Author: Ross C. D'Emanuele

Ross C. D'Emanuele

Ross works in the health care provider, payor, and drug and medical device segments of the health care industry. His areas of expertise include health care fraud and abuse, Stark and anti-kickback laws, HIPAA and other privacy and security laws, reimbursement rules and appeals, clinical trial agreements and regulation, FDA regulation, open payments and state "Sunshine Act" laws, accountable care organizations, value-based reimbursement, and telemedicine.

False Claims Act Exposure for Beneficiaries of the Public Health and Social Services Emergency Relief Fund: Mitigating Risks of Ambiguous Terms & Conditions

Ross C. D'Emanuele

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Andrew Brantingham, Ross C....

Privacy of Substance Use Disorder Records and The CARES Act: Steps Toward Harmonizing Part 2 Privacy Laws with HIPAA

Ross C. D'Emanuele

The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) is generally known for providing relief funds and other resources to help individuals, small businesses, state and local governments, and hospitals and healthcare providers address the COVID-19 public health emergency.  However, among the lesser-known of the CARES Act provisions are changes to federal...

HHS Releases Notices of $30 Billion to Healthcare Providers and Suppliers

Ross C. D'Emanuele

On Mach 27, 2020, President Trump signed the CARES Act, providing in part for $100 billion in relief funds to eligible health care providers and suppliers affected by COVID-19.  The funding is intended to support healthcare-related expenses, including lost revenue, attributable to the pandemic. Many providers and suppliers received notice on Friday, April 10 that...

Medicare Payment Rules Changed to Allow Broad Use of Remote Communications Technology

Ross C. D'Emanuele

On Monday, April 6th the Centers for Medicare and Medicaid Services (“CMS”) adopted an interim final rule to change a wide range of Medicare payment policies during the COVID-19 public health emergency so that Medicare providers and suppliers have flexibility to furnish services to beneficiaries using remote communications technology. As healthcare providers implement infection prevention...

New CMS COVID-19 Blanket Waivers for Health Care Providers

Ross C. D'Emanuele

On March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a compilation of COVID-19 Emergency Declaration Blanket Waivers for Health Care Providers (each, a “Blanket Waiver”). Section 1135 of the Social Security Act gives CMS the authority to issue waivers that ease requirements for providers affected by an emergency if: (1) the...

Accelerated and Advance Payments: Financial Relief for Medicare Participating Providers & Suppliers – A COVID-Prompted CMS Announcement

Ross C. D'Emanuele

With the aim of enabling providers to focus attention and resources on fighting the COVID1-19 pandemic, CMS announced over the weekend that it intends to alleviate some of Medicare participating providers’ and suppliers’ financial burden by expanding its Medicare accelerated and advance payment (AAP) program to a broader group of Medicare Part A providers and...

CARES Act Summary of Provisions that Support America’s Health Care System

Ross C. D'Emanuele

On March 27, 2020, the President signed into law the “Coronavirus Aid, Relief, and Economic Security Act’’ (“CARES Act”). The CARES Act is the third phase of the federal government’s response to the coronavirus following two other laws to support American families and address health sector needs that were approved on March 6, 2020 (Phase...

Clinical Trials During the COVID-19 Pandemic

Ross C. D'Emanuele

In light of the COVID-19 pandemic, the Food and Drug Administration (“FDA”) issued recent non-binding guidance (“Guidance”) on the conduct of ongoing clinical trials of medical products. The FDA acknowledges that the public health emergency may result in unavoidable protocol modifications and/or deviations. Quarantines, site closures, travel limitations, interruptions in the supply chain for the...

COVID-19 and Cross-State Clinician Licensure: Federal and State Regulations, Revisited, and What To Do About Them

Ross C. D'Emanuele

The COVID-19 pandemic has dramatically increased the number of patients and providers seeking to implement and use telehealth visits and other digital health solutions – and rapidly, at that.  The challenge of implementing digital health solutions, particularly telehealth, has historically been the patchwork setup of both federal and various state regulations that made it difficult...