On January 17, the Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) jointly published two final rules addressing the prescription of controlled substances via telemedicine in...more
On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more
9/19/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Employer Group Health Plans ,
Health Insurance ,
Healthcare ,
Medicare ,
Medicare Advantage Organizations (MAOs) ,
OIG ,
Shared Savings Program
On September 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, in which it declined to approve an anatomic pathology laboratory’s proposal to purchase...more
The Health Resources and Services Administration (HRSA) is seeking repayment of Provider Relief Fund (PRF) payments from providers who failed to submit the required report(s) on their use of the funds. Recipients were...more
On August 19, the federal government issued a final rule addressing certain aspects of the No Surprises Act (NSA). The NSA was enacted in December 2020 to protect commercially insured patients from receiving surprise medical...more
On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more
10/25/2021
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Investigational Device Exemptions ,
Investigations ,
IRB ,
Life Sciences ,
Medical Devices ,
Research and Development ,
The Common Rule
On July 1, the Department of Health and Human Services (HHS), Department of Labor, and Department of the Treasury (Departments) jointly issued interim final rules (IFR) implementing certain aspects of the No Surprises Act...more
8/9/2021
/ Comment Period ,
Cost-Sharing ,
Department of Health and Human Services (HHS) ,
Department of Labor (DOL) ,
Disclosure Requirements ,
Federal Employees ,
Health Care Providers ,
Health Insurance ,
Healthcare Facilities ,
Interim Final Rules (IFR) ,
Notice Requirements ,
Out of Network Provider ,
Patients ,
Proposed Regulation ,
Rulemaking Process ,
State and Local Government ,
Surprise Medical Bills ,
U.S. Treasury
After months of quiet introspection, on June 11, 2021, the U.S. Department of Health and Human Services (HHS) released long-awaited updated Post-Payment Notice of Reporting Requirements, which outlines updated reporting...more
On March 17, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and the Department of Health and Human Services (HHS) all took steps to improve access to COVID-19 screening. HHS...more
After a drawn-out drafting-and-review process, the hotly contested No Surprises Act (Act) has made its way into law after being tucked into the 5,500+ pages of the Consolidated Appropriations Act, 2021, signed into law on...more
2/8/2021
/ Consolidated Appropriations Act (CAA) ,
Department of Health and Human Services (HHS) ,
Dispute Resolution ,
Health Care Providers ,
Healthcare ,
Medical Billing Codes ,
Notice and Comment ,
Patients ,
Price Transparency ,
Proposed Rules ,
Reimbursements ,
Reporting Requirements ,
Stakeholder Engagement ,
Surprise Medical Bills ,
Telehealth
Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more
2/4/2021
/ Annual Reports ,
Anti-Kickback Statute ,
CARES Act ,
Coronavirus/COVID-19 ,
Criminal Investigations ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Long Term Care Facilities ,
Medical Devices ,
Medicare ,
Medicare Advantage Organizations (MAOs) ,
Nurses ,
Nursing Homes ,
OIG ,
Opioid ,
Pharmaceutical Industry ,
Pharmacist ,
Physicians ,
Qui Tam ,
Settlement Agreements ,
Stark Law ,
Telemedicine
On December 4, the U.S. Department of Health and Human Services (HHS) revised its Public Health and Social Services Emergency Fund (Relief Fund) Frequently Asked Questions (FAQs), indicating that providers must return Relief...more
12/9/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Financial Reporting ,
Health Care Providers ,
Healthcare Facilities ,
Hospitals ,
Income Taxes ,
Provider Payments ,
Provider Relief Fund ,
Public Health Emergency ,
Relief Measures ,
Tax Revenues
The COVID-19 pandemic has stressed the M&A market at every stage of the deal-making process – from complicating on-site visits and intensifying the diligence process to introducing valuation gaps (relative to pre-COVID-19...more
12/7/2020
/ Accelerated Payments ,
Buyers ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Economic Injury Disaster Loans ,
Employee Retention ,
False Claims Act (FCA) ,
Families First Coronavirus Response Act (FFCRA) ,
Government Investigations ,
Indemnification ,
Loan Forgiveness ,
Main Street Lending Programs ,
Material Adverse Effects ,
Paycheck Protection Program (PPP) ,
Payroll Taxes ,
Private Equity ,
Provider Relief Fund ,
Representations and Warranties ,
SBA ,
Securities and Exchange Commission (SEC) ,
Sellers ,
SIGPR ,
Tax Credits ,
Tax Deferral
In an unprecedented move touted as necessary to address the COVID-19 testing shortage, the U.S. Department of Health and Human Services (HHS) made a brief statement on August 19 that effectively rescinded the federal Food and...more
9/3/2020
/ CARES Act ,
Clinical Laboratories ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Use Authorization (EUA) ,
Families First Coronavirus Response Act (FFCRA) ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Public Health Emergency ,
Uninsured Patients ,
Virus Testing
The U.S. Department of Health and Human Services (HHS) recently issued new guidance regarding reporting and auditing requirements that may impact providers and suppliers who retain payments received from the Public Health and...more
8/10/2020
/ Audit Policies ,
Children's Health Insurance Program (CHIP) ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Hospitals ,
Medicaid ,
New Guidance ,
Provider Relief Fund ,
Secretary of HHS ,
Skilled Nursing Facility ,
Suppliers
On Tuesday, June 9, the U.S. Department of Health and Human Services (HHS) announced in a press release that it expects to distribute approximately $15 billion from the Public Health and Social Services Emergency Fund (Relief...more
On Friday, May 22, the U.S. Department of Health and Human Services (HHS) issued a press release announcing that it has begun distributing nearly $4.9 billion to skilled nursing facilities (SNFs) to “support nursing homes...more
Following the announcement of additional allocations from the $100 billion Public Health and Social Services Emergency Fund (PHSSEF) under the CARES Act, on April 24, the U.S. Department of Health and Human Services (HHS)...more
On April 21, the U.S. Senate approved an additional $100 billion in funding for the Public Health and Social Services Emergency Fund established under the CARES Act, including $75 billion for eligible healthcare providers and...more
On Wednesday, April 22, the U.S. Department of Health and Human Services (HHS) issued a press release announcing additional allocations from the $100 billion Public Health and Social Services Emergency Fund (PHSSEF) for...more
With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable tests to diagnose infection....more
On Friday, April 10, the U.S. Department of Health and Human Services (HHS) issued a press release announcing the immediate delivery of the first $30 billion tranche of the $100 billion Public Health and Social Services...more
In a coordinated effort, CMS and the Office of Inspector General (OIG) published proposed rules to modernize regulations implementing the federal physician-self referral law, commonly referred to as the “Stark Law” (Stark),...more
10/30/2019
/ Anti-Kickback Statute ,
Beneficiary Inducement ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Comment Period ,
Department of Health and Human Services (HHS) ,
EHR ,
Health Care Providers ,
OIG ,
Proposed Rules ,
Public Comment ,
Safe Harbors ,
Stark Law ,
Value-Based Care
While the industry awaits more sweeping value-based related changes to the Stark Law regulations, on July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) took a small step toward updating its Stark Law advisory...more
8/6/2019
/ Advisory Opinions ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Certification Requirements ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Fees ,
Health Care Providers ,
OIG ,
Physician Fee Schedule ,
Physicians ,
Proposed Rules ,
Public Comment ,
Request For Information ,
Stark Law
In a bipartisan effort to combat the opioid crisis, H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the Act), was enacted on October 24,...more
11/16/2018
/ Controlled Substances ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
Drug & Alcohol Abuse ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medicaid Expansion ,
Medicare ,
Opioid ,
Pain Management ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Public Health ,
Substance Abuse ,
Telehealth ,
Telemedicine ,
Unfair or Deceptive Trade Practices