Archives: Other OIG Developments

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Patient access to health information at the forefront of government initiatives and scrutiny

Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information. In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability … Continue Reading

HHS Office of General Counsel advises that the PREP Act preempts state and local requirements that prevent pharmacists from testing for COVID-19

Earlier this week, the Department of Health and Human Services (HHS) Office of General Counsel issued Advisory Opinion 20-02, which declared that the Public Readiness and Emergency Preparedness Act (PREP Act), combined with the HHS Secretary’s March 10, 2020 declaration, preempts state or local requirements that would prevent pharmacists from ordering or administering COVID-19 tests … Continue Reading

OIG Accepting Recommendations for New Anti-kickback Safe Harbors and Fraud Alerts

The HHS Office of Inspector General (OIG) has issued its annual solicitation of recommendations for new or revised Anti-kickback Statute (AKS) safe harbors and new Special Fraud Alerts.  In reviewing proposed safe harbor changes, the OIG will consider the extent to which the proposals would increase or decrease: Access to health care services Quality of health … Continue Reading

HHS OIG Report Touts FY 2019 Enforcement and Audit Accomplishments

According to its latest Semiannual Report to Congress, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) expects fiscal year (FY) 2019 investigative recoveries from criminal and civil actions to top $5 billion – up from $2.9 billion in FY 2018.  Additionally, the OIG expects to recover $819 million as … Continue Reading

HHS Scraps Pending Rule to Remove Anti-Kickback Safe Harbor Protection for Drug Rebates to Health Plans, PBMs

The Trump Administration has decided against finalizing a controversial proposed Office of Inspector General (OIG) regulation that would have modified Federal Anti-Kickback Statute safe harbor protection for certain prescription drug rebates to health plans and pharmacy benefit managers (PBMs).  As we previously reported, the proposed rule would have (i) removed safe harbor protection for drug … Continue Reading

HHS OIG Recaps FY 2018 Enforcement Highlights  

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued its Semiannual Report to Congress, which summarizes key program integrity efforts in fiscal year (FY) 2018.  Notably, during FY 2018, OIG achieved: Expected investigative recoveries of $2.91 billion (compared to $4.13 billion in FY 2017) Criminal actions against 764 … Continue Reading

OIG Evaluates Risks of Relying on Unverified Patient Lists in Home Health Surveys

The Department of Health and Human Services, Office of Inspector General, has issued a new Risk Alert focusing on the home health agency (HHA) survey process.  The alert specifically examined whether HHA-supplied patient lists during surveys may omit certain patients from review and thereby present opportunities to conceal fraudulent activity or health and safety violations. Upon … Continue Reading

Trump Administration’s Proposed FY 2019 Budget Targets Medicare, Medicaid for Savings, Seeks (Again) to Repeal/Replace ACA

The Trump Administration has released its fiscal year (FY) 2019 budget proposal, which includes extensive health policy provisions. While most of the President’s policy proposals for Department of Health and Human Services (HHS) programs would require Congressional approval, others are characterized as administrative proposals that presumably would not involve Congress.… Continue Reading

OIG Invites Anti-kickback Safe Harbor, Fraud Alert Recommendations

The HHS Office of Inspector General (OIG) has published its annual solicitation of recommendations for new or revised anti-kickback statute safe harbors and new Special Fraud Alerts. The OIG states that in considering any recommendations, it will seek to determine potential financial benefits to health care providers in ordering or referring health care services. The … Continue Reading

OIG Report Assesses Accuracy of Manufacturer-Reported Medicaid Rebate Program Data

The OIG recently issued a report evaluating the accuracy of pharmaceutical manufacturer-reported Medicaid drug rebate program data, including pricing information and FDA classification (e.g., innovator/brand or noninnovator/generic). The OIG determined that the “vast majority” of the drugs in the Medicaid rebate program were classified appropriately in 2016, but about 3% of these drugs (885 drugs) … Continue Reading

OIG Highlights Recent Audit, Investigation, and Enforcement Accomplishments

The Office of Inspector General (OIG) of the Department of Health and Human Services has released its semiannual report for the period of April 1, 2017, through September 30, 2017. The report also includes aggregated data for all of fiscal year (FY) 2017.  For instance, during FY 2017, the OIG achieved: $4.13 billion in expected … Continue Reading

OIG: Medicare Program Integrity at the Top of HHS Management Challenges

The OIG’s latest compilation of top HHS management and performance challenges flags vulnerabilities in key HHS health and social services programs, including includes the following: Ensuring Program Integrity in Medicare (addressing improper payments, fraud, payment policies, health care reforms, and health information technology). Ensuring Program Integrity in Medicaid (including compliance with fiscal controls, fraud prevention, … Continue Reading

OIG Wants CMS to Track Medicare Costs from Device Failures

A recent Office of Inspector General (OIG) report suggests that the lack of medical device-specific information on Medicare claim forms complicates CMS efforts to identify and track Medicare costs related to the replacement of recalled or prematurely failed medical devices. The OIG also believes the lack of device information on claims data “impedes the ability … Continue Reading

OIG: “High-Performing” ACOs Point the Way for Medicare Shared Savings Program Savings

The OIG has examined the results of the first three years of the Medicare Shared Savings Program, under which accountable care organizations (ACOs) coordinate care to reduce Medicare costs and improve quality of care. The OIG reports that 428 participating ACOs serving 9.7 million beneficiaries saved almost $1 billion in net Medicare spending while generally … Continue Reading

OIG Issues “Early Alert” on Potential Cases of SNF Abuse/Neglect

The Office of Inspector General has issued an “early alert” warning that “CMS procedures are not adequate to ensure that incidents of potential abuse or neglect of Medicare beneficiaries residing in [skilled nursing facilities] are identified and reported.” In the course an ongoing review, the OIG identified 134 Medicare beneficiaries with injuries resulting from potential … Continue Reading

OIG Estimates CMS Made $730 Million in Improper EHR Incentive Payments, Based on Small Sample of Claims

The HHS Office of Inspector General (OIG) estimates that CMS made $729.4 million in Electronic Health Incentive (EHR) payments to providers who did not meet meaningful use requirements from May 2011 to June 2014 – representing about 12% of the $6 billion in total EHR payments made during this period. This dramatic finding is based … Continue Reading

OIG Issues Top 25 Unimplemented Cost-Savings and Quality-Improvement Recommendations for HHS Programs

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has released the 2017 edition of its Compendium of Unimplemented Recommendations  (“Compendium”). In the Compendium, OIG identifies the top 25 unimplemented recommendations that HHS would need to prioritize in order to facilitate OIG’s recommendations on cost savings, program effectiveness, efficiency, … Continue Reading

OIG and HCCA Offer Suggestions for Measuring Health Organization Compliance Program Effectiveness

The OIG and the Health Care Compliance Association (HCCA) recently held a roundtable where the discussion focused on a broad range of ideas regarding how health care organizations can measure their compliance program effectiveness – while stressing that each organization must tailor its compliance program to reflect the organization’s specific circumstances. These ideas are contained … Continue Reading

OIG Tallies Medicaid Fraud Control Unit Achievements in FY 2016

The OIG has released national and state-by-state data quantifying State Medicaid Fraud Control Unit (MFCUs) accomplishments in fiscal year 2016. During this period MFCUs were credited with a total of: 1,721 indictments (1,249 involving fraud and 472 involving abuse or neglect); 1,564 convictions (1,160 involving fraud and 404 involving abuse or neglect); 998 civil settlements … Continue Reading

OIG Assesses Diabetes Testing Supplies Market Share Data for Competitive Bidding Purposes

The HHS Office of Inspector General (OIG) has released another in series of Congressionally-mandated reports on Medicare market shares of mail order diabetes test strips, this one covering the three-month period after implementation of the National Mail-Order recompete on July 1, 2016. This market share data is intended to help CMS determine if competitive bidding … Continue Reading

OIG Report Cites Continuing Vulnerabilities Under Medicare’s 2-Midnight Policy

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has issued a report, “Vulnerabilities Remain Under Medicare’s 2-Midnight Hospital Policy,” which assessed changes in hospital inpatient and outpatient stays since implementation of the “2-midnight” policy. This policy generally provides that an inpatient stay generally requires at least two midnights … Continue Reading
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