This is the fifth edition of our blog series on decentralized clinical trials DCTs. Click here to explore the series.
The COVID-19 Pandemic required the health care industry to adapt to accommodate remote patient care,...more
On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have...more
9/25/2024
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Department of Justice (DOJ) ,
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Investigations ,
New Regulations ,
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Public Health Service (PHS) ,
Statute of Limitations ,
Transcripts ,
Willful Misconduct
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
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
8/18/2023
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OIG
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 (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
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
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
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
4/8/2022
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CARES Act ,
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Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Department of Labor (DOL) ,
Families First Coronavirus Response Act (FFCRA) ,
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OIG ,
Reimbursements ,
U.S. Treasury
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
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
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
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
7/16/2021
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Health Insurance Portability and Accountability Act (HIPAA) ,
OCR ,
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Public Health Emergency ,
Relief Measures ,
Rural Health Care Providers ,
Telehealth
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
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
1/13/2021
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Affordable Care Act ,
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Corrective Action Plans (CAPs) ,
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Hospitals ,
New Regulations ,
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PHSA ,
Price Transparency ,
Public Disclosure ,
Secretary of HHS
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
12/10/2020
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Petition for Review ,
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Qui Tam ,
SCOTUS
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
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 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
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
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
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
... 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
1/23/2020
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Substance Abuse
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
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