Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more
8/29/2024
/ Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Health Insurance ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
OIG ,
Telehealth
The 60-day Refund Rule, created by the 2010 Affordable Care Act, requires providers to report and return Medicare and Medicaid overpayments within 60 days of identifying them. See Section 1128J(d) of the Social Security Act,...more
7/16/2024
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Deadlines ,
False Claims Act (FCA) ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
Overpayment ,
Proposed Regulation ,
Refunds
On June 28, 2024, the Supreme Court rejected the doctrine of Chevron deference in the closely watched case of Loper Bright Enterprises v. Raimondo. In a 6-3 decision, the Court held that Chevron’s rule that courts must defer...more
7/2/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Federal Health Care Programs (FHCP) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
HRSA ,
Loper Bright Enterprises v Raimondo ,
Magnuson-Stevens Act (MSA) ,
Medicaid ,
Medicare ,
National Marine Fisheries Service ,
SCOTUS
Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more
2/2/2024
/ Business Operations ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Exclusions ,
Healthcare Fraud ,
Medicaid ,
Medicare Advantage ,
New Guidance ,
OIG ,
Risk Assessment ,
Self-Disclosure Requirements ,
Telemedicine
On December 7, 2023, the Senate Budget Committee (the “Committee”) launched a bipartisan investigation into the reality of private equity ownership of hospitals in the United States. This investigation stems from concerns...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
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Justice (DOJ) ,
Enforcement ,
Fraud ,
HRSA ,
Medicaid ,
Medicare ,
Noncompliance ,
OIG
Continuing a now annual tradition, the Centers for Medicare & Medicaid Services (CMS) has included expansions and enhancements to its authorities to deny enrollment or revoke a provider’s Medicare billing privileges...more
7/18/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Diagnostic Tests ,
DMEPOS ,
Durable Medical Equipment ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Medicare ,
Misdemeanors ,
OIG ,
Proposed Rules ,
Revocation ,
Risk Assessment
Session #1: State of the Healthcare Industry Effective Compliance Plans and Enforcement Trends -
In their discussion of compliance program effectiveness and enforcement, attorneys Kolarik and Waltz and Ms. Sumner...more
2/23/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Consolidated Appropriations Act (CAA) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Dispute Resolution ,
Enforcement ,
Health Care Providers ,
Healthcare ,
Medicaid ,
Medicare ,
Mental Health ,
No Surprises Act (NSA) ,
Physician Fee Schedule ,
Public Health Emergency ,
Risk Assessment
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 August 17, 2022, the Centers for Medicare and Medicaid Services (CMS) issued a bulletin (Bulletin) to states addressing potentially inappropriate cost-based proposals and practices related to governmental ambulance...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
In a Press Release issued on October 14 2021 by the Office of Massachusetts Attorney General Maura Healy, a potentially groundbreaking settlement was announced. Below is an excerpt from the release, followed by our takeaways....more
Laboratory testing is a key factor in identifying or diagnosing COVID-19 patients, including during the asymptomatic phase, and determining appropriate treatment. With respect to COVID-19, laboratory testing is also critical...more
On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released its long-awaited Proposed Rule (Proposed Rule) updating and clarifying the physician...more
10/17/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Medicare ,
Physicians ,
Proposed Regulation ,
Self-Referral ,
Stark Law ,
Value-Based Care
Welcome to Foley & Lardner LLP’s Health Care MarketTrends. In this issue, we examine private equity investment in specialty areas of the health care industry, specifically dermatology and orthopedics....more
9/17/2019
/ Anti-Kickback Statute ,
Audits ,
Billing ,
Centers for Medicare & Medicaid Services (CMS) ,
Coding ,
Health Care Providers ,
Hospitals ,
Investors ,
Medicaid ,
Medicare ,
Private Equity ,
Private Equity Firms ,
Specialty Healthcare ,
Stark Law
At this early point in the 2020 presidential race, it appears that a key issue for the candidates will be a push for national health insurance, or some variation thereof, possibly even including proposals that Medicare or...more
On February 14, 2019, CMS’ Innovation Center announced its Emergency Triage, Treat, and Transport (ET3) Model for EMS / ambulance suppliers to partner with other health care providers such as telehealth entities and urgent...more
5/2/2019
/ 911 Calls ,
Ambulance Providers ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Medicare ,
Stark Law ,
Waivers
A new wave of change is poised to disrupt the way health care is delivered in the United States. This time around, the disruption is coming not from lawmakers or the president, who have struggled to repeal or improve upon...more
1/30/2019
/ Affordable Care Act ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
Department of Veterans Affairs ,
Drug Pricing ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Internet of Things ,
Legislative Agendas ,
Medicaid ,
Medicare Advantage ,
Popular ,
Request For Information ,
Stark Law ,
Telehealth
Providers and suppliers who have been assessed overpayments for Medicare services are entitled, by statute, to a stay of recoupment while the provider or supplier’s appeal is pending – but only at the first two levels of...more
7/19/2018
/ Administrative Appeals ,
Administrative Law Judge (ALJ) ,
Centers for Medicare & Medicaid Services (CMS) ,
Due Process ,
Health Care Providers ,
Medicare ,
Medicare Provider Agreements ,
Overpayment ,
Physician Medicare Reimbursements ,
Recoupment ,
ZPIC
The Centers for Medicare and Medicaid Services (CMS) has demonstrated that it will not hesitate to use one of its most crippling administrative enforcement tools—the revocation of Medicare billing privileges—against one of...more
1/25/2017
/ Centers for Medicare & Medicaid Services (CMS) ,
Competitive Bidding ,
Department of Health and Human Services (HHS) ,
Departmental Appeals Board (DAB) ,
Federal Contractors ,
Healthcare Fraud ,
Irreparable Harm ,
Medicare ,
Medicare Billing Privileges ,
Motion to Dismiss ,
Preliminary Injunctions ,
Revocation ,
TRO
The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the...more
12/28/2016
/ 21st Century Cures Act ,
Barack Obama ,
Cancer ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Hospitals ,
Long Term Care Facilities ,
Medical Research ,
Medicare Part B ,
New Legislation ,
Off-Campus Departments ,
OPPS ,
Outpatient Services ,
Physician Fee Schedule ,
Provider Payments ,
Site-Neutral Exception
Center for Medicare and Medicaid Services (CMS) issued the long-awaited implementation of the “site-neutrality” provisions of the H.R. 1314 Bipartisan Budget Act of 2015 (BiBA Section 603) on November 1, 2016. The Final Rule...more
Despite the July 4 holiday, the past week featured significant regulatory and legislative action addressing the use of opioids and pain management. The changes are in keeping with the Government-wide push to better understand...more
7/14/2016
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Congressional Committees ,
Drug & Alcohol Abuse ,
Hospitals ,
Legislative Agendas ,
Medicare ,
Opioid ,
Pain Management ,
Pending Legislation ,
Prescription Drugs ,
Proposed Regulation ,
Surveys ,
Value-Based Purchasing
CMS issued its Outpatient Prospective Payment System (“OPPS”) Proposed Rule for 2017 (the “Proposed Rule”) on July 6, 2016. The Proposed Rule will be published in the Federal Register on July 14, 2016. One highly-anticipated...more
7/13/2016
/ Bipartisan Budget Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Grandfathered Status ,
Health Care Providers ,
Hospitals ,
Medicare ,
MPFS ,
Off-Campus Departments ,
OPPS ,
Proposed Legislation ,
Proposed Regulation ,
Section 340B
As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more
10/12/2015
/ Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
CLFS ,
Clinical Laboratories ,
Comment Period ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Health Insurance ,
Hospitals ,
Managed Care Contracts ,
Medicaid ,
Medicare ,
Medicare Advantage ,
Medicare Part B ,
Misrepresentation ,
OIG ,
Omissions ,
PAMA ,
Physicians ,
Proposed Regulation ,
Reporting Requirements