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Keeping you afloat amidst the rising sea of regulations

How FDA’s Program Alignment Initiative Will Impact Industries: An Insider’s Perspective

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. The reorganization, termed “Program Alignment,” reassigns field staff based on product type rather than geographic regions. Under the new organizational model, inspection and compliance staff in FDA’s Office of Regulatory Affairs will specialize in the five commodities and two enforcement areas:

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.

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.

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.  

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. 

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.

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.

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. 

New Director, Same Direction for OCR HIPAA Enforcement

What’s New? 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.