OIG Solicits Safe Harbor, Fraud Alert Proposals

The HHS Office of Inspector General (OIG) has published its annual solicitation of recommendations for developing new and modifying existing safe harbor provisions under the federal anti-kickback statute, as well as developing new OIG special fraud alerts. The comment deadline is March 1, 2010.  A status report on the comments received in response to last year's solicitation is set forth in Appendix D to the OIG’s latest semiannual report

Potential Monitors for Quality-of-Care Corporate Integrity Agreements (CIAs).

On October 15, 2009, the OIG published a notice that seeks information from organizations that believe they have the capability to be monitors of health care entities under quality-of-care CIA with OIG.  Such monitors typically are responsible for assessing the effectiveness, reliability, and thoroughness of the health care entity's: (1) internal quality control systems; (2) response to quality-of-care issues; (3) development and implementation of corrective action plans and the timeliness of such actions; (4) proactive steps to ensure that each patient receives care in accordance with basic care, treatment, and protection-from-harm standards; the governing regulations; and the policies and procedures required to be adopted under the CIA; and (5) in residential settings, compliance with staffing requirements. In making these assessments, the monitor conducts site visits, analyzes available data, observes facility and corporate-level committee meetings, and reviews relevant documents, and the monitor submits regular written reports to the provider and OIG. The OIG notes that in order to select an appropriate monitor for any individual quality-of-care CIA, the OIG consider, but is not limited to, selecting an organization that responds to this notice. Responses may be submitted to the OIG on an ongoing basis.

OIG Report on Medicaid Fraud Data Usefulness

The HHS Office of Inspector General (OIG) has issued a report on the Medicaid Statistical Information System (MSIS) that concludes that MSIS data -- the only source of nationwide Medicaid claims and beneficiary eligibility information -- were not timely, accurate, or comprehensive for fraud, waste, and abuse detection. The OIG notes opportunities to improve and expand Medicaid data collection and reporting to further assist in fraud, waste, and abuse detection.  

State Medicaid Fraud Control Units

The HHS Office of Inspector General (OIG) has issued it Annual Report on the State Medicaid Fraud Control Units (MFCU) for FY 2008. During this period, MFCUs: recovered more than $1.3 billion in court-ordered restitution, fines, civil settlements, and penalties; obtained 1,314 convictions; and reported 971 civil settlements and/or judgments. 

Nonphysicians Performing Physician Services

The OIG has issued a report identifying a number of potential vulnerabilities associated with Medicare payment for Part B services billed by physicians but performed by nonphysicians under the "incident to" rule. In particular, the OIG raised concerns regarding the performance of invasive services by unqualified nonphysicians. The OIG recommends revisions to the "incident to" rule, including new limits on the circumstances under which physicians who do not personally perform the services may bill Medicare.  

DME In Nursing Homes

The OIG has issued a report entitled Part B Services During Non-Part A Nursing Home Stays: Durable Medical Equipment.” The OIG found that $30 million was inappropriately allowed for DME during non-Part A skilled nursing facility stays in 2006, most of which were also certified by Medicaid. Also, the OIG found that nearly $11.9 million more was inappropriately allowed by Part B during Medicaid nursing facility stays and distinct-part nursing home stays providing primarily skilled care. The OIG recommends that CMS take a number of steps to prevent inappropriate payments.

Inappropriate Medicare Payments for Pressure-Reducing Support Surfaces

A new OIG report concludes that 86% of group 2 support surface claims for the first half of 2007 did not meet Medicare coverage criteria, resulting in an estimated $33 million in inappropriate payments. The OIG recommends that CMS take a series of steps to prevent improper payments for these products, including additional prepayment and postpayment medical reviews.

Power Wheelchair Claims

The HHS Office of Inspector General (OIG) has issued a report entitled "Miscoded Claims for Power Wheelchairs in the Medicare Program." According to the OIG, 7% of Medicare standard rehabilitation power wheelchair claims and 23% of complex rehabilitation power wheelchair claims from the first half of 2007 were miscoded because the supplier used procedure codes that did not match the wheelchairs' model information. The OIG believes suppliers may need additional education on power wheelchair coding, and CMS can improve its review of power wheelchair claims.

Medicare Part B Billing for Ultrasound Services

The OIG reports that 20 high-use counties with 6% of Medicare beneficiaries accounted for 16% of Part B spending on ultrasound services in 2007. In addition, the OIG believes that 3.2 million ultrasound claims (almost one in five nationwide) might be inappropriate. The OIG recommended that CMS monitor ultrasound claims data to detect and review questionable claims prior to payment, and take certain action when providers bill for high numbers of questionable claims; CMS concurred.

Part D Drug Information

An OIG report on the Medicare Prescription Drug Plan Finder found that Plan Finder Part D drug price data frequently overestimate the charges to beneficiaries when they have their prescriptions filled at the pharmacy. Specifically, based on a review of 10 drugs commonly used by seniors, the Plan Finder drug prices were a median of 28% higher than actual drug costs, and exceeded actual drug costs for 92% of claims. The OIG recommended that CMS take steps to ensure that Plan Finder drug prices accurately reflect actual drug costs. 

Clinical Laboratory Fee Schedule Payments

The OIG has issued a report on Variation in the Clinical Laboratory Fee Schedule,” in which the OIG recommends that CMS seek legislative authority to establish a new process for setting laboratory test payment rates. According to the OIG, 97% of lab tests had at least one carrier rate that varied from the national limit amount. Setting all carrier rates at 73% of the median carrier rate (rather than the current 74% rate) would have eliminated variation without a change in overall Medicare payments. CMS stated that it is committed to improving payment policies for lab tests and to refining methodologies for setting new payment rates, and it will consider the OIG’s recommendation (although it did not endorse the measure at this time).  

FDA Medical Product Program Funding

According to a recent Government Accountability Office (GAO) report, the FDA faces challenges fulfilling its growing medical product oversight responsibilities, particularly those not funded by industry user fees. While FDA reports that funding levels allow it to address the most urgent needs and priorities, the agency did not receive enough resources to meet some statutory requirements, such as biennially inspecting certain manufacturing establishments. The GAO recommends that the FDA establish a comprehensive and reliable basis for substantiating the agency’s resource needs; the FDA concurred.

Medicare Chemotherapy Administration Policy

The HHS Office of Inspector General (OIG) has issued a report on Medicare Part B Chemotherapy Administration: Payment and Policy.” The OIG points out that while questionable claims exceeded $60 million from 2005 to 2007, Medicare data are insufficient to determine consistently whether chemotherapy administration payments are appropriate. The OIG recommends that CMS: (1) establish a process to determine which specific drugs qualify for the chemotherapy administration payment rate, (2) instruct carriers that have not done so to consider a probe review of unmatched chemotherapy administration claims, and (3) ensure that drug administration claims are coded correctly and paid appropriately.

OIG Audit of ARRA Funding/FMAP Amounts

A Department of Health and Human Services (HHS) Office of Inspector General (OIG) audit found that HHS correctly calculated temporary increases in Medicaid’s Federal Medical Assistance Percentages (FMAP) in accordance with Recovery Act requirements.

Unimplemented OIG Recommendations

The OIG has released its annual “Compendium of Unimplemented Office of Inspector General Recommendations,” outlining previous OIG recommendations that the agency believes could achieve substantial savings and increase the effectiveness of HHS programs. Priority recommendations listed in the report address the following issue areas:

  • Oversight of Medicare Part D -- Ensure accurate Medicare Part D sponsors bids and prospective payments; and implement safeguards to prevent and detect fraud and abuse in Medicare prescription drug plans.
  • Medicare Integrity -- Ensure DME suppliers’ compliance with Medicare standards, modify Medicare hospital bad debt policy; reduce the rental period for Medicare home oxygen equipment; modify payments to managed care organizations; place a ceiling on administration costs included in managed care organizations’ rate proposals; and improve CMS performance evaluation process for program safeguard contractors.
  • Medicaid and SCHIP Integrity -- Extend additional rebate payment provision to generic drugs; limit enhanced payments to cost and require that Medicaid payments returned by public providers be used to offset the federal share, resolve excessive Medicaid disproportionate share hospital payments; ensure Medicaid reimbursement for brand-name and generic drugs accurately reflects pharmacy acquisition costs, and link Medicaid drug rebate and drug reimbursement calculations.
  • Quality of Care -- Ensure the appropriate processing of denial of Medicare payment remedies for noncompliant nursing homes; and improve Medicare hospice oversight.
  • Oversight of Food, Drugs, and Medical Devices -- Update and maintain an accurate new drug code directory; improve FDA postmarketing oversight of drugs.
  • Grants Management -- Increase oversight of NIH’s grantee institutions to ensure their compliance with federal financial conflict-of-interest regulations.
  • Ethics Program Oversight and Enforcement -- Strengthen FDA oversight of clinical investigators.

Part D Payments for SNF Beneficiaries

The OIG has issued a report entitled “Medicare Part D Payments for Beneficiaries in Part A Skilled Nursing Facility Stays in 2006.” The OIG concluded that the majority of the $75 million in Medicare Part D payments on behalf of beneficiaries in Part A SNF stays in 2006 “were most likely inappropriate,” since they may have been used in the facility or to facilitate the beneficiaries’ discharge, in which case they should have been excluded from Part D (with certain exceptions). The OIG recommends that CMS: provide additional guidance about when Parts A and D can pay for drugs for beneficiaries preparing for discharge; educate SNFs, pharmacies, and Part D sponsors that drugs covered under Parts A or B for beneficiaries in SNF stays are not eligible for Part D coverage; implement retrospective reviews; and follow up with the SNFs and pharmacies responsible for a large percentage of Part D payments for beneficiaries in Part A SNF stays.

State Medicaid Nonemergency Medical Transportation Services (NEMT)

The OIG has released a report summarizing state fraud and abuse safeguard activities related to Medicaid NEMT. According to the OIG, such safeguard activities include screening providers, requiring prior approval for services, and other methods to prevent and detect improper payments. OIG also found that state Medicaid fraud control units investigated a total of 509 NEMT fraud and abuse cases from 2004 to 2006, with the most common types involving billing for services not rendered, unspecified overbilling, and upcoding.

Emergency Department Crowding

A new GAO report on emergency department overcrowding concludes that emergency department crowding continues to occur in hospital emergency departments, with about one-fourth of hospitals reporting diverting ambulances at least once in 2006. Wait times in emergency department have increased nationally, and in some cases exceeded recommended time frames. Boarding of patients in the emergency department while awaiting transfer to an inpatient bed or another facility continues to be reported as a problem, but national data is limited. Based on articles and interviews, the GAO concludes that a lack of access to inpatient beds continues to be the main factor contributing to emergency department crowding.

Part B Drug Prices

The OIG has issued its quarterly report comparing Medicare Part B drug average sales prices (ASPs) and average manufacturer prices (AMPs), this one comparing third-quarter 2008 ASPs and AMPs and reviewing the impact on Medicare reimbursement for first quarter 2009. In the report, the OIG identified 36 HCPCS codes with ASPs that exceeded AMP by at least 5 percent in the third quarter of 2008.  If reimbursement amounts for these 36 codes had been based on 103 percent of the AMPs, Medicare expenditures would have been reduced by $9.4 million during the first quarter of 2009.  The OIG notes that could not compare ASPs and AMPs for 67 HCPCS codes because of missing AMP data; the OIG will continue to work with CMS to evaluate appropriate actions against manufacturers that fail to submit required data.

Clinical Diagnostic Laboratory Services

The HHS Office of Inspector General (OIG) has issued a report entitled MedicaidPayments for Outpatient Clinical Diagnostic Laboratory Services for Dual-Eligible Beneficiaries.” The OIG found that Medicaid programs in 8 of 11 selected states spent a total of $1.3 million in potential improper payments for clinical diagnostic laboratory services that were provided on an assignment-related basis to Medicare/Medicaid dual eligibles in FY 2005 and 2006. Over half of the potential improper payments identified corresponded to five Current Procedural Terminology codes (36415, 85025, 80053, 81000, and 87536). The OIG points out that state Medicaid programs should not pay for any portion of outpatient clinical diagnostic laboratory services that were provided on an assignment-related basis to dual eligibles who are enrolled in Medicare Part B.

Annual OIG Safe Harbor, Fraud Alert Proposal Solicitation

On December 17, 2008, the HHS Office of Inspector General (OIG) published its annual solicitation of proposals and recommendations for new or revised safe harbor provisions under the federal anti-kickback statute, and new OIG special fraud alerts. The comment deadline is February 17, 2009. A status report on the comments the OIG received in response to last year's solicitation is set forth in Appendix D to the OIG’s Semiannual Report for the period of April 1, 2008 through September 30, 2008. 

Excessive Medicaid Personal Care Services

The HHS Office of Inspector General (OIG) has issued a report entitled “Medicaid-Funded Personal Care Services in Excess of 24 Hours per Day.” Based on a sampling of cases in five states, the OIG found 871 instances in which states paid claims for Medicaid reimbursement for personal care services (such as assistance with activities of daily living) in excess of 24 hours per day, and many other cases in which services totaled close to 24 hours a day. The OIG suggested that CMS inform states regarding vulnerabilities in this area, including problems associated with allowing providers to submit such claims in date ranges that include days on which no services were provided.

OIG Advisory Opinions

On July 17, 2008, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) finalized its March 26, 2008 interim final rule revising the process for advisory opinion requestors to submit payments for advisory opinion costs. The text of the rule, which is effective July 17, 2008, is posted here.

OIG Semiannual Report to Congress

On June 12, 2008, the HHS Office of Inspector General (OIG) released its Semiannual Report to Congress” for the first half of fiscal year 2008. The OIG announced expected recoveries of $2.2 billion resulting from efforts to reduce fraud, waste, and abuse in HHS programs, including $1.1 billion in audit-related recoveries and another $1.1 billion in investigative-related recoveries. Also for this period, OIG reported exclusions of 1,291 individuals and organizations for fraud or abuse involving federal health care programs; 293 criminal actions against individuals or organizations that engaged in crimes against HHS programs; and 142 civil actions, which include False Claims Act and unjust enrichment suits filed in district court, Civil Monetary Penalties Law settlements, and administrative recoveries related to provider self-disclosure matters.

OIG Report on FDA Generic Drug Reviews

The OIG has released a report entitled "The Food and Drug Administration's Generic Drug Review Process". The OIG found that FDA disapproved 96 percent of original Abbreviated New Drug Applications (ANDA) under review in 2006 because they did not meet FDA review standards, and that many reviews exceeded the statutory review timeframe. In response, the FDA stated that it is implementing process improvements to address these areas.

Provider Self-Disclosure

On April 15, the OIG posted an "Open Letter to Health Care Providers from the Inspector General" announcing refinements to the OIG Provider Self-Disclosure Protocol.  Most notably, under the new policy, providers who voluntarily disclose self-discovered evidence of potential health care fraud in good faith, fully cooperate with the OIG, and provide requested information in a timely manner generally will not be required to enter into corporate integrity or certification of compliance agreements with OIG.  The OIG also has expanded the information that must be included with the provider’s initial disclosure submission. 

Nursing Facility Compliance Guidance

The OIG is soliciting comments on its Draft Supplemental Compliance Program Guidance (CPG) for Nursing Facilities.  The document supplements the OIG’s 2000 CPG for Nursing Facilities with new compliance recommendations and an expanded discussion of risk areas, including a greater emphasis on quality of care.  The OIG will accept comments on the document until June 2.  For details, click here.  

OIG Reports on LTCHs, Respite Care

An OIG report entitled "Long Term Care Hospitals (LTCHs) Short-Stay Outliers" suggests that despite a decline in short-stay outliers in recent years, some discharge patterns raise concerns that patients are inappropriately placed in LTCHs or discharged based on financial incentives.  The OIG also has issued a report analyzing "Hospice Beneficiaries' Use of Respite Care".  The report identified limited instances where the use of respite care may have been inappropriate because it exceeded 5 consecutive days or because the beneficiary received respite care while residing in a nursing facility.