Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

PART D BENEFICIARIES 

WITH QUESTIONABLE 

UTILIZATION PATTERNS 

FOR HIV DRUGS 

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, CMS’s 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 beneficiary’s 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 

month’s 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): 

171–183. 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/pressreleases/2013/manhattan-doctor-pleads-guilty-to-8.5-million-medicare-fraud-scheme on 

September 5, 2013. 

8

 Kings County District Attorney’s 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 O’Donnell 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-blackmarket-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 plan’s 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-drugplan/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 received—both overall and within certain 

classes of drugs—to 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 sponsor’s 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 patient’s 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 System—Updates, 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. C1–C10. 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 CMS’s 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. 

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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 drug’s 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 FDA’s 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 beneficiary’s 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 beneficiary’s 

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 prescriber’s National Provider Identifier (NPI), we 

searched the beneficiary’s 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 beneficiary’s 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 prescriber’s NPI. We excluded from this analysis any PDE records for which 

we were unable to identify the prescriber’s 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. 

50 

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. 

52 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 male—75 percent—compared 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 
 

 

 

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. 

drugs. For example, the pharmacy could have submitted claims for drugs that 

were never dispensed, or the beneficiary’s identification number could have 

been stolen. These drugs were dispensed by 556 pharmacies. 

Two of these pharmacies stand out. These two pharmacies—both located in 

Miami—billed 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. 

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 beneficiary’s 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 beneficiary’s 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 ritonavir—the active ingredient in Norvir—is 

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 beneficiary’s 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 beneficiary’s 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 
 

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. 

 

 

 

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. 

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 beneficiary’s 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 beneficiary’s 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 System—which currently 

focuses on opioids and acetaminophen—to include other drugs susceptible to 

fraud, waste, and abuse, such as HIV drugs. Specifically, CMS should—on a 

quarterly basis—identify 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 

System’s 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 OIG’s other recommendations are more likely to 

effectively address OIG’s intent to limit an individual’s 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 CMS’s 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 CMS’s 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 

Stribild elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil 

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 

Release) nevirapine, NVP 

Viramune XR (Extended 

Release) nevirapine, NVP 

(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 FDA’s 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 

Combination of Drugs Total Number of 

Beneficiaries 

Total Number of 

Days Taken 

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 

HIV Drug 

Total Number 

of 

Beneficiaries 

Total Number of

 Prescriptions Total Dollars 

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 Centers lOt Medicare & Medicaid Se!'lices DEPA!UMENT OF HEALTH & HUMAN SERVICES 

Administrator 

Washington. DC 20201 

DATE: HAY 3 0 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 OIG’s 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.