Tag Archives: Fraud and Abuse

SCOTUS Review of Rule 9(b) in False Claims Act cases may be on the way

Supreme Court review of Rule 9(b)’s application in False Claims Act cases may finally be coming whether the Executive Branch likes it or not. In January, the Supreme Court, which is considering a certiorari petition in Johnson v. Bethany Hospice and Palliative Care, LLC, asked the Solicitor General to weigh in on whether the Court … Continue Reading

CMS Issues Updated Open Payments FAQs

CMS recently issued updated Open Payments Frequently Asked Questions (FAQs). The FAQs are revised periodically to reflect the most up to date program requirements. This latest revision both added and removed FAQs, and also included some general edits. The following FAQs were added: #2014, #2015, #2016, #2017, #2018, #2019, #2020, #2021 and #2022. Each new … Continue Reading

OIG blesses digital health substance use disorder treatment program paid for by providers and suppliers

The Department of Health and Human Services’ Office of Inspector General (“OIG”) recently issued a favorable advisory opinion to a digital health company that offers direct monetary incentives to patients as part of a technology-enabled contingency management program for patients with substance use disorders. Contingency management, also known as motivational incentives, is a treatment approach … Continue Reading

AdvaMed announces revisions to code of ethics for interactions with health care professionals

On March 18, 2022, the Advanced Medical Technology Association (AdvaMed) – the world’s largest trade organization representing medical technology manufacturers – announced revisions to its Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code). The effective date of the revised AdvaMed Code is June 1, 2022. The AdvaMed Code was updated to address … Continue Reading

OIG permits home health agency to pay nurse aide certification tuition costs

In its February 14, 2022 advisory opinion the Department of Health and Human Services Office of Inspector General (OIG) allowed a Home Health Agency (HHA), that predominantly serves Medicaid eligible children, to pay the nurse certification program tuition costs for new employees seeking to work as certified nurse aides (CNAs). According to OIG, the tuition … Continue Reading

FBA’s 2022 Qui Tam Conference Puts Annual Spotlight on FCA Enforcement Trends and Developments

On February 23, 2022, the Federal Bar Association (FBA) kicked off its fifth annual Qui Tam Conference to highlight key areas for False Claims Act (FCA) enforcement in the coming year. The conference opened with a keynote address by Gregory E. Demske, Chief Counsel to the Inspector General, Department of Health and Human Services (HHS), … Continue Reading

Pending investigations/cases no longer prevent OIG advisory opinions

The Department of Health and Human Services’ Office of Inspector General (OIG) will be lifting its long-standing refusal to accept requests for advisory opinions if the request describes a course of action that is “the same or substantially the same” as a course of action that is either under investigation by OIG, or is the … Continue Reading

Future of discount safe harbor for prescription drugs remains uncertain

In November 2020, four months after the Trump Administration issued a series of Executive Orders reiterating its policy goals on reducing the costs to consumers for prescription drugs and directing the Department of Health and Human Services, Office of Inspector General (“HHS-OIG”) to implement those policy objectives, HHS-OIG issued a Final Rule to amend certain … Continue Reading

Plausibility Pleading in the Digital Age: Federal appellate courts take fresh look at Rule 8 in FCA context

In recent years, the U.S. Department of Justice (“DOJ”) has increasingly leveraged data analytics to combat fraud. Principal Deputy Chief of DOJ’s Fraud Section, Joe Beemsterboer, described the department’s data-mining capabilities as the “foundation of how [DOJ] investigate[s] and analyze[s] cases,” and explained that digital forensics equips the department with “powerful” tools for identifying “trends,” … Continue Reading

Congress considers the future of telehealth in the wake of COVID-19

It is no secret that the coronavirus pandemic has driven our daily lives digital—work, education, social gatherings, and, of course, health care. Congress and CMS responded to the public health emergency by waiving limitations on reimbursement for telehealth services rendered to Medicare patients. These waivers introduced new flexibility and vastly expanded Medicare patients’ access to … Continue Reading

OIG releases strategic plan for oversight of COVID-19 response

Following the distribution of billions of relief aid to healthcare providers and amidst the guidance issued around reopening of nursing homes throughout the country, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) unveiled a COVID-19 Response Strategic Plan on May 26, 2020 after updating its Workplan a few days earlier. … Continue Reading

Medicare/Medicaid Policy Provisions in Trump Administration’s FY 2021 Budget Proposal

The Trump Administration’s proposed fiscal year (FY) 2021 budget calls for significant cuts to federal health spending, including a 10% decrease in Department of Health and Human Services (HHS) discretionary spending in FY 2021 and a $1.6 trillion net reduction in health entitlements over the next decade.  House Budget Committee leaders have blasted the HHS … Continue Reading

HHS Boosts Civil Monetary Penalties Again

The Departments of Health and Human Services (HHS) has just published its “annual” inflation update to civil monetary penalty amounts (CMP) in its regulations – even though those penalties were just increased for inflation in November 2019.  Under the latest update, CMPs are increased by a 1.01764 “multiplier” (that is, a 1.764% increase), applicable to … 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

Speakers from WebMD, CMS, PhRMA, AdvaMed, AHCA, and More to Present at Reed Smith’s Dec. 4 Washington Health Care Conference

Reed Smith is hosting its 6th Annual Washington Health Care Conference on December 4, 2019 at The Almas Center in Washington, D.C., and is pleased to welcome another impressive line-up of speakers this year. Our keynote speaker is Dr. John Whyte, Chief Medical Officer of WebMD, who will be discussing “Artificial Intelligence in Health Care: … Continue Reading

HHS Health Fraud Penalties Climb Again

Maximum civil monetary penalty (CMP) amounts that may be imposed by the Department of Health and Human Services (HHS) and its agencies have increased once again under the latest HHS inflation adjustment notice.  Specifically, in conformance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (“the Act”), HHS is applying a 1.02522 … Continue Reading

Expansive New CMS Enrollment and Participation Rules Set to Go Live November 4, Although Comments Still Being Accepted

The Centers for Medicare & Medicaid Services (CMS) has published a final rule with comment period establishing sweeping disclosure and monitoring obligations for providers and suppliers enrolled or enrolling in federal health programs, and expanding CMS’s authority to deny or revoke enrollment status.  In particular, the rule establishes an expansive new “affiliations” disclosure requirement that … Continue Reading

President Trump Signs Executive Order on “Protecting and Improving Medicare for Our Nation’s Seniors”

President Donald Trump has signed an executive order that commits the Department of Health and Human Services (HHS) to taking a series of regulatory and subregulatory actions intended to enhance the fiscal sustainability of the Medicare program, reduce regulatory burdens on providers, and increase beneficiary choice.  The planned initiatives, which would require further policy development … Continue Reading

HHS OIG Pulls CMP, Safe Harbor Proposed Regs Pending for More Than a Decade

Seeking to “eliminate any confusion,” the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has formally withdrawn proposed civil money penalty (CMP) and anti-kickback (AKS) safe harbor regulations that it no longer intends to finalize.  Specifically, the OIG is withdrawing: A 1994 proposed rule that would have codified the … Continue Reading

Health Fraud Recoveries Continue to Dip in FY 2018, According to Latest OIG/DOJ Fraud Report

Federal health care fraud judgments and settlements totaled $2.3 billion in fiscal year (FY) 2018 – down from $2.6 billion in recoveries in FY 2017 and $3.3 billion in FY 2016 — according to latest Health Care Fraud and Abuse Control (HCFAC) Program Annual Report.  During FY 2018, the Department of Justice (DOJ) opened 1,139 new … Continue Reading

Trump Administration Calls for Medicare/Medicaid Cuts, Program Reforms in FY 2020 Budget Proposal

The Trump Administration’s proposed fiscal year (FY) 2020 budget includes extensive health policy provisions – as evidenced by the 162-page Department of Health and Human Services (HHS) “Budget in Brief.”  This summary focuses on the major Medicare and Medicaid proposals most directly impacting providers and suppliers; note that we discuss the Administration’s proposed prescription drug … Continue Reading

HHS Finalizes Updates to State Medicaid Fraud Control Unit Rules

The Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) have finalized changes to State Medicaid Fraud Control Unit (MFCU) regulations to reflect statutory changes and policies adopted since the MFCU rules were first issued in 1978.  Among other things, the regulations incorporate statutory policies that:  authorize a federal matching … 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

Federal Health Fraud Penalties Are Rising Once Again

The Department of Health and Human Services (HHS) has just announced annual inflation-related increases to civil monetary penalties (CMPs) in its regulations, including those promulgated by the Office of Inspector General, the Centers for Medicare & Medicaid Services, and the Food and Drug Administration.  Specifically, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements … Continue Reading
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