for anticancer drug therapies complete initial self-disclosure forms identifying any direct or 

indirect financial interests and that they periodically update the forms. All four publishers 

required staff to file disclosure forms at least annually. 

CMS staff provided oversight of publishers’ publicly transparent processes. CMS staff reported 

corresponding with publishers to ensure compliance with Federal law related to transparency 

policies for evaluating anticancer drug therapies and identifying conflicts related to those 

therapies. CMS staff also reported reviewing the publishers’ Web sites and making internal notes 

as to how these Web sites complied with Federal law. 

The number and nature of staff disclosures varied across publishers 

All four publishers defined potential conflicts of interest as financial interests that exceeded a 

specific dollar threshold, and all four maintained policies that prohibit staff from participating in 

reviews if their financial interests exceed the threshold. The specific dollar amounts for these 

thresholds varied among the publishers. These varying dollar thresholds may have led to the 

differences among the publishers in the numbers of potential conflicts of interest that they 

disclosed. See Table 2 for information regarding the publishers’ respective dollar thresholds and 

the number and percentage of staff who disclosed a potential conflict of interest. 

The nature of staff disclosures also varied among publishers. NCCN staff disclosed potential 

conflicts related to (1) conducting clinical research for a pharmaceutical company or drug 

manufacturer for which the staff member has a direct or indirect financial interest; (2) serving as 

a board member, speaker, expert witness, or consultant for a pharmaceutical company or drug 

manufacturer; and (3) receiving equity or royalty interests. ASHP disclosed potential conflicts 

related to receiving equity or royalty interests. Truven Health Analytics disclosed that one staff 

member disclosed a potential conflict that was categorized as “other payment,” a term that was 

not further defined. 

Drug Compendia Publishers Maintained Transparent Processes (OEI-07-13-00220) 
Page 5 – Marilyn Tavenner 

Table 2: Publishers’ Dollar Thresholds for Conflicts of Interest and the Number and Percentage of 

Disclosed Potential Conflicts of Interest Identified by Publishers in 2013 

Publisher 

Potential Conflict of 

Interest 

Dollar Threshold 

Number of Staff 

Evaluating 

Anticancer Drug 

Therapies 

Number of Staff 

Who Disclosed 

Potential 

Conflicts of 

Interest in 2013 

Percentage of 

Staff Who 

Disclosed 

Potential 

Conflicts of 

Interest in 2013 

NCCN A financial relationship 

with a drug sponsor 

Equal to or greater than 

$20,000 or if aggregate 

annual financial 

relationships are equal to or 

greater than $50,000 

507 264 52% 

ASHP 

Relevant direct or indirect 

financial interests in drug 

manufacturers 

Combined value exceeding 

$50,000 17 2 17% 

Truven Health 

Analytics 

Stock or equity ownership 

in any single 

pharmaceutical company 

$100,000 or greater 

12 1 8% 

Elsevier/Gold 

Standard 

Stock or equity ownership 

in any single 

pharmaceutical company 

$100,000 or greater 24 0 0% 

Source: OIG analysis of publishers’ policies and disclosed potential conflicts identified by publishers, 2014. 

CONCLUSION 

We found that all four publishers complied with Federal law to maintain a transparent process 

for evaluating anticancer drug therapies and identifying potential conflicts of interest among 

staff. Insufficient evaluation criteria and conflicts of interest among compendia staff could lead 

to anticancer drugs being inappropriately recommended for inclusion in a compendium. Because 

Medicare Parts B and D cover anticancer drugs supported by one or more of the four authorized 

compendia, transparency of publishers’ policies helps safeguard against inappropriate Federal 

payments for these drugs and protects Medicare beneficiaries from being prescribed drugs for 

medically inappropriate uses. 

This report is being issued directly in final form because it contains no recommendations. If you 

have comments or questions about this report, please provide them within 60 days. Please refer 

to report number OEI-07-13-00220 in all correspondence. 

Drug Compendia Publishers Maintained Transparent Processes (OEI-07-13-00220)