Health Care Counsel Blog

On January 20, 2017, President Trump’s Chief of Staff, Reince Priebus, issued a memorandum implementing an immediate regulatory freeze of any new or pending regulations until they have been reviewed and approved by Trump Administration appointees.

Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.

What is most notable about this guidance is that FDA has taken the position that this type of information may be shared before a product has been approved. 

This is HHS’ first enforcement action against a covered entity that reported a breach, but did not do so timely.

The Health Resources and Services Administration, part of the Department of Health and Human Services, published a Final Rule on January 5, 2017 addressing how 340B covered outpatient drug “Ceiling Prices” are to be calculated under the 340B Drug Pricing Program.

Please join Arent Fox on Friday, February 3 from 7:00 AM – 5:00 PM Pacific for our annual Medical Staff Leaders and the Law Conference being held at the Avenue of the Arts Hotel in Costa Mesa. 

Just before Christmas, The Joint Commission (TJC) published an update clarifying its previous guidance regarding practitioners’ use of text messaging. TJC now says that practitioners may communicate with each other via secure text messaging systems.

The change to the definition provides for exceptions to the prohibition of the offer or transfer of certain Medicare beneficiary inducements tied to their choice of provider for covered health care items or services. 

The US Attorney’s Office for the District of New Jersey recently announced an agreement with BioTelemetry Inc. to settle allegations that its recently-acquired subsidiary, MedNet, Inc., violated the Anti-Kickback Statue and False Claims Act by improperly inducing health care providers to use the com

The Department of Health and Human Services Office of Inspector General recently published its 2017 Work Plan, which furnishes key guidance to providers and suppliers and others doing business in the health care industry on the agency’s enforcement priorities for the upcoming year.

Last week, FDA issued a final version of Guidance for Industry, Contract Manufacturing Arrangements for Drugs: Quality Agreements.

The standard, which was sponsored by several labor unions, will require covered healthcare providers to develop workplace violence prevention plans, training programs, and recordkeeping procedures to track certain incidents of workplace violence. 

On November 17, FDA announced that it had revised, and finalized in part, Guidance for Industry, Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments. 

On November 1, 2016, the Supreme Court heard argument in a False Claims Act case in which the defendant sought dismissal of a qui tam action after the whistleblower violated the FCA’s seal requirement and publicly disclosed the complaint.

Recently, the Health Resources and Services Administration released a new addendum to amend the existing Pharmaceutical Pricing Agreements that drug manufacturers participating in the 340B Drug Pricing Program must have in place with the Secretary of Health and Human Services.

In addition to federal regulations affecting healthcare providers, many states, including California, have laws prohibiting the abuse of elderly individuals, as well as dependent adults.

Mylan recently announced a $465 million settlement with the US Department of Justice and other government agencies regarding the company’s covered outpatient drug (COD) classification of its EpiPen (and EpiPen, Jr.), an epinephrine auto-injector, under the Medicaid Drug Rebate Program (MDRP).

Kindred Healthcare, Inc., the country’s largest provider of post-acute care, recently paid over $3 million for violating its Corporate Integrity Agreement, the largest issued for a violation of a CIA to date.

In a ruling that could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability, on August 23, 2016, Judge Rya Zobel in the United States District Court for the District of Massachusetts denied Omnicare, Inc.’s motion for summary judgment.

Vermont has published the first list of pharmaceutical products for which manufacturers are required to submit annual price transparency reports.

Life science companies, health care providers, and government contractors will be at risk for significantly larger penalties due to substantial increases to False Claims Act (FCA) penalties and civil monetary penalties (CMPs).

This survey focuses on the data breach notification statutes of the states and territories within the US, and should be a useful tool and guide for data security planning and response purposes.

Earlier this month, the California Board of Registered Nursing (BRN) proposed significant changes to regulations affecting nurse practitioners (NP) practicing in the state.