News & Analysis as of

Office of the Inspector General Department of Health and Human Services (HHS) Patient Protection and Affordable Care Act (PPACA)

Proskauer - Health Care Law Brief

OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more

Quarles & Brady LLP

Is Your Employee or Contractor Excluded?

Quarles & Brady LLP on

Employers must check its employees, contractors and vendors to see if an individual or organization is excluded from participating in federal and/or state programs. While there are a variety of exclusion programs at the...more

Mintz - Health Care Viewpoints

CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard

The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more

Foley & Lardner LLP

Will CMS’s Proposed Rule on “Identified Overpayments” Increase Reverse FCA Cases?

Foley & Lardner LLP on

On December 27, 2022, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule which, in part, seeks to amend the existing regulations for Medicare Parts A, B, C, and D regarding the standard for when an...more

Foley & Lardner LLP

DOJ Antitrust Division and HHS OIG Enter into Partnership to Increase Coordination and Enforcement in Health Care

Foley & Lardner LLP on

On December 9, 2022, the U.S. Department of Justice Antitrust Division (DOJ) and Office of Inspector General of the U.S. Department of Health and Human Services (OIG) announced they had entered a Memorandum of Understanding...more

Health Care Compliance Association (HCCA)

Credible Information Is Heart of 60-Day Rule; OIG: Self-Disclosure Pauses the Clock

Report on Medicare Compliance 30, no. 28 (August 2, 2021) - When a hospital realized it had been billing for annual wellness visits without documentation of opioid and substance use screening, it wasn’t a heavy lift to...more

Foley & Lardner LLP

Latest Open Payments Data Released Under Heightened Government Scrutiny

Foley & Lardner LLP on

On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

Alston & Bird

Alston & Bird Health Care Week in Review - March 2021 #4

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

King & Spalding

New Risks, New Rewards, New Exposure

King & Spalding on

Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

Foley & Lardner LLP

COVID-19: Resources for Oncology Providers (Medicaid, Grants, & Stark Law Waivers)

Foley & Lardner LLP on

The Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), the Office of the Inspector General (OIG), and other Federal and State agencies and...more

Seyfarth Shaw LLP

HHS Issues Advisory Opinion on PREP Act: Immunity May Extend Beyond Actual Covered Persons and Approved Countermeasures

Seyfarth Shaw LLP on

With crisis comes uncertainty, and even the best-intentioned regulations can leave those combating the current COVID-19 public-health emergency out in the cold.  Many have asked whether the recent Declaration under the...more

Seyfarth Shaw LLP

CMS Announces New Priorities for Facility Surveys and Inspections

Seyfarth Shaw LLP on

In light of findings from the COVID-19 outbreak at a nursing home in Kirkland, Washington, the Centers for Medicare and Medicaid Services (CMS) has announced that it will suspend all routine facility inspections and surveys...more

McGuireWoods Consulting

Washington Healthcare Update - December 2019 #3

McGuireWoods Consulting on

This Week in Washington: The House and Senate are out of session until the new year. Congress - House - House Passes USMCA Trade Deal ...more

Foley & Lardner LLP

Healthcare Law Review: Overview of the U.S. Healthcare System

Foley & Lardner LLP on

The U.S. healthcare industry remains at a crossroads. The healthcare reform legislation passed under President Barack Obama in 2010, officially called the Patient Protection and Affordable Care Act (ACA) but widely referred...more

McGuireWoods Consulting

Washington Healthcare Update April 2019

Upcoming Hearings - Tuesday, April 2, 2019 - House Committee on Energy and Commerce: “Priced Out of a Lifesaving Drug: The Human Impact of Rising Insulin Costs” - The Subcommittee on Oversight and Investigations of the...more

Baker Donelson

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

Baker Donelson on

Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

Bass, Berry & Sims PLC

Stark Under the Microscope: Congress and HHS Examine Reform of the Stark Law for a Value-Based System

Bass, Berry & Sims PLC on

On July 17, 2018, the U.S. House of Representatives' Ways and Means Committee Subcommittee on Health ("Subcommittee") expressed its commitment to modernizing the Stark Law during a hearing in which industry and government...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Faegre Drinker Biddle & Reath LLP

Telehealth Remains a Top Priority for Advancing Quality Health Care

Even with the prospect of Obamacare repeal and replace on the backburner for now, the federal government continues to focus on health care. Following August recess, Congress will have less than four weeks to work through...more

McDermott Will & Emery

New OIG Rules Change Patient Incentive Program Landscape: Where Are the Limits Now?

McDermott Will & Emery on

With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are...more

Sheppard Mullin Richter & Hampton LLP

New OIG Exclusion Authority Rule Set To Go Into Effect on March 21, 2017

On January 12, 2017, just a week prior to President Trump’s Inauguration, the Department of Health and Human Service (HHS) Office of Inspector General (OIG) published a final Rule (Rule) regarding one of its most important...more

McDermott Will & Emery

New OIG Exclusion Regulations About to Go into Effect

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Baker Donelson

Despite Uncertain Future of ACA, OIG Issues Final Rule Revising Permissive Exclusion Authority

Baker Donelson on

On January 12, 2017, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) published a final rule expanding its permissive exclusion authority while also codifying certain statutory changes made...more

Arnall Golden Gregory LLP

Stretching the Rules: HHS-OIG Expands its Exclusionary Authority

On January 12, 2017, the Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule expanding its authority to exclude providers from participation in federal healthcare programs. This...more

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