Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel
Pharmaceutical & Device Compliance, Prescription Drug Pricing & Government Price Reporting, Wholesaler & Pharmacy Benefits Compliance
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HRSA Delays Effective Date of 340B Final Rule…Again

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.

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E-Health, mHealth, Telemedicine & E-health
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Tally-ho! Flurry of Legislative Activity Signals Ease on Federal Barriers to Telehealth

What’s New?

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. But bipartisan groups of Senators have introduced two bills seeking to expand telehealth services covered by Medicare.

Similarly, bipartisan groups in both the Senate and House introduced bills to eliminate the Department of Veterans Affairs’ restrictions on telehealth across state lines. Introduction of these bills comes just a few months after Congress approved a defense bill making telehealth services available under the US Defense Department’s TRICARE program, the health plan for active duty military members and their families.

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Medical Staff Credentialing & Peer Review Law
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Do Physicians Get Jury Trials in Retaliation Claims?

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

Historically, California physicians facing peer review actions first had to exhaust their administrative remedies before filing a lawsuit related to the action. In 2007, California carved out an exception to this general rule in a revision to California Health & Safety Code § 1278.5. This statute prohibits health care facilities from discriminating or retaliating against employees, health care workers, and medical staff members for raising issues of unsafe patient care and conditions; in 2014, the California Supreme Court found that the statute allows physicians to pursue retaliation claims without first having to exhaust administrative remedies.   

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HIPAA / Health Privacy & Security
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What’s in a Name? A HIPAA Violation: Texas Health System Settles with HHS for $2.4 Million

On May 10, 2017, the US Department of Health & Human Services (HHS) announced a settlement with Texas-based Memorial Hermann Health System (MHHS) for $2.4 million due to MHHS’s unauthorized disclosure of patient protected health information (PHI). HHS also announced that HHS and MHHS entered into a Resolution Agreement, and MHHS agreed to a corrective action plan. 

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E-Health, HIPAA / Health Privacy & Security
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Our Allies Under Attack! Ransomware Hits the Brits and Quickly Spreading Across Globe – Batten Down the Hatches NOW

What’s New?

Earlier today, numerous hospitals operated by Britain’s National Health Service (NHS) suffered a ransomware event in which hospital computer systems were encrypted, phone lines became inoperable, patients were diverted, and a Bitcoin ransom was demanded. Hospitals across Britain shut down their computer systems in order to protect patient data and prevent further spread and advised people to stay home unless there was an emergency. NHS Digital, Britain’s national hospital cybersecurity overseer, stated that 16 NHS organizations across Britain had reported an incident, but that the attack did not appear to be specifically targeting NHS hospitals. At this time, there is no indication that the ransomware has exfiltrated any personal data from the NHS.

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Fraud & Abuse Compliance
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In A Must Read, New OIG Guidance Provides Practical Ways to Evaluate Compliance Program Effectiveness

The Department of Health and Human Services recently issued an important new compliance guide, called Measuring Compliance Program Effectiveness: A Resource Guide. The Guide is a combined effort of HHS’s Office of Inspector General and the Health Care Compliance Association and provides guidance on evaluating compliance program effectiveness based on the input of 40 compliance professionals and OIG staff.

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Stark Law
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Counsel's Corner: Making Stark Self-Disclosures in 2017

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 revised protocol completely replaces the initial version of the protocol that was posted in 2010. Under the Affordable Care Act, providers generally must return overpayments within 60 days after identification (the 60 Day Rule), and the SRDP is the primary tool that providers can use to return overpayments that are solely caused by an actual or potential violation of the Stark law.

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E-Health, mHealth
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FCC Paving the Way for Advancement of Telehealth

What’s New?

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. Initial comments are due on May 24, while reply comments are due June 8 of this year. 

The FCC recognizes that it plays an important role in advancing innovation in health care through its Rural Health Care Program, spectrum licensing, and various broadband infrastructure programs. The FCC also noted that by some estimates, “broadband-enabled health information technology can help to improve the quality of health care and significantly lower health care costs by hundreds of billions of dollars in the coming decades.” 

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Pharmaceutical & Device Compliance
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Chemical & Life Sciences Litigation: Year In Review

As in previous years, 2016 brought us a combination of both expected and unexpected holdings by the Supreme Court and the Federal Circuit.

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ABOUT ARENT FOX LLP

Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.