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Testimony — Update on FAA’s Progress and Challenges in Advancing the Next Generation Air Transportation Syste m

September 21, 2012 Comments off

Update on FAA’s Progress and Challenges in Advancing the Next Generation Air Transportation System (PDF)

Source: U.S. Department of Transportation, Office of Inspector General (Testimony Before the Committee on Transportation and Infrastructure, Subcommittee on Aviation , United States House of Representatives)

FAA has made progress in improving air traffic management at congested airports in major cities—one of the task force’s most critical recommendations. For example, FAA has completed studies to identify recommended changes for seven metroplex locations and is performing airspace and procedures design work at six of them. However, industry representatives are concerned that the effort may not deliver all desired benefits and that FAA has not yet integrated metroplex with other related initiatives, such as better managing surface operations. Additionally, FAA has not fully resolved key organizational, policy, and training barriers to implementing NextGen capabilities in the near term. Central to realizing benefits from the task force recommendations and other NextGen initiatives is the successful deployment of ERAM—a multibillion dollar program for processing flight data. However, extensive software-related problems have significantly delayed ERAM’s nationwide deployment, resulting in hundreds of millions of dollars in increased costs. FAA is taking steps to address our concerns about a number of ERAM programmatic and contract management issues, such as modifying its contract to better track costs, but considerable risks remain to complete the effort within the Agency’s revised cost and schedule parameters. FAA faces similar cost and schedule risks with its NextGen transformational programs, as the Agency has not approved total cost, schedule, or performance baselines for any of the programs or developed an integrated master schedule for managing and executing NextGen.

Just Released — A Review of ATF’s Operation Fast and Furious and Related Matters

September 19, 2012 Comments off

A Review of ATF’s Operation Fast and Furious and Related Matters (PDF)

Source: U.S. Department of Justice, Office of Inspector General

During the course of our review we received information about other ATF firearms trafficking investigations that raised questions about how those investigations were conducted. This report describes one of them, Operation Wide Receiver. We plan to issue a separate report on at least one other ATF investigation that involves an individual suspected of transporting grenade components into Mexico, converting them into live grenades, and then supplying them to drug cartels. The OIG also is completing its investigation of an allegation that one or more Department employees provided to a member of the media a copy of a May 2010 undercover operation proposal drafted by one of the ATF agents who publicly testified about his concerns with the conduct of Operation Fast and Furious. Additionally, we are reviewing allegations that two ATF agents who publicly testified about their concerns regarding Operation Fast and Furious were reassigned to positions within ATF that could have subjected them to retaliation. We also will continue to review information that has been provided to us to determine whether other reports are warranted on additional topics related to Operation Fast and Furious, such as information sharing among ATF, the Drug Enforcement Administration (DEA), and the FBI regarding key figures in parallel investigations.

DOC OIG — Testimony on Mismanagement of Funds at the National Weather Service and the Impact on the Future of Weather Forecasting

September 14, 2012 Comments off

Testimony on Mismanagement of Funds at the National Weather Service and the Impact on the Future of Weather Forecasting (PDF)

Source: U.S. Department of Commerce, Office of Inspector General

I appreciate the opportunity to testify today about the Department of Commerce’s response to National Oceanic and Atmospheric Administration (NOAA) National Weather Service’s (NWS’) mismanagement of budgetary resources. Our testimony will address three areas:

1. Numerous whistleblower complaints, dating back to 2010, many of which have since been validated by multiple reviews of NWS financial mismanagement;

2. Separate Departmental and NOAA internal inquiries, resulting in both the Department and NOAA undertaking significant corrective action; and

3. Recent and current Office of Inspector General (OIG) follow-up reviews, to measure the sufficiency of the internal inquiries and the resulting corrective actions.

States Collection of Medicaid Rebates for Drugs Paid Through Medicaid Managed Care Organizations

September 10, 2012 Comments off

States Collection of Medicaid Rebates for Drugs Paid Through Medicaid Managed Care Organizations (PDF)

Source: U.S. Department of Health and Human Services, Office of Inspector General

WHY WE DID THIS STUDY

In general, drug manufacturers must pay rebates for covered outpatient drugs reimbursed under Medicaid for States to receive Federal matching funds. Drugs dispensed by Medicaid Managed Care Organizations (MCO) were excluded from this requirement until March 23, 2010, when section 2501(c) of the Patient Protection and Affordable Care Act expanded the rebate requirement to include these drugs. To realize the full savings under this expansion, it is important that States collect accurate drug utilization data from MCOs and that States invoice and collect rebate payments from manufacturers.

HOW WE DID THIS STUDY

In October 2011, we sent surveys about rebate collections involving MCOs to all 50 States and the District of Columbia (hereinafter referred to as States) and received responses from all but 1 State. States that paid for drugs through their MCOs (the carve-in approach) were asked about the drug utilization data collected from MCOs, their processes for invoicing and collecting rebates from manufacturers using these data, and the amounts of rebates collected between the second quarter of 2010 and the second quarter of 2011. We asked States that did not pay for drugs through their MCOs (the carve-out approach) or did not contract with MCOs about potential changes to their drug programs’ structures as a result of the rebate expansion.

WHAT WE FOUND

Between April 1, 2010, and June 30, 2011, 18 of the 22 States using a carve-in approach collected all the data needed to invoice manufacturers for rebates from their MCOs, 3 collected data from a portion of their MCOs, and 1 never collected any drug utilization data. All but one State that used a carve-in approach performed some type of data verification check. Twelve of the twenty-two States using a carve-in approach invoiced manufacturers and collected $1.6 billion in rebates for utilization in the second quarter of 2010 through the second quarter of 2011. However, 10 of the 22 States did not invoice manufacturers and collect rebates because, for example, they had to complete programming changes to the systems that process MCO claims. Additionally, the rebate expansion has prompted five States that used the carve-out approach to change to a carve-in approach.

WHAT WE RECOMMEND

We recommend that CMS follow up with the 10 States that had not collected rebates for drugs dispensed to Medicaid MCO beneficiaries and take action to enforce rebate collection if necessary. CMS concurred.

FAA Has Not Effectively Implemented its Wildlife Hazard Mitigation Program

September 4, 2012 Comments off

FAA Has Not Effectively Implemented its Wildlife Hazard Mitigation Program
Source: U.S. Department of Transportation, Office of Inspector General

On August 22, we issued a report on the Federal Aviation Administration’s (FAA) Wildlife Hazard Mitigation Program, which aims to reduce the risk of wildlife strikes to aviation. Under the Program, FAA requires airports to create and implement wildlife hazard management plans to assess and minimize the risk of future strikes. However, we found that FAA’s oversight and enforcement activities are not sufficient to ensure airports fully adhere to Program requirements or effectively implement their wildlife hazard plans. In addition, FAA’s policies and guidance for monitoring, reporting, and mitigating wildlife hazards are mostly voluntary, thereby limiting their effectiveness. For example, FAA recommends but does not mandate that airports and aircraft operators report all wildlife strikes to FAA’s strike database. As a result, FAA’s strike data are incomplete, which impacts the Agency’s ability to evaluate the effectiveness of its Program in reducing wildlife hazards. Finally, FAA coordinates effectively with the U.S. Department of Agriculture Wildlife Services, its main partner in wildlife hazard mitigation, but its efforts to coordinate with other relevant Government agencies are limited and infrequent. We made 10 recommendations intended to improve FAA’s management and oversight of the Program. FAA concurred with six, partially concurred with three, and did not concur with one. We are requesting additional information or revised responses for five recommendations—particularly related to improving the quality and quantity of the Agency’s wildlife strike data.

Questionable Billing by Community Mental Health Centers

August 21, 2012 Comments off

Questionable Billing by Community Mental Health Centers (PDF)

Source: U.S. Department of Health and Human Services, Office of Inspector General

WHY WE DID THIS STUDY

During 2010, 206 community mental health centers (CMHC) received an estimated $218.6 million for providing partial hospitalization program (PHP) services to approximately 25,000 Medicare beneficiaries with mental disorders. Past OIG studies have found vulnerabilities in Medicare payments to CMHCs for PHPs. Additionally, in 2011, four CMHC owners and managers in Miami-Dade County, Florida, were convicted of fraudulently billing Medicare approximately $200 million for medically unnecessary PHP services from 2002 to 2010.

HOW WE DID THIS STUDY

We developed nine questionable billing characteristics based on past OIG work and input from CMS staff. We used 2009 and 2010 Medicare claims from CMS’s National Claims History File to identify CMHCs that had unusually high billing for at least one of nine OIG questionable billing characteristics in 2010 and the metropolitan areas where these CMHCs were located. We also determined whether the percentage of CMHCs with questionable billing varied according to whether States had licensure or certification requirements.

WHAT WE FOUND

In 2010, approximately half of CMHCs met or exceeded thresholds that indicated unusually high billing for at least one of nine questionable billing characteristics. Approximately one-third of these CMHCs had at least two of the characteristics. Additionally, approximately two-thirds of CMHCs with questionable billing were located in eight metropolitan areas. Finally, 90 percent of CMHCs with questionable billing were located in States that do not require CMHCs to be licensed or certified.

WHAT WE RECOMMEND

We recommend that CMS:

(1) Increase its monitoring of CMHCs’ Medicare billing and fraud prevention controls,

(2) Enforce the requirement that certifying physicians be listed on the PHP claims submitted by CMHCs,

(3) Finalize and implement the proposed conditions of participation for CMHCs, and

(4) Review and take appropriate action against CMHCs with questionable billing that we identified. CMS concurred with all four recommendations.

Inappropriate and Questionable Billing by Medicare Home Health Agencies

August 2, 2012 Comments off

Inappropriate and Questionable Billing by Medicare Home Health Agencies (PDF)

Source: U.S. Office of Health and Human Services, Office of Inspector General

WHY WE DID THIS STUDY
In 2010, Medicare paid $19.5 billion to 11,203 home health agencies (HHA) for services provided to 3.4 million beneficiaries. Recent investigations and prior Office of Inspector General studies have found that home health services are vulnerable to fraud, waste, and abuse.

HOW WE DID THIS STUDY

We analyzed data from home health, inpatient hospital, and skilled nursing facility claims from 2010 to identify inappropriate home health payments. In addition, we identified HHAs that billed unusually high amounts according to at least one of our six measures of questionable billing. Although these six measures indicate potential fraud, there may be legitimate reasons for an HHA to exceed the threshold for unusually high billing on any of the six measures. We also determined the geographic locations of HHAs that had questionable billing.

WHAT WE FOUND

In 2010, Medicare inappropriately paid $5 million for home health claims with three specific errors: overlapping with claims for inpatient hospital stays, overlapping with claims for skilled nursing facility stays, or billing for services on dates after beneficiaries’ deaths. Further, we found that approximately one in every four HHAs exceeded the threshold that indicated unusually high billing for at least one of our six measures of questionable billing. Overall, HHAs with questionable billing were located mostly in Texas, Florida, California, and Michigan.

WHAT WE RECOMMEND

We recommend that CMS:

(1) Implement claims processing edits or improve existing edits to prevent inappropriate payments for the three specific errors we reviewed,

(2) Increase monitoring of billing for home health services,

(3) Enforce and consider lowering the 10‑percent cap on the total outlier payments an HHA may receive annually,

(4) Consider imposing a temporary moratorium on new HHA enrollments in Florida and Texas, and

(5) Take appropriate action regarding the inappropriate payments we identified and HHAs with questionable billing.

CMS concurred with all five recommendations; however, it disagreed with our estimate of the inappropriate payments for home health claims overlapping with claims for inpatient hospital stays and skilled nursing facility stays.

Medicare Could Be Paying Twice for Prescription Drugs for Beneficiaries in Hospice

July 12, 2012 Comments off

Medicare Could Be Paying Twice for Prescription Drugs for Beneficiaries in Hospice

Source: U.S. Department of Health and Human Services, Office of Inspector General

During calendar year 2009, Medicare Part D paid for prescription analgesic, antinausea, laxative, and antianxiety drugs, as well as prescription drugs used to treat chronic obstructive pulmonary disease and amyotrophic lateral sclerosis, that likely should have been covered under the per diem payments made to hospice organizations. As a result, the Medicare program could be paying twice for prescription drugs for hospice beneficiaries: once under the Medicare Part A hospice per diem payments and again under Medicare Part D.

To be eligible for Medicare hospice care, a beneficiary must be entitled to Part A of Medicare and be certified as terminally ill (i.e., having a medical prognosis that life expectancy is 6 months or less if the disease runs its normal course). Under the Medicare Part D program, individuals entitled to benefits under Medicare Part A may obtain voluntary coverage for prescription drugs.

We recommended that CMS (1) educate sponsors, hospices, and pharmacies that it is inappropriate for Medicare Part D to pay for drugs related to hospice beneficiaries’ terminal illnesses; (2) perform oversight to ensure that Part D is not paying for drugs that Medicare has already covered under the per diem payments made to hospice organizations; and (3) require sponsors to develop controls that prevent Medicare Part D from paying for drugs that are already covered under the per diem payments. CMS concurred with our first and third recommendations but did not concur with our second recommendation.

Oversight of Quality of Care in Medicaid Home and Community Based Services Waiver Programs

June 22, 2012 Comments off

Oversight of Quality of Care in Medicaid Home and Community Based Services Waiver Programs

Source: U.S. Department of Health and Human Services, Office of Inspector General

WHY WE DID THIS STUDY

In recent years, States have altered their approach to providing Medicaid-funded long-term care services. Rather than providing the majority of that care in institutions-such as nursing homes-States are now providing more care in homes and other community-based settings. States most often provide this care through 1915(c) home and community-based services (HCBS) waiver programs, and the individuals served by these programs are most commonly disabled and/or over age 65. In fiscal year 2010, Medicaid expenditures for HCBS waiver programs serving this population totaled an estimated $8.9 billion. Strong oversight of waiver programs is critical to ensuring the quality of care provided to HCBS beneficiaries. The beneficiaries who rely on HCBS waiver programs are among Medicaid’s most vulnerable, and the nature of these programs puts beneficiaries at particular risk of receiving inadequate care.

HOW WE DID THIS STUDY

States must operate their HCBS waiver programs in accordance with certain "assurances," including three assurances related to quality of care. To meet these assurances, States must demonstrate that they have systems to effectively monitor the adequacy of service plans, the qualifications of providers, and the health and welfare of beneficiaries. We based this study on a review of documents from CMS’s most recent quality review of waiver programs from 25 States, as well as information gathered from structured interviews with staff from the 10 CMS regional offices.

WHAT WE FOUND

Seven of the twenty-five States that we reviewed did not have adequate systems to ensure the quality of care provided to beneficiaries. Although CMS renewed the waiver programs in all seven of these States, three did not adequately correct identified problems. Not only did these States fail to correct these problems before renewal of their programs, they also had still not adequately addressed the problems long after renewal. In addition, CMS did not consistently use the few tools it has to ensure that States correct problems related to quality of care.

WHAT WE RECOMMEND

We recommend that CMS: (1) provide additional guidance to States to help ensure that they meet the assurances, (2) require States that do not meet one or more assurances to develop corrective action plans, (3) require at least one onsite visit before a waiver program is renewed and develop detailed protocols for such visits, (4) develop a broader array of approaches to ensure compliance with each of the assurances, and (5) make information about State compliance with the assurances available to the public. CMS concurred with four of the recommendations and partially concurred with our recommendation to require onsite visits.

Vaccines for Children Program: Vulnerabilities in Vaccine Management

June 20, 2012 Comments off

Vaccines for Children Program: Vulnerabilities in Vaccine Management
Source: U.S. Department of Health and Human Services, Office of Inspector General

WHY WE DID THIS STUDY
CDC’s Vaccines for Children (VFC) program provides free vaccines to eligible children through a network of 61 grantees and 44,000 enrolled providers. In 2010, approximately 82 million VFC vaccine doses were administered to an estimated 40 million children at a cost of $3.6 billion. VFC providers must meet certain requirements for vaccine management, such as storing vaccines within required temperature ranges and monitoring expiration dates, to ensure that these vaccines provide children with maximum protection against preventable diseases. These requirements are also intended to decrease VFC program fraud, waste, and abuse.

HOW WE DID THIS STUDY
Using CDC data, we selected a sample of 45 VFC providers from the 5 grantees with the highest volume of vaccines ordered in 2010. We conducted site visits at these providers’ medical practice locations, interviewed their vaccine coordinators, and observed their vaccine management practices. We also independently measured these providers’ vaccine storage unit temperatures for a 2-week period. Finally, we interviewed the five grantees’ VFC program staff regarding their program oversight.

WHAT WE FOUND
Although the majority of storage temperatures we independently measured during a 2 week period were within the required ranges, VFC vaccines stored by 76 percent of the 45 selected providers were exposed to inappropriate temperatures for at least 5 cumulative hours during that period. Exposure to inappropriate temperatures can reduce vaccine potency and efficacy, increasing the risk that children are not provided with maximum protection against preventable diseases. Thirteen providers stored expired vaccines together with nonexpired vaccines, increasing the risk of mistakenly administering the expired vaccine. Finally, the selected providers generally did not meet vaccine management requirements or maintain required documentation. Similarly, none of the five selected grantees met all VFC program oversight requirements, and grantee site visits were not effective in ensuring that providers met vaccine management requirements over time.

WHAT WE RECOMMEND
We recommend that CDC continue to work with grantees and providers to ensure that:
(1) VFC vaccines are stored according to requirements,
(2) Expired vaccines are identified and separated from nonexpired vaccines,
(3) Grantees better manage providers’ vaccine inventories, and
(4) Grantees meet oversight requirements.

CDC concurred with all four of our recommendations and noted that vaccination is one of the most successful public health tools in preventing and controlling disease.

Medicare Contractors Lacked Controls To Prevent Millions in Improper Payments for High Utilization Claims for Home Blood-Glucose Test Strips and Lancets

June 17, 2012 Comments off
This report summarizes the results of our individual reviews of the 4 contractors that processed claims for home blood-glucose test strip and/or lancet supplies (test strips and lancets) for Jurisdictions A through D, which included all 50 States, 5 territories, and the District of Columbia.  Medicare Part B covers test strips and lancets that physicians prescribe for diabetics. The quantity of test strips and lancets that Medicare covers depends on the beneficiary’s usual medical needs.
For calendar year 2007, based on our analyses of our individual samples of the four contractors, we estimated that the contractors improperly allowed for payment a total of approximately $271 million in claims that we identified as high utilization claims for test strips and/or lancets.  Of this amount, we estimated that the contractors improperly paid a total of approximately $209 million to suppliers.
Of the 400 sampled claims for test strips and/or lancets that we reviewed at the 4 contractors, 303 claims (76 percent) had 1 or more deficiencies, including:

(1) The quantity of supplies that exceeded utilization guidelines was not supported with documentation that specified the reason for the additional supplies, the actual frequencies of testing, or the treating physicians’ evaluation of the patients’ diabetic control within 6 months before ordering the supplies;

(2) There was no supporting documentation that indicated refill requirements had been met;

(3) Physician orders were missing or incomplete; or

(4) Proof-of-delivery records were missing.

We recommended that CMS:

(1) Ensure that contractors implement system edits recommended in our individual reports,

(2) Ensure that contractors are enforcing Medicare documentation requirements for claims for test strips and/or lancets, and

(3) Consider the results of our reviews when developing and evaluating coverage and reimbursement policies related to test strips and lancets.

 CMS concurred with all of our recommendations.

Coverage and Payment for Genetic Laboratory Tests

June 15, 2012 Comments off
Source:  U.S. Department of Health and Human Services, Office of Inspector General
Why We Did This Study
OIG is currently conducting an evaluation entitled Payments for Laboratory Tests: Comparing Medicare, State Medicaid, and Federal Employees Health Benefits Programs (OEI-07-11-00010). The objectives of that evaluation are to determine:
(1) How the methods for establishing Medicare laboratory test payment rates vary from State Medicaid and Federal Employee Health Benefits (FEHB) programs, and
(2) The extent to which 2011 Medicare payment rates for 20 high volume and/or high expenditure laboratory tests vary from State Medicaid and FEHB plans.
During a meeting on June 29, 2011, CMS officials informed us that, in addition to high volume and high expenditure laboratory tests, a collection of pricing data for genetic tests from other health care insurers would assist CMS in establishing payment rates for genetic tests.
How We Did This Study
We surveyed State Medicaid and FEHB plan staff and interviewed Veterans Health Administration staff about their coverage policy and establishment of payment rates, and obtained 2011 payment rates for selected genetic tests by name and by Common Procedural Terminology code from each of the health care insurers we surveyed.
What We Concluded
In our memorandum report, we present information provided to us through surveys and interviews in the areas of coverage policies, payment methods, and payment rates for genetic tests. We have provided this information for CMS’s use in setting Medicare coverage and payment policies for genetic tests. Because State Medicaid programs and private health insurance plans closely monitor Medicare’s coverage and reimbursement decisions, CMS’s formulation of reimbursement rates for genetic tests may be useful to them.

Military Benefits — Action is Needed to Improve the Completeness and Accuracy of DEERS Beneficiary Data

June 9, 2012 Comments off
Source:  U.S. Department of Defense, Office of Inspector General
We are providing this report for your information and use. The Defense Manpower Data Center lacked controls to identify when Real-time Automated Personnel Identification System personnel failed to maintain supporting documentation. Therefore, DoD lacked certainty that only eligible beneficiaries were enrolled in the Defense Enrollment Eligibility Reporting System and issued military identification cards. The unsupported and inaccurate data adversely affected the integrity of the DoD process for issuing military identification cards. Further, ineligible beneficiaries could obtain unauthorized access to health care benefits and, conceivably, to Government facilities and other privileges.
We considered comments from the Defense Human Resources Activity and the Defense Manpower Data Center when preparing this final report. Comments on the draft of this report conformed to the requirements of DoD Directive 7650.3 and left no unresolved issues. Therefore we do not require any additional comments.

Scientific Disagreements Regarding Medical Device Regulatory Decisions

June 6, 2012 Comments off

Scientific Disagreements Regarding Medical Device Regulatory Decisions (PDF)
Source: U.S. Department of Health and Human Services, Office of Inspector General

WHY WE DID THIS STUDY
FDA plays a critical role in ensuring the safety and effectiveness of medical devices and other products. At the Center for Devices and Radiological Health (CDRH), a series of scientific disagreements received media attention between 2008 and 2010. In these instances, CDRH reviewers and their managers disagreed over whether medical devices under review met applicable review standards. In October 2009, CDRH issued new policies and procedures for resolving internal scientific disagreements related to regulatory decisions.

HOW WE DID THIS STUDY
We surveyed CDRH managers and reviewers, requesting that they identify scientific disagreements that occurred during the fiscal year 2008-2010 period. We then reviewed the administrative files related to 36 reported scientific disagreements for the same period. We also surveyed respondents about their awareness of and training on CDRH’s new policies and procedures for addressing scientific disagreements.

WHAT WE FOUND
Of the 36 reported scientific disagreements, 3 occurred after October 2009, and the new procedures were used to resolve them. The nature and resolutions of these 36 disagreements varied widely. Scientific disagreements often involved multiple issues, and most of their resolutions did not lead directly to the approval or clearance of devices. Most administrative files related to scientific disagreements contained required documentation, although accountability for file completeness is unclear. In addition, not all of CDRH’s managers and reviewers have received training on the new procedures. CDRH also faces broader challenges in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion.

WHAT WE RECOMMEND
We recommend that FDA:

(1) Define more clearly its requirements for documenting and resolving scientific disagreements,

(2) Train all reviewers and managers on the new policies and procedures for resolving scientific disagreements, and

(3) More clearly assign accountability for the contents of the administrative files of all submissions.

FDA concurred with our three recommendations.

Military Benefits — Action is Needed to Improve the Completeness and Accuracy of DEERS Beneficiary Data

June 2, 2012 Comments off
Source:  U.S. Department of Defense, Office of Inspector General
We are providing this report for your information and use. The Defense Manpower Data Center lacked controls to identify when Real-time Automated Personnel Identification System personnel failed to maintain supporting documentation. Therefore, DoD lacked certainty that only eligible beneficiaries were enrolled in the Defense Enrollment Eligibility Reporting System and issued military identification cards. The unsupported and inaccurate data adversely affected the integrity of the DoD process for issuing military identification cards. Further, ineligible beneficiaries could obtain unauthorized access to health care benefits and, conceivably, to Government facilities and other privileges.
We considered comments from the Defense Human Resources Activity and the Defense Manpower Data Center when preparing this final report. Comments on the draft of this report conformed to the requirements of DoD Directive 7650.3 and left no unresolved issues. Therefore we do not require any additional comments.

Retail Pharmacies with Questionable Part D Billing

May 16, 2012 Comments off

Retail Pharmacies with Questionable Part D Billing (PDF)
Source: U.S. Department of Health and Human Services, Office of Inspector General

WHY WE DID THIS STUDY
Under the Medicare Part D program, CMS contracts with private insurance companies, known as sponsors, to provide prescription drug coverage to beneficiaries who choose to enroll. In the 6 years since Part D began, OIG has issued several reports that found that Part D had limited safeguards in place.

HOW WE DID THIS STUDY
We based this study on an analysis of prescription drug event records. Sponsors submit these records to CMS for each drug dispensed to beneficiaries enrolled in their plans. Each record contains information about the pharmacy, prescriber, beneficiary, and drug. We analyzed all of the records for drugs billed by retail pharmacies in 2009. We developed eight measures to describe Part D billing and to identify pharmacies with questionable billing.

WHAT WE FOUND
Retail pharmacies each billed Part D an average of nearly $1 million for prescriptions in 2009. Over 2,600 of these pharmacies had questionable billing. These pharmacies had extremely high billing for at least one of the eight measures we developed. For example, many pharmacies billed extremely high dollar amounts or numbers of prescriptions per beneficiary or per prescriber. This could mean that a pharmacy is billing for drugs that are not medically necessary or were never provided to the beneficiary. Although some of this billing may be legitimate, pharmacies that bill for extremely high amounts warrant further scrutiny. The Miami, Los Angeles, and Detroit areas were the most likely to have pharmacies with questionable billing.

WHAT WE RECOMMEND
Together, the findings of this report and prior OIG reports call for a strong response to improve Part D oversight. Therefore, we recommend that CMS: (1) strengthen the Medicare Drug Integrity Contractor’s monitoring of pharmacies and ability to identify pharmacies for further review, (2) provide additional guidance to sponsors on monitoring pharmacy billing, (3) require sponsors to refer potential fraud and abuse incidents that may warrant further investigation, (4) develop risk scores for pharmacies, (5) further strengthen its compliance plan audits, and (6) follow up on the pharmacies identified as having questionable billing. CMS concurred with four of the recommendations and partially concurred with the other two.

Medicare Payments for Drugs Used To Treat Wet Age Related Macular Degeneration

April 28, 2012 Comments off
Source:  U.S. Department of Health and Human Services, Office of Inspector General
WHY WE DID THIS STUDY
Wet age-related macular degeneration (AMD), a leading cause of vision loss in people aged 60 and older, affects millions of Americans. Lucentis is a Medicare Part B-covered drug approved by the Food and Drug Administration (FDA) for the treatment of wet AMD. Avastin is a Part B-covered drug approved by FDA for the treatment of various forms of cancer, but smaller doses of the drug are being used off-label to treat wet AMD. A dose of Avastin used to treat wet AMD costs a small fraction of the cost of a dose of Lucentis. CMS established a national Medicare payment amount for Lucentis; however, there is no national Medicare payment amount for Avastin when used to treat wet AMD in a physician’s-office setting. In 2010, combined Part B expenditures for Lucentis and Avastin totaled nearly $2 billion.
HOW WE DID THIS STUDY
Using Medicare claims data, we selected 2 stratified random samples: 1 sample of 160 physicians who received Medicare payment for Lucentis and 1 sample of 160 physicians who received Medicare payment for Avastin. We sent electronic surveys asking physicians to provide the total dollar amount and quantity purchased of Lucentis and Avastin in the first quarter of 2010. We also asked physicians to describe the factors that they consider when choosing Avastin instead of Lucentis for the treatment of wet AMD. We compared physician acquisition costs to Medicare payment amounts obtained from CMS and Medicare contractors. Additionally, we analyzed Medicare contractor payment policies and the reasons physicians reported for administering Avastin instead of Lucentis.
WHAT WE FOUND
In the first quarter of 2010, physician acquisition costs for Lucentis and Avastin were 5 and 53 percent below the Medicare payment amount, respectively. Medicare contractors’ payment amounts for Avastin when used to treat wet AMD differed by as much as 28 percent, although payment policies were similar. Additionally, we found that the majority of physicians who administered Avastin to treat wet AMD reported the substantial cost difference compared to Lucentis as a primary factor in their decision.
WHAT WE RECOMMEND
We recommend that CMS:
(1) Establish a national payment code for Avastin when used for the treatment of wet AMD and
(2) Educate providers about the clinical and payment issues related to Lucentis and Avastin.
CMS did not concur with our first recommendation at this time but did concur with our second recommendation.

Review of Veterans’ Access to Mental Health Care

April 25, 2012 Comments off

Review of Veterans’ Access to Mental Health Care
Source: U.S. Department of Veterans Affairs, Office of Inspector General

Congress and the VA Secretary requested the OIG determine how accurately the Veterans Health Administration records wait times for mental health services for both new patients and established patients visits and if the wait time data VA collects is an accurate depiction of the veteran’s ability to access those services. VHA policy requires all first-time patients referred to or requesting mental health services receive an initial evaluation within 24 hours and a more comprehensive diagnostic and treatment planning evaluation within 14 days. The primary goal of the initial 24-hour evaluation is to identify patients with urgent care needs and to trigger hospitalization or the immediate initiation of outpatient care when needed.

One method VHA uses to monitor access to mental health services is to calculate patients’ waiting times by measuring the elapsed days from the desired dates of care to the dates of the treatment appointments. Medical facility schedulers must enter the correct desired dates of care in the system to ensure the accuracy of this measurement. VHA’s goal is to see patients within 14 days of the desired dates of care.

VHA does not have a reliable and accurate method of determining whether they are providing patients timely access to mental health care services. VHA did not provide first-time patients with timely mental health evaluations and existing patients often waited more than 14 days past their desired date of care for their treatment appointment. As a result, performance measures used to report patient’s access to mental health care do not depict the true picture of a patient’s waiting time to see a mental health provider.

The Under Secretary for Health concurred with the OIG’s findings and recommendations and stated VHA is unequivocally committed to providing Veterans the best care possible.

+ Full Report (PDF)

Testimony of Daniel R. Levinson, Inspector General, before the U.S. Senate Committee on Finance – “Anatomy of a Fraud Bust: From Investigation to Conviction”

April 24, 2012 Comments off

Testimony of Daniel R. Levinson, Inspector General, before the U.S. Senate Committee on Finance – "Anatomy of a Fraud Bust: From Investigation to Conviction" (PDF)

Source: U.S. Department of Health and Human Services, Office of Inspector General

Good morning, Chairman Baucus, Ranking Member Hatch, and other distinguished Members of the Committee. Thank you for the opportunity to testify about the Office of Inspector General’s (OIG) role in the prevention, investigation, and prosecution of fraud, waste, and abuse in the Federal health care programs.

In September 2011, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) announced indictments against 91 defendants, including doctors, nurses, and other medical professionals, for their alleged participation in Medicare fraud schemes involving approximately $295 million in false billing. At that time, this coordinated takedown involved the highest amount of false Medicare billings in a single takedown in Strike Force history. My testimony provides an inside view of how OIG conducts health care fraud investigations and coordinates national Strike Force takedowns.

Assessment of DoD Wounded Warrior Matters — Camp Lejeune

April 19, 2012 Comments off

Assessment of DoD Wounded Warrior Matters — Camp Lejeune (PDF)

Source: U.S. Department of Defense, Office of Inspector General

We identified several initiatives implemented at both WWBn-East and the Naval Hospital Camp Lejeune that we believed to be noteworthy practices for supporting the comprehensive care, healing, and transition of Warriors. Further, we observed that the WWBn-East and Naval Hospital Camp Lejeune management and staff were fully dedicated to providing the best available care and services for helping Warriors heal and transition.

We also identified a number of significant challenges that we recommend the WWBn-East and Naval Hospital Camp Lejeune management address, which if resolved, we believe will increase program effectiveness in providing quality and timely care and services in support of the Warriors healing and transition.

Finally, we recognized as a result of this assessment, that it was important to give a voice to the Warriors themselves. We suggest that the WWBn-East and Naval Hospital Camp Lejeune management and staff consider Warrior comments, as discussed in this report, so they are cognizant of the Warriors’ views and concerns and can take appropriate action.

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