Health Care Counsel Blog

Earlier this month, the Health Care Industry Cybersecurity Task Force sent to Congress the Report On Improving Cybersecurity in the Health Care Industry.

Alleged price gouging by drug manufacturers and distributors has been in the news the past several years, causing many lawmakers to threaten to take action. 

The Supreme Court issued a stunning ERISA decision on Monday, overturning the law in the three federal circuits as to what constitutes a “church plan” that is exempt from ERISA’s requirements.

Pursuant to the Bipartisan Budget Act of 2015, manufacturers participating in the Medicaid Drug Rebate Program must pay an Additional Discount on Non-Innovator products to the extent the Average Manufacturer Prices of their products are rising faster than inflation.

Last week, eClinicalWorks (ECW)—an electronic health records (EHR) vendor—settled an intervened False Claims Act case with the Department of Justice for $155 million.

In his first major announcement since taking office, FDA Commissioner Scott Gottlieb, M.D. finalized a major reorganization plan that had been under development since 2013. 

In a notice published in the Federal Register on Friday, May 19, 2017, the Health Resources and Services Administration announced that it would further delay the effective date of a final rule applicable to all drug manufacturers participating in the 340B Drug Pricing Program.

In recent months, a number of bills have been introduced or passed in Congress that would ease federal health care programs’ restrictions on telehealth. Currently, Medicare has strict limitations on telehealth.

A recent California Supreme Court ruling could significantly impact trials of physician “whistleblower” claims under California Health & Safety Code Section 1278.5 – maybe.  

On May 10, 2017, the US Department of Health & Human Services (HHS) announced a settlement with Texas-based Memorial Hermann Health System for $2.4 million due to MHHS’s unauthorized disclosure of patient protected health information.

The Department of Health and Human Services recently issued an important new compliance guide, called Measuring Compliance Program Effectiveness: A Resource Guide.

The Federal Communications Commission recently solicited public comment on how it can better facilitate broadband-enabled health care solutions by adopting new policies or removing existing regulatory barriers.

A recent decision from the Ninth Circuit Court of Appeals in DB Healthcare, LLC v. Blue Cross Blue Shield of Arizona, Inc., No. 14-16518, 2017 WL 1075050 (9th Cir. Mar. 22, 2017) reaffirms that health care providers are not health plan “beneficiaries” with the ability to sue under ERISA.

A recent string of advertising and privacy crackdowns on mobile health apps should have developers on high alert as regulators are scrutinizing advertising statements and privacy policies.

The Confidentiality of Medical Information Act, permits hospitals and other health care providers to disclose medical information without the patient’s consent for the purposes of reviewing the competence or qualifications of health care professionals or health care services.

On March 27, 2017, Rachel Yount attended the Health Care Compliance Association’s Compliance Institute 2017, where Illiana Peters, a senior advisor at Health and Human Services, Office for Civil Rights (“OCR”), provided an “OCR Enforcement Update.”

A recent decision from the Fourth Circuit Court of Appeals in Beck v. McDonald, 848 F.3d 262 (4th Cir. 2017), adds to the list of circuit courts of appeal that have held that that the mere threat of future harm resulting from a data breach, without more, is insufficient to satisfy the injury-in-fact

The HRSA announced that it will delay the effective date of the January 5, 2017 final rule that provided guidance on the calculation of drug ceiling prices and the imposition of civil monetary penalties on certain drug manufacturers participating in the 340B Drug Pricing Program.

National Academies of Sciences, Engineering, and Medicine committee concluded that the bioeconomy is growing rapidly and the US regulatory system needs to provide a balanced approach to the many competing interests.

For the first time in nearly three decades, the Substance Abuse and Mental Health Services Administration (SAMHSA) has updated the regulations on the confidentiality of substance abuse treatment records found in 42 C.F.R. Part 2.

Last month, Baxter International Inc. and Baxter Healthcare Corporation settled a qui tam False Claims Act case with the Department of Justice for $18 million. The settlement is not monumental in terms of the amount, but does highlight the unique theory of FCA liability.

Please join us for a free webinar (noon-1:00 pm PT/3:00-4:00 pm ET) designed to help health care facilities prepare for the new CALOSHA regulation that addresses the threat of workplace violence.