Archives: Office of Inspector General Regulations

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OIG Seeks Anti-Kickback Safe Harbor, Fraud-Alert Topic Proposals

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published its annual solicitation of recommendations for new or modified safe harbor provisions under the federal anti-kickback statute, as well as potential topics for new OIG Special Fraud Alerts.  Comments will be accepted until February 25, 2014. For a … Continue Reading

Final Rules Issued Extending Protections of Electronic Health Record Donations

On December 27, 2013, the Office of Inspector General and the Centers for Medicare & Medicaid Services each published, in the Federal Register, a final rule that amends regulations protecting, from the Anti-Kickback Statute and Stark law, certain arrangements related to the donation of interoperable electronic health records (EHR) software or information technology and training services related to such EHR software. Among these amended regulations was the extension of protections of the Stark law exception and the Anti-Kickback safe harbor from December 31, 2013 to December 31, 2021 (the "sunset" provisions).… Continue Reading

OIG Call for Medicare Part B Drug Rebates Rejected by CMS

A new OIG report estimates that Medicare could realize significant savings if drug manufacturers were required to pay rebates on Medicare Part B drugs, similar to rebates under the Medicaid program. Specifically, Medicare could have collected $3.1 billion in 2011 if manufacturers had been required to pay rebates based on average manufacturer price (AMP) for 60 … Continue Reading

OIG Report Examines Critical Access Hospital Qualifications

Almost two-thirds of critical access hospitals (CAHs) would not meet Medicare CAH location requirements if they were required to re-enroll today, according to the OIG. Many of these rural hospitals were permanently exempted from CAH distance requirements under previous authority of states to designate “necessary provider” (NP) CAHs. Medicare reimburses CAHs at 101% of their reasonable … Continue Reading

OIG Focuses on Improper Medicare Diabetes Test Strip Payments

A recent OIG report examines the extent of improper Medicare reimbursement for diabetes test strips (DTS), including the effect of mail-order DTS being subject to competitive bidding in nine geographic areas beginning in 2011 (CMS subsequently implemented a national competitive bidding program for mail-order DTS, effective July 1, 2013). According to the OIG, in 2011, … Continue Reading

OIG Reports Point States to Potential Medicaid DMEPOS Savings

Two recent OIG reports point out the savings that state Medicaid programs could attain if they based reimbursement for DME, prosthetics, orthotics, and supplies (DMEPOS) on Medicare competitive bidding payment amounts – although at least one state is pushing back on this idea. In the first report, “Medicaid DMEPOS Costs May be Exceeding Medicare Costs … Continue Reading

OIG Seeks Improvements to RAC Program, Enhanced CMS Efforts to Stop Improper Medicare Payments

The OIG has called on CMS to strengthen activities to prevent improper Medicare payments, including enhancements to the Recovery Audit Contractor (RAC) program. For instance, the OIG notes that RACs identified half of all claims they reviewed in FYs 2010 and 2011 as having resulted in improper payments totaling $1.3 billion. While CMS took corrective … Continue Reading

OIG Urges CMS Action on Medicaid Drug Pricing Changes in Preparation of ACA Enrollment Expansion

In a recent report, “Medicaid Drug Pricing in State Maximum Allowable Cost Programs,” the OIG examines options for controlling state Medicaid prescription drug costs, particularly given a surge in Medicaid enrollment expected in the coming years as a result of the ACA. The OIG highlights the value of state Maximum Allowable Cost (MAC) programs as … Continue Reading

Medicare Billing For Cancelled Elective Surgeries

The HHS Office of the Inspector General (OIG) has issued a report entitled “Medicare Could Save Millions by Strengthening Billing Requirements for Canceled Elective Surgeries.” Based on a review of 100 claims, the OIG estimates that Medicare made $38.2 million in Part A inpatient hospital payments in calendar years 2009 and 2010 for short-stay, canceled … Continue Reading

OIG Questions Hospital Use of Observational Stays

A recent OIG report examined “Hospitals’ Use of Observation Stays and Short Inpatient Stays for Medicare Beneficiaries.” The report was conducted in response to concerns about hospitals’ use of observation stays, which may be resulting in Medicare beneficiaries paying more as outpatients than if they were admitted as inpatients, and which may prevent beneficiaries from qualifying … Continue Reading

OIG Examines Clinical Trial Data and Safety Monitoring Boards

The OIG has issued a report entitled “Data and Safety Monitoring Boards in NIH Clinical Trials: Meeting Guidance, But Facing Some Issues.” The report examines the effectiveness of data and safety monitoring boards (DSMB) – or committees of experts that provide ongoing reviews of clinical trial data to ensure the safety of study subjects and … Continue Reading

OIG Final Rule on Data Mining by State Medicaid Fraud Control Units

On May 17, 2013, the HHS Office of Inspector General (OIG) published a final rule amending current regulations prohibiting State Medicaid Fraud Control Units (MFCU) from using federal matching funds to identify fraud through screening and analyzing State Medicaid data (known as data mining). In order to “support and modernize MFCU efforts to effectively pursue … Continue Reading

OIG Finds Medicare Plans Generally Cover Drugs Commonly Used by Dual Eligibles

The OIG has issued an ACA-mandated report on Medicare Part D prescription drug plan and MA drug plan coverage of drugs commonly used by full-benefit dual-eligible individuals (that is, individuals eligible for Medicare and Medicaid and who receive full Medicaid benefits and Medicare premium and cost-sharing assistance). The OIG determined that for 2013, Part D/MA … Continue Reading

OIG Recommends Changes to Medicare Dialysis Payments to Reflect Lower Drug Utilization

The OIG has issued a report entitled “Medicare and Beneficiaries Could Save Millions If Dialysis Payments Were Adjusted for Anemia Management Drug Utilization.” The OIG estimates that if CMS had adjusted the payments for dialysis services to incorporate anemia management drug utilization in 2011 — rather than use 2007 data reflecting higher utilization — the … Continue Reading

OIG Identifies Gaps in Private Insurer Reporting to HealthCare.Gov Plan Finder Portal

All private health insurers in the individual and small group markets must submit data to the Plan Finder, an online portal created to help consumers compare health insurance coverage options. According to a recent OIG report, "Oversight of Private Health Insurance Submissions to the Plan Finder," while most private insurers reported data to … Continue Reading

OIG Finds Some LTCHs Have Not Reported Co-Located Status

The OIG has examined the extent to which long-term care hospitals (LTCHs) that are co-located with another hospital-level provider or a skilled nursing facility disclose their co-location status to their Medicare contractor. Because co-located status can impact Medicare payments, co-located LTCHs and satellite facilities must notify their MAC and CMS Regional Office about the provider(s) … Continue Reading

CMS Plans to Include DME Infusion Drugs in Competitive Bidding in Response to OIG Findings

A new OIG report, “Part B Payments for Drugs Infused through Durable Medical Equipment,” calls for changes in the Medicare reimbursement methodology for Part B infusion drugs administered in conjunction with DME in light of potentially inaccurate pricing. By way of background, DME infusion drugs are reimbursed at 95% of the drug’s average wholesale price … Continue Reading

OIG Calls for Stronger Conflict-of-Interest Oversight for Medicare Part D P&T Committees

A recent OIG report, “Gaps in Oversight of Conflicts of Interest in Medicare Prescription Drug Decisions,” examines how Medicare Part D drug plan pharmacy and therapeutics (P&T) committees ensure that formulary decisions are not biased by conflicts of interest. Based on a survey of P&T committees and a review of their written policies, along with … Continue Reading

OIG Continues to Call on CMS to Implement Medicare Part B Drug Pricing Reforms

For the 29th time, the OIG has issued a report comparing Medicare Part B drug average sales prices (ASP) and average manufacturer prices (AMP), this report covering all of 2011. The OIG again concludes that the Medicare would realize savings if it exercised its authority to lower reimbursement for Part B drugs when the drugs … Continue Reading

OIG Continues to Fault Efforts to Prevent Medicare Fraud in Community Mental Health Centers

The OIG has examined CMS efforts to prevent fraud and abuse at community mental health centers (CMHCs), which provide partial hospitalization program services (structured outpatient mental health treatment programs) to qualifying Medicare beneficiaries. The OIG has previously reported that CMHCs may be particularly vulnerable to fraud, waste, and abuse involving PHP services, with approximately half … Continue Reading

OIG Calls for Improvements to Medicare Parts C & D Benefit Integrity Activities

The OIG recently identified barriers to the effectiveness of the Medicare Drug Integrity Contractor (MEDIC) in performing Medicare Parts C and D benefit integrity activities between April 2010 and March 2011. For instance, the MEDIC reported that it does not have access to centralized Part C data, it lacks access to certain prescription drug event … Continue Reading

OIG Assesses State Medicaid Third-Party Liability Collection

The OIG has reviewed the extent to which states have improved collection of third-party liability (TPL) payments in situations where Medicaid beneficiaries have additional sources of health insurance that are responsible for payment. According to the OIG report, Medicaid Third-Party Liability Savings Increased, But Challenges Remain, states reported that TPL savings increased from almost $34 … Continue Reading