The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently released its Work Plan for Fiscal Year 2013 (Work Plan), which summarizes new and ongoing reviews and activities that OIG plans to pursue with respect to HHS programs and operations during the next fiscal year (FY) and
beyond. The fiscal year starts on October 1, 2012 and runs through September 31st 2013. Below is a summary of some of the reviews and activities OIG plans to pursue, but some of the highlights include:
- Use of antipsychotics in nursing homes
- Off-label drug use
- Conflicts of interest in drug compendia
- Drug shortages; and
- FDA Risk Evaluation and Mitigation Strategies (REMS)
In addition to announcing the Work Plan, OIG announced a webinar it will hold on October 24, 2012, entitled OIG Outlook 2013.
OIG was created to protect the integrity of HHS programs and operations and the wellbeing of beneficiaries by detecting and preventing fraud, waste, and abuse; identifying opportunities to improve program economy, efficiency, and effectiveness; and holding accountable those who do not meet program requirements or who violate Federal laws. OIG’s mission encompasses the more than 300 programs administered by HHS at agencies such as the Centers for Medicare & Medicaid Services (CMS), National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and Administration for Children and Families (ACF).
For FY 2011, OIG reported expected recoveries of about $5.2 billion consisting of $627.8 million in audit receivables and $4.6 billion in investigative receivables (which includes $952 million in non-HHS investigative receivables resulting from our work in areas such as the States’ share of Medicaid restitution). OIG also identified about $19.8 billion in savings estimated for FY 2011 as a result of legislative, regulatory, or administrative actions that were supported by our recommendations. Such savings generally reflect third-party estimates (such as those by the Congressional Budget Office (CBO)) of funds made available for better use through reductions in Federal spending.
OIG reported FY 2011 exclusions of 2,662 individuals and entities from participation in Federal health care programs; 723 criminal actions against individuals or entities that engaged in crimes against HHS programs; and 382 civil actions, which included false claims and unjust-enrichment lawsuits filed in Federal district court, civil monetary penalty settlements, and administrative recoveries related to provider self-disclosure matters.
Hospitals—Inpatient Billing for Medicare Beneficiaries (New): OIG will describe how hospital billing for inpatient stays changed from FY 2008 to FY 2012.
Hospitals—Diagnosis Related Group Window (New): OIG will analyze claims data to determine how much CMS could save if it bundled outpatient services delivered up to 14 days prior to an inpatient hospital admission into the diagnosis related group (DRG) payment. Medicare currently bundles all outpatient services delivered 3 days prior to an inpatient hospital admission.
Hospitals—Same-Day Readmissions: OIG will review Medicare claims to determine trends in the number of same-day hospital readmission cases.
Hospitals—Compliance With Medicare’s Transfer Policy (New): OIG will review Medicare payments made to hospitals for beneficiary discharges that should have been coded as transfers and will determine whether such claims were appropriately processed and paid.
Hospitals—Payments for Discharges to Swing Beds in Other Hospitals (New): OIG will review Medicare payments made to hospitals for beneficiary discharges that were coded as discharges to a swing bed in another hospital. Swing beds are inpatient beds that can be used interchangeably for either acute care or skilled nursing services.
Hospitals—Payments for Canceled Surgical Procedures (New): OIG will determine costs incurred by Medicare related to inpatient hospital claims for canceled surgical procedures.
Hospitals—Quality Improvement Organizations’ Work With Hospitals (New): OIG will determine the extent to which Quality Improvement Organizations (QIO) worked with hospitals either to conduct quality improvement projects or to provide technical assistance.
Hospitals—Acquisitions of Ambulatory Surgical Centers: Impact on Medicare Spending (New): OIG will determine the extent to which hospitals acquire ASCs and convert them to hospital outpatient departments.
Nursing Homes—Use of Atypical Antipsychotic Drugs (New): OIG will assess nursing homes’ administration of atypical antipsychotic drugs, including the percentage of residents receiving these drugs and the types of drugs most commonly received. We will also describe the characteristics associated with nursing homes that frequently administer atypical antipsychotic drugs.
HHAs—Home Health Face-to-Face Requirement (New): OIG will determine the extent to which home health agencies (HHA) are complying with a statutory requirement that physicians (or certain practitioners working with physicians) who certify beneficiaries as eligible for Medicare home health services have face-to-face encounters with the beneficiaries.
Quality Standards—Accreditation of Medical Equipment Suppliers (New): OIG will examine accreditation organizations’ (AO) requirements and processes for granting accreditation to ensure that medical equipment suppliers meet each of Medicare’s quality standards.
Diabetes Testing Supplies—Improper Supplier Billing for Test Strips in Competitive Bidding Areas (New): OIG will determine the extent to which suppliers improperly billed Medicare non-mail-order diabetes test strips in Competitive Bidding Areas (CBA) in 2011.
Anesthesia Services —Payments for Personally Performed Services (New): OIG will review Medicare Part B claims for personally performed anesthesia services to determine whether they were supported in accordance with Medicare requirements.
Ophthalmological Services—Questionable Billing (New): OIG will review Medicare claims data to identify questionable billing for ophthalmological services during 2011.
Ethics—Conflicts of Interest Involving Prescription Drug Compendia (New): OIG will determine the extent to which the prescription drug compendia oversee conflicts of interest through reporting requirements and/or mitigation policies and the number and nature of the compendia’s reported conflicts.
Patient Safety and Quality of Care—Off-Label Use of Medicare Part B Drugs: OIG will review off-label (prescribed for a condition that is not listed on the product’s label) and off-compendia use of certain Medicare Part B prescription drugs and determine the extent to which specified compendia provide support for coverage. OIG will also identify CMS oversight mechanisms related to off-label use of drugs.
Patient Safety and Quality of Care—Physicians’ Experiences With Drug Shortages (New): OIG will determine the extent to which providers of selected Part B-covered drugs in short supply report difficulty acquiring those drugs.
Patient Safety and Quality of Care—Hospitals’ Experiences With Drug Shortages (New): OIG will determine hospitals’ reported experiences with drug shortages.
Patient Safety and Quality of Care—Manufacturer Sales of Prescription Drugs in Short Supply (New): OIG will quantify the effect of drug shortages on manufacturer sales. OIG will also use data from CMS to determine the extent to which demand and average sales prices of drugs changed when the drugs were reportedly in shortage. For any drug that did not show substantial decline in unit during the shortage quarter, OIG will analyze Part B claims data to determine whether there was an increase in Part B utilization during that period.
Potential Savings From Manufacturer Rebates for Part-B Drugs (New): OIG will determine the potential savings associated with requiring manufacturers to pay rebates to Medicare Part B for those drugs Part B pays for on behalf of beneficiaries who are not also eligible for Medicaid (i.e., are not dual eligibles).
Payments for Prostate Cancer Drugs Under Current Policy (New): OIG will determine the financial impact of rescinding least costly alternative policies (LCA) for certain prostate cancer drugs covered under Medicare Part B. OIG will also determine how Medicare Part B utilization for those drugs changed after the LCA policies were rescinded.
Overview of CMS’s Contracting Landscape (New): OIG will provide an overview of the contracting landscape at CMS. CMS relies extensively on contractors to help it carry out its basic mission, including administration, management, and oversight if its health programs. This review will determine the number, types, and dollar amount of active CMS contracts and examine how CMS maintains all of its contract formation.
Medicare Integrity Program—CMS’s Overall Strategy (New): OIG will review CMS’s overall strategy to maintain the integrity of the Medicare. OIG will also determine how CMS allocates funds for MIP activities and review the measures CMS uses to evaluate the performance and overall effectiveness of the MIP.
Program Integrity—Beneficiary Use of Manufacturer Copayment Coupons (New): OIG will identify safeguards pharmaceutical manufacturers have in place to ensure that beneficiaries do not use copayment coupons to obtain prescription drugs paid for by Medicare Part D.
Program Integrity—Voluntary Reporting of Fraud, Waste, and Abuse by Plan Sponsors (New): OIG will review the extent to which plan sponsors offering Part D prescription drug coverage have voluntarily reported Part D antifraud activity data to CMS since 2010.
Pharmacy Benefit Managers—Part D Sponsors’ Oversight of Pharmacy Benefit Managers’ Administration of Plan Benefits (New): OIG will assess Part D sponsors’ abilities to oversee the ways in which pharmacy benefit managers (PBM) carry out their responsibilities to administer their formularies and manage prescription drug use.
Patient Safety and Quality of Care—Part D Drugs Approved and Registered by FDA: OIG will determine whether the drugs used in the Part D program were previously found to be safe and effective by the Food and Drug Administration (FDA) and whether Part D beneficiaries were dispensed only drugs that FDA had deemed safe and effective.
Drug Payments—Specialty Tier Formularies and Related Cost Sharing (New): OIG will analyze the variation in prescription drug plans’ (PDP) specialty tier formularies and beneficiary cost-sharing requirements.
Drug Payments—Characteristics Associated With Atypically High Billing: OIG will review Part D drugs billed in 2009 to identify characteristics of associated prescribers and beneficiaries. OIG will identify the prescribers and beneficiaries associated with atypically high billing and determine what, if any, characteristics they have in common.
Coverage Gap—Quality of Sponsor Data Used in Calculating Coverage-Gap Discounts: OIG will review data submitted by Part D sponsors used in calculating the coverage gap discount.
Patient Safety and Quality of Care—Claims for and Use of Atypical Antipsychotic Drugs Prescribed to Children in Medicaid (New): OIG will determine the extent to which children ages 18 and younger had Medicaid claims for atypical antipsychotic drugs during the selected timeframe. On the basis of medical record reviews, OIG will also determine the extent to which the atypical antipsychotic drug claims were for off-label uses and for indications not listed in one or more of the approved drug compendia.
FDA—Oversight of Wholesale Prescription Drug Distributors (New): OIG will assess the adequacy of FDA’s oversight of wholesale prescription drug distributors and determine the extent to which FDA ensures that States are licensing wholesalers according to applicable State and Federal laws.
FDA—Implementation of the Risk Evaluation and Mitigation Strategies Program: OIG will examine the extent to which FDA ensures drug manufacturer compliance with the requirements of the Risk Evaluation and Mitigation Strategies (REMS) program, designed to identify risks and benefits of drugs. FDA may require a REMS plan for a drug associated with risks that may outweigh its benefits. OIG will also review drug manufacturer assessments of the REMS program’s efficacy in minimizing risk to consumers.