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 lfuHN: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 ofa therapy, the 
evidentiary materials they reviewed, a listing ofall 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 andon the basis of this literaturepublishes 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 compendiums 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 compendiums 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 publishers policies and proceduresas posted on its 
Web sitefor 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  
Corresponding 
Publisher  
Compendium  
American Society of Health-System Pharmacists (ASHP)  AHFS-DI  
Truven Health Analytics  DrugDEX  
NCCN Drugs and 
National Comprehensive Cancer Network (NCCN)  
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  
Percentage of  
Number of Staff  
Number of Staff   Staff Who 
Potential Conflict of  Who Disclosed  
Evaluating  Disclosed  
Publisher   Dollar Threshold  Potential 
Interest   Anticancer Drug   Conflicts of  Potential 
Therapies   Conflicts of 
Interest in 2013  
Interest in 2013  
Equal to or greater than 
$20,000 or if aggregate 
A financial relationship 
NCCN   annual financial  507  264  52%  
with a drug sponsor 
relationships are equal to or 
greater than $50,000 
Relevant direct or indirect 
Combined value exceeding 
ASHP  financial interests in drug  17  2  17%  
$50,000 
manufacturers 
Truven Health  Stock or equity ownership  $100,000 or greater  
in any single  12  1  8%  
Analytics 
pharmaceutical company   
Stock or equity ownership 
Elsevier/Gold 
in any single  $100,000 or greater  24  0  0%  
Standard  
pharmaceutical company 
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)