Sheppard Mullin

Subscribe to Sheppard Mullin's Posts
Contact:Read more about Sheppard Mullin

On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) finalized policies that “aim to increase choice, lower patients’ out-of-pocket costs, empower patients, and protect taxpayer dollars” with changes to the Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and the Ambulatory Surgical Center (“ASC”) Payment System in the Medicare OPPS and ASC Final Rule (“Final Rule”). These changes include: elimination of the “Inpatient Only List” and additions and revisions to the “ASC Covered Procedures List” – two key areas of “site neutrality”. Site neutrality is a move to diminish or eliminate the reimbursement differences between different sites of service.
Continue Reading Forthcoming Medicare Rule Furthers Push for Site Neutrality

On October 6, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released guidance regarding the requirements and enforcement process for hospital reporting of COVID-19 data elements (the “Guidance”). The Guidance follows the September 2, 2020 Interim Final Rule, which included new requirements for Medicare and Medicaid participating hospitals and critical access hospitals (“CAHs”) to report data that allows CMS “to monitor whether individual hospitals and CAHs are appropriately tracking, responding to, and mitigating the spread and impact of COVID-19 on patients, the staff who care for them, and the general public.”
Continue Reading Clarity on Reporting and Enforcement: CMS Issues Guidance Regarding Hospital COVID-19 Reporting Requirements

In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts patients’ and is being ‘abused’ by hospitals. Its defenders say it’s ‘vital’ to the health of low-income patients and essential to helping safety net hospitals care for their communities.”
Continue Reading Maneuvers on the 340B Drug Pricing Program Battlefield: Duplicate Discounts and Contract Pharmacies

As noted in our March 31, 2020 blog article, “Strategies in Responding to COVID-19: Expanding Scope of Practice to Increase Patient Access to Healthcare” and in our May 8, 2020 blog article, “COVID-19: Medical Liability for Expanded Scope of Services,” the COVID-19 pandemic has revealed limitations in the healthcare system that have impeded access to medical care, often for rural, low-income, and minority communities. In order to increase healthcare access, many states and the federal government have worked to (i) expand the scope of practice for different types of non-physician practitioners (“NPPs”) to provide a wider range of healthcare services; (ii) eliminate or relax physician supervision requirements so that NPPs can practice independently without having to rely on physicians who are, themselves, scarce healthcare resources; and (iii) insulate NPPs from liability for the provision of those healthcare services that fall outside of their traditional scopes of practice.
Continue Reading The Scope-of-Practice Debate Takes Center Stage: The 2021 Medicare Inpatient Rehabilitation Facility Prospective Payment System Final Rule

On Wednesday, April 9, 2020, the Centers for Medicare and Medicaid Services (“CMS”) hosted a call entitled “COVID-19 with Nursing Homes.” CMS leadership aimed to provide updates on the agency’s latest guidance, joined by leaders in the field interested in sharing best practices with their peers.
Continue Reading CMS Addresses Nursing Home and Long-Term Care Providers Amidst COVID-19 Pandemic: Best Practices and What’s to Come

As the COVID-19 pandemic continues and our health system is pushed to and beyond capacity, lawmakers and stakeholders are assessing different ways to handle the incredible volume of patients suddenly needing care. One approach being examined, largely at the state level although supported at the federal level, is expanding the scope of practice for different types of individual health care providers.
Continue Reading Strategies in Responding to COVID-19: Expanding Scope of Practice to Increase Patient Access to Healthcare

The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week.  The first authorization was issued to Roche Molecular Systems, Inc., for its cobas SARS-CoV-2 Test, and the second issued the following day to Thermo Fisher Scientific, Inc., for its TaqPath COVID-19 Combo Kit.  Both tests are for the qualitative detection of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). FDA granted the authorizations within 24 hours of receiving the requests.
Continue Reading FDA Grants COVID-19 Diagnostic Emergency Use Authorizations, And Other Recent FDA Actions to Address COVID-19

The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning enabled medical devices. FDA continued to take action to lower drug prices by focusing on approvals of competitive biosimilars and generic drugs, and FDA enforcement actions signaled the Agency’s ongoing interest in ensuring GMP compliance overseas.
Continue Reading FDA Year in Review: A Shifting Regulatory Landscape