Perspectives on Health Care

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. 

Health Care partner Linda Baumann was heavily quoted in several Bloomberg BNA publications on the outlook for health care fraud and abuse enforcement in 2017.

Arent Fox LLP is pleased to announce the election of five new partners and two new counsel, effective January 1, 2017.

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.

On December 6, 2016, the Supreme Court determined in State Farm Fire & Casualty Co. v. United States ex rel. Rigsby that violation of the statutorily mandated seal requirement, 31 U.S.C. § 3730(b)(2), in a qui tam False Claims Act case does not automatically require dismissal,

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. 

Former Representative (R-PA) and Arent Fox Senior Government Relations Advisor Phil English was quoted in the article “Trump Win Gives China Keys to Asian Economic Integration” in the Financial Times.

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. 

Health Care partner Linda Baumann was quoted in the article “Medicare to Closely Review Nursing Home, Psychiatric Payments” in Bloomberg BNA’s Health Care Daily Report.

From large corporations to small nonprofits, from urban centers to rural communities, the 2016 elections will have an impact across all sectors of the economy and globally as well.

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.

Twenty Arent Fox LLP practices have been recognized in the 2016 “Best Law Firms” rankings that are published annually by U.S. News & World Report and Best Lawyers.

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).

In Compliance Today, Arent Fox Health Care partner and leader of the DC practice Linda Baumann and Health Care associates Samuel Cohen and Hillary Stemple discuss the updated criteria that the US Department of Health and Human Services Office of Inspector General (OIG).

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.

Republicans from the Senate Finance Committee and House Energy and Commerce Commitee issued two letters this month to the Health and Human Services Office of Inspector General (HHS OIG) to review EpiPen’s status within the Medicaid drug rebate program.