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ORI Proposes New Rulemaking for Research Misconduct Regulations

On October 5, 2023, the Office of Research Integrity (ORI) of the Department of Health and Human Services (HHS) issued a notice of proposed rulemaking to update the Public Health Service (PHS) Policies on Research Misconduct...more

HRSA Uninsured Program COVID-19 Services: What Were the Standards to Determine Uninsured Status?

The Health Resources and Services Administration (HRSA) Uninsured Program (UIP), which reimbursed providers for provision of COVID-19 related services to uninsured individuals, paid out more than $24.5 billion in claims....more

HRSA Uninsured Program Covid-19 Services: OIG Audit Finds HRSA Paid for Claims that did not Comply with Federal Requirements

On July 13, 2023 the Office of Audit Services of the Department of Health & Human Services Office of Inspector General (OIG) released the long-awaited audit (A-02-21-01013) of the Health Resources and Services Administration...more

Decentralized Clinical Trials Blog Series: Introduction

Decentralized Clinical Trials (DCTs) are clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites, such as via telemedicine or in a clinical trial participant’s...more

“Acute Hospital Care at Home”: Omnibus Bill Extends Flexibility Period to December 31, 2024

As part of the $1.7 million omnibus spending bill that became law December 29, 2022, the Centers for Medicare & Medicaid Services (CMS) extended, through December 31, 2024, the Acute Hospital Care at Home (H@H) initiative...more

Accredited Health Care Providers Rejoice: The Joint Commission is Eliminating 14% of its Standards Across Accreditation Programs

On Wednesday, December 21, 2022, The Joint Commission announced that, effective January 1, 2023, it is eliminating 168 (or 14%) of its accreditation standards across its accreditation programs, and revising 14 more. The Joint...more

Health Providers Must Avoid COVID Reimbursement Missteps

One Health Resources and Services Administration program, “COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured,” has been a huge source of...more

HRSA Uninsured Program Shutdown: Funding to End March 22, 2022 for COVID-19 Testing and Treatment; April 5, 2022 for COVID-19...

On March 15, 2022, the Health Resources & Services Administration (HRSA) announced that the Uninsured Program will stop accepting claims for COVID-19 testing and treatment on March 22, 2022 at 11:59 PM ET due to lack of...more

COVID-19 At-Home Tests: Do CLIA Requirements Apply and what do Health Care Providers Need to Know?

Demand for COVID-19 tests, including over-the-counter at-home tests, has soared with the surge of the Omicron variant of the COVID-19 virus. However, health care providers, employers, and individuals have lacked clarity on if...more

OIG’s Revised Self-Disclosure Protocol: Top Takeaways

On November 8, 2021, the Department of Health & Human Services (HHS) Office of Inspector General (OIG) released a revised and renamed Provider Self-Disclosure Protocol: the OIG “Health Care Fraud Self-Disclosure” protocol...more

A Target on Telehealth: Government Action Against Telehealth Fraud in the Wake of COVID-19

The COVID-19 Public Health Emergency (PHE) is expected to prompt unprecedented levels of regulatory enforcement activity that is focused on the use of telemedicine. In fact, fraudulent and abusive telehealth practices was an...more

Supreme Court Declines to Resolve Circuit Split on FCA “Objective Falsity” Issue

On Monday February 22, 2021, the U.S. Supreme Court declined to grant certiorari in CareAlternatives v. United States (CareAlternatives), a case on appeal from the Third Circuit that could have assessed the issue of...more

D.C. Circuit Upholds Hospital Price Transparency: Regulations Paving Way for January 1, 2021 Effectiveness

On December 29, 2020, the United States Court of Appeals for the District of Columbia issued its opinion in American Hospital Association v. Azar (the Opinion) upholding the Hospital Transparency Regulation (the Rule) issued...more

Challenging Physician Judgment: Is Your Institution Exposed to False Claims Act Liability?

Many health care providers treating senior patients rely on Medicare reimbursement and undertake significant measures to ensure proper billing and compliant practices. However, providers across the country may soon be subject...more

Provider Relief Fund: Protecting Your Institution from False Claims Act Allegations after Receipt of CARES Act Funding

In April 2020, the Department of Health and Human Services (HHS) revealed a plan to disperse $175 billion in funding for health care providers allocated by the Coronavirus Aid, Relief, and Economic Security (CARES) Act and...more

COVID-19: CMS Issues FAQ Regarding Emergency Medical Treatment and Labor Act

Hospitals across the country are questioning whether and how the Emergency Medical Treatment and Labor Act (EMTALA) requirements apply during the COVID-19 pandemic. Last week, CMS issued a list of Frequently Asked Questions...more

COVID-19: States Protect Long-Term Care Facilities from Liability

COVID-19 has hit long-term care facilities very hard.  Every day brings reports of lethal outbreaks in such facilities and one-quarter or more of the reported COVID-19 related deaths in the United States have been connected...more

COVID-19: CMS Issues Telehealth Guidance for State Medicaid and CHIP Programs

On April 23, 2020, the Centers for Medicare & Medicaid Services (CMS) released the “State Medicaid & CHIP Telehealth Toolkit: Policy Considerations for States Expanding Use of Telehealth” (the Toolkit). Telehealth allows...more

COVID-19: FDA Issues Guidance for Ventilator and Respirator Manufacturers

Patients with COVID-19 may develop respiratory illness, distress, and insufficiency and may require respiratory devices including ventilators, anesthesia gas masks, and other devices to support their treatment. However, with...more

COVID-19: CMS Issues EMTALA Guidance

As the coronavirus pandemic has unfolded, hospitals across the country have begun asking how the Emergency Medical Treatment and Labor Act (EMTALA) will be applied to them when they are confronted with individuals coming to...more

Behavioral Health & Substance Abuse Services: Massachusetts Proposal Reflects Focus on Expanding Access and Coverage

... Massachusetts House Bill 4134 includes several provisions aimed at expanding access to treatment for mental health and substance use conditions in the Massachusetts Commonwealth. Most notably, the Bill would require...more

Organ Procurement Organizations: CMS Proposes Revisions to Conditions For Coverage Designed To Increase Donated Organs

On July 10, 2019, President Trump issued an Executive Order entitled Advancing American Kidney Health. The Executive Order stated that the “state of care for patients with chronic kidney disease and end-stage renal disease...more

Impossible or Laudable: The Proposed Massachusetts Primary and Behavioral Health Care Spending Requirement

Massachusetts Governor Charlie Baker has restarted the discussion on health care cost containment in the Commonwealth with a proposed bill that contains a raft of initiatives. Foley & Lardner will be addressing each of the...more

Massachusetts Governor Proposes Facility Fee Ban

Massachusetts Governor Charlie Baker has restarted the discussion on health care cost containment in the Commonwealth with a proposed bill that contains a raft of initiatives. This is the first in a series of blog posts to...more

Oncology Care First: What You Need to Know About the Proposed Oncology Care First Model

On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (Innovation Center) released a Request for Information (RFI) on the Oncology Care First (OCF) model. The...more

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