Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

MEDICARE PAID FOR 

HIV DRUGS FOR 

DECEASED BENEFICIARIES 

Suzanne Murrin 

Deputy Inspector General for 

Evaluation and Inspections 

October 2014 

OEI-02-11-00172 
 

Medicare Paid for HIV Drugs for Deceased Beneficiaries 

OEI-02-11-00172 

WHY WE DID THIS STUDY 

Under the Medicare Part D program, the Centers for Medicare & Medicaid Services 

(CMS) contracts with private insurance companies, known as sponsors, to provide 

prescription drug coverage to beneficiaries who choose to enroll. The Office of Inspector 

General (OIG) has had ongoing concerns about Medicare paying for drugs and services 

after a beneficiary has died. 

Drugs that treat the human immunodeficiency virus (HIV) can be a target for fraud, 

waste, and abuse, primarily because they can be very expensive. Although this report 

focuses on HIV drugs, the issues raised are relevant to all Part D drugs. 

HOW WE DID THIS STUDY 

We based this study on an analysis of Prescription Drug Event (PDE) records for HIV 

drugs in 2012. Part D sponsors submit these records to CMS for each drug dispensed to 

beneficiaries enrolled in their plans. Each record contains information about the drug, 

beneficiary, pharmacy, and prescriber. We used the Beneficiary Enrollment Database, 

the Social Security Administration’s Death Master File, and Accurint’s Death Records to 

identify beneficiaries’ dates of death. 

WHAT WE FOUND 

Medicare paid for HIV drugs for over 150 deceased beneficiaries. CMS’s current 

practices allowed most of these payments to occur. Specifically, CMS has edits 

(i.e., systems processes) in place that reject PDE records for drugs with dates of service 

more than 32 days after death. CMS’s practices allow payment for drugs that do not meet 

Medicare Part D coverage requirements. Most of these drugs were dispensed by retail 

pharmacies. 

This review looked only at HIV drugs, which account for one-quarter of one percent of 

all Part D drugs in 2012. However, our findings have implications for all drugs because 

Medicare processes PDE records for all drugs the same way. Considering the enormous 

number of Part D drugs, a change in practice would affect all Part D drugs and could 

result in significant cost savings for the program and for taxpayers. 

WHAT WE RECOMMEND 

We recommend that CMS change its practice of paying for drugs that have a date of 

service within 32 days after the beneficiary’s death. CMS should eliminate or—if 

necessary for administrative processing issues—shorten the window in which it accepts 

PDE records for drugs dispensed after a beneficiary’s death. Such a change would 

prevent inappropriate payments for drugs for deceased beneficiaries and lead to cost 

savings for the program and for taxpayers. CMS concurred with our recommendation. 
TABLE OF CONTENTS 

Objective......................................................................................................1 

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

Methodology................................................................................................5 

Findings........................................................................................................7 

Medicare paid for HIV drugs for over 150 deceased beneficiaries 

as a result of CMS’s current practices .............................................7 

Most of the drugs were dispensed by retail pharmacies ..................8 

Conclusion and Recommendation .............................................................10 

Agency Comments and Office of Inspector General Response .....11
 

Appendix 

A: HIV Drugs ......................................................................................12 

B: Agency Comments .........................................................................14 

Acknowledgments......................................................................................15
 
 

 

 

OBJECTIVE 

To determine the extent to which Medicare Part D paid for human 

immunodeficiency virus (HIV) drugs for deceased beneficiaries in 2012. 

BACKGROUND 

Medicare Part D provides an optional prescription drug benefit to 

Medicare beneficiaries. 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.1 In 2012, 37 million beneficiaries were enrolled in 

Part D.2 

The Office of Inspector General (OIG) has had ongoing concerns about 

Medicare payments for drugs and services after a beneficiary has died. 

OIG has found that although CMS has some safeguards to prevent these 

improper payments, it continues to make some payments on behalf of 

deceased beneficiaries.3 This raises questions about how effective the 

efforts of CMS and its contractors are in preventing improper payments 

and what opportunities exist for cost savings. 

This report addresses payments on behalf of deceased beneficiaries for 

Part D drugs, specifically HIV drugs. HIV drugs are antiretroviral drugs 

that are the primary treatment of people living with HIV. These drugs can 

be a target for fraud, waste, and abuse, primarily because they can be very 

expensive. For example, one common HIV drug costs about $1,700 for a 

month’s supply. Although the report focuses on HIV drugs, the issues 

raised are relevant to all Part D drugs because controls to prevent 

payments after death are not specific to HIV drugs. 

Medicare Part D 

Medicare Part D covers drugs prescribed for medically accepted 

indications.4

 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 

____________________________________________________________ 

1 42 U.S.C. §§ 1395w-101(a)(1) and 1395w-112(b)(1). 

2

 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 Medicare Insurance Trust 

Funds, pp. 151 and 157. Accessed at http://downloads.cms.gov/files/TR2013.pdf on 

November 26, 2013. 

3

 For example, OIG, Medicare Payments Made on Behalf of Deceased Beneficiaries in 

2011 (OEI-04-12-00130), October 2013. 4 42 U.S.C. 1395w-102(e)(1). 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 1 
 

 

 

 

 

 

 

 

 

 

(known as Medicare Advantage plans or Medicare Part C) also include 

medical benefits. 

Most beneficiaries are responsible for certain costs under Part D, which 

may include a monthly premium, an annual deductible, and coinsurance.5 

However, certain low-income beneficiaries are eligible to receive 

assistance to pay some or all of these Part D costs.6 These beneficiaries 

pay minimal or no co-pays for drugs. 

CMS requires that Part D sponsors develop a network of pharmacies to 

dispense drugs to beneficiaries enrolled in their plans.7 CMS requires 

these pharmacy networks to be geographically diverse and to include 

different types of pharmacies, such as retail pharmacies and 

long-term-care pharmacies. 

Pharmacies submit claims to sponsors (or to sponsors’ Pharmacy Benefit 

Managers) for drugs they dispense for beneficiaries. If the medication is 

never picked up, then the pharmacy must reverse the claim and return the 

drugs to stock.8 

Sponsors then submit prescription drug event (PDE) records to CMS for 

all covered drugs that are dispensed to beneficiaries throughout the year.9 

These records include cost data as well as information about each drug, 

including the date of service, the pharmacy, and the beneficiary. 

Payments to Sponsors 

CMS makes monthly prospective payments to sponsors for each 

beneficiary enrolled in their plans. These payments are based on the bids 

that sponsors submit before the beginning of the plan year. Each bid 

estimates the sponsor’s anticipated drug costs as well as its administrative 

costs. 10 CMS uses the approved bids to determine the premium amounts 

that beneficiaries pay and the monthly payments that it makes to each 

____________________________________________________________ 

5 42 CFR §§ 423.293 and 423.104(d), (e), and (f). 

6 42 CFR § 423.315(d). 

7

 42 CFR § 423.120.
 8

 CMS, Announcement of Calendar Year (CY) 2014 Medicare Advantage Capitation 

Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter, 

April 1, 2013, p. 144. Accessed at http://www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/Downloads/RateNotice.pdf on July 7, 2014.
 9

 CMS, 2011 Regional Prescription Drug Event Technical Assistance Participant Guide, 

p. 1-15. Accessed at http://www.csscoperations.com/internet/Cssc.nsf/files/ 

PDEParticipantGuide%20cameraready%20081811.pdf/$FIle/PDEParticipantGuide 

%20cameraready%20081811.pdf on July 8, 2014. 10 42 CFR § 423.265(c)(1). 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 2 
 

 

 

 

 

 

 

 

 

sponsor.11 These monthly payments are for three subsidies—the direct 

subsidy, the low-income cost-sharing subsidy, and the reinsurance 

subsidy.12 

	 The direct subsidy, together with the beneficiary premium, is 

designed to cover the sponsor’s cost of providing the benefit to 

each beneficiary. 

	 The reinsurance subsidy covers the Federal Government’s share 

of drugs costs for beneficiaries who reach a certain cost threshold 

(known as catastrophic coverage), and 

	 The low-income cost-sharing subsidy covers the Federal 

Government’s portion of the cost-sharing payment for certain 

low-income beneficiaries. 

After the close of the plan year, CMS reconciles these monthly 

prospective payments with the actual costs incurred by the sponsors to 

determine at the end of the year whether CMS owes money to sponsors or 

sponsors owe money to CMS. 13 CMS determines each sponsor’s actual 

costs based primarily on the PDE records that the sponsor submits.14 If 

sponsors submit PDE records for drugs that should not have been covered 

by Part D, payments to sponsors may be too high. This is particularly an 

issue when the PDE records submitted are for beneficiaries who receive 

the low-income cost-sharing subsidy or who have reached the catastrophic 

coverage threshold, because the Federal Government is responsible for a 

larger share of their drug costs.15 

Under current practice, CMS has edits (i.e., systems processes) in place 

that will not accept any PDE records for drugs with dates of service more 

than 32 days after the beneficiary’s date of death. 16 However, according 

to CMS it is possible that—because of delays in receiving death 

information—it will accept a PDE with a date of service that is after the 

32-day window. For this reason, beginning with contract year 2013, CMS 

began conducting additional analysis to identify and exclude these PDE 

____________________________________________________________ 

11 42 CFR §§ 423.286 and 423.315(b). 

12 42 CFR § 423.315. Also see, CMS, 2011 Regional Prescription Drug Event Technical
 

Assistance Participant Guide, pp. 1-16–1-18. 13 42 CFR § 423.343.
 14 CMS, 2011 Regional Prescription Drug Event Technical Assistance Participant Guide, 

p. 1-15. Sponsors are also required to report direct and indirect remuneration, such as 

drug manufacturer rebates.
 15 Part D sponsors are also subject to risk sharing. Risk-sharing payments may also be 

inaccurate if PDE records for noncovered drugs are included in reconciliation. For more 

information about risk sharing, see 42 CFR § 423.336.
 16 See CMS, 2011 Regional Prescription Drug Event Technical Assistance Participant 

Guide, p. 8-13. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 3 
 

 

 

records from the reconciliation process.17 CMS has informational edits 

that alert Part D sponsors if the date of service on the PDE record is 32 or 

fewer days after the beneficiary’s date of death. 

This study focuses on PDE records submitted by sponsors for drugs 

dispensed after the beneficiary’s date of death because these PDE records 

affect payments to sponsors and the overall cost of the Part D program. 

See Methodology section for more detailed information. 

Related Work 

A recent OIG report found that nearly 1,600 Part D beneficiaries had 

questionable utilization patterns for HIV drugs in 2012.18 In total, 

Medicare paid $32 million for HIV drugs for these beneficiaries. 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 drugs. These questionable patterns indicate that 

beneficiaries may be receiving inappropriate or unnecessary drugs. It may 

also indicate that a pharmacy is billing for drugs that a beneficiary never 

received, or that a beneficiary’s identification number has been stolen. 

Another OIG report looked at the extent to which CMS made monthly 

prospective payments in 2011 to Part C and D sponsors for deceased 

beneficiaries.19 According to CMS policy, Medicare pays the sponsor the 

full payment for the month in which a beneficiary dies. OIG found that in 

2011, CMS made monthly payments to Part C and D sponsors totaling 

$21 million for deceased beneficiaries in the months after death. 

Lastly, another OIG report found that in 2006 and 2007 CMS paid 

$3.6 million in monthly prospective payments to certain Part D sponsors 

for deceased beneficiaries.20 It found that although CMS had correctly 

stopped payments for the vast majority of deceased beneficiaries in 2006 

and 2007, its systems did not always identify and prevent improper 

payments. In addition, CMS did not always recover on a timely basis the 

payments it had made on behalf of deceased beneficiaries. 

____________________________________________________________ 

17 CMS, Reconciliation PDE Exclusion Process, January 6, 2014. 18 OIG, Part D Beneficiaries with Questionable Utilization Patterns for HIV Drugs
 

(OEI-02-11-00170), August 2014. 

19 OIG, Medicare Payments Made on Behalf of Deceased Beneficiaries in 2011
 

(OEI-04-12-00130), October 2013. 

20 OIG, Review of Medicare Payments to Prescription Drug Plans on Behalf of Deceased
 

Enrollees (A-05-09-00027), May 2011. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 4 
 

 

METHODOLOGY 

This current study takes a different approach than the two previous studies 

that have identified Part D payments made on behalf of deceased 

beneficiaries. Whereas the other studies focused on monthly prospective 

payments, this study focuses on PDE records with dates of service after 

the beneficiary’s date of death. Both the monthly payments and the 

prescription drug costs are factored into the amount that CMS ultimately 

pays for Part D. 

Analysis of HIV Drugs 

This study is based on an analysis of all PDE records for HIV drugs in 

2012. Each record contains information about the drug and beneficiary, as 

well as the identification number for the pharmacy. 

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 the Food 

and Drug Administration’s (FDA) list of HIV drugs to First Databank and 

Red Book to identify the National Drug Codes (NDC) for HIV drugs.21 In 

total, we identified 654 NDCs. Using these NDCs, we identified 

3,177,937 PDE records for HIV drugs that were dispensed to 

146,121 beneficiaries in 2012. These PDE records accounted for 

0.26 percent of the 1.24 billion records for all Part D drugs dispensed that 

year. See Appendix A for a list of HIV drugs and their generic names. 

Next, we took several steps to identify beneficiaries for whom HIV drugs 

were dispensed after their date of death. Using the Health Insurance 

Claims Number (HICN), we matched the PDE records to the Beneficiary 

Enrollment Database (EDB) to determine the beneficiary’s date of the 

death. Next, we compared the beneficiary’s date of death with the date of 

service on the PDE record. 

For records where the date of service was after the date of death, we took 

additional steps to ensure the date of death listed in the EDB was accurate. 

Specifically, we consulted two additional sources—the Social Security 

Administration’s Death Master File and Accurint’s Death Records—to 

____________________________________________________________ 

21 FDA, Antiretroviral Drugs Used in the Treatment of HIV Infection, August 2013. 

Accessed online at http://www.fda.gov/ForConsumers/byAudience/ForPatientAdvocates/
 

HIVandAIDSActivities/ucm118915.htm on November 12, 2013. First Databank and 

Red Book contain both NDCs and drug names. We used both sources to ensure we had a 

comprehensive list of NDCs for HIV drugs. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 5 
 

 

 

 

 

 

 

 

verify the date of death.22 If the dates of death did not match across the 

three sources, we took the latest date and used it in our analysis. 

Next, we calculated the total number of HIV drugs dispensed after the date 

of death.23 We then determined the number of beneficiaries and the total 

drug costs. We also calculated the difference between the date of service 

and the date of death. We determined the total number of drugs with dates 

of service that were within certain numbers of days after death and the 

total cost of these drugs. 

Lastly, we identified the pharmacies that dispensed each of these drugs. 

To determine the type of each pharmacy, we matched the National 

Provider Identifiers (NPIs) on the PDE record to the database of the 

National Council for Prescription Drug Programs. This database contains 

descriptive information about each pharmacy, including the type of 

pharmacy (e.g., retail, long-term care, mail order).24 

Limitations 

We did not independently verify the accuracy of the PDE records, 

including the accuracy of the dates of service on the PDE records. 

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. 

____________________________________________________________ 

22 Accurint is a LexisNexis data repository that contains more than 20 billion records 

from more than 10,000 data sources. Accurint’s primary source for dates of death is 

SSA’s Death Master File. Accurint also contains death information from obituaries and 

State death records. We matched beneficiaries’ Social Security Numbers, first and last 

names, and dates of birth. 

23 For the purposes of this report, we considered a drug to be one PDE record. 

24 For the purposes of this report, we used the type that the pharmacy identified as its 

primary type. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 6 
 

 

 

 

 

 

FINDINGS 

Medicare paid for HIV drugs for over 150 deceased 

beneficiaries as a result of CMS’s current practices 

In 2012, Medicare paid for 348 HIV drugs for 158 deceased beneficiaries. 

The total cost for these drugs was $292,381.25 For each of these drugs, the 

date of service on the PDE record was after the beneficiary’s death. 

CMS’s current practices allowed most of these payments to occur. 

Specifically, CMS has processing edits in place that should reject PDE 

records with dates of services that are more than 32 days after death. As 

Table 1 shows, all but 3 of the 348 drugs were dispensed within 32 days 

after death. About half the HIV drugs were dispensed within 7 days after 

death. A total of 142 drugs were dispensed between 8 and 20 days after 

death, while 24 drugs were dispensed between 21 and 32 days after. 

Table 1: Number of Days After Death that the HIV Drugs Were Dispensed 

Number of Days After Death Number of Drugs* Total Drug Costs 

1 to 7 days 179 $151,433 

8 to 20 days 142 $120,314 

21 to 32 days 24 $18,183 

33 days or more 3 $2,450

 Total 348 $292,381 

*For the purposes of this report, we considered a drug to be one PDE record. 

Source: OIG analysis of Part D data, 2014. 

CMS’s practices allow payment for drugs that do not meet Medicare 

coverage requirements. Part D covers only drugs that are prescribed for 

medically indicated purposes. Drugs dispensed after death cannot be used 

for medically indicated purposes and therefore are not covered by Part D. 

According to CMS staff, the 32-day window is in place because some 

long-term-care pharmacies bill for Part D drugs once a month and 

inaccurately put this billing date, rather than the actual date of service, on 

the PDE record. 

____________________________________________________________ 

25 This figure includes the amount paid by sponsors, by the Government, and on behalf of 

deceased beneficiaries. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 7 
 

 

 

 

Each of the 158 beneficiaries had between 1 and 6 drugs dispensed after 

the date of death; most beneficiaries had at least 2. The most common 

drugs dispensed for deceased beneficiaries were Norvir and Truvada.26 

See the text box below for examples of HIV drugs dispensed for deceased 

beneficiaries. 

Examples of Drugs Dispensed After the Beneficiary’s Death 

and Paid for by Medicare 

 Medicare paid for three HIV drugs for a deceased beneficiary in 

Miami on two different dates after his death. The drugs cost a total 

of $7,160. 

 Medicare paid for six HIV drugs for a deceased beneficiary in 

Michigan. The drugs were ordered by two different prescribers 

and cost $5,616. 

 Medicare paid for four HIV drugs dispensed in Pennsylvania after 

a beneficiary’s death. These drugs cost $4,414. 

 Medicare paid for four HIV drugs for a deceased beneficiary in 

Florida. The drugs cost $3,452. 

Most of these drugs were dispensed by retail 

pharmacies 

Retail pharmacies dispensed 81 percent (283 of 348) of the HIV drugs for 

deceased beneficiaries.27 In total, 124 pharmacies dispensed drugs for 

deceased beneficiaries. Of these, 106 were retail pharmacies, 8 were 

long-term-care pharmacies, and the remaining 10 were other types of 

pharmacies, such as clinics and mail-order pharmacies. See Table 2. 

____________________________________________________________ 

26 Norvir and Truvada were also the most commonly dispensed HIV drugs among all 

Part D beneficiaries.
 27 Retail pharmacies dispensed 82 percent of all Part D drugs in 2009. See OIG, Retail 

Pharmacies With Questionable Part D Billing, (OEI-02-09-00600), May 2012. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 8 
 

 

 

 

 

Table 2: Types of Pharmacies That Dispensed HIV Drugs for Deceased 

Beneficiaries, 2012 

Pharmacy Type Number of 

Pharmacies 

Number of HIV 

Drugs Dispensed 

After Beneficiaries’ 

Deaths* 

Percentage of 

HIV Drugs 

Dispensed 

After 

Beneficiaries’ 

Deaths 

Retail 106 283 81% 

Long-Term Care 8 31 9% 

Clinic 4 16 5% 

Mail Order 2 4 1% 

Specialty 1 4 1% 

Other 3 10 3%

 Total 124 348 100% 

*For the purposes of this report, we considered a drug to be one PDE record. 

Source: OIG analysis of Part D data, 2014. 

The 8 long-term-care pharmacies dispensed a total of 31 HIV drugs for 

deceased beneficiaries. Of these, 20 drugs were dispensed within 7 days 

after death, 8 were dispensed between 8 and 20 days after death, and 

3 were dispensed between 21 and 31 days after death. The small number 

of these drugs attributed to long-term-care pharmacies indicates that the 

billing practices of these pharmacies do not result in many claims for HIV 

drugs within 32 days after a beneficiary’s death. 

Furthermore, it is problematic if pharmacies are submitting their 

once-a-month billing date, rather than the actual date of service, on their 

PDE records. Sponsors are paid on the basis of PDE records, so it is 

important for these data to be accurate. Also, sponsors, CMS, and OIG 

use PDE records to detect and prevent fraud, waste, and abuse, and poor 

data can hinder these efforts. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 9 
 

 

 

CONCLUSION AND RECOMMENDATION 

Our review focuses on HIV drugs; however, the findings have 

implications for all Part D drugs because Medicare processes PDE records 

for all drugs the same way. The findings show that CMS’s current practice 

of permitting Medicare to pay for drugs with a date of service that is after 

a beneficiary’s date of death has resulted in Medicare’s inappropriately 

paying for drugs. Drugs for deceased beneficiaries are clearly not 

medically indicated, which is a requirement for Part D coverage. 

This review looked only at HIV drugs, which account for one-quarter of 

one percent of all Part D drugs in 2012. A change in CMS’s practice 

would affect all Part D drugs, not just HIV drugs. Considering the 

enormous number of Part D drugs, a change in practice could result in 

significant cost savings for the program and for taxpayers. 

We recommend that CMS: 

Change Its Practice of Paying for Drugs That Have a Date of 

Service Within 32 Days After the Beneficiary’s Death 

CMS should eliminate or—if necessary for administrative processing 

issues—shorten the window in which it accepts PDE records after a 

beneficiary’s death. Having no window or a short window would prevent 

inappropriate payments for drugs for deceased beneficiaries and lead to 

cost savings for the program and for taxpayers. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 10 
 

 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

CMS concurred with our recommendation that it change its practice of 

paying for drugs that have a date of service within 32 days after a 

beneficiary’s death. CMS stated that it has had preliminary discussions 

with the industry to revisit the need for the 32-day window, which it had 

instituted because the date of service in some pharmacies reflects the date 

on which the prescription was billed, rather than the date on which the 

prescription was dispensed. CMS further stated that it will continue 

discussions with the industry with the goal of reducing the window to the 

absolute minimum, taking into consideration current industry billing 

practices and systems constraints. 

CMS also stated that because many of the prescriptions identified by our 

study were filled at retail pharmacies, it will also “evaluate the potential 

use of additional PDE fields in the current editing logic of evaluating the 

relationship of the date of service to the date of death.” Lastly, CMS 

stated that if OIG provides the PDE data for deceased beneficiaries, it will 

post these data for sponsors’ review and, if necessary, correction. Any 

corrected or deleted PDE records would be considered in the reopening of 

the 2012 Part D reconciliation. (This reopening will adjust the final 

payment amounts that CMS made to sponsors for 2012.) 

We support CMS’s efforts to address this issue. As requested, we will 

provide CMS with a separate memorandum that includes the PDE records 

for deceased beneficiaries. The full text of CMS’s comments is provided 

in Appendix B. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 11 
 

 

 

APPENDIX A

 HIV Drugs 

Brand Name Generic Name 

Multi-Class Combination Products 

Atripla efavirenz, emtricitabine, and tenofovir disoproxil fumarate 

Complera emtricitabine, rilpivirine, and tenofovir disoproxil fumarate 

Stribild elvitegravir, cobicistat, emtricitabine, and 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 

Source: FDA, Antiretroviral Drugs Used in the Treatment of HIV Infection, August 2013. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 12 
 

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. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 13 
APPENDIX 8 

Agency Comments 

DEPARTMENT OF I !EALTII & HUMAN SERVICES Centers for Merhcare & Med!CiliO Serv1ces 

Atlmiuistrator 

Wnshmqton. OC 20201 

DATE: .SEP Z Z 2014 

TO: Daniel R. Levinson 

Inspector Cieneral 

FROM: 	 Marily!> Tavenuer 

Administrator 

SUBJECT: 	 Office of Inspector General (O!G) Oral\ Rcpnrt: "Medicnre Paid fin HJV Drugs fi>r 

Deceased Beneficiaries" (OEI-02-11-00 172) 

The Centers lor Medicare & Medicaid Servin:s (CMS) appreciates the opportunity to review and 

comment on the ahove-rclerenced OIG dral\ report. The purpose oi' this report was to determine the 

extent to which Medicare Part D paid ((n human immunodeficiency virus (I-! IV) drugs Ji1r deceased 

heneficiaries in 2012. CMS appreciates OIG ·s concerns ahout Medicare paying li1r drugs and 

services after a hcnef1cimy has died. and has impkmented sall:guards to address these vulnerahilitics. 

For example. CMS has put into place processes to prevent payments made al\er a heneficlary·s death 

and recover improper payments. Our response lO the OIG rcct>mmendation l(llfnws. 

OIG Recommendation 

OJG recommends that CMS change its practice or paying lor drugs that have a date orservice within 

32 days al\er the heneficiary·s death. OIG stated thai CMS should climinntc or. if necessary l(>r 

administrative processing issues. shorten the window in which it accepts prescription drug event 

(PDE) data alkr a heneticiary's death. OIG helieves that having no window or a short window 

would prevent inappropriate payments li>r drugs l(lr deceased hene!lciaries and lead to cost-savings 

li1r the program and 1\>r taxpayers. 

CMS Response 

CMS concurs. Arter reviewing this report. CMS has hml preliminary discussions with the industry to 

revisit the need llw a 32-day window, which was instituted because the date oi'service in some 

phannacies ret1ects the date the prescription was hilled, not the date the prescription was dispensed. 

CMS will continue discussions with the industry with a goal ofn.:ducing the margin to the ahsolute 

minimum given current industry hilling practices and systems constraints. CMS will <dso evaluate 

the potential usc of additional PDE lie ids in the current editing logic or evaluating the relationship nf 

the date of service to the date of death since many of the pn.:scriptions were filled at retail 

pharmacies. In addition. ifOIG can provide the PDE data. CMS will post the data to the PDE 

website lor sponsor review and ifnecessm-y. correction. Any corrected or clcktccl !'DEs would be 

considered in the 2012 Part D reopening. 

Thank you 1()1· the opportunity to review and comment on the drali OICi report. 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 14 
 

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; Kevin Farber; David Graf; Meghan Kearns; and 

Christine Moritz.
 

Medicare Paid for HIV Drugs for Deceased Beneficiaries (OEI-02-11-00172) 15 
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.