Insights on Health Care

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.

Earlier today, numerous hospitals operated by Britain’s National Health Service suffered a ransomware event in which hospital computer systems were encrypted, phone lines became inoperable, patients were diverted, and a Bitcoin ransom was demanded.

Health Care partner Linda Baumann and associates Hillary Stemple and Kathryn Steffen authored an article for Bloomberg BNA’s Health Law Reporter on the revised Voluntary Self-Referral (Stark) Disclosure Protocol, which the Centers for Medicare and Medicaid Services posted on March 28, 2017.

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.

On Monday, the US Department of Health & Human Services’ Office for Civil Rights announced that CardioNet has entered into a $2.5 million HIPAA settlement.

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.

In an effort to streamline the process for self-disclosing Stark Law violations, the government has introduced several new forms that must be used for any disclosure as of June 1, 2017.

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.

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 Forum focused on the consumer implications of artificial intelligence (AI) and blockchain, two rapidly developing technologies.

Join Arent Fox for a free half-day conference dedicated to equipping your medical staff team with the most current skills, tools, and information to navigate challenging issues and provide effective leadership.

Vox recently interviewed Arent Fox Senior Policy Advisor and former Senator Byron Dorgan on how eliminating “lifetime limits” in health insurance policies became a part of the Affordable Care Act.

Responding to requests from the cannabis industry, ASTM International, one of the world’s largest voluntary standards-developing organizations, recently announced plans to develop industry standards that would apply to “the full life cycle of cannabis” and consumable cannabis products.

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.

A recent Bloomberg BNA article in the Health Care Daily Report “Former Tenet Executive Indicted in $400M Medicaid Kickback Scheme” describes an ongoing prosecution against a health care industry ex-executive.

Arent Fox LLP is pleased to announce the return of health care regulatory attorney Rachel Hold-Weiss as a partner in the firm’s New York office.

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.

The recent Bloomberg BNA article in both the Health Care Daily Report and Medicare Report “Health Fraud Rule Withdrawal May Hurt Enforcement Efforts” discussed how fraud enforcement efforts in the health care industry may be hindered by the Trump Administration.