In 2016, states began passing pharmaceutical price reporting laws. These laws are designed to bring transparency to a pharmaceutical manufacturer’s drug pricing process by requiring drug manufacturers to report pricing and...more
On October 1, 2021, Nevada became the latest of a small but growing number of states extending regulatory oversight of healthcare transactions involving physician practices. Over the past decade, several states have passed or...more
10/5/2021
/ Acquisitions ,
Attorney General ,
Department of Health and Human Services (HHS) ,
Filing Requirements ,
Health Care Providers ,
Hospitals ,
Joint Venture ,
Mergers ,
Notification Requirements ,
Physicians ,
Regulatory Oversight ,
Reporting Requirements
The use of telehealth continues to grow rapidly across the U.S. Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely...more
9/13/2021
/ Artificial Intelligence ,
Business Associates ,
Business Associates Agreement (BAA) ,
Corporate Practice of Medicine ,
Data Privacy ,
Data Protection ,
Data Security ,
Disparate Impact ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Machine Learning ,
Medical Malpractice ,
PHI ,
Physicians ,
Professional Liability ,
Telehealth
The Centers for Medicare & Medicaid Services (CMS) released its proposed 2022 Physician Fee Schedule rule (Proposed Rule) on July 13, 2021. Included in the rule are several proposed updates to the CMS Open Payments Program,...more
7/28/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Delays ,
Health Care Providers ,
Open Payments ,
Ownership Interest ,
Physician Fee Schedule ,
Physician-Owned Distributors ,
Physicians ,
Proposed Rules ,
Public Comment ,
Short-Term Loans ,
Sunshine Act ,
Teaching Hospitals
On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets,...more
7/14/2021
/ Biden Administration ,
Biosimilars ,
Competition ,
Drug Pricing ,
Executive Orders ,
Generic Drugs ,
Health Care Providers ,
Health Insurance ,
Healthcare Reform ,
Hospitals ,
Industry Consolidation ,
Life Sciences ,
Medical Equipment ,
Mergers ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Price Transparency
The U.S. Congress passed the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (“Ryan Haight Act”) because of “the increasing use of prescription controlled substances by adolescents and others for non-medical...more
On December 27, 2020, former President Trump signed the Consolidated Appropriations Act, 2021 (H.R. 133) (the “Consolidated Appropriations Act”), an appropriations and stimulus package that includes changes to the Public...more
The U.S. Department of Health & Human Services, Centers for Medicare and Medicaid Services’ Hospitals Without Walls Program (the “Program”) may be more crucial to helping hospitals handle the latest surge in COVID-19 cases...more
On Wednesday, September 30, 2020, the Department of Justice (DOJ), along with the Federal Bureau of Investigation (FBI), Department of Health and Human Services Office of Inspector General (HHS-OIG), and the Drug Enforcement...more
The U.S. Department of Health and Human Services (HHS) announced last week that, on Thursday, October 5, it would begin to accept applications for an additional $20 billion in funding to reimburse providers for...more
On April 24, 2020, President Trump signed the U.S. Paycheck Protection Program and Health Care Enhancement Act (PPP Enhancement Act), approving an additional $100 billion for the Public Health and Social Services Emergency...more
In the first case of its kind, the Antitrust Division of the U.S. Department of Justice (“DOJ”) announced that it had entered into a deferred prosecution agreement (DPA) with Florida Cancer Specialists & Research Institute...more
5/1/2020
/ Anticompetitive Agreements ,
Antitrust Investigations ,
Antitrust Violations ,
Criminal Conspiracy ,
Criminal Investigations ,
Criminal Penalties ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Disgorgement ,
Health Care Providers ,
Market Allocation Scheme ,
Popular
As discussed in Goodwin’s prior Client Alert, on April 10, 2020, the U.S. Department of Health and Human Services (HHS) began disbursing $30 billion to Medicare providers and suppliers under the Public Health and Social...more
On Friday, April 10, 2020, the U.S. Department of Health and Human Services (HHS) announced it will begin disbursing $30 billion of the $100 billion of the Public Health and Social Services Emergency Fund recently allocated...more
4/14/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Fee-for-Service ,
Financial Stimulus ,
Health Care Providers ,
Healthcare Facilities ,
Medicare ,
Public Health ,
Reimbursements ,
Relief Measures
In response to the COVID-19 public health emergency, the Centers for Medicare & Medicaid Services (CMS) announced on Saturday March 28, 2020, that it is expanding its Medicare Accelerated and Advance Payment Program (AAPP) to...more
4/7/2020
/ Accelerated Payments ,
CARES Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Health Care Providers ,
Hospitals ,
Medicare ,
Medicare Part A ,
Medicare Part D ,
Physician Medicare Reimbursements ,
Physicians ,
Relief Measures
On Friday, March 27, 2020, President Trump signed the “Coronavirus Aid, Relief, and Economic Security Act” or “CARES Act” (H.R. 748), which will make available to small businesses $349 billion in “paycheck protection loans”...more