In a March 11 advisory opinion the Department of Health and Human Services’ Office of Inspector General (“OIG”) permitted a medical device manufacturer to pay Medicare-reimbursable costs for subjects enrolled in a clinical trial sponsored by the manufacturer and involving the manufacturer’s therapy. The OIG indicated it would not impose administrative sanctions, despite the fact … Continue Reading
With another presidential transition in the history books, you may find it unsurprising to hear that many of us at Reed Smith are continuing to closely monitor and track which of the outgoing Trump administration’s “midnight regulations” will survive past the early months of the Biden administration. But for those less familiar with the topic … Continue Reading
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The OIG has added 18 reviews to its FY 2017 Work Plan – most of which target CMS programs, with a particular emphasis on prescription drug policies. For instance, the OIG now intends to examine the following Medicare and Medicaid topics (among others): Excessive Use of Opioids in Medicare Part D Including Non-Covered Versions When … Continue Reading
The HHS Office of Inspector General (OIG) expects its investigative recoveries during the first half of fiscal year (FY) 2017 to top $2.04 billion – which is down from $2.77 billion for the first half of FY 2016. During this period, the OIG reports 468 criminal actions against individuals or entities that engaged in crimes … Continue Reading
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
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
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
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
The HHS Office of Inspector General (OIG) is warning the public that scammers are spoofing the OIG’s hotline telephone number to obtain personal information from individuals that then can be used to steal money from the victim’s bank account or other fraudulent activity. The OIG stresses that it does not use the HHS OIG Hotline … Continue Reading
