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Supreme Court Decides Becerra v. San Carlos Apache Tribe

On June 6, 2024, the Supreme Court decided Becerra v. San Carlos Apache Tribe, No. 23-250, holding that the Indian Self-Determination and Education Assistance Act (ISDA), 25 U.S.C. § 5301 et seq., requires the Indian Health...more

Healthcare compliance in a post-pandemic world

On January 31, 2020, pursuant to Section 319 of the Public Health Service Act, the secretary of the U.S. Department of Health & Human Services (HHS) determined that a public health emergency (PHE) exists due to the soaring...more

A New Normal: Preparing Compliance Programs for Changes to Federal Telehealth Policy in a Post-Pandemic World

The rapid growth of telehealth during the COVID-19 pandemic continued and expanded access to care for millions of patients. Despite telehealth’s success in promoting continuity of care amid stay-at-home orders and social...more

HHS-OIG Updates Its Self-Disclosure Protocol

On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (OIG) updated and renamed its Self-Disclosure Protocol (SDP). The OIG had last updated the SDP in 2013. The update changes and...more

HHS OIG Expands the Warranties Safe Harbor to the Anti-Kickback Statute

The Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule that expands the extremely narrow warranties safe harbor to include bundled items and services. Consistent with other changes brought...more

OIG Revises Local Transportation Safe Harbor

One of the most frustrating issues for hospitals, particularly during a public health emergency with extremely limited bed capacity, is the inability to discharge a patient in a timely manner because they do not have...more

Patient Engagement Tools and Supports: Analysis of the New Anti-Kickback Statute Regulatory Safe Harbor

Providers have a new tool in their toolbox to promote population health. The Health and Human Services Office of Inspector General (OIG) has adopted a new, extremely broad safe harbor that allows certain providers to give...more

Sweeping Stark Law and Anti-Kickback Statute Final Rules Published

As part of its Regulatory Sprint to Coordinated Care, on November 20, 2020, the Department of Health and Human Services (HHS) published two final rules which make significant and sweeping changes to regulations relating to...more

FEMA Relief for Hospitals and Health Systems: What’s Covered and How to Apply

On March 13, 2020, President Donald Trump issued emergency declarations for all states, tribes, territories and the District of Columbia under the Stafford Act in response to the COVID-19 pandemic. This unprecedented...more

HHS Extends Attestation Deadline, Releases Additional General Distribution FAQs and Issues Payment Allocation Methodology Guidance...

HHS has recently issued a great number of clarifications to multiple aspects of its Provider Relief Fund programs authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act....more

HHS Issues Guidance on COVID-19 Uninsured Reimbursements

On April 27, 2020, the Health Resources and Services Administration (HRSA), a component of the U.S. Department of Health and Human Services (HHS), announced guidance for health care providers regarding HRSA COVID-19 Claims...more

HHS Begins Distribution of Provider Relief Funds to Hospitals With High COVID-19 Admissions and to Rural Providers

The Coronavirus Aid, Relief and Economic Security (CARES) Act makes $100 billion in funds available to hospitals and other health care providers for health care-related expenses or lost revenues attributable to COVID-19. The...more

HHS Announces Additional Details Regarding $50 Billion Provider Relief Fund General Distribution

The Department of Health and Human Services (HHS) is in the process of completing a $50 billion general distribution (General Distribution) from the $100 billion available to health care providers through the Public Health...more

Liability Protections for Health Care Workers in an Emergency

Public health emergencies give rise to exceptional powers that can be exercised by federal and state officials. One of these powers is the ability to shield health care workers from liability in certain limited circumstances....more

FDA and TTB Take Steps to Ease Hand Sanitizer Shortage

Food and Drug Administration - Although some distilleries have tried to pitch in to produce hand sanitizer in the wake of a national shortage caused by the coronavirus public health emergency, hand sanitizers are actually...more

‘Text Me Your Symptoms’: CMS Proposes Expanding Coverage for Digital Health Services

In what can only be described as “out of the box” thinking, the Centers for Medicare and Medicaid Services (CMS) is proposing to pay physicians for virtual check-ins, and for asynchronous interactions with patients in which...more

Big Issues Front and Center at Annual Conference for the American Society for Pharmacy Law

In the midst of the opioid epidemic, pharmacists and attorneys from across the country gathered last week for the 28th Annual Conference for the American Society for Pharmacy Law (ASPL). The conference brought together...more

Department of Veterans Affairs Releases Long-Awaited Proposed Rule to Allow Telehealth Services Across State Lines

On Friday, September 29, the Department of Veterans Affairs (VA) released its long-awaited proposed rule amending medical regulations to improve access to care for beneficiaries regardless of patient or provider locations....more

In Removing HSD Tables From Applications, CMS Opens the Door to Medicare Advantage Growth

Recently, the Centers for Medicare & Medicaid Services (CMS) released its draft 2019 Medicare Advantage application. Health plans seeking to participate in the Medicare Advantage (MA) program for the first time or expanding...more

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

An Unsettling Settlement: Health Plan to Pay $32 Million to Settle Coding and Provider Network Misrepresentation Charge

On May 30, the Department of Justice (DOJ) announced that it reached a settlement with commonly-owned Freedom Health Inc. and Optimum Healthcare, Inc. (Freedom Health) — two Tampa, Florida, managed care plans — to settle...more

Meaningful Use Changes in 2017 OPPS Final Rule

On November 14, 2016, the Centers for Medicare and Medicaid Services (CMS) published the 2017 Outpatient Prospective Payment System (OPPS) final rule in the Federal Register. The rule finalizes changes to the Electronic...more

False Claims Act Violations to Become Much Costlier Starting August 1

On June 29, the U.S. Department of Justice (DOJ) confirmed that penalties for False Claims Act (FCA) violations will increase substantially. The DOJ’s interim final rule nearly doubles the per violation penalty for FCA...more

Finally, A Final Rule on ACA's 60-Day Repayment Rule

On February 11, 2016, the Centers for Medicare & Medicaid Services (CMS) released the much anticipated final rule on the so-called “60-day rule.” The long road to the final rule began when the Affordable Care Act (ACA)...more

Whether Naughty or Nice, Recovery Audit Contractors Are Coming to Medicare Advantage

During the holiday season lull, the Centers for Medicare and Medicaid Services (CMS) issued a weighty document. The agency put out a draft statement of work to procure Recovery Audit Contractors (RACs) for the Medicare...more

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