Health Law Monitor

HHS Office of Inspector General Issues Special Fraud Alert Regarding Pharmaceutical and Medical Device Company Speaker Programs

November 19, 2020

On November 16, 2020, the HHS Office of Inspector General (“OIG”) issued a special fraud alert regarding “the offer, payment, solicitation, or receipt of remuneration” relating to speaker programs for pharmaceutical and medical device companies. 

The targeted speaking engagements involve programs presented by physicians or other healthcare provider, who are not employed by the company, and the…

SHOW ME THE DATA: ONC COMPLIANCE DEADLINE EXTENDED

November 19, 2020

The Office of the National Coordinator extended compliance deadlines to its 21st Century Cures Act: Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”). This extension postpones compliance requirements for the Information Blocking provisions that were set to go into effect November 2, 2020 until April 5, 2021. Clearly this provides…

Are you Ready for It? ONC Information Blocking Rule Compliance Deadline is Fast Approaching

September 17, 2020

The time is now for compliance teams to review their systems, policies, and procedures to ensure they are ready to comply with the Final Rule on Information Blocking (the “Final Rule”)¹ issued by the Office of the National Coordinator for Health Information Technology (ONC) in March of this year. The Final Rule stems from the 21st Century Cures Act (the “Cures Act”),²  which was passed by…

WEST VIRGINIA LEGISLATURE REQUIRES PEIA TO COVER TELEHEALTH SERVICES

July 1, 2020

On June 5, 2020, a new statute covering telehealth services under the West Virginia Public Employees Insurance Act (“PEIA”) went into effect.¹ This statute endeavors to formulate definitions regarding telehealth while also setting forth what telehealth services PEIA must cover.² According to the statute, a distant site is defined as “the telehealth site where the health care practitioner is…

Deregulation = More Flexibility for Hospital Boards

June 15, 2020

West Virginia non-profit hospitals and hospitals owned by local governments are no longer required by law to comply with strict board composition requirements. West Virginia Code Section 16-5B-6A required hospitals to maintain at least forty percent of its directors in an equal proportion of four consumer representative categories – small business, organized labor, elderly persons, and lower…

Reminder for Health Care Providers: Communicate and Document to Help Avoid Litigation

May 27, 2020

As we begin to “reopen” following the initial assault from COVID-19, health care providers continue to adjust to the “new normal” of practicing medicine during an ongoing pandemic. Amid discussions of personal protective equipment, installation of plexiglass waiting room enclosures and increased testing availability, it is important to remember some basics to help avoid litigation. For health…

CMS Promotes Expansion of Telehealth to Fight COVID-19

April 7, 2020

Healthcare providers fight the COVID-19 public health crisis on the front lines and at the same time must be able to adapt and use telehealth technology to not only protect their patients, but to also protect their employees, staff, themselves and their families.

Congress recognizing this crucial predicament, passed the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), which…

ONC Report on Policy Gaps for Privacy and Security of mHealth Data

August 31, 2016

In July, the Office of the National Coordinator for Health Information Technology (“ONC”) released a report that examines the oversight of the privacy and security of health data collected by entities not regulated by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The report primarily focuses on two areas of emerging technologies provided by entities that are not…

West Virginia Supreme Court Clarifies Statutory Peer Review Privilege

February 17, 2016

On February 9, 2016, the West Virginia Supreme Court (“Supreme Court”) decided State ex rel. Wheeling Hospital, Inc. v. Wilson, No. 15-0558 (W. Va. February 9, 2016), which took up the issue of the Peer Review Privilege codified at W. Va. Code § 30-3C-1 et seq.  In clarifying the meaning of the language contained in West Virginia’s Peer Review Statute, the Supreme Court recognized “an urgent need…

EPA Proposes New Rule Governing The Disposal Of Hazardous Waste Pharmaceuticals At Healthcare Facilities

September 29, 2015

Introduction

On September 25, 2015, the United States Environmental Protection Agency (“EPA”) proposed a rule to address the management and disposal of hazardous waste pharmaceuticals at healthcare facilities. The proposed rule seeks to do the following:

• Ban all drain disposal of hazardous waste pharmaceuticals at hospitals, pharmacies, clinics, dentists, and long-term care facilities
• Clarify that…

IRS Releases Guidance For Charitable Hospital Organizations and ACA-Mandated Financial Assistance Policies

July 1, 2015

This month, the IRS released Notice 2015-46, which provides further guidance for charitable hospitals to comply with Treasury Regulation (“Treas. Reg.”) § 1.501(r)-4(b)(1)(iii)(F), which requires that a hospital facility include a provider list in its financial assistance policy (“FAP”) in order to maintain its tax-exempt status. Section 501(r)(1) of the Internal Revenue Code provides that a…

SCOTUS Rules In Favor Of ACA

June 25, 2015

In the landmark case of King v. Burwell, the United States Supreme Court has upheld the ability of federally-run insurance exchanges to offer federal subsidy monies to Americans seeking health coverage under the Affordable Care Act. The vote was 6-3, with Justices Alito, Scalia, and Thomas dissenting. Justice Kennedy joined Chief Justice Roberts and the majority from the National Federation of…