Health Care Counsel Blog

856 total results. Page 14 of 35.

Stephanie Trunk

In a move with far reaching implications for the health care industry, the Department of Health and Human Services (HHS) recently released a proposed rule that would codify into regulation specific requirements that it and its related agencies must follow when issuing guidance to the public or regul

D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

Stephanie Trunk

CMS is soliciting comments on whether future payments for devices that may have been impacted by the COVID-19 PHE should be adjusted.

Sarah G. Benator

Due to the broader spread of COVID-19 in California, the Department of Consumer Affairs (DCA) has extended numerous professional licensing waivers to facilitate the delivery of patient care during the state of emergency.

On August 17, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a Guidance Memorandum (Guidance) setting forth revised state survey agency priorities as well as providing information regarding the resumption of enforcement activities and resolution of open enforcement cases.

On August 17, 2020, CMS encouraged State Survey Agencies to resume some of their normal enforcement activities.

D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Stephanie Trunk, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

After a four-month hold, CMS announced on August 6 that it would resume Medicare Fee-For Service (FFS) medical reviews.

Stephanie Trunk

Members of the industry should be on the lookout for proposed rules related to this Order and take advantage of all public comment periods.

D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

Gerald J. Billow

On July 22, 2020, the Centers for Medicare & Medicaid Services (CMS) announced new initiatives designed to protect nursing home residents from the novel coronavirus (COVID-19).

D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

Stephanie Trunk

The White House released three Executive Orders on July 24, 2020 setting forth policies that the Administration believes will “deliver lower prescription drug prices to American patients.” 

D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

Brian D. Schneider, Caroline Turner English

For health care providers that are out-of-network with a patient’s insurance, navigating reimbursement is a tactical imperative. The current economic environment makes it more difficult for patients to pay coinsurance, while insurers are increasingly motivated to cut expenses.

D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

Anne M. Murphy

As healthcare providers turn their attention to resuming elective surgeries and procedures, it is important that this entry into the “new normal” be undertaken with care. Health care governing boards have an essential fiduciary oversight role in this process.

D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

The California Privacy Rights and Enforcement Act (CPRA) has qualified for the November 3, 2020 ballot, according to a recent update by the California Secretary of State’s office.

D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

Headlines that Matter for Companies and Executives in Regulated Industries

Stephanie Trunk

Pharmaceutical manufacturers and other stakeholders should submit comments on the Proposed Rule by July 20, 2020.

Wayne H. Matelski

The FDA has just issued a Guidance on what it considers to be appropriate Current Good Manufacturing Practices (CGMPs) for Responding to COVID-19 infections in employees in drug and biological manufacturing facilities. 

D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Rebecca W. Foreman, Nadia Patel, Laura Zell

On June 15, 2020, the owner of several information technology companies was charged in a criminal complaint with bank fraud and for making false statements to a financial institution. 

Wayne H. Matelski

FDA’s website allows you to determine if a particular COVID-19 test has been reviewed by the FDA.