Department of Health and Human Services 
  OFFICE OF 
  INSPECTOR GENERAL 
 
 
 
 
P D B
ART    ENEFICIARIES 
 
 
W Q
ITH  UESTIONABLE 
 
U  P
TILIZATION  ATTERNS 
 
  F HIV D  
OR    RUGS 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Daniel R. Levinson   
   
Inspector General  
 
 
August 2014 
OEI-02-11-00170 
   
   
EXECUTIVE SUMMARY:   Part D Beneficiaries With Questionable Utilization Patterns 
for HIV Drugs, OEI-02-11-00170 
 
WHY WE DID THIS STUDY 
Under Medicare Part D, the Centers for Medicare & Medicaid Services (CMS) contracts with private 
insurance companies, known as sponsors, to provide prescription drug coverage.  The Office of 
Inspector General (OIG) has found that Part D is vulnerable to fraud, waste, and abuse.  Prior work 
has focused on questionable practices by pharmacies and prescribers; this report addresses 
beneficiaries with questionable utilization patterns. 
 
CMS has placed few restrictions on specific beneficiaries, and these restrictions have focused on 
opioids.  For example, CMSs Overutilization Monitoring System provides each sponsor with a list 
of beneficiaries who are potentially overutilizing opioids.  However, opioids are not the only Part D 
drugs vulnerable to fraud, waste, and abuse.  Other types of drugs, including those that treat human 
immunodeficiency virus (HIV), are also vulnerable because they can be very expensive and can 
have psychoactive effects. 
 
HOW WE DID THIS STUDY  
We based this study on an analysis of Prescription Drug Event records for HIV drugs in 2012.  
Part D sponsors submit one record to CMS for each drug that is dispensed to a beneficiary enrolled 
in their plans. Each record contains information about the drug, beneficiary, pharmacy, and 
prescriber. We developed six measures to identify beneficiaries with questionable utilization 
patterns on the basis of results of past OIG analyses and fraud investigations and input from CMS 
staff.   
 
WHAT WE FOUND 
Medicare Part D paid $2.8 billion for HIV drugs in 2012.  Almost 1,600 Part D beneficiaries had 
questionable utilization patterns for HIV drugs. These beneficiaries had no indication of HIV in 
their Medicare histories, received an excessive dose or supply of HIV drugs, received HIV drugs 
from a high number of pharmacies or prescribers, or received contraindicated HIV drugs (i.e., HIV  
drugs that should not be used in combination with one another).  In total, Medicare paid $32 million 
for HIV drugs for these beneficiaries. While some of this utilization may be legitimate, all of these 
patterns warrant further scrutiny.  These patterns may indicate that a beneficiary is receiving 
inappropriate drugs and diverting them for sale on the black market.  They may also indicate that a 
pharmacy is billing for drugs that a beneficiary never received or that a beneficiarys identification 
number was stolen.   
 
WHAT WE RECOMMEND 
We recommend that CMS (1) expand sponsors drug utilization review programs, (2) expand the 
Overutilization Monitoring System to include additional drugs susceptible to fraud, waste, and 
abuse, (3) expand sponsors use of beneficiary-specific controls, (4) restrict certain beneficiaries to a 
limited number of pharmacies or prescribers, (5) limit the ability of certain beneficiaries to switch 
plans, (6) increase monitoring of beneficiaries utilization patterns, and (7) follow up on questionable 
utilization patterns. CMS concurred with all but the second and fifth recommendations. 
   
   
TABLE OF CONTENTS 
 
Objectives ....................................................................................................1 

Background..................................................................................................1 

Methodology................................................................................................7 

Findings......................................................................................................13 

Medicare Part D Paid $2.8 Billion for HIV drugs in 2012... .........13 

Almost 1,600 Part D Beneficiaries Had Questionable Utilization 

Patterns for HIV Drugs  ..................................................................14 

Conclusion and Recommendations ............................................................21 

Agency Comments and Office of Inspector General Response .....24 

Appendix....................................................................................................26 

A: HIV Drugs ................................................................................26 

B:  Most Common HIV Drugs and Combinations .........................28 

C: Agency Comments  ...................................................................30 

Acknowledgments......................................................................................34 

   
OBJECTIVES 
1. 	  To determine the extent to which beneficiaries received human 
immunodeficiency virus (HIV) drugs paid for by Medicare Part D in 2012. 
2. 	  To determine the extent to which beneficiaries had questionable utilization 
patterns for HIV drugs in 2012. 
BACKGROUND 
Medicare Part D provides an optional prescription drug benefit to Medicare 
beneficiaries.1  The Centers for Medicare & Medicaid Services (CMS) 
contracts with private insurance companies, known as Part D sponsors, to 
provide drug coverage to beneficiaries who choose to enroll in the program.2 
In 2012, 37 million beneficiaries were enrolled in Part D.3  
In the 9 years since Part D began, the Office of Inspector General (OIG) and 
others have raised concerns about Part D billing.  OIG has found that the 
program has limited safeguards and is vulnerable to fraud, waste, and abuse.  
Recent OIG reports have focused on questionable practices by pharmacies and 
prescribers. This report addresses beneficiaries with questionable utilization 
patterns.  
CMS has placed few restrictions on specific beneficiaries in Part D.  These 
restrictions have focused on opioids, as this type of drug is especially 
vulnerable to fraud, waste, and abuse. However, opioids are not the only 
Part D drugs that are vulnerable. Other types of drugs are also susceptible to 
fraud, waste, and abuse, particularly if they are very expensive or have 
psychoactive effects.  For example, antipsychotic drugs and certain respiratory 
and cardiac drugs are susceptible.   
In addition, antiretroviral drugs that treat HIV4 are a target for fraud, waste, 
and abuse because they can be very expensive and can have psychoactive 
effects.  For example, one common HIV drug costs about $1,700 for a 
months supply. Also, when certain HIV drugs and commonly abused 
painkillers are taken together, the HIV drugs can enhance the effects of the 
 
1 42 U.S.C.  1395w-101(a).  
 
2  42 U.S.C.  1395w-112(b)(1). 
  
3 The Boards of Trustees, Federal Hospital  Insurance and Federal Supplementary Medical
  
Insurance Trust Funds, 2013  Annual Report  of the Boards of Trustees of the Federal  Hospital  
Insurance and Federal Supplementary Medical Insurance Trust Funds, pp. 151 and  157. 
Accessed at http://downloads.cms.gov/files/TR2013.pdf on November  26, 2013.   
4 For the purposes of this report, we refer to antiretroviral drugs that treat HIV as HIV  
drugs.  
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  1   
   
painkillers.5  Further, one study reported that another HIV drug is used by 
HIV-negative individuals for its intoxicating effects.6  
A number of recent fraud cases have involved HIV drugs.  In one case, 
Medicare paid over $8.5 million for medications for HIV/AIDS patients that 
either were medically unnecessary or were never provided.7 In another case, a 
pharmacy owner was charged with fraudulently billing Medicaid for HIV 
drugs that he never filled or only partially filled.8  He is accused of paying 
cash and other kickbacks to beneficiaries in exchange for their HIV drugs.   
In a third case, 48 people were charged with defrauding Medicaid of 
$108 million.9  They are accused of trafficking hundreds of millions of 
dollars worth of prescription drugs, including HIV drugs.  In this scheme, 
Medicaid beneficiaries allegedly filled their prescriptions for HIV drugs using 
their Medicaid benefits and then sold the medication for cash.  The medication 
was repackaged and resold to pharmacies that then dispensed the drugs to 
unsuspecting customers.  In a similar case, four people were charged with a 
scheme to distribute HIV drugs on the black market and defraud Medicaid of 
$155 million.10    
This study focuses on beneficiaries who have questionable utilization patterns 
for HIV drugs. Although the report addresses HIV drugs, the issues that it 
raises are relevant to other Part D drugs susceptible to fraud, waste, and abuse.  
This report is part of a larger body of work examining Part D.  Two other 
 
5 T.H. Nieminen et al., Oxycodone Concentrations Are Greatly Increased by the  
Concomitant Use of Ritonavir or Lopinavir/Ritonavir.  European Journal of Clinical  
Pharmacology, August 10, 2010.  For a list of HIV  drugs  brand  names, see Appendix  A.  
6 James A. Inciardi et al., Mechanisms of Prescription Drug  Diversion Among 
Drug-Involved Club- and Street-Based Populations,  Pain Medicine, March  2007; 8(2):  
171183.  Accessed at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2879025/ on  
February 21, 2014.   
7 Federal Bureau  of Investigation, Manhattan Doctor  Pleads Guilty to $8.5 Million  Medicare 
Fraud Scheme, February 25, 2013.  Accessed at http://www.fbi.gov/newyork/press-
releases/2013/manhattan-doctor-pleads-guilty-to-8.5-million-medicare-fraud-scheme on  
September 5, 2013.  
8 Kings County  District Attorneys Office,  Kings County District Attorney Charles J. Hynes, 
NYC Human Resources Administration Commissioner Robert Doar and  U.S. Department of  
Health and  Human Services,  Special Agent  In Charge, Thomas ODonnell Announce the 
Indictment of the Owner of a Williamsburg  Pharmacy for Illegally Receiving Nearly 
$800,000 in Medicaid Payments, August 29, 2013.  Accessed on  September 5, 2013 (link no 
longer works). 
9 United States of America -v- Juan Carlos Viera et al., S1 11 Cr. 1072  (DLC), July 17, 2012.  
Accessed at http://www.justice.gov/usao/nys/pressreleases/July12/drugs/vierajoseetals1 
indictment.pdf  on October  22, 2013.   
10 Attorney General Eric Schneiderman, A.G. Schneiderman Announces Arrests In  
$274 Million Black Market Prescription Drug  Operation,  April 4, 2012.  Accessed at 
http://www.ag.ny.gov/press-release/ag-schneiderman-announces-arrests-274-million-black-
market-prescription-drug-operation on  November 14, 2013.  
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  2   
   
reports identified pharmacies and prescribers with questionable billing 
patterns.11 A third report identified inappropriate Part D payments for 
Schedule II drugs billed for as refills.12 A fourth report identified Part D drugs 
ordered by individuals who do not have the authority to prescribe.13 All of 
these reports are part of the Health Care Fraud Prevention and Enforcement 
Action Team (HEAT) Initiative, which focuses on detecting health care fraud 
through innovative data analysis and enhanced cooperation between the 
Department of Justice, OIG, and CMS. 
Medicare Part D 
Medicare beneficiaries have the option of enrolling in stand-alone prescription 
drug plans, or they may receive prescription drug coverage as a part of 
managed care plans.  The managed care plans (known as Medicare Advantage 
plans, or Medicare Part C) also include medical benefits.  They are offered as 
an alternative to traditional Medicare (known as Medicare Parts A and B).14   
Most beneficiaries are responsible for certain costs under Part D, which may 
include a monthly premium, an annual deductible, and coinsurance.  However,  
certain low-income beneficiaries are eligible to receive assistance to pay some  
or all of these Part D costs. The portion that is paid by Medicare is referred to 
as the low-income subsidy.15    
Medicare beneficiaries are generally not allowed to switch prescription drug 
plans during the year.  However, those who qualify for the low-income  
subsidy are allowed to change plans every month.  Other beneficiaries may 
also switch under special circumstances.  For example, they may switch if 
they move out of their plans service area.  They may also switch if they have 
a severe or disabling condition, such as HIV, and if there is a Medicare 
Chronic Care Special Needs Plan that serves that condition.16  
 
11  Office of  Inspector General (OIG),  Retail Pharmacies With  Questionable Part D Billing, 
OEI-02-09-00600, May 2012, and  OIG,  Prescribers With  Questionable Patterns in Medicare  
Part D, OEI-02-09-00603, June 2013.  
12 Schedule II  drugs are controlled substances with the highest potential for abuse of any  
prescription  drugs legally available in the United States.  OIG, Inappropriate Medicare Part  
D Payments for Schedule II Drugs Billed As Refills, OEI-02-09-00605, September 2012. 
13 OIG,  Medicare Inappropriately Paid for Drugs Ordered  by Individuals Without 
Prescribing Authority, OEI-02-09-00608, June 2013. 

14 Medicare Part A covers services such as inpatient hospitalizations and skilled nursing care, 

while Medicare Part B covers physician and  outpatient services.  

15  42  CFR  423.315(d).   

16 For more information about the circumstances under  which a beneficiary may switch plans, 

see CMS, Special Circumstances (Special Enrollment Periods). Accessed at 

http://www.medicare.gov/sign-up-change-plans/when-can-i-join-a-health-or-drug-
plan/special-circumstances/join-plan-special-circumstances.html#collapse-3206  on 
 
December 23, 2013. 

Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  3   
   
Medicare Part D covers drugs prescribed for medically accepted indications.17   
For each plan, sponsors develop a list of covered drugs, known as a formulary.  
A formulary often gives preference to certain drugs over other drugs that treat 
the same condition.  Each formulary must include at least two drugs within 
each category or class. Sponsors can also use utilization management tools, 
such as requiring prior authorization or establishing quantity limits, to place 
restrictions on the use of certain drugs on their formularies.   
Under Part D, HIV drugs are considered a protected class, which helps to 
ensure that beneficiaries have access to them.18  As such, CMS requires that 
each formulary include all or substantially all HIV drugs.  Further, unlike 
they may for most drugs, sponsors may not use certain utilization management 
tools, such as prior authorization, for HIV drugs.   
Monitoring of Medicare Part D 
CMS contracts with the National Benefit Integrity Medicare Drug Integrity 
Contractor (MEDIC) to detect and prevent fraud, waste, and abuse.  Its 
responsibilities include identifying  and investigating potential fraud and 
abuse, referring cases, and fulfilling requests for information from law 
enforcement.  The MEDIC is  required to identify  potential fraud and abuse 
through external sources, such as tips, as well as proactive methods, such as  
data analysis.19  
CMS also relies on sponsors to help safeguard the Part D program.  CMS 
requires sponsors to have compliance plans that contain measures to detect, 
prevent, and correct fraud, waste, and abuse.20  CMS recommends that 
sponsors use data analysis and specifically calculate the total number of 
prescriptions each beneficiary receivedboth overall and within certain 
classes of drugsto identify possible fraud, waste, or abuse.  
CMS also requires sponsors to have a drug utilization review program to assist 
in preventing overutilization of prescribed medications and to reduce fraud, 
waste, and abuse.21  These programs should include concurrent reviews, which 
 
17  42 U.S.C.  1395w-102(e)(1).  

18 The six protected classes are immunosuppressants, antidepressants, antipsychotics, 

anticonvulsants, antiretrovirals, and antineoplastics.  See 42 CFR  423.120(b)(2)(i); CMS, 

Prescription  Drug Benefit Manual, ch. 6  30.2.5.  

19 See OIG, MEDIC Benefit Integrity Activities in Medicare Parts C and  D, 

OEI-03-11-00310, January 2013. 

20 42 CFR   423.504(b)(4)(vi). 

21 CMS, Announcement  of Calendar Year (CY) 2013 Medicare Advantage Capitation Rates 

and  Medicare Advantage and Part D  Payment Policies and Final Call Letter, April 2, 2012.  
Accessed at http://www.cms.gov/Medicare/Health-Plans/HealthPlansGenInfo/Downloads/ 
2013-Call-Letter.pdf  on October 4,  2012.  See also CMS,  Supplemental  Guidance Related to 
Improving Drug Utilization Review Controls in  Part D,  August 31, 2012. 
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  4   
   
are claim-level edits at the point of sale.  These edits commonly include three 
types.22  They include refills too soon, which can prevent the refilling of a 
drug before a certain date. They include maximum therapeutic dose 
exceeded, which can prevent prescriptions with unsafe doses from being 
dispensed. Lastly, these edits include therapeutic duplication, which can 
prevent beneficiaries from receiving multiple concurrent drugs in the same 
class. Sponsors drug utilization review programs should also include 
retrospective reviews, which occur after the drug is dispensed.  
CMS has stated that sponsors need to employ more effective drug utilization 
review programs and outlined three levels of improvements that it expected 
sponsors to apply in 2013.23  Specifically, CMS stated that sponsors should 
(1) improve their concurrent claims edits for all drugs (e.g., limit dosage at the 
point of sale to the maximum  allowable dose on the Food and Drug 
Administration (FDA)-approved label); (2) improve their formulary utilization 
design (e.g., implement quantity limits based on the FDA-approved label); 
and (3) for opioids, improve retrospective reviews and case management.   
CMS recommended that sponsors take several steps to improve their 
retrospective review and case management for opioids.24 First, sponsors 
should use data analysis to identify patterns of apparent duplicative drug use.  
Next, when warranted, clinical staff should communicate with prescribers and 
beneficiaries to ascertain medical necessity.  When the prescriber agrees that 
the beneficiary may be overutilizing the drugs or when the prescriber does not 
respond to the sponsors inquiries, sponsors may place point-of-sale edits on 
beneficiaries.   These edits are specific to the beneficiary and can vary on the 
basis of the situation. For example, they may prevent a beneficiary from  
receiving any drug in a certain class or an excessive dose of a particular drug 
ingredient. 
In July 2013, CMS implemented the Overutilization Monitoring System to 
ensure that sponsors have reasonable and appropriate drug utilization 
 
22 CMS, Improving Drug  Utilization Review Controls in Part D, September 28, 2011.  
23 CMS, Announcement  of Calendar Year (CY) 2013 Medicare Advantage Capitation Rates 
and  Medicare Advantage and Part D  Payment Policies and Final Call Letter, April 2, 2012.  
Accessed at http://www.cms.gov/Medicare/Prescription-Drug-Coverage/  
PrescriptionDrugCovContra/Downloads/RateNoticeA.pdf  on October  15, 2013.   
24 CMS, Medicare Advantage and Prescription Drug Plan Fall Conference:  Medicare 
Part D Overutilization  Monitoring  System Update and Lessons  Learned, September 4, 2013.   
Accessed at http://www.cms.gov/Outreach-and-Education/Training/CTEO/ 
Event_Archives.html#CMS%20Medicare%20Advantage%20Prescription%20Drug%20Plan 
%20Fall%20Conference%20%28Webcast%29  on November 14, 2013.  (Also online at  
http://www.ustream.tv/recorded/38234985.)   
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  5   
   
management programs.25 On a quarterly basis, CMS provides each sponsor 
with a list of beneficiaries with potential issues regarding overutilization of  
opioids or acetaminophen.26 Sponsors are required to review these 
beneficiaries and report the status of these reviews to CMS.    
Guidelines for the Use of HIV Drugs 
The Department of Health and Human Services (HHS) has published 
guidelines for practitioners on the use of HIV drugs.27   The March 2012 
guidelines recommended, among other things, that all patients taking HIV  
drugs receive certain laboratory tests  regularly.  These tests include a CD4 
count and a measure of the patients viral  load.  The CD4 count measures 
immune function and can help to determine how well the patient is 
progressing with the treatment and whether the treatment needs to be changed.  
The measure of viral load indicates how well the patient is responding to the 
drugs. The guidelines recommend that these two tests be performed at the 
beginning of care when a patient is first diagnosed and every 3 to 6 months 
thereafter.28  A third laboratory test, which tests for drug resistance, is 
recommended when care begins and if treatment does not seem to be 
working.29    
Related Work   
A recent OIG report found that 2,637 retail pharmacies had questionable 
billing in 2009.30  These pharmacies had extremely high billing for at least one 
of eight measures we developed.  For example, many pharmacies billed 
extremely high dollar amounts or numbers of prescriptions per beneficiary or 
per prescriber, which could mean that a pharmacy is billing for drugs that are 
not medically necessary or were never provided to the beneficiary.  Among 
other things, the report recommended that CMS strengthen its monitoring of 
 
25 CMS, Medicare Part D Overutilization  Monitoring System, July 5, 2013.  Accessed  at 
http://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/ 
Downloads/HPMS-memo-Medicare-Part-D-Overutilization-Monitoring-System-07-05-13-
.pdf on December 23, 2013. 
26 The list can also include other beneficiaries identified by CMS.  See CMS, Medicare 
Part D Overutilization  Monitoring  SystemUpdates, October 25, 2013. 

27  HHS Panel on Antiretroviral Guidelines for Adults and Adolescents, Guidelines for the Use 

of Antiretroviral Agents in  HIV-1-infected Adults and Adolescents, pp. C1C10.  March 27, 

2012.  Accessed at http://aidsinfo.nih.gov/contentfiles/AdultandAdolescentGL003093.pdf on 
 
August 26, 2013. 

28A CD4 count is also  known as a CD4+  T-cell count, and a viral load test is also  known as an 

HIV RNA plasma test.  According to the guidelines, in certain clinically stable patients, the 

CD4 count can be monitored  every  6 to  12  months, rather  than every 3 to 6 months.
  
29 Drug  resistance occurs when  the drug is no longer effective in stopping the virus from 
 
replicating. 

30 OIG,  Retail Pharmacies With  Questionable Part D Billing, OEI-02-09-00600, May 2012. 

Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  6   
   
pharmacies, provide additional guidance to sponsors on monitoring pharmacy 
billing, and further strengthen its compliance plan audits. 
Another recent report found that 736 general-care physicians had questionable 
prescribing patterns.31  Each of these physicians prescribed extremely high 
amounts for at least one of five measures we developed.  For example, many 
of these physicians prescribed extremely high numbers of prescriptions per 
beneficiary or high percentages of Schedule II drugs, which may indicate that 
these prescriptions are medically unnecessary.  The report recommended that 
CMS instruct the MEDIC to expand its analysis of prescribers and provide 
sponsors with additional guidance on monitoring prescribing patterns.   
Another recent OIG report found that Part D inappropriately paid $25 million 
for Schedule II drugs billed as refills in 2009.32 Sponsors should not have paid 
for any of these drugs because Federal law prohibits refills on prescriptions 
for Schedule II drugs; such drugs require a new prescription.33   Among other 
things, the report recommended that CMS issue guidance to sponsors to 
prevent billing of Schedule II refills and to exclude Schedule II refills when 
calculating payments to sponsors. 
A fourth report found that Part D inappropriately paid for drugs ordered by 
individuals who clearly did not have the authority to prescribe, such as 
massage therapists, athletic trainers, home contractors, interpreters, and 
transportation companies.34  This raises concerns about the appropriateness of 
Part D payments and about patient safety. The report recommended that CMS 
require sponsors to verify that prescribers have the authority to prescribe 
drugs and ensure that Medicare does not pay for prescriptions from  
individuals without prescribing authority.   
METHODOLOGY 
We based this study on an analysis of prescription drug event (PDE) records 
for HIV drugs in 2012.  Part D sponsors submit a PDE record to CMS for 
each time that a drug is dispensed to a beneficiary enrolled in their plans.  
Each record contains information about the drug and beneficiary, as well as 
the identification numbers for the pharmacy and the prescriber.  We matched 
these records to beneficiaries Part A and B claims from CMSs National 
 
31 OIG,  Prescribers With Questionable Patterns in Medicare Part D, OEI-02-09-00603,  
June 2013. 

32 OIG,  Inappropriate Part D Payments for Schedule II Drugs Billed as  Refills, 

OEI-02-09-00605, September  2012. 

33 Federal law permits partial refills under certain circumstances.  It is possible some of these 
drugs may have been inaccurately billed as refills when they were partial fills.   
34 OIG,  Medicare Inappropriately Paid for Drugs Ordered  by Individuals Without 
Prescribing Authority, OEI-02-09-00608, June 2013. 
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  7   
   
Claims History File to determine whether beneficiaries had an indication of 
HIV in their medical histories.  For each HIV drug, we also reviewed the 
FDA-approved label to identify the drugs indications, recommended dose, 
and contraindications. 
Analysis of HIV Drugs 
We first identified all PDE records for HIV drugs with dates of service from  
January 1 to December 31, 2012.  To do this, we matched FDAs list of HIV  
drugs to First Databank and Red Book to identify the National Drug Codes 
(NDCs) for HIV drugs.35 In total, we identified 654 NDCs. For a list of HIV  
drugs and their generic names, see Appendix A. 
We identified 3,177,937 PDE records with these NDCs.  Using the Health 
Insurance Claims Number (HICN), we matched the PDE records to the 
National Claims History File and obtained Part A and B claims for each 
beneficiary for 2011 and 2012.  Using the HICN, we also matched the PDE 
records to the Beneficiary Enrollment Database (EDB).  For the purposes of 
this review, we excluded 174,504 PDE records for beneficiaries who appeared 
to be taking HIV drugs as pre- or post-exposure prophylaxis or for 
hepatitis B.36     
We analyzed these data to determine the total amount Medicare paid for HIV 
drugs, the most common drugs, and the most common combinations of HIV 
drugs.37  We also analyzed the demographics of the beneficiaries receiving 
HIV drugs. Specially, we looked at their age, sex, and Medicare status.  
Analysis of Questionable Utilization Patterns 
We developed six measures to identify beneficiaries with questionable 
utilization patterns that warrant further scrutiny for fraud, waste, or abuse.38   
We developed these measures on the basis of the results of past OIG analyses 
and fraud investigations related to HIV drugs, as well as input from CMS 
staff.  These measures focused on beneficiaries Medicare histories, doses of 
HIV drugs, supplies of HIV drugs, the number of pharmacies per beneficiary, 
 
35 FDA,  Antiretroviral Drugs Used in the Treatment of HIV Infection, August 2013. Accessed 
at http://www.fda.gov/ForConsumers/byAudience/ 
ForPatientAdvocates/HIVandAIDSActivities/ucm118915.htm  on November 12, 2013.  
36 We  excluded a total of 10,566 beneficiaries.  For beneficiaries with Parts A and B claims, 
we assumed that those who received Truvada only and had  an HIV test in  2011 and 2012  
were taking the drug  for pre-exposure prophylaxis.  Next, we assumed that beneficiaries with  
a diagnosis of  V0179 (contact with  or exposure to  other  viral diseases)  were taking  HIV  
drugs as post-exposure prophylaxis.  Lastly, we assumed that beneficiaries who received 
Viread  only and  had a diagnosis of hepatitis B were taking the drug for hepatitis B.  
37 To calculate the total amount that Part D paid, we summed three fields on the PDE records 
that represent the total gross drug costs:  ingredient cost, dispensing fee, and sales tax.    
38 These measures are not intended to  be clinical standards for treatment. 
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  8   
   
the number of prescribers per beneficiary, and contraindicated drugs.  We  
developed these measures to address a variety of concerns so each measure is 
independent of the others. As a result, we considered beneficiaries to have 
questionable utilization patterns if they had extreme results on one or more 
measures.  
Below is a description of each measure and how we identified beneficiaries 
with questionable utilization patterns.  
Medicare history had no indication of HIV.   The beneficiarys Medicare 
claims history (1) did not show a diagnosis of HIV, (2) did not include any of 
three laboratory tests that are used to monitor the use of HIV drugs, and 
(3) did not show that the beneficiary received any medical services from any 
of his or her HIV drug prescribers.   
For this measure, we identified beneficiaries who received HIV drugs and 
were enrolled in Medicare Parts A and B for all of 2012.39  We reviewed the 
Part A and B claims from January 1, 2011, to December 31, 2012 for each of 
these beneficiaries. We first determined whether any of the beneficiarys 
Part A or B claims from this 2-year period had any of the following HIV  
diagnosis codes: 
	   042 (human immunodeficiency virus (HIV-140) disease);  
	   V08 (asymptomatic human immunodeficiency virus), which indicates 
that the patient tested positive for HIV, but has no symptoms; 
	   079.53 or 07953 (HIV-2); and 
	   795.71 or 79571 (nonspecific serologic evidence of human 
immunodeficiency virus, which indicates an inconclusive HIV test). 
We then determined whether there were claims for the beneficiary for any of 
the three laboratory tests that monitor the use of HIV drugs.  Specifically, we 
reviewed the Healthcare Common Procedure Coding System (HCPCS) codes 
in the claims to determine whether each beneficiary received at least 1 CD4 
count, viral load test, or drug resistance test during the 2-year period.   
Next, we analyzed the claims data to determine whether beneficiaries received 
a medical service during the 2-year period from any of the prescribers of their 
HIV drugs. Using the prescribers National Provider Identifier (NPI), we  
searched the beneficiarys Part A and B claims to determine whether the 
 
39 For this measure, we analyzed claims for  90,351 beneficiaries who were enrolled in 
 
Medicare Parts A and B for all of 2012. 

40 HIV-1 is the  most common strain  of the virus.  HIV-2 is  not widely seen  outside Africa. 
 
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  9   
   
beneficiary received any medical services, such as office visit or surgery, from  
the prescriber.41      
Excessive doses of an HIV drug. The beneficiary received greater than two 
times the daily recommended dose of an active ingredient. 
For this measure, we first reviewed the FDA-approved labels for each HIV  
drug and identified the recommended dose for each active ingredient of the 
drug.42  Using the PDE records, we calculated the average daily dose that each 
beneficiary received for each HIV drug ingredient.  We did this by summing 
the total amount dispensed and dividing it by the number of unique days the 
beneficiary had a prescription for that drug.  If the beneficiarys average daily 
dose over the entire year was more than two times the recommended dose on 
the FDA-approved label, we considered it to be questionable.   
Excessive supply of an HIV drug. The beneficiary received more than a  
16-month (480-day) supply of an HIV drug. 
For each drug and strength, we calculated the total number of days supplied 
using the PDE records.43  If the total was more than 480 days, we considered it 
to be questionable. 
High number of pharmacies. The beneficiary received HIV drugs from six or 
more pharmacies. 
For this measure, we used the pharmacies NPIs to calculate the total number 
of pharmacies for each beneficiary.44   We used a standard technique, known as 
the Tukey method, to identify the beneficiaries who were outliers (i.e., those 
who were above the 75th percentile plus three times the interquartile range).  
Using this method, we determined that beneficiaries who received HIV drugs 
from six or more pharmacies were extremely different from their peers, and 
we considered this to be questionable.45    
 
41 To do this analysis, we also checked  whether the prescriber was listed on the claims as the 
rendering  provider,  attending provider, operating provider, or  other provider.  For records  that  
did not contain an NPI for the prescriber, we used a crosswalk developed by OIG analysts  
to identify the prescribers NPI.  We excluded  from this analysis any PDE records for which 
we were unable to identify the prescribers NPI. 
42 In cases in which the recommended dose varied  on the basis of the beneficiaries  weight, 
age, or  health status, we identified the dose that was for an average adult, without  special  
circumstances or comorbidities.  When doses varied  on the basis of past HIV drug  use, we 
used the higher of the two doses.    
43 For this analysis, we combined  brand-name  drugs with their generic equivalents.   
44 Most PDE  records included an  NPI for the pharmacy.  In cases in  which  we  were unable to  
identify the NPI, we used the provider identifier on the PDE record  for this analysis. 
45 See J.W. Tukey, Exploratory Data  Analysis.  Addison-Wesley, 1977.  The interquartile 
range is calculated by  subtracting the value at the 25th percentile from the value at the  
75th percentile.   
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  10    
   
High number of prescribers. The beneficiary received HIV drugs from six or 
more prescribers. 
For this measure, we used the prescribers NPIs to calculate the total number 
of prescribers for each beneficiary.46  As we did with the pharmacies, we used 
the Tukey method to identify the beneficiaries who were outliers.  We  
determined that beneficiaries with six or more prescribers were extremely 
different from their peers.  For each beneficiary with six or more prescribers, 
we then reviewed the prescribers addresses and phone numbers to determine 
whether they appeared to be from  the same group practice or institution.47 If a 
beneficiary had six or more prescribers who did not appear to be from the 
same group practice or institution, we considered it to be questionable.  For 
example, if a beneficiary had a total of seven prescribers, but four of the seven 
were in the same practice, we did not consider it questionable. 
Contraindicated combination of HIV  drugs. The beneficiary received a 
contraindicated combination of HIV drugs for more than 60 days during the 
year.  
The labels for two HIV drugs state that the drug is contraindicated with 
another HIV drug.  Specifically, the label for Lexiva states that it is 
contraindicated with delavirdine.48   The label for Reyataz states that it is 
contraindicated with indinavir.   To determine whether beneficiaries took these 
drugs at the same time, we used the dispensing date and number of days 
supplied to determine the approximate dates the beneficiary took the drugs.  
For example, if a 30-day supply of drug was dispensed on January 1, 2012, we 
assumed the beneficiary took the drug from January 1, 2012, to January 30, 
2012. If the PDE records indicated that the beneficiary took the same  
combination of contraindicated drugs for more than 60 days of the year, we 
considered it to be questionable. 
Analysis of Beneficiaries With Questionable Utilization Patterns   
We analyzed the characteristics of the beneficiaries who had one or more 
questionable utilization patterns.  We determined the total amount that Part D 
paid for HIV drugs for these beneficiaries.  We determined the proportion of 
these beneficiaries that were located in each Core Base Statistical Area 
 
46 Most PDE records included an  NPI for the prescriber.  In cases in which the PDE record 
included a different identifier, we used a crosswalk developed  by OIG staff to identify the 
NPI. If we could not identify the NPI, we used the prescriber identifier on the PDE for this 
analysis.   
47  We  obtained the addresses and phone numbers from the National Plan and Provider  
Enumeration System. 

48 For a full list of HIV drugs  brand names, see Appendix  A.   (Many  HIV drugs are currently 
 
available only in  brand-name  form.) 

Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  11    
   
(CBSA).  A CBSA is a region around an urban center that has at least 
10,000 people.49   We also determined the number of times that these 
beneficiaries changed Part D plans during the year. We then determined the 
extent to which these beneficiaries received HIV drugs from any of the 
2,637 retail pharmacies or 736 general-care physicians with questionable 
Part D patterns that we identified in two earlier reports.5 0    
Limitations 
We designed this study to identify utilization patterns that warrant further 
scrutiny.  None of the measures we analyzed independently confirm that a 
particular beneficiary is engaging in fraud, waste, or abuse.   
We did not independently verify the accuracy of the PDE records or the 
Medicare Part A and B claims data.  In addition, our review was limited to 
medical services paid for by Medicare.  In some cases, beneficiaries may have 
received services that were not included in this review, such as services from  
free clinics or services for which the beneficiary paid out of pocket. 
Standards 
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.  
   
 
49 CBSAs include the entire metropolitan area, not just the urban center.  See U.S. Census  
Bureau, Metropolitan and Micropolitan Statistical  Areas. Accessed at 
http://www.census.gov/population/www/metroareas/aboutmetro.html  on November 21, 2013.  
50 OIG,  Retail Pharmacies With  Questionable Part D Billing, OEI-02-09-00600, May 2012.  

OIG, Prescribers With Questionable Patterns in Medicare Part D, OEI-02-09-00603,  

June 2013.  

Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  12    
   
FINDINGS 
Medicare Part D Paid $2.8 Billion for HIV Drugs in 2012  
In 2012, 135,554 beneficiaries received HIV drugs that were paid for by 
Medicare Part D. On average, Medicare paid $20,989 per beneficiary for 
these drugs, totaling $2.8 billion for the year.51   Typically, each beneficiary had 
one or two prescribers and used one pharmacy for their HIV drugs.  On 
average, beneficiaries received 23 1-month supplies of HIV drugs. 
Beneficiaries typically received more than one type of HIV drug  
A full treatment regimen usually includes multiple drugs because different 
classes of HIV drugs fight the disease differently.   The most common 
combination of drugs was Norvir, Reyataz, and Truvada.  Norvir and Reyataz 
work by interfering with the enzymes that HIV uses to produce viral particles.  
Truvada interferes with the building of the HIV DNA.   
Some beneficiaries took certain drugs known as multiclass combination drugs 
instead of taking separate HIV drugs.  These HIV drugs contain active 
ingredients from multiple classes and are considered a full treatment regimen.  
Atripla was the most commonly used multiclass combination drug, followed 
by Complera and then Stribild.  For more information about the most common 
drugs and most common combinations of drugs, see Appendix B. 
Beneficiaries who received HIV drugs were more likely to be 
younger and male 
Beneficiaries who received HIV drugs were more likely to be younger and  
male than the Medicare Part D population as a whole.5 2   Eighty-two percent of 
beneficiaries who received HIV drugs were under the age of 65.  In contrast, 
15 percent of all Part D beneficiaries were under 65.  This may be because 
many of the beneficiaries who received HIV drugs qualified for Medicare 
because of disability, rather than age.  Beneficiaries who received HIV drugs 
were predominantly male75 percentcompared to 40 percent of all Part D 
beneficiaries. In addition, beneficiaries who received HIV drugs were much  
 
51 This includes the amount  paid  by sponsors, by the Government, and by or  on behalf  of  
beneficiaries.  
52 The estimates for age and sex for the entire Part D population are taken from CMS, Chronic 
Conditions Data Warehouse:   Medicare Part  D Charts,  September 2013. Accessed at 
https://www.ccwdata.org/web/guest/medicare-charts/medicare-part-d-charts#f1_age_2011 on  
November 7, 2013.  
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  13    
   
more likely to receive the low-income  subsidy; 82 percent received a subsidy 
compared to 29 percent of all Part D beneficiaries.53  
 
Almost 1,600 Part D Beneficiaries Had Questionable 
Utilization Patterns for HIV Drugs 
In 2012, a total of 1,578 Medicare Part D beneficiaries had questionable 
utilization patterns for HIV drugs.  Eighty-three percent of these beneficiaries 
received the low-income subsidy, meaning that they paid little or no 
cost-sharing to receive drugs under Part D. 
These 1,578 beneficiaries had no indication of HIV in their Medicare claims  
histories, received an excessive dose or supply of HIV drugs, received HIV  
drugs from a high number of pharmacies or prescribers, and/or received 
contraindicated HIV drugs.  See Table 1 for the number of beneficiaries with 
each questionable utilization pattern.  
 
Table 1: Number of Beneficiaries With Questionable Utilization Patterns for 
 
HIV Drugs, 2012  
 
  Number of Beneficiaries  
 
No Indication of HIV   888 
 
  Excessive Dose   226 
 
Excessive Supply  206 
 
High Number of Pharmacies  213 
 
High Number of Prescribers  179 
 
  Contraindicated HIV Drugs   10 
        Total   1,578*  
 
*Sum does not equal 1,578 because a  number of beneficiaries had more than 1 questionable utilization pattern. 
Source:  OIG analysis of Part D data, 2013. 
 
In total, Medicare paid $32 million for HIV drugs for beneficiaries with 
questionable utilization patterns.  While some of this utilization may be 
legitimate, all of these patterns warrant further scrutiny.  These patterns 
 
53 Estimates of the percentage  of all beneficiaries receiving the low-income subsidies in 2012 
are calculated from data in The Boards of Trustees, Federal Hospital Insurance and Federal  
Supplementary Medical Insurance Trust Funds, 2013  Annual Report of the Boards  of  
Trustees of the Federal Hospital Insurance and Federal  Supplementary Medical  Insurance 
Trust Funds, p. 151.  Accessed at http://downloads.cms.gov/files/TR2013.pdf on  
November 26, 2013.   
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  14    
   
indicate that a beneficiary may be receiving inappropriate or unnecessary 
drugs. The HIV drugs for beneficiaries with questionable patterns were 
ordered by 2,698 prescribers and billed by 2,221 pharmacies.  Of these, 
183 pharmacies and 25 prescribers were previously identified by OIG as 
having questionable Part D billing.54    
Beneficiaries with questionable patterns were more likely to live in or near 
Miami or New York.  Twenty-four percent of the beneficiaries with 
questionable patterns lived in or near Miami, while just 2 percent of all 
beneficiaries who received HIV drugs lived there.  Fourteen percent of 
beneficiaries with questionable patterns lived in the New York area, while  
10 percent of all beneficiaries who received HIV drugs lived there.  
Five Part D sponsors accounted for more than three-quarters of the 
beneficiaries with questionable patterns. These sponsors were also the most 
common among all beneficiaries who received HIV drugs.  Two of these 
sponsors, however, had a disproportionate number of beneficiaries with 
questionable patterns enrolled in their plans.  These sponsors had 54 percent 
of the beneficiaries with questionable patterns enrolled in their plans but had 
43 percent of all beneficiaries who received HIV drugs enrolled. 
Almost 900 beneficiaries had no indication of HIV in their 
Medicare histories 
As Table 1 shows, 888 beneficiaries received HIV drugs paid for by Medicare 
Part D but did not have Medicare histories that indicated they had HIV.   
According to their Medicare claims from 2011 and 2012, these beneficiaries 
had none of the following three indicators of HIV: 
 	  a diagnosis of HIV,  
 	  any of the laboratory tests that monitor the use of HIV drugs, and   
 	  a service from any of the providers who prescribed them HIV  
drugs. 
In total, Medicare paid $6.5 million for HIV drugs for beneficiaries who had 
no indications of HIV in their Medicare histories.  Eighty-three percent of 
these beneficiaries received the low-income subsidy. 
When Medicare pays for HIV drugs and there is no indication in the Medicare 
history that the beneficiary has HIV, it raises concerns about fraud and abuse.  
The beneficiary may have received the drugs and diverted them for sale on the 
black market.  Another possibility is that the beneficiary never received the 
 
54  For more information, see OIG,  Retail Pharmacies With Questionable Part D Billing, 
OEI-02-09-00600, May 2012, and  OIG,  Prescribers With  Questionable Patterns in Medicare 
Part D, OEI-02-09-00603, June 2013. 
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  15    
   
drugs.  For example, the pharmacy could have submitted claims for drugs that 
were never dispensed, or the beneficiarys identification number could have 
been stolen. These drugs were dispensed by 556 pharmacies.   
Two of these pharmacies stand out.  These two pharmaciesboth located in 
Miamibilled for HIV drugs for more than one-third (321 of 888) of the 
beneficiaries who had no indication of HIV.   These 321 beneficiaries had 
characteristics different from those of the beneficiaries who typically received 
HIV drugs.  Most of the beneficiaries associated with the two pharmacies 
were women and their average age was 74, which is 21 years older than the 
average for beneficiaries who received HIV drugs in 2012.  In addition, they 
typically received just over a 1-month supply of HIV drugs.  Medicare paid 
these two pharmacies a total of $359,456 for HIV drugs for beneficiaries who 
had no indication of HIV. 
The remaining two-thirds of the beneficiaries with no indication of HIV  
(567 of 888) also received drug supplies for fewer months than average.  They 
typically received 12 1-month supplies of HIV drugs, whereas the average for 
all beneficiaries receiving HIV drugs was 23 1-month supplies.55   The 
difference in these patterns raises further concern that pharmacies may be 
billing for drugs that beneficiaries are not receiving or do not need.  
Interestingly, 1 pharmacy in Pennsylvania billed for 19 of these beneficiaries.   
 
 
Example of a Beneficiary With No Indication of HIV 
 
In 2012, Medicare paid $33,536 for HIV drugs for a 77-year old Detroit 
  woman who had no indication of HIV in her Medicare claims history.  She 
had prescriptions for 10 different types of HIV drugs prescribed by 
 
6 different doctors.  There is no evidence that she visited any of these 
  doctors. 
 
 
About 230 beneficiaries received an excessive dose of an HIV 
drug; about 210 received an excessive supply 
A total of 226 Part D beneficiaries received an excessive dose of at least 
1 HIV drug in 2012. Each of these beneficiaries received an average daily 
dose that was more than twice the recommended dose for an active ingredient.  
Thirteen of these beneficiaries received an average daily dose that was more 
than five times the recommended dose.  For example, 1 beneficiary received 
 
55 As noted earlier, a full treatment regimen usually includes multiple drugs because different 
classes of HIV drugs fight the disease differently. 
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  16    
   
30 times the recommended dose of lopinavir. Four beneficiaries received five 
or more times the recommended dose of zidovudine.   
More than half of the 226 beneficiaries had excessive doses because they 
received multiple drugs containing the same ingredient.  When added 
together, the dose for the ingredient was excessive.  In one example, a 
New York beneficiary received three different HIV drugs containing tenofovir 
almost every month, resulting in five times the recommended dose of 
tenofovir. 
Although a higher dose may sometimes be appropriate, excessive doses over 
long periods of time raise questions about whether these drugs are medically 
necessary.  Such high dosages may mean that the drugs are being diverted or 
that claims were submitted for drugs that were never dispensed.  It may also 
mean that the beneficiarys drugs are not being properly monitored and, as a 
result, the beneficiary is taking potentially dangerous levels of drugs.   
 
 
Example of a Beneficiary With Excessive Doses 
 
One beneficiary received $17,509 of HIV drugs in a single day and no 
 
other HIV drugs the rest of the year. On that single day, she received more 
  than twice the recommended dose for five different HIV drug ingredients.  
Further, two of the drugs, Atripla and Complera, are complete drug 
 
regimens that do not need to be taken with other HIV drugs.   
 
 
A total of 206 Part D beneficiaries received an excessive supply of HIV drugs 
in 2012. Each of these beneficiaries received more than a 16-month supply of 
at least one HIV drug.  An excessive supply may indicate that the beneficiary 
is receiving drugs that are not medically necessary or that the beneficiary or 
pharmacy is diverting these drugs and selling them for profit.  It also may 
indicate that the beneficiarys drugs are not being properly monitored for 
safety.   
Nearly one-third of these beneficiaries received excessive supplies of multiple 
HIV drugs.  This includes three beneficiaries who each received excessive  
supplies of four different drugs.  In one case, the beneficiary received supplies 
that were more than a 480-day supply each of Prezista, Norvir, Intelence, and 
Selzentry.   Another beneficiary received a 600-day supply of Atripla, a 
600-day supply of Isentress, and a 510-day supply of Lexiva. 
  
 
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  17    
   
 
 
 
Example of a Beneficiary With an Excessive Supply 
 
One beneficiary from New York received a 720-day supply of Norvir 
  100 mg. Almost every month in 2012, this beneficiary received this drug 
from two different pharmacies and two different prescribers.  Recent 
 
research indicates that when ritonavirthe active ingredient in Norviris 
  mixed with some illicit drugs, including ecstasy, it heightens the 
psychoactive effects of the drugs. 
 
 
Over 210 beneficiaries obtained HIV drugs from a high number of 
pharmacies; nearly 180 beneficiaries had a high number of 
prescribers   
Two hundred thirteen Part D beneficiaries obtained HIV drugs from a high 
number of pharmacies in 2012.  Each of these beneficiaries went to six or 
more pharmacies for their HIV drugs during the year.  Twenty beneficiaries 
each went to more than 10 pharmacies.  When a beneficiary obtains HIV 
drugs from many pharmacies, it could mean the beneficiary is seeking drugs 
to divert for profit or the beneficiarys identification number was stolen.  
Another concern is that the beneficiary is getting excessive doses or supplies.  
About one-third of the beneficiaries who went to a high number of pharmacies 
were from the Miami or New York areas.  
A total of 179 beneficiaries had a high number of prescribers for their HIV 
prescriptions, raising concerns about doctor-shopping.56 Each of these 
beneficiaries had at least six prescribers for HIV drugs.  Twenty-nine 
beneficiaries had 10 or more prescribers.  When a beneficiary goes to a high 
number of prescribers to obtain HIV drugs, it could indicate that the 
beneficiary is acquiring drugs with the intention of diverting them.  It might 
also signal that the beneficiarys care is not being monitored or coordinated 
properly. Forty-five percent of the beneficiaries who had a high number of 
prescribers were from the Miami or New York areas.  
Beneficiaries with a high number of pharmacies or prescribers were far more 
likely to change their Part D prescription drug plans two or more times during 
the year, meaning they were enrolled in three or more plans.  These 
beneficiaries were at least 10 times more likely to change their plans multiple 
 
56  Doctor-shopping occurs when a beneficiary consults a number of  doctors for the purpose 
of inappropriately obtaining prescriptions.    
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  18    
   
times compared to all beneficiaries taking HIV drugs.  Specifically, 12 percent 
of the beneficiaries with a high number of pharmacies switched plans more 
than once in 2012, and 16 percent with a high number of prescribers switched 
more than once. In contrast, 1 percent of all beneficiaries taking HIV drugs 
changed their plans more than once. Notably, eight beneficiaries were 
enrolled in six or more plans during 2012.   
The patterns of 61 beneficiaries are of particular concern.  Each of these 
beneficiaries obtained HIV drugs from a high number of pharmacies and a 
high number of prescribers.   
 
Example of a Beneficiary With a High Number of Pharmacies 
 
and Prescribers 
 
A 48-year-old from Miami went to 28 pharmacies and had 16 prescribers 
  for HIV drugs, which included 15 different types of drugs.  The 
beneficiary received excessive doses and excessive supplies during the 
 
year.  In total, Medicare paid $198,272 for the HIV drugs for this 
 
beneficiary.  
 
Ten beneficiaries received contraindicated HIV drugs   
Ten beneficiaries each received a potentially dangerous combination of HIV  
drugs for at least 60 days in 2012. According to the FDA-approved labels for 
these drugs, these combinations are contraindicated, meaning the risks of 
using the drug combination clearly outweigh any potential therapeutic 
benefit.57  One of the beneficiaries received contraindicated HIV drugs for 
almost the entire year.   These drugs were often dispensed on the same date by 
the same pharmacy, despite warning labels.  Even though the number of 
beneficiaries who received such combinations is small, these combinations  
should not happen at all, as taking such combinations could put beneficiaries 
at great risk. 
Over 100 beneficiaries had questionable utilization patterns for 
more than 1 measure 
One hundred two beneficiaries had questionable utilization patterns for 
multiple measures.  Ninety-three beneficiaries had questionable patterns for 
two or three measures, while nine beneficiaries had questionable patterns for 
 
57 See FDA, Guidance of Industry:  Warning and Precautions, Contraindications, and  Black 
Box Warning Sections of Labeling for Human Prescriptions Drugs and Biological  Products  
Content and Format, October 2011.  Accessed at http://www.fda.gov/downloads/Drugs/  
GuidanceComplianceRegulatoryInformation/Guidances/UCM075096.pdf on May  14, 2013.  
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  19    
   
four or more measures.  See the text box below for examples of beneficiaries 
with several questionable patterns.  
 
   
 
Examples of Beneficiaries With Several Questionable Patterns 
 
   Medicare paid $349,854 in 2012 for one Florida beneficiarys HIV 
drugs. This beneficiary received 20 different HIV drugs from  
32 prescribers and 20 different pharmacies.  In total, he received 
284 HIV drugs. This resulted in excessive doses of seven HIV drugs 
and an excessive supply of three drugs. He was enrolled in five 
different Part D plans during the year. 
 
   Medicare paid $146,160 for HIV drugs for a 37-year-old Miami 
beneficiary. In 1 month alone, he received 16 HIV drugs.  Several 
times during the year, he received these drugs from two different 
pharmacies on the same day.  He had prescriptions from nine 
physicians and was enrolled in two Part D plans during the year. 
 
   Medicare paid $154,549 for HIV drugs for a 44-year-old beneficiary in 
Miami who had 12 prescribers.  The beneficiary used 19 pharmacies 
and received more than 3 times the recommended doses of 
emtricitabine and tenofovir.  
 
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  20    
   
CONCLUSION AND RECOMMENDATIONS 
Various types of Part D drugs can be targets for fraud, waste, and abuse, 
particularly if they are expensive or have psychoactive effects.  HIV drugs are 
an example of such Part D drugs.  They are costly and can be profitable to 
beneficiaries and others who choose to sell them on the black market.    
We found that almost 1,600 Part D beneficiaries who received HIV drugs had 
questionable utilization patterns in 2012.  While some of this utilization may 
be legitimate, all of these patterns warrant further scrutiny.  These patterns 
indicate that beneficiaries may be receiving inappropriate or unnecessary 
drugs. Other possibilities include that the pharmacy submitted claims for 
drugs never dispensed or that the beneficiarys identification was stolen.  
Almost 900 of the 1,600 beneficiaries had no indication of HIV in their 
Medicare histories. Others received an excessive dose or excessive supply of 
HIV drugs, obtained HIV drugs from a high number of pharmacies, had a high 
number of prescribers, or received contraindicated HIV drugs. 
CMS has placed few restrictions on specific beneficiaries in Part D.  These 
restrictions have focused on opioids.  This report addresses another group of 
drugs that is susceptible to fraud, waste, and abuse.  It shows that CMS needs 
to increase its program integrity efforts focused on beneficiaries beyond 
opioids and limit certain beneficiaries from receiving other potentially 
inappropriate or unnecessary drugs. CMS needs to do this while also 
maintaining beneficiaries access to needed drugs.   
We recommend that CMS: 
Expand Sponsors Drug Utilization Review Programs  
The purpose of drug utilization review programs is to address inappropriate 
utilization to protect beneficiaries and to reduce fraud, waste, and abuse.  
CMS required sponsors to improve these programs beginning in 2013.  
Specifically, it required that sponsors make improvements to the concurrent 
claims review and formulary design for all drugs.  However, improvements to 
retrospective reviews and case management were required only for opioids.   
CMS should require sponsors to improve retrospective reviews and case 
management for other drugs susceptible to fraud, waste, and abuse, including 
HIV drugs.  As they do with opioids, sponsors should use data analysis to 
identify beneficiaries who may be overutilizing these drugs and to identify  
possible fraud, waste, and abuse. CMS should require sponsors to contact the 
prescribing physicians to determine whether utilization is appropriate.   
   
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  21    
   
Expand the Overutilization Monitoring System To Include 
Additional Drugs Susceptible to Fraud, Waste, and Abuse 
CMS should ensure that sponsors have made the necessary changes to 
improve their drug utilization review programs.  As part of its efforts, CMS 
should expand the Overutilization Monitoring Systemwhich currently 
focuses on opioids and acetaminophento include other drugs susceptible to 
fraud, waste, and abuse, such as HIV drugs.  Specifically, CMS shouldon a 
quarterly basisidentify beneficiaries who are receiving excessive amounts 
of certain drugs, including HIV drugs; provide a list of these beneficiaries to 
sponsors; and require sponsors to review each beneficiary and report on the 
status of these reviews. 
Expand Sponsors Use of Beneficiary-Specific Controls 
Under certain conditions, CMS allows sponsors to implement edits at the 
point of sale for beneficiaries identified as overutilizing opioids.  The goal of 
these edits is to prevent these beneficiaries from receiving inappropriate and 
unsafe drugs and to prevent fraud, waste and abuse.  CMS should encourage 
sponsors to develop similar controls for other drugs.  As a part of this effort, 
CMS should provide additional guidance to sponsors about the circumstances 
under which they can use point-of-sale edits and similar controls for 
beneficiaries identified as overutilizing other drugs susceptible to fraud, 
waste, and abuse, including HIV drugs.   
CMS should balance the need for these controls with maintaining access to 
needed drugs. CMS should closely monitor the sponsors to ensure that they 
use these controls only after appropriate case management and 
communication with the prescriber and beneficiary.  
Restrict Certain Beneficiaries to a Limited Number of Pharmacies 
or Prescribers 
We found that a number of beneficiaries received similar drugs from  
extremely high numbers of pharmacies or prescribers.  CMS should seek 
legislative authority, if necessary, to restrict certain beneficiaries to a limited 
number of pharmacies or to a limited number of prescribers, a practice 
commonly referred to as lock-in.  This practice is currently used by some  
State Medicaid programs. CMS would need to balance these restrictions with 
ensuring access to quality care for these beneficiaries.  Restricting certain 
beneficiaries to a limited number of pharmacies or prescribers could reduce 
program costs and inappropriate utilization.  It could also improve 
coordination of services and quality of care for these beneficiaries.   
   
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  22    
   
Limit the Ability of Certain Beneficiaries To Switch Plans  
We found that a number of beneficiaries with questionable utilization patterns 
switched their Part D plans multiple times during the year.  CMS should seek 
legislative authority to restrict the ability of certain beneficiaries to switch 
plans multiple times during the year.  Currently, beneficiaries who receive the 
low-income subsidy are allowed to switch plans every month.  While CMS 
needs to continue to allow beneficiaries to switch plans under certain 
circumstances, it needs to implement some restrictions.  Sponsors cannot 
effectively monitor the drugs that beneficiaries are receiving when 
beneficiaries frequently switch plans.  Limiting certain beneficiaries ability to 
switch plans could save taxpayer dollars and improve the quality of care for 
these beneficiaries.   
Increase Monitoring of Beneficiaries Utilization Patterns  
CMS should instruct the MEDIC to routinely monitor beneficiaries 
utilization patterns. CMS should focus on drugs susceptible to fraud, waste, 
and abuse, including HIV drugs.  To do this, CMS should use the measures in 
this report or other methods that it deems appropriate.  It should use claims  
data from Medicare Parts A and B to identify beneficiaries who do not have a 
history, such as a diagnosis, that supports the use of the drugs.  CMS should 
then identify the pharmacies and prescribers that are associated with these 
beneficiaries. 
Follow Up on Questionable Utilization Patterns 
In a separate memorandum, we will refer to CMS the beneficiaries with 
questionable utilization patterns. CMS or the MEDIC should further assess 
these utilization patterns by using other methods, such as reviewing medical 
records and supporting documentation.  CMS should then determine the most 
appropriate actions. 
   
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  23    
   
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL  
RESPONSE 
In its comments on our draft report, CMS concurred with five of our seven 
recommendations.  CMS concurred with our first recommendation (to expand 
sponsors drug utilization review programs), stating that it has indicated that 
Part D sponsors may adapt its guidance with respect to opioids and nonopioid 
medications.  It also said that it will reiterate and clarify this guidance with 
respect to the potential overutilization, misuse, and safety issues identified in 
this report related to HIV drugs.  
CMS did not concur with our second recommendation (to expand the 
Overutilization Monitoring System).  It stated that the system is not 
functionally designed to be a comprehensive safety and/or fraud-identification 
tool.  Instead, it is primarily a tool focused on medication safety to ensure that 
Part D sponsors adequately address the overutilization of opioids and 
acetaminophen.  While we understand that the Overutilization Monitoring 
Systems primary focus is opioids and acetaminophen, we see benefits in  
expanding it to include other drugs to ensure that sponsors are improving their 
drug utilization review programs.  
CMS concurred with our third and fourth recommendations (that it expand 
sponsors use of beneficiary-specific controls and that it restrict certain 
beneficiaries to a limited number of pharmacies or prescribers).  It noted that 
current guidance states that sponsors may expand their use of 
beneficiary-specific controls to drugs other than opioids and acetaminophen, 
as long as they use the same level of diligence and internal documentation that 
the agency expects with respect to opioids and acetaminophen.  With respect 
to restricting certain beneficiaries to a limited number of pharmacies or 
prescribers, CMS stated it would be receptive to legislative authority for 
lock-in in Part D. 
CMS said that it did not concur with our fifth recommendation (to limit the 
ability of certain beneficiaries to switch plans) at this time.  The agency said 
that it believes that new legislative authority to limit prescribers or pharmacies 
and the implementation of OIGs other recommendations are more likely to 
effectively address OIGs intent to limit an individuals ability to commit 
fraud or obtain more than necessary doses of Part D drugs.  Further, CMS said 
that it is concerned about the potential unintended consequences from creating 
limitations for certain beneficiaries receiving the low-income subsidy.   While 
we share CMSs concern about the vulnerability of this population, we believe 
this recommendation can be implemented with minimal impact on these 
beneficiaries. It could be used in only the most extreme cases, where other 
steps have failed to prevent potential abuse or overutilization.  
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  24    
   
CMS concurred with the sixth and seventh recommendations (that it increase 
monitoring of beneficiaries utilization patterns and that it follow up on 
questionable utilization patterns).  It stated that it will conduct future analysis 
that will use Medicare Part A and B claims data to identify beneficiaries, as 
well as the pharmacies and prescribers linked to these beneficiaries, to 
monitor fraud, waste, and abuse in Medicare Parts C and D.  CMS further 
stated that it will review the OIG data and take appropriate actions.  The full 
text of CMSs comments is provided in Appendix C.    
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  25    
   
APPENDIX A   
HIV Drugs   
Brand Name   Generic Name  
Multiclass Combination Products  
Atripla  efavirenz, emtricitabine and tenofovir disoproxil fumarate  
 
Complera  emtricitabine, rilpivirine, and tenofovir disoproxil fumarate  
 
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil 
Stribild 
  fumarate  
Nucleoside Reverse Transcriptase Inhibitors (NRTIs)  
Combivir  lamivudine and zidovudine 
 
Emtriva  emtricitabine, FTC 
 
Epivir  lamivudine, 3TC 
 
Epzicom  abacavir and lamivudine 
 
Retrovir  zidovudine, azidothymidine, AZT, ZDV  
 
Trizivir  abacavir, zidovudine, and lamivudine 
 
Truvada  tenofovir disoproxil fumarate and emtricitabine 
 
Videx EC  enteric coated didanosine, ddI EC  
 
Videx  didanosine, dideoxyinosine, ddI  
 
Viread  tenofovir disoproxil fumarate, TDF  
 
Zerit  stavudine, d4T  
 
Ziagen  abacavir sulfate, ABC 
 
Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)  
Edurant  rilpivirine  
 
Intelence  etravirine 
 
Rescriptor  delavirdine, DLV 
 
Sustiva  efavirenz, EFV 
 
Viramune (Immediate 
nevirapine, NVP 
Release) 
 
Viramune XR (Extended  
nevirapine, NVP 
Release) 
 
                      (continued on next page)  
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  26    
   
HIV Drugs (continued)  
Brand Name   Generic Name  
Protease Inhibitors (PIs)  
Agenerase  amprenavir, APV (no longer marketed)  
 
Aptivus  tipranavir, TPV  
 
Crixivan  indinavir, IDV, 
 
Fortovase  saquinavir (no longer marketed)  
 
Invirase  saquinavir mesylate, SQV  
 
Kaletra  lopinavir and ritonavir, LPV/RTV  
 
Lexiva  fosamprenavir calcium, FOS-APV 
 
Norvir  ritonavir, RTV  
 
Prezista  darunavir  
 
Reyataz  atazanavir sulfate, ATV  
 
Viracept  nelfinavir mesylate, NFV  
 
Fusion Inhibitors  
Fuzeon  enfuvirtide, T-20  
 
Entry Inhibitors - CCR5 Co-Receptor Antagonist  
Selzentry  maraviroc  
 
HIV Integrase Strand Transfer Inhibitors  
Isentress  raltegravir  
 
Source:  FDA, Antiretroviral Drugs Used in the Treatment  of HIV Infection, August 2013.   
Note: For more information about these drugs, see FDAs full table at  
http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/hivandaidsactivities/ucm118915.htm.  
 
   
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  27    
   
APPENDIX B 
Table B-1:  Most Common Combinations of HIV Drugs  
Total Number of  
Total Number of  
Combination of  Drugs   Days Taken 
Beneficiaries  
Together  
Norvir, Reyataz, and Truvada   14,311   3,175,807  
Norvir, Prezista, and Truvada   10,121   1,848,085  
Isentress and Truvada  8,656   1,539,604  
Norvir and Truvada  7,980   140,186  
Norvir and Prezista  6,853   159,757  
Norvir and Reyataz  6,388   144,163  
Kaletra and Truvada  5,252   1,099,948  
Reyataz and Truvada  4,869   231,498  
Isentress, Norvir, and Prezista  4,282   312,290  
Isentress, Norvir, Prezista, and Truvada  3,471   651,307  
Source:  OIG analysis of Part D data, 2013.  

Note: For a list of the generic names  for these drugs, see Appendix A. 

. 
 
 
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  28    
Table B-2:  Most Common HIV Drugs 
Total Number 
Total Number of 
HIV Drug   of  Total Dollars  
 Prescriptions  
Beneficiaries  
Norvir  56,018   471,146   $170,984,046 
Truvada  52,574   441,399   $545,137,647 
Isentress  33,748   282,629   $306,824,485 
Reyataz  28,564   238,718   $255,817,941 
Prezista  28,012   227,405   $248,064,989 
Atripla  27,514   237,458   $448,889,051 
Epzicom  18,408   156,654   $164,068,263 
Viread  14,946   116,203   $88,529,258 
Kaletra  14,886   119,312   $93,417,187 
Intelence  11,178   90,926   $79,094,787 
Sustiva  10,702   92,229   $60,042,837 
Epivir / lamivudine*  10,381   76,477   $22,419,341 
Combivir / lamivudine-zidovudine*  9,665   75,764   $61,281,517 
Ziagen / abacavir*  8,155   61,994   $34,389,214 
Viramune / Viramune XR / nevirapine*  7,648   70,367   $37,013,755 
Lexiva  5,457   45,615   $47,083,756 
Complera  3,908   21,800   $42,214,282 
Retrovir / zidovudine*  3,358   23,284   $1,414,313 
Selzentry  3,210   27,365   $33,262,235 
Emtriva  3,119   22,821   $9,334,652 
Trizivir  3,100   24,634   $38,571,285 
Videx / Videx EC / didanosine*  2,487   19,518   $4,559,596 
Viracept  2,112   18,267   $15,304,005 
Zerit / stavudine*  1,698   12,812   $1,810,603 
Stribild  1,200   2,456   $6,106,062 
Invirase  1,130   9,936   $9,445,175 
Edurant  742  4,437   $3,150,003 
Fuzeon  504  3,816   $10,685,586 
Crixivan  463  3,487   $1,607,226 
Aptivus  431  3,658   $4,328,383 
Rescriptor  102  846  $288,390 
Source:  OIG analysis of Part D data, 2013.  

*When determining the most common drugs, we considered the drugs listed with slashes (/) between them to be 
 
the same.  

Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  29   APPENDIX C 
Agency Comments 
l4
.... ... 
/ 
~
DEPA!UMENT OF HEALTH & HUMAN SERVICES  Centers lOt Medicare & Medicaid Se!'lices 
Administrator 
Washington. DC 20201 
DATE:  HAY 30  2014 
TO: 	 Daniel R. Levinson 

Inspector General 

FROM: 	 Marl'lyn "'N!venner 

Administtator 

SUBJECT: 	 Office ofInspector General {OIG) Draft Report: " Part D Beneficiaries with 
Questionable Utilization Patterns for HIV Drugs" (OEI-02-11-00170) 
The Centers for Medicare & Medicaid Services (CMS) appreciates the opportunity to review and 
comment on the above-refc.renced OIG draft report. The purpose of this report was to identify 
patternsofquestionable drug utilization in the Medicare Part D program that may warrant further 
scrutiny. 
The CMS is committed to preventing fraud, waste, and abuse in the Medicare Part D program. 
To help protect the Medicare Part p program, CMS requires plan sponsors to have compliance 
programs in place to help detect, prevent, and correct fraud, waste, and abuse. CMS also 
contracts with a Medicare Drug Intcgri.ty Contractor (MEDIC) that is tasked with identifying and 
investigating potential fraud and abuse, referring such cases to law enforcement. and fulfilling 
requests for information from law enforcement We appreciate OIG' s efforts in working with 
CMS to prevent fraud, waste, and abuse in the Medicare Part D program. Our response to each 
of the O!G recommendations follows. 
OJG Recommendation 
The OJG recommends CMS expand sponsors' drugs utilization review programs. CMS should 
require sponsors to improve retrospective reviews and case management for other drugs 
susceptible to frau~ waste. and abuse, including HlV drugs . Similar to opioids, sponsors should 
use data analysis to identify beneficiaries who may be over-utilizing these drugs and to identify 
possible fraud , waste, and abuse. CMS should require that sponsors contact the prescribing 
physicians to determine whether utilization is appropriate. 
CMS Response 
The CMS concurs with this re.commendation. In guidance since 2012, CMS has repeatedly 
indicated that Part D sponsors may adapt CMS ' guidance with respect to opioids to non-opioid 
medications. (See September 6, 2012 memorandum, "Supplemental Guidance Related to 
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  30   
   
   
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  31    
   
   
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  32    
   
   
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  33    
   
ACKNOWLEDGMENTS 
This report was prepared under the direction of Jodi Nudelman, Regional 
Inspector General for Evaluation and Inspections in the New  York regional 
office, and Nancy Harrison and Meridith Seife, Deputy Regional Inspectors 
General. 
Miriam  Anderson served as the team leader for this study.  Other Office of 
Evaluation and Inspections staff from the New York regional office who 
conducted the study include Jenell Clarke-Whyte and Jason Kwong.  Central 
office staff who provided support include Eddie Baker, Jr.; Mandy Brooks; 
David Graf; Kevin Farber; Meghan Kearns; and Christine Moritz.  We would 
also like to acknowledge the contributions of other Office of Inspector 
General staff, including Scott Hutchison and Julie Taitsman.   
Part D Beneficiaries With Questionable Utilization Patterns for HIV Drugs (OEI-02-11-00170)  34    
Office of Inspector General
http://oig.hhs.gov  
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as  
amended, is  to protect the integrity of the Department of  Health and Human Services  
(HHS)  programs, as well as the health and welfare of beneficiaries  served by those 
programs.  This statutory mission  is  carried  out through  a nationwide network  of  audits, 
investigations, and inspections conducted by the  following operating components: 
Office of Audit Services 
The Office  of  Audit Services  (OAS) provides auditing services  for HHS, either by  conducting  
audits  with its own audit resources or by  overseeing  audit work done by others.  Audits  
examine the performance of HHS programs and/or its grantees and contractors in carrying  
out their respective responsibilities and are intended  to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and  
mismanagement and promote economy and efficiency  throughout  HHS. 
Office of Evaluation and Inspections 
The Office  of  Evaluation and Inspections (OEI)  conducts national evaluations to  provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud,  waste, or abuse  and promoting  
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations  
of  fraud and misconduct  related to HHS programs, operations, and beneficiaries.  With 
investigators working in all 50 States and the District of Columbia, OI  utilizes its resources 
by actively  coordinating with the Department  of Justice  and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to  criminal 
convictions, administrative sanctions,  and/or  civil monetary  penalties.  
Office of Counsel to the Inspector General 
The Office of Counsel to the  Inspector  General (OCIG) provides general legal services to 
OIG, rendering  advice and opinions on HHS programs and operations and  providing all  
legal support for OIGs  internal operations.  OCIG represents  OIG in all civil and 
administrative fraud and abuse cases involving HHS programs,  including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In  connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program  guidance, publishes fraud alerts, and provides other  
guidance  to  the health care industry concerning the anti-kickback statute and other  OIG  
enforcement authorities.