Ober, Kaler, Grimes & Shriver, A Professional Corporation  
Ober|Kaler Health Law Alert - Spring 2005




In this Issue

From the Chair

Congratulations

Guide to Terms

Ober|Kaler in Print

OIG Activity
OIG Approves Six Gainsharing Arrangements

OIG Advisory Opinions

OIG 2005 Work Plan

CMS Developments
CMS Proposes Plan to Pay Unpaid Costs of Emergency Health Care

Trailblazer Fraud Alert Reveals Provider Identity Theft

Long Term Care
Discerning the New Pressure Ulcer Guidelines

Pharma
TAP Pharmaceuticals Settles with Lupron Consumers

Hospitals
Pay for Performance: Will Your Hospital Be Ready?

Nonphysician Practitioners
"Incident To" Rule Changes

Compliance
OIG Finalizes Supplemental Hospital Compliance Guidance

OIG's Supplemental Hospital CPG Looks at Hospital-based Physicians

OIG/AHLA Release Second Compliance Resource

Reimbursement
IRF "75 Percent Rule" Blocked

Correct Minor Errors and Omissions Without Appeals

Self-referral
Hospitals Meet "Under-development"

FCA
Courts Apply Strict Interpretation of Officer or Employee Under FCA

Lack of Pharmaceutical Recycling Guidance Precludes FCA Liability

Questionable Incentive Program Raises FCA Liability

Enforcement
Supreme Court Declares Sentencing Guidelines "Advisory"

Tax
IRS Penalizes Health System for PAC/Payroll Deduction Plan

Antitrust
DOJ/FTC Report on Antitrust in Health Care

Physican Focus
Physician Retention Arrangements: Stark and Antikickback Issues

Employment
Alien Certification Exemption to Avert Staffing Crisis

 

OIG 2005 Work Plan

Emily H. Wein
410-347-7324
ehwein@ober.com

The OIG publishes a Work Plan on an annual basis to provide a broad description of the various project areas that the OIG perceives as critical to the mission of the OIG and HHS. The issues identified in the OIG's Work Plan for fiscal year 2005 (2005 Work Plan) represent issues and concerns that the OIG plans to review during the year. The OIG's stated objective is to focus on projects that identify vulnerabilities in HHS programs. Overall, the 2005 Work Plan seeks to promote the economy, efficiency, and effectiveness of those programs. In addition to identifying various issues for study, the OIG indicated that pharmaceutical fraud and quality-of-care issues for beneficiaries residing in care facilities continue to be two major areas of investigation. The 2005 Work Plan also reports that the OIG hopes to publish final supplemental compliance guidance for hospitals based on public comments received in response to the draft supplemental guidance published in June 2004 (which it did on January 31, 2005), and issue several new safe harbors, including safe harbors related to the MMA, to assist the provider community with compliance.

This article summarizes the OIG's investigative priorities for fiscal year 2005, as set forth in the 2005 Work Plan.

Hospitals
Quality Improvement Organization Mediation of Beneficiary Complaints: The OIG is assessing the early experiences of Medicare Quality Improvement Organizations with using a mediation process for beneficiary complaints.

Medical Education Payments for Dental and Podiatry Residents: The OIG is continuing to determine the appropriateness of including dental and podiatry residents in hospitals' counts of full-time equivalent residents for purposes of direct and indirect medical education (GME) payments. The OIG also is reviewing written agreements to determine the financial arrangement between the teaching hospital and dental school.

Nursing and Allied Health Education Payments: The OIG is working to determine the appropriateness of payments for nursing and allied health education programs. This determination will extend to the validity of claims submitted for these payments.

Graduate Medical Education Voluntary Supervision in Nonhospital Settings: The OIG is studying the appropriateness of alternative payment methodologies for GME involving the costs of training residents in nonhospital settings.

Post-acute Care Transfers: The OIG is assessing the ability of Medicare contractors to limit payments to acute care hospitals for patients who are discharged from a prospective payment system inpatient hospital and admitted to one of several post-acute care settings. The OIG's previous assessments indicated that a lack of controls had resulted in significant overpayments.

Diagnosis Related Group Coding: The OIG is examining DRGs that have a history of aberrant coding to determine whether some acute care hospitals exhibit aberrant coding patterns.

Inpatient Prospective Payment System Wage Indices: The OIG believes that wage indices for the inpatient PPS are vulnerable to inaccuracies because the data used to calculate the indices for many metropolitan areas are significantly influenced by information reported by a single hospital. The OIG is assessing whether hospital and Medicare controls are adequate to ensure the accuracy of the hospital wage data used for calculating wage indices for the inpatient PPS.

Inpatient Outlier and Other Charge-related Issues: The OIG is continuing to assess whether claims for inpatient outlier payments were submitted in accordance with Medicare laws and regulations.

Inpatient Rehabilitation Facilities Payment: The OIG is reviewing payments and admissions to inpatient rehabilitation facilities under PPS and assess whether they meet the Medicare regulatory requirements. The OIG also is assessing whether the facilities properly billed for services in accordance with the PPS regulations including the regulation that concerns interrupted stays.

Inpatient Rehabilitation Payments — Late Assessments: The OIG is assessing the accuracy of Medicare payments for inpatient rehabilitation stays when the patient assessments are entered late.

Medical Necessity of Inpatient Psychiatric Stays: The OIG is assessing the extent of any improper Medicare payments for inpatient psychiatric stays due to medical necessity or coverage issues, particularly within PPS-exempt psychiatric units and specialty hospitals. The OIG also is examining the accuracy of controls in place to detect such improper payments.

Consecutive Inpatient Stays: The OIG is examining the extent to which Medicare beneficiaries receive acute and postacute care through sequential stays at different hospitals and is analyzing claims to identify questionable patterns of inpatient and long-term care.

Long-term Care Hospital Payments: The OIG is reviewing the payments to long-term-care hospitals under PPS to determine the extent to which these payments were made in accordance with Medicare laws and regulations. The OIG is specifically reviewing the appropriateness of early discharges to home, interrupted stays, and outlier payments to these hospitals.

Level of Care in Long Term Care Hospitals: In response to concerns that beneficiaries may be inappropriately referred for acute level services when they only require a skilled nursing level of care, the OIG is assessing whether Medicare beneficiaries in long-term-care hospitals who are receiving acute-level services could be cared for in skilled nursing facilities.

Critical Access Hospitals: The OIG is reviewing hospital cost reports to examine the administrative and other costs incurred by critical access hospitals for inpatient and outpatient services for time periods both prior and subsequent to their conversion to critical access hospital status.

Organ Acquisition Costs: The OIG is assessing whether organ acquisition costs claimed on Medicare hospital cost reports were accurate and appropriate and excluded costs that should have been allocated to post transplant activities or other benefiting cost centers. The OIG also is reviewing payments related to organ procurement organizations.

Rebates Paid to Hospitals: The OIG is examining hospital cost reports to determine whether hospitals are properly identifying purchase credits as a separate line item in their Medicare cost reports and whether rebates are properly credited.

Coronary Artery Status: The OIG is reviewing inpatient and outpatient claims involving arterial stent implantation to determine whether Medicare payments for these services are appropriate. It also is reviewing the claims to determine medical necessity and whether implantations that were performed in conjunction with other surgical procedures should have been done simultaneously instead.

Outpatient Outlier and Other Charge-related Issues: The OIG is assessing whether outlier payments to hospital outpatient departments and community mental health centers were in accordance with Medicare laws and regulations and whether current Medicare reimbursement mechanisms properly reimburse providers.

Lifetime Reserve Days: The OIG is reviewing hospital compliance with the current beneficiary notification requirement regarding the use of lifetime reserve days and is assessing the appropriateness and feasibility of providing such notice prior to a beneficiary's exhaustion of such days.

Hospital Reporting of Restraint-related Deaths: The OIG is assessing hospital compliance with Medicare's requirement that hospitals report all patient deaths related to restraints or seclusion.

Home Health Agencies
Beneficiary Access to Home Health Agencies: The OIG is assessing the effect of PPS on access to home health services by beneficiaries who have been discharged from the hospital.

Effect of PPS on Quality of Home Health Care: The OIG is conducting a study to assess the quality of home health care since the implementation of the Home Health PPS. The study is specifically examining whether any changes have occurred in the number of hospital readmissions or emergency room admissions.

Home Health Outlier Payments: The OIG is determining whether outlier payments to home health agencies were in compliance with Medicare regulations. It is specifically evaluating the frequency of outliers, whether outliers cluster in certain Home Health Resource Groups or geographical areas and whether the current outlier methodology is equitable to all home health agencies.

Enhanced Payments for Home Health Therapy: The OIG is assessing whether home health agencies' therapy services met the threshold for higher payments in compliance with Medicare regulations. The OIG is analyzing the number and the duration of therapy visits provided per episode period.

Medicare Nursing Homes
Access to Skilled Nursing Facilities Under PPS: The OIG is evaluating whether PPS for skilled nursing facilities has adversely affected Medicare beneficiaries' access to care (a/k/a delays in care).

Nurse Aid Registries: The OIG is evaluating nursing home and state compliance with the federal nurse aide registry requirements. It is specifically evaluating how registries are established and maintained, how consistently nursing homes check registries, and how state nursing home surveyors assess compliance with registry requirements.

Nursing Home Deficiency Trends: The OIG is examining the nature and extent of survey and certification deficiencies in nursing homes. The OIG is updating its previous work in this area as well as identifying patterns of repeated noncompliance with federal quality standards.

Nursing Home Compliance with Minimum Data Set Reporting Requirements: The OIG is examining nursing home compliance with reporting requirements related to the Minimum Data Set. The OIG is assessing the timeliness of reporting for all nursing home residents and the accuracy of reporting for beneficiaries in Part A covered stays.

Nursing Home Resident Assessment and Care Planning: The OIG is examining the type, frequency, and severity of deficiencies related to assessment and care planning for nursing home residents. The OIG in particular is examining compliance issues and methods that state survey agencies use to identify and deal with MDS assessments and care plans that do not address all the needs of residents.

Nursing Home Informal Dispute Resolution: The OIG is preparing a study to review trends and outcomes of the nursing home Informal Dispute Resolution process. The OIG is evaluating whether states are offering and providing informal dispute resolution and whether they are following federal requirements.

Nursing Home Residents' Rights: The OIG is assessing the extent to which nursing home residents and their families are aware of their rights and how nursing homes ensure the protection of these rights.

Skilled Nursing Facilities' Involvement in Consecutive Inpatient Stays: The OIG is preparing a study to determine whether skilled nursing facility care provided to beneficiaries with consecutive inpatient stays was medically reasonable and necessary. The study focuses on beneficiaries who experience three or more consecutive stays, including at least one skilled nursing facility stay, as well as consecutive hospital inpatient stays.

Imaging and Laboratory Services in Nursing Homes: The OIG is assessing the extent and nature of any medically unnecessary or excessive billing for imaging and laboratory services provided to nursing home residents. The OIG is reviewing a sample of services and examining utilization patterns in nursing facilities.

Skilled Nursing Facility Rehabilitation and Infusion Therapy Services: The OIG is performing a medical review to analyze whether rehabilitation and infusion therapy services provided to Medicare beneficiaries in skilled nursing facilities were medically necessary, adequately supported, and actually provided as ordered.

State Compliance with Complaint Investigation Guidelines: The OIG is evaluating the extent to which states follow CMS guidelines, as well as their own procedures, in investigating abuse complaints. The OIG is examining the states' procedures used to receive, investigate, and resolve complaints.

Physicians and Other Health Professionals
Billing Service Companies: The OIG is identifying and reviewing the relationships among billing companies and the physicians and other providers who use their services. The OIG also is identifying various types of arrangements physicians and other Medicare providers have with billing services and determining the impact of these arrangements on the physicians' billing.

Medicare Payments to VA Physicians: The OIG is assessing the validity of Medicare reimbursement for services billed by physicians who receive remuneration from the Department of Veterans Affairs for the time the physicians were on duty at a VA hospital.

Care Plan Oversight: The OIG is evaluating the efficiency of controls over Medicare payments for care plan oversight claims submitted by physicians. The OIG is assessing whether the services were provided in accordance with Medicare regulations.

Ordering Physicians Excluded from Medicare: The OIG is reviewing and quantifying the extent of services, if any, ordered by physicians excluded from federal health care programs and the amount paid by Medicare Part B.

Physician Services at Skilled Nursing Facilities: The OIG is examining Medicare Part A and Part B claims with overlapping services for skilled nursing facility patients and determine whether duplicate pay-ments were made, in error, to either the physicians or the nursing homes for the same patient services.

Physician Pathology Services: The OIG is focusing on pathology services performed in physicians' offices, including a physician's examination of cells or tissue samples. The OIG is identifying and reviewing the relationships between physicians who furnish pathology services in their offices and outside pathology companies.

Cardiography and Echocardiography Services: The OIG is reviewing Medicare payments for cardiography and echocardiography services to determine whether physicians billed appropriately for the professional and technical components of the services.

Physical and Occupational Therapy Services: The OIG is reviewing Medicare claims for therapy services provided by physical and occupational therapists to determine whether the services were reasonable and medically necessary, adequately documented, and certified by physician certification statements.

Part B Mental Health Services: The OIG is evaluating whether Medicare Part B mental health services provided in physicians' offices were medically necessary and billed in accordance with Medicare requirements.

Wound Care Services: The OIG is evaluating whether claims for wound care services were medically necessary and billed in accordance with Medicare regulations. The OIG also is examining the adequacy of controls to prevent inappropriate payments for wound care services.

Coding of Evaluation and Management Services: The OIG is examining patterns of physician coding of evaluation and management services and determining whether these services were coded accurately. The OIG also is assessing the adequacy of controls to identify physicians with aberrant coding patterns.

Use of Modifier 25: The OIG is assessing whether providers used modifier 25 appropriately. Modifier 25 is used when an evaluation and management service is a significant, separately identifiable service from a procedure or other service. The OIG also is assessing whether these claims were billed and reimbursed appropriately.

Use of Modifiers with National Correct Coding Initiative Edits: The OIG is assessing whether claims were paid appropriately when modifiers were used to bypass National Correct Coding Initiative edits. The OIG also is determining whether modifiers were used appropriately.

"Long Distance" Physician Claims: The OIG is reviewing Medicare claims for face-to-face physician encounters where a significant distance separated the practice setting and the beneficiary's location. The OIG is examining these claims to confirm that services were provided and accurately reported. If necessary, the OIG will recommend enhancements to existing program integrity controls.

Provider-based Entities: The OIG is assessing the extent to which health care entities that have been designated as "provider based" are in compliance with requirements for receiving this designation. The OIG also is evaluating the impact on Medicare reimbursements of entities billing as provider based instead of freestanding.

Medical Equipment and Supplies
Medical Necessity of Durable Medical Equipment: The OIG is reviewing and determining the appropriateness of Medicare payments for certain items of durable medical equipment, such as power wheelchairs and therapeutic footwear. The OIG also is assessing whether the suppliers' documentation supports the claim, whether the item was medically necessary, and whether the beneficiary actually received the item.

Pricing of Equipment and Supplies: The OIG is comparing Medicare payment rates for certain medical equipment and supplies with the rates of other federal and State health programs, as well as with wholesale and retail prices. The OIG's review covers such items as wheelchairs, enteral nutrition, and oxygen.

Medicare Drug Reimbursement
Prescription Drug Cards: The OIG is reviewing the processes and controls for the prescription drug discount card program. The OIG is specifically addressing general and application system controls at CMS and for selected sponsors participating in the program. The OIG is ascertaining whether controls are in place to minimize or eliminate fraud, waste, and abuse in transitional assistance payments.

Employer Subsidies for Drug Coverage: The MMA includes a provision that provides for subsidy payments to sponsors of qualified retiree prescription drug plans. The OIG is ascertaining the effectiveness of the controls that CMS will implement to administer this MMA provision. This may include verifying some of the sponsors' data - both the actuarial equivalency and qualified retiree information.

Beneficiary Understanding of Drug Discount Card Program: The OIG is assessing beneficiary understanding of the Medicare Prescription Drug Discount Card program and materials CMS provides to beneficiaries. The OIG also is examining whether the beneficiary materials comply with MMA requirements and whether beneficiaries understand the program.

Computation of Average Sales Price: The OIG is evaluating drug manufacturers' methodologies for computing the average sales price (ASP). The ASP is used for determining the Medicare reimbursement of certain drugs as required by the MMA.

Collecting and Maintaining Average Sales Price Data: Under the MMA, Medicare will base payments for most prescription drugs on ASP. Drug manufacturers are required to report accurate ASP information to CMS. The OIG is evaluating CMS's system for collecting and maintaining this data and its oversight of ASP reporting.

Adequacy of Reimbursement Rate for Drugs Under ASP: Under the MMA, the OIG is conducting a study to determine whether physicians' practices in the specialties of hematology, hematology/oncology, and medical oncology are able to purchase drugs at reimbursement amounts based on ASP.

Payments for Non-end-stage Renal Disease Epoetin Alfa: The OIG is assessing the appropriateness of Medicare payments for epoetin alfa used by beneficiaries who have not been diagnosed with end-stage renal disease. The OIG is conducting a medical review to determine whether the drug was medically necessary, administered properly, and provided for an indicated usage.

Other Medicare Services
Laboratory Services Rendered During an Inpatient Stay: The OIG is assessing the extent to which laboratory services rendered during an inpatient stay are unallowable. In response to a considerable increase in payment for laboratory services in 2001, the OIG is assessing what percentage of these costs are related to the unallowable technical component.

Laboratory Proficiency Testing: The OIG is assessing laboratory compliance with CLIA requirements to participate in proficiency testing, which is a mandatory condition of participation.

Independent Diagnostic Testing Facilities: The OIG is reviewing the medical necessity of Medicare services provided to beneficiaries by independent diagnostic testing facilities (formerly known as independent physiological laboratories). The OIG also is assessing whether (1) individual facilities provided services for which they had prior approval, (2) the designated level of physician supervision was provided, and (3) the nonphysician personnel who performed the diagnostic tests were properly licensed.

Therapy Services Provided by Comprehensive Outpatient Rehabilitation Facilities: The OIG is evaluating whether comprehensive outpatient rehabilitation facilities (CORFs) provided and billed physical therapy, speech language pathology, and occupational therapy services in accordance with Medicare eligibility and reimbursement requirements.

New Payment Provisions for Ambulance Services: The OIG's review is evaluating whether payments for ambulance services complied with Medicare reimbursement regulations implementing a new fee schedule for various forms of transport services. The OIG specifically is evaluating whether payments under the new fee schedule, which is being phased in as of April 1, 2002, exceeded levels that would have been paid if it were not in effect.

Air Ambulance Services: The OIG is evaluating whether air ambulance services are provided in accordance with Medicare guidelines.

Quality of Care in Dialysis Facilities: In response to previous reports showing that the length of time between ESRD facility surveys is increasing, the OIG is examining the level of CMS oversight of ESRD facilities. Specifically, the OIG is assessing the current level of oversight, especially in facilities showing indications of possible poor quality of care.

Monitoring of Market Prices for Part B Drugs: In response to the MMA requirement that Medicare pay for prescription drugs based on the average sales prices, the OIG is conducting studies to determine market prices for Part B drugs and compare them to the ASP.

Follow-up on Medicare Part B Payments for Ambulance Services: The OIG is evaluating whether ambulance companies were paid for services provided to beneficiaries who were in an inpatient status. This review is being conducted in response to recent survey results showing that in 2001 Medicare Part B improperly paid ambulance services for periods when beneficiaries were inpatients.

Follow-up on Medicare Part B Payments for Radiology Services: The OIG is evaluating whether Medicare Part B paid for radiology services provided to beneficiaries who were in an inpatient status. This review is being conducted in response to recent survey results showing that in 2001 Medicare Part B improperly paid radiology services for periods when the beneficiary was an inpatient.

Emergency Health Services for Undocumented Aliens: The OIG is evaluating whether the $250 million appropriation enacted by the MMA for emergency health services furnished to undocumented aliens is appropriately distributed to each state and provider and is used for its intended purpose.

Medicare Managed Care
Benefit Stabilization Fund: The OIG is examining CMS's controls over payments into and withdrawals from the adjusted community rate proposal benefit stabilization fund. The fund was formed to act as a savings account from which the MCO can withdraw monies in years when capitation payments from Medicare fall short of the MCO's estimated costs of serving Medicare enrollees.

Adjusted Community Rate Proposals: The OIG is assessing whether modifications to the 2001 and 2004 adjusted community rate proposals were properly supported. The OIG also is verifying documentation that MCOs used the additional payments in accordance with BIPA and the MMA.

Follow-up on Adjusted Community Rate Proposals: The OIG is examining CMS's actions to resolve the problems identified in prior audits of adjusted community rate proposals and remedies to ensure that future proposals are accurate and that repayments or enhanced benefits are provided to account for audit findings.

Administrative Costs: Using the Federal Employees Health Benefits guidelines, the OIG is examining the administrative accounts currently claimed by MCOs. This is, in part, in response to Congress's expressed interest in how MCOs determine funding amounts to meet administrative costs, which must be allocable, reasonable, and limited under the program.

Managed Care Encounter Data: The OIG is assessing the accuracy of Part A encounter data on Medicare beneficiaries. MCOs are required to submit this data for CMS's use in developing a portion of each organization's monthly capitation rate, the risk-adjusted portion that will eventually comprise 100 percent of the monthly rate. As a result, incorrect encounter data could have a significant impact on future Medicare reimbursement.

Enhanced Managed Care Payments: The OIG is completing several reviews determining whether CMS made proper enhanced capitation payments to MCOs. The OIG review focuses on the accuracy of controls at both CMS and the MCOs regarding special status categories, such as ESRD status, dual eligibles, and institutionalized beneficiaries, warranting these enhanced payments.

Enhanced Payments Under the Risk Adjustment Model: The OIG is reviewing CMS's actuarial assumptions and calculations applicable to current payment rates for special status beneficiaries, as well as any projection of future rates. Enhanced payment rates are paid for beneficiaries who are institutionalized or dually eligible for Medicaid. The OIG is reviewing whether there is a need for the continued enhanced payments.

Managed Care Excessive Medical Costs: The OIG is analyzing the cost of health care services furnished to beneficiaries enrolled in Medicare+Choice MCOs. The OIG notes that some MCOs reported certain medical costs that were significantly higher than the national average or than similar costs at other plans in the same geographic area or under Medicare fee-for-service. The OIG believes that understanding the reasons for wide cost variations could help in evaluating the adequacy of Medicare payments.

Duplicate Medicare Payments to Cost-based Plans: The OIG is quantifying the extent, if any, of duplicate Medicare capitation and fee-for-service payments to select cost-based MCOs. Pursuant to CMS regulations, MCOs are responsible for establishing internal controls to detect and prevent such duplicate reimbursement.

Prompt Payment: The OIG is assessing whether MCOs have adhered to Medicare+Choice prompt-payment requirements for noncontracting providers. The prompt payment provisions require that claims be denied or approved within 30 days. The OIG will examine CMS's oversight of MCOs' compliance with the regulation.

Marketing Practices of MCOs: The OIG is assessing whether Medicare MCOs market their plans to beneficiaries according to CMS guidelines and assessing how CMS monitors compliance with federal marketing requirements, including preventing discriminatory marketing activities such as selectively enrolling beneficiaries, soliciting enrollment door-to-door, and using providers to distribute plan materials.

Managed Care "Deeming" Organizations: The OIG is assessing whether CMS effectively oversees the Medicare+Choice "deeming" organizations, which are private, national accreditation organizations that deem an entity's compliance with certain Medicare+Choice requirements.

Contractor Operations
Preaward Reviews of Contract Proposals: Pursuant to a request of the CMS contracting officer, the OIG is reviewing the cost proposals of various bidders for Medicare contracts. The reports produced by these reviews should assist CMS in negotiating favorable and cost-beneficiary contract awards.

CMS Oversight of Contractor Performance: The OIG is evaluating CMS oversight of contractor performance. This includes reviewing performance evaluation findings and recommendations, corrective action plans, and CMS actions taken as a result of evaluation findings. The OIG also is assessing whether the evaluation process is an effective mechanism for monitoring contractor performance.

Program Safeguard Contractor Performance: The OIG is examining the effectiveness of CMS program safeguard contractors in identifying fraud and abuse. The OIG also is evaluating whether the contractors effectively coordinate information with CMS and its other contractors, determining whether inefficiencies result from any duplication of effort, and determining the adequacy of CMS oversight of these activities.

Accuracy of the Provider Enrollment, Chain and Ownership System: The OIG is assessing the accuracy of the provider enrollment information in the Provider Enrollment Chain and Ownership System to determine whether it contains providers that should have been deactivated in the system.

Handling of Beneficiary Inquiries: The OIG is assessing Medicare carriers' handling of the nearly 15 million beneficiary inquiries and complaints that carriers receive annually. The OIG is evaluating the accuracy of information provided by carriers and assessing beneficiary satisfaction with carrier services.

Carrier Medical Review Progressive Corrective Action: The OIG is assessing whether Medicare Part B carriers have implemented medical review progressive corrective action strategies in line with CMS guidelines. The OIG also is determining the extent to which the progressive correction action is achieving CMS's desired results.

Duplicate Medicare Part B Payments: The OIG is assessing if carriers made duplicate payments for the same Medicare Part B services. The OIG is identifying whether CMS or its carriers have taken sufficient corrective actions to prevent such duplicate payments from occurring.

Contractors' Administrative Costs: Per CMS's request, the OIG is reviewing administrative costs claimed by various contractors for their Medicare activities, with special attention to costs claimed by terminated contractors. The OIG will determine whether the costs claimed were reasonable, allocable, and allowable under the terms of the contract with CMS as well as applicable Federal Acquisition Regulations.

Pension Segmentation: At CMS's request, the OIG is assessing whether Medicare contractors have fully implemented contract clauses requiring them to determine and separately account for the assets and liabilities of the Medicare segments of their pension plans.

Pension Costs Claimed: At CMS's request, the OIG is assessing whether Medicare contractors have calculated pension costs claimed for reimbursement in accordance with their Medicare contracts and Cost Accounting Standards. The OIG also is assessing whether the costs claimed were allocable and allowable under Medicare contracts.

Unfunded Pension Costs: The OIG is assessing, as requested by CMS, whether Medicare contractors identified and eliminated unallowable costs when computing pension costs charged to the Medicare program. The OIG also is assessing whether pension costs that would have been tax deductible had they been funded were reassigned to future periods.

Pension Segment Closing: The OIG is reviewing Medicare carriers and fiscal intermediaries whose Medicare contracts have been terminated, resulting in the closing of their Medicare segments. The OIG is assessing the amount of any excess pension assets related to each Medicare segment as of the segment closing date.

Postretirement Benefits and Supplemental Employee Retirement Plan Costs: Per CMS's request, the OIG is reviewing the postretirement health benefit costs and the supplemental employee retirement plans of fiscal intermediaries and carriers. The OIG's review is evaluating the allowability, allocability, and reasonableness of the benefits and plans.

Medicaid Hospitals
Graduate Medical Education Payments: The OIG is reviewing Medicaid Graduate Medical Education (GME) payment programs and coordination of these payments with Medicare GME payments.

Hospital Outlier Payments: The OIG is assessing whether Medicaid state agencies ensured that day and cost outliers paid were limited to extraordinarily long lengths of stay or high costs.

Medicaid Diagnosis-related Group Payment Window: The OIG is conducting a review to determine whether PPS hospitals submitted Medicaid claims for inpatient-stay-related laboratory and other services provided within three days of hospital admission and the potential cost savings that would result from state prohibition of this practice. It also is assessing if overpayments exist in state Medicaid programs that have regulations similar to the Medicare program.

Disproportionate Share Hospital Payments: In response to CMS's request, the OIG is reviewing several states' disproportionate share hospital (DSH) payments to selected hospitals to verify that the states calcu-lated the payments according to their approved state plans and that payments do not exceed the applicable limits of OBRA of 1993.

Hospital Eligibility for DSH Payment: The OIG is conducting a review to determine whether states are appropriately determining hospitals' eligibility for Medicaid DSH payments. Under the Social Security Act, hospitals must meet certain criteria to receive DSH payments; however, previous reviews showed that states were making DSH payments to hospitals that did not meet these criteria.

Medicaid Long-term and Community Care
Payments to Public Nursing Facilities: The OIG is assessing the adequacy of Medicaid payments to public nursing facilities. The OIG is focusing on those facilities that have been identified as providing low quality of care, to determine if such care resulted from inappropriately spent Medicaid payments or from Medicaid payment rates that were not adequate to support higher quality of care.

Community Residence Claims: The OIG is conducting a review to determine whether states have improperly claimed federal financial participation under the Medicaid program for beneficiaries who reside in community residences for the mentally ill or mentally disabled. This review is specifically focusing on claims for beneficiaries who have changed living arrangements and are no longer living at the community residences.

Assisted Living Facilities: The OIG is assessing whether, in certain states, providers were improperly reimbursed for services provided to residents of assisted living facilities.

Medicaid Home Health Care Services: The OIG is reviewing Medicaid home health services in a state with an elderly home care waiver program that provides for reimbursement of traditional non-medical home health services. The OIG is determining whether the services paid under this waiver program were in accordance with the state plan waiver. The OIG also is determining whether any Medicaid payment duplicated any Medicare coverage.

Targeted Case Management: The OIG is conducting a review to determine whether Medicaid payments for targeted case management services were in accordance with federal requirements. Payments for such services cannot duplicate payments made to public agencies under other program authorities for the same service.

Personal Care Services: Per CMS's request, the OIG is conducting a review to determine if states have improperly claimed federal financial participation for personal care services related to assistance with daily living activities provided under the Medicaid program.

Home- and Community-based Services Administrative Costs: At CMS's request, the OIG is assessing whether selected states claimed costs for home and community based services in accordance with federal and state regulations and whether the states are properly monitoring compliance with the requirements of the program. Within one particular state, the OIG is reviewing how a mental retardation agency administers services under a waiver and if it properly followed federal rules governing provider rate setting and payment.

Medicaid Eligibility and the Working Disabled: The OIG is assessing how federal and state agencies determine Medicaid eligibility for working disabled individuals. Through programs commonly referred to as "pathways," disabled individuals are able to retain their Medicaid eligibility as their income increases.

Mental Health Services
Nursing Home Residents with Mental Illness and Mental Retardation: The OIG is assessing the Preadmission Screening and Resident Review (PASRR) program for Medicaid nursing facility residents aged 22 to 64 with a serious mental illness or mental retardation. The OIG is evaluating CMS's oversight of the states' programs, state Medicaid agencies' oversight of the PASRR process, and the extent to which nursing facilities comply with PASRR requirements.

Claims for Residents of Institutions for Mental Diseases: The OIG is conducting a review to determine whether states improperly claimed federal Medicaid funds for 21- to 64-year-old residents of private and county institutions for mental disease.

Medicaid Services for Mentally Disabled Persons: Per CMS's request, the OIG is reviewing the methodology under which one state claims costs for services to mentally disabled persons, focusing on whether the state is claiming excess federal funds by reimbursing its providers less than the amount it claims as federal financial participation.

Rehabilitation Services for Persons with Mental Illness: Per CMS's request, the OIG is reviewing one state's claims for Medicaid rehabilitation services for persons with mental illnesses to determine the allowability of those claims. The state Medicaid agency under review is also reporting payments for rehabilitation services made by three other state agencies.

Community Mental Health Centers: Per CMS's request, the OIG is conducting a review to determine whether Medicaid payments to community mental health centers are made in accordance with applicable federal and state regulation and guidance. Specifically, the OIG is looking for payments for noncovered services and for services provided to beneficiaries who did not meet eligibility requirements.

Medicaid Reimbursement for Intermediate Care Facilities: The OIG is conducting a review to determine if the Medicaid per diem rates for intermediate care facility services are reasonable and adequately supported. The OIG also is examining whether states are monitoring the development of per diem rates to ensure that they are all based on accurate costs.

Restraint and Seclusion in Children's Psychiatric Residential Treatment Facilities: The OIG is conducting a study to determine whether psychiatric residential treatment facilities for children are in compliance with CMS regulations regarding the use of restraint and seclusion. The OIG also is reviewing CMS oversight of state monitoring activities as well as state oversight.

Medicaid/State Children's Health Insurance Program
Duplicate Claims for Medicaid and State Children's Health Insurance Program (SCHIP): Per CMS's request, the OIG is conducting a review to determine whether states have obtained federal funds under both the Medicaid program and SCHIP for services provided to the same beneficiary.

Enrollment of Medicaid Eligibles in SCHIP: The OIG is performing a study to determine whether states have enrolled Medicaid-eligible children in SCHIP. The scope of this study is larger than that conducted in 2001.

State Evaluation of SCHIP Programs: The OIG is assessing states' evaluation of their SCHIP performance goals, particularly those focused on reducing the number of uninsured children. The OIG is specifically assessing the extent to which HHS has enhanced its technical assistance to states on using program evaluations to reduce the number of uninsured children.

Detecting and Investigating Fraud and Abuse in SCHIP: The OIG is conducting an inspection to determine the extent to which separate SCHIP programs comply with federal regulations for detecting and investigating fraud and abuse and to examine states' experiences with fraud and abuse. This inspection also establishes a benchmark for SCHIP fraud and abuse activities for future work in this area.

Medicaid Drug Reimbursement
Average Manufacturer Price (AMP) and Average Wholesale Price (AWP): The OIG is conducting a review to examine the relationship between AMP and AWP. AMP is used for Medicaid drug rebate purposes and AWP is used for Medicaid drug reimbursement. The review is aimed at providing information to help ensure that Medicaid does not overpay for prescription drugs and examining Medicaid drug rebate trends to determine whether drug manufacturers are circumventing requirements of Medicaid drug rebate legislation.

Medicaid Drug Rebates - Computation of AMP and Best Price: The OIG is evaluating the adequacy of drug manufacturers' methodologies for computing AMP and best price.

Oversight of Drug Manufacturer Recalculations for Medicaid Drug Rebates: The OIG is assessing CMS's oversight of drug manufacturer's recalculations of AMP and best price. This oversight is critical to ensure that state Medicaid programs are receiving appropriate drug rebates.

Indexing the Generic Drug Rebate: The OIG is analyzing generic drug expenditures over a period of time to determine whether pricing substantially increased compared with the consumer price index for urban consumers. The review quantifies potential savings from indexing generic drugs.

Drug Rebate Impact from Drugs Incorrectly Classified as Generic: The OIG is assessing whether drug manufacturers are incorrectly classifying brand-name drugs as generic drugs for rebate purposes. The OIG selected a sample of the most utilized drugs for this review.

Dispute Resolution in the Medicaid Prescription Drug Rebate Program: The OIG is conducting a study to assess how Medicaid drug rebate disputes between state Medicaid programs and drug manufacturers are resolved. The OIG is reviewing the dispute process and how CMS facilitates resolution between states and manufacturers.

Medicaid Drug Rebate Collections: The OIG is conducting a review to determine the amount of uncollected drug rebates that states have billed to drug manufacturers as well as the controls that states have for their rebate programs.

Overprescribing of OxyContin and Other Psychotropic Drugs: The OIG is analyzing Medicaid paid claims data to identify beneficiaries who have received significant amounts of OxyContin and the prescribing physicians. The OIG also is reviewing prescribing patterns for other psychotropic drugs, such as Hydrocodone, Xanax, Diazepam, and Soma.

Accuracy of Pricing Drugs in the Federal Upper Limit Program: The OIG is examining how CMS administers the Federal Upper Limit Program for drugs covered under Medicaid and determining whether CMS is setting appropriate prices for drugs.

Medicaid Drug Utilization Review Program: The OIG is conducting a study to assess Medicaid Drug Utilization Review programs and how states monitor the cost of drugs and safety to patients. It also is evaluating prepayment and postpayment controls and outcomes.

Other Medicaid Services
Family Planning Services: Per CMS's request the OIG is assessing whether several states improperly claimed enhanced federal funding for family planning services and the resulting financial impact on the Medicaid program.

School-based Health Services: The OIG is assessing whether Medicaid payments for school-based health services are in accordance with laws and regulations.

Adult Rehabilitative Services: Per CMS's request, the OIG is assessing whether adult rehabilitative services claimed by a selected state met federal Medicaid reimbursement requirements.

Controls Over the Vaccine for Children Program: At the request of CMS, the OIG is reviewing a few states to determine whether controls are in place to prevent Medicaid payments to providers for vaccines obtained through the Vaccines for Children Program.

Outpatient Alcoholism Services: The OIG is assessing whether providers were reimbursed for improper claims for outpatient alcoholism services. In several states, the OIG is conducting reviews at the providers that receive the largest amounts of Medicaid reimbursement.

Claims Paid for Clinical Diagnostic Laboratory Services: The OIG is assessing whether Medicaid payments for certain laboratory and pathology tests exceed Medicare rates for the same tests.

Payment for Services Provided After Beneficiaries' Deaths: The OIG is conducting a review in selected states to determine whether providers billed and were reimbursed for Medicaid services that occurred after beneficiaries' dates of death.

Marketing and Enrollment Practices by Medicaid Managed Care Entities: The OIG is assessing whether managed care entities used appropriate marketing and enrollment practices for Medicaid beneficiaries in accordance with the BBA.

Factors Affecting the Development, Referral, and Disposition of Medicaid Fraud Cases — State Agency and Medicaid Fraud Control Unit Experiences: The OIG is reviewing how state Medicaid agencies identify and refer suspected fraud cases to Medicaid Fraud Control Units (MFCUs). The OIG will evaluate state processes and the effectiveness of Medicaid fraud referrals to MFCUs.

Medicaid Administration
Contingency Fee Payment Arrangements: The OIG is assessing the extent to which state Medicaid agencies have contracted with consultants through contingency fee payment arrangements and the impact of these arrangements on the submission of questionable or improper claims to the federal government.

Upper Payment Limits: The OIG is assessing how CMS's January 2001 regulations revising upper payment limit (UPL) requirements have affected state enhanced payments. See 66 Fed. Reg. 3,148 (Jan. 12, 2001). States have flexibility to pay different rates to the same class of providers so long as, in the aggregate, the payments do not exceed the UPL. The OIG is focusing on the amount and use of Medicaid funding claimed by certain states as part of UPL programs.

Calculation of Upper Payment Limits for Transition States: Per CMS's request, the OIG is assessing whether state UPLs were reasonable and calculated in accordance with CMS's January 2001 revised regulations and the approved state plans. The OIG also is reviewing states' inclusion of UPL payments when calculating DSH payment limits and whether selected states are properly transitioning to the new regulations.

State Match for Medicaid Upper Payment Limit Reimbursement: The OIG is reviewing whether states are appropriately contributing at least 40 percent of the required Medicaid state/local match for Medicaid UPL payments and whether certified public expenditures are being used inappropriately as the state's share of Medicaid UPL payments.

Medicaid Provider Tax Issues: Per CMS's request, the OIG is examining state and health care-related taxes imposed on various Medicaid providers to determine whether those taxes comply with applicable federal regulations and are being used for the stated purposes.

State-employed Physicians and Other Practitioners: The OIG is reviewing Medicaid payments to physicians and other health care practitioners who are state employees. The OMB also has expressed interest in this area.

Skilled Professional Medical Personnel: At the request of CMS, the OIG is assessing whether states have improperly claimed federal funding at the enhanced rate of 75 percent for skilled professional medical personnel.

Physician Assistant Reimbursement: The OIG is assessing whether improper or ineligible claims for physician assistant reimbursement have been made to Medicaid.

Medicaid Claims for Excluded Providers: The OIG is conducting a review to determine whether states have improperly claimed federal financial participation under the Medicaid program for providers who have been excluded from participation.

Administrative Costs for Other Public Agents: Per CMS's request, the OIG is assessing whether the administrative costs claimed by selected states are reasonable, allocable, and allowable for reimbursement under the Medicaid program.

Administrative Costs for Medicaid Managed Care Contracts: The OIG is evaluating administrative cost levels for each managed care organization, health insuring organization, prepaid inpatient health plan, and prepaid ambulatory health plan in all states with managed care programs.

University-contributed Indirect Costs: The OIG is evaluating whether state agencies are claiming indirect costs related to contracts with state universities as Medicaid administrative costs although the state agencies do not pay these indirect costs.

Federal Financial Participation for Medicaid Cost-allocation Plans: The OIG is assessing whether Medicaid administrative costs claimed through cost-allocation plans are allowable, reasonable, and supported in accordance with applicable laws, regulations, program policies, and the state plan.

Medicaid Accounts Receivable: Per CMS's request, the OIG is examining states' procedures for identifying, recording, and collecting Medicaid overpayments from providers. The examination also is focusing on states' repayment of the federal share of such overpayments.

Section 1115 Demonstration Waiver: Per CMS's request, the OIG is evaluating the financial management of a demonstration project for a county with a large Medicaid population.

Medicaid Management Information System Expenditures: At CMS's request, the OIG is reviewing a state's Medicaid Management Information System (MMIS) to determine whether MMIS expenditures claimed at the 75 percent reimbursement level are reasonably supported and properly classified. Appropriateness of Medicaid Payments: The OIG is identifying Medicaid expenditures for services such as home health, dental, and outpatient mental health that are duplicative, unsupported, or unnecessary.

Medicaid FFS Payments for Beneficiaries Enrolled in Managed Care: The OIG is conducting a study to determine the appropriateness of Medicaid fee-for-service provider payments made on behalf of beneficiaries enrolled in Medicaid or Medicare managed are organizations. The OIG is identifying duplicate fee-for-service payments and vulnerabilities in the state processes.

CMS Oversight of Home- and Community-based Waivers:The OIG is evaluating CMS regional office oversight of Medicaid Home- and Community-based Services (HCBS) waivers.

Information Systems Control
Security Planning for CMS Systems Under Development: The OIG is assessing whether CMS has adequately addressed information systems security requirements as major new systems are designed, developed/acquired, and implemented. The OIG also is reviewing security plans and related internal control deliverables for major new systems to determine whether they conform to federal guidelines and incorporate best practices from the public and private sectors.

Accuracy of the Fraud Investigation Database: The OIG is conducting a study to determine the uses, accuracy, and reliability of CMS's Fraud Investigation Database. The study is a follow-up on specific complaints about the database and identify ways to correct any problems identified.

Medicaid Statistical Information System: In two states, the OIG is assessing the integrity and completeness of eligibility and claim data in the Medicaid Statistical Information System.

State Controls Over Medicaid Payments and Program Eligibility: The OIG is assessing state information systems controls over Medicaid claim processing and program eligibility. The OIG's review covers (1) entity-wide security program planning and management, (2) access controls, (3) application software development and change controls, (4) system software, (5) segregation of duties, and (6) service continuity.

Replacement State Medicaid System: The OIG is assessing the effectiveness of one state's monitoring of a replacement Medicaid system. The review focuses on oversight of key dates for implementation and actions taken to ensure that controls are in place as the new system goes online.

Smart Card Technology: Per CMS's request, the OIG is assessing the use of "smart card" technology in Medicare demonstrations as a means of creating portable, electronic patient medical records. The review focuses on information security, data privacy, and program integrity concerns.

Compliance with the HIPAA Privacy Final Rule — University Hospital: The OIG is conducting a review to determine whether a university hospital meets the requirements of HIPAA's Privacy Rule (45 C.F.R. pts. 160 and 164) by having mandated protections in place to ensure that internal use, disclosure, and amendment of protected health information of Medicare beneficiaries is in accordance with the Privacy Rule.

MCO's Compliance with HIPAA: The OIG is evaluating an MCO's general and application controls over electronic transmission of patient data to determine compliance with HIPAA security requirements.

General Administration
FY 2004 Medicare Error Rate Estimate: The OIG's annual review is assessing whether CMS has produced a valid and reliable Medicare fee-for-service paid claims error rate estimate for FY 2004.

FY 2005 Medicare Error Rate Estimate: The OIG's annual review is assessing whether CMS has produced a valid and reliable Medicare fee-for-service paid claims error rate estimate for FY 2005.

Group Purchasing Organizations: The OIG is continuing to evaluate how group purchasing organizations (GPOs) and their members use revenue obtained from vendor fees and analyzing how GPO owners and members report vendor fees on Medicare cost reports.

Contractual Arrangements with Suppliers: The OIG is evaluating contractual arrangements in which a supplier, such as labora-tory or durable medical equipment company, agrees to operate on behalf of a physician's practice or a hospital. The OIG is assessing whether the contractual arrangements have an effect on the Medicare program.

Corporate Integrity Agreements: The OIG is continuing to review compliance and audit work plans and annual audit reports submitted by health care providers as required by the corporate integrity agreements that providers signed to settle false claims actions.

State Medical Boards as a Source of Patient Safety Data: The OIG is examining the extent and type of patient safety data available to state medical boards concerning possible systemic problems, as well as the extent that this data is shared or could be shared with CMS and health care facilities to reduce preventable medical errors.

Payments for Services to Dually Eligible Beneficiaries: The OIG is conducting a study to determine whether state Medicaid agencies and Medicare contractors have complied with Medicare and Medicaid requirements when paying dually eligible claims. The OIG is examining how these entities coordinate to ensure timely and adequate payments.

Nursing Home Quality of Care Promising Approaches: The OIG is evaluating effective practices that lead to high quality of care in nursing homes. It also is exploring ways to assess the impact of reimbursement levels on quality of care.

Payments to Psychiatric Facilities Improperly Certified as Nursing Facilities: The OIG is assessing whether psychiatric facilities have been improperly certified as nursing homes and is quantifying any resulting inappropriate Medicare and Medicaid expenditures.

Investigations
The OIG is continuing to focus its fraud investigations in the areas of pharmaceutical fraud and increase its focus on quality of care issues for beneficiaries residing in nursing facilities.

The OIG's work plan for fiscal year 2005 is available on the OIG's website at:

http://www.oig.hhs.gov/publications/docs/
workplan/2005/2005%20Work%20 Plan.pdf
.

Copyright© 2005, Ober, Kaler, Grimes & Shriver