Health Law Observer

Timely insights and legal commentary on various health care issues and developments surrounding regulations, employment, transactions and a range of key industry matters. This blog is maintained by the Health Care Department of Stevens & Lee.

Health care law

HHS Proposes Setting Expiration Dates on Regulations Not Periodically Reviewed

The proposed rule has been referred to by HHS Chief of Staff, Brian Harrison, as “the boldest and most significant regulatory reform effort ever undertaken by HHS.”
Implications of Federal Court’s Ruling

HHS ONC Extends 21st Century Cures Act Final Rule Compliance Dates

The new timeline is in recognition of ongoing efforts to address the effects of the COVID-19 pandemic.
Folder with tab that says confidential

The Broad Application of 4 Pa. Code 255.5 Regarding Confidentiality of Substance Use Disorder Records

When reviewing any issue in PA involving the disclosure of SUD information, it’s important to remember the broad application (through reference) of Section 255.5.
man talking to doctor on phone video chat

DOJ Charges Emphasize Importance of Telemedicine Provider Compliance

The enormous surge in the use of telemedicine as a result of the COVID-19 pandemic has also resulted in increased attention by federal regulators to potential fraud and abuse schemes by telemedicine providers.
doctor in goggles and mask

Some Tax-Free Ways to Provide Pandemic Relief to Employees

Given the very trying times due to the COVID-19 pandemic, many employers are looking for ways to provide financial relief to their employees in a tax-advantaged manner.
dollar bill with hole in the middle that says medicare

Stopgap Funding Provides Welcome Relief on Medicare Loans

Health care providers who obtained Medicare Accelerated and Advance Payment Program (“MAAPP”) loans received welcome relief from the Continuing Appropriations Act, 2021 and Other Extensions Act.
photo of microphones in a room

Delaware Department of Health and Social Services 2020 Strategic Plan

On July 16, 2020, the Delaware Department of Health and Social Services issued its Strategic Plan, which focuses on efficiency and accountability reflecting the priorities of Governor John Carney’s Government Efficiency and Accountability Review Board.
A puzzle with the word policies update in the middle

HIPAA Enforcement Updates

Health care providers should take heed of the message and the guidance HHS/OCR and the ONC have made available to ensure that the necessary HIPAA Privacy and Security Rule measures are in place.
non compete agreement with blank signature line

Pennsylvania Bill Prohibiting Enforcement of Health Care Non-Competes Referred to House Health Committee

If history repeats itself, this bill won’t likely get much traction, but on September 15, 2020, the Pennsylvania House of Representatives, Committee on Professional Licensure, recommended that House Bill 2636 be referred to the House Health Committee.
doctor office waiting room

Before You Sell Your Medical Practice …

There are myriad questions that arise when a physician considers selling out. And there are lots of reasons to sell. But, before moving forward, physicians should consider the following.
doctor holding swab and testing tube

CMS Issues Interim Final Rule with Comment Period for COVID-19 Reporting, Testing and Enforcement  

On September 2, 2020, CMS issued an interim final rule with comment period enacting regulations related to, among other things, COVID-19 reporting and testing by Medicare and Medicaid health care providers and related enforcement of those requirements.
Doctor holding an hourglass

Deadline Approaching for 21st Century Cures Act Interoperability and Information Blocking Regulatory Compliance by Health Care Providers

November 2, 2020 is the deadline by when certain provisions of the 21st Century Cures Act implementing regulations come into effect.
Judge's gavel with clock and calendar on table

Stark Law Overhaul Delayed

On August 27, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it was extending the timeline for finalizing its proposed changes to the Stark Law until August 31, 2021.
photo of walkway and a wheelchair

CMS Maintains Focus on Nursing Home Infection Control Practices with Bulletin Encouraging Use of Flexibility to Increase Medicaid Reimbursement Rates

The CIB is the latest in CMS’s continued focus on safeguarding nursing home residents from the ongoing COVID-19 public health emergency.
gavel and stethoscope

Don’t Forget About the Stark Law Fair Market Value Exception

Essentially, the FMV Exception requirements are the basic Stark Law elements without any “extras” added.
covid-19 families first coronavirus response act

Federal District Court Vacates DOL’s Overly Broad Definition of Health Care Provider in FFCRA Regulations

On August 3, 2020, a Federal District Court in New York struck down certain aspects of the regulations issued by the U.S. Department of Labor implementing the Families First Coronavirus Response Act.
Practical Guidance for Health Care

PA State Senate Considers Liability Protection Bill for Health Care Providers, PPE Manufacturers and Certain Employers

On July 27, 2020, Pennsylvania State Senator Lisa Baker (R, Dist. 20) introduced Senate Bill 1239, which the Pennsylvania State Senate referred to its Senate Judiciary Committee.
Books, Gavel, healthcare law

Will Pandemic Stimulus Payments Result in Whistleblower Lawsuits?

The False Claims Act allows whistleblowers to pursue cases even if the Justice Department decides not to intervene.
columns of historic building

Legislature to Provide COVID-related Financial Relief to Nonprofits

. The new law allows nonprofits to increase the rate at which they spend their endowments for three years, and allows them and their donors to relieve restrictions on gifts indefinitely.
FMLA Forms

DOL Publishes New FMLA Forms – Solicits Input on FMLA

The new forms can be used to comply with the many technical nuances of the FMLA. As with the prior versions, the DOL forms are voluntary.
Healthcare Worker with PPE

Pennsylvania Makes Grants Available to Provide Additional “Hazard” Pay to Employees in Certain Life-Sustaining Occupations

Using funds provided under the federal CARES Act, the Pennsylvania Department of Community and Economic Development has announced a "COVID-19 PA Hazard Pay Grant Program."
covid 19 virus

Delaware and COVID-19: The Effect and Response

The state’s response to the COVID‑19 pandemic appears to have been timely and largely effective.
two cities as puzzle pieces merging together

Federal Antitrust Agencies Release Vertical Merger Guidelines

The new guidelines outline how the Agencies will evaluate whether vertical mergers violate the federal antitrust laws and replace the DOJ’s 1984 Non-Horizontal Merger Guidelines.
Hospital bed in home with wheelchair

Temporary Medicare Billing of Outpatient Hospital Services in the Patient’s Home

On June 19, 2020, CMS issued additional FAQs to clarify the process for billing outpatient hospital services provided by hospital clinical staff in the patient’s home using telecommunication technology during the COVID-19 public health emergency.
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