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
Widespread testing of patients and the public for COVID-19 exposure appears to be the key to reopening society sooner rather than later. Current estimates suggest that clinical laboratories across the United States have...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
At the White House Coronavirus Task Force press briefing on April 7, Seema Verma, the Administrator of the Centers for Medicare and Medicaid Services (CMS), announced that this week CMS will begin distributing $30 billion of...more
Financial Relief for Healthcare Providers -
The CARES Act provides financial relief to healthcare providers that are being hit hard by the COVID-19 public health emergency. Perhaps most notably, the CARES Act establishes a...more
On Wednesday, March 18, 2020, President Trump signed into law the Families First Coronavirus Response Act (FFCRA) which allocates billions of dollars to aid Americans impacted by the novel coronavirus disease (COVID-19)...more
As the number of confirmed cases of the novel coronavirus disease (COVID-19) continues to tick upward in the United States, administrative agencies are taking steps on a national scale to ensure that adequate healthcare items...more
3/23/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Emergency Response ,
EMTALA ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Infectious Diseases ,
Medicaid ,
Medicare ,
Public Health ,
Relief Measures ,
State of Emergency ,
Waivers
On March 13, 2020, President Trump issued a formal Declaration of a National Emergency as of March 1, 2020, based on the pandemic of COVID-19. In this Declaration, the president states that “[t]he spread of COVID-19 within...more
As novel coronavirus disease (COVID-19) outbreaks spread across the globe and the number of confirmed cases in the United States rise, healthcare providers nationwide are in the process of preparing for a potential...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
On September 10, 2019, the Centers for Medicare & Medicaid Services (CMS) published a final rule significantly expanding its authority to deny or revoke participation in Medicare, Medicaid or the Children’s Health Insurance...more
9/24/2019
/ Affiliates ,
Bad Actors ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Comment Period ,
Disclosure Requirements ,
Enforcement Authority ,
Enrollment ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Medicaid ,
Medicare ,
New Rules ,
Reporting Requirements
On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) took the first steps toward welcoming opioid treatment programs (OTPs) into the Medicare program and expanding Medicare coverage of opioid use disorder...more
8/14/2019
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Treatment ,
Food and Drug Administration (FDA) ,
HCPCS ,
Medicare Part D ,
Opioid ,
Physician Fee Schedule ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
SAMHSA
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 the wave of physician practice management transactions, urology is poised to be one of the next hot sectors. In addition to the issues to consider in connection with any physician practice transaction, below we discuss...more
6/26/2019
/ Anti-Kickback Statute ,
False Billing ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Medical Devices ,
Pharmaceutical Industry ,
Physician-Owned Hospitals ,
Physicians ,
Private Equity ,
Safe Harbors ,
Stark Law ,
Value-Based Care
Despite it being a continual topic of discussion, the Food and Drug Administration (FDA) enforcement in the realm of laboratory developed tests (LDTs) has been relatively quiet in recent years. That is, until earlier this...more
4/18/2019
/ Clinical Laboratories ,
Direct to Consumer Sales ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Human Genes ,
Laboratory Developed Tests ,
Life Sciences ,
Marketing ,
Public Health
As part of the 2019 Medicare Physician Fee Schedule Final Rule (Final Rule) published on November 23, 2018, the Centers for Medicare & Medicaid Services (CMS) took significant steps toward modernizing Medicare to expand...more
12/6/2018
/ Bipartisan Budget Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
Medicare ,
Patients ,
Physician Fee Schedule ,
Physician Medicare Reimbursements ,
Physicians ,
Substance Abuse ,
Telehealth
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
August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more
9/7/2018
/ Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
CMMI ,
Comment Period ,
Commercial Reasonableness ,
Cost-Sharing ,
Cybersecurity ,
Data-Sharing ,
Department of Health and Human Services (HHS) ,
EHR ,
Fraud and Abuse ,
Health Care Providers ,
Hospitals ,
Incentives ,
Medicare Shared Savings Program ,
OIG ,
Physicians ,
Public Comment ,
Request For Information ,
Safe Harbors ,
Stark Law ,
Telehealth ,
Value-Based Care ,
Waivers
The popularity of radiology practice consolidation is increasing, in part, due to the same catalysts that have driven other outsourced physician groups to consolidate – (a) the need to achieve scale and leverage in order to...more