Articles and Blogs

The Centers for Medicare & Medicaid Services (“CMS”) announced that it will delay enforcement of its final rule (“Final Rule”) requiring physicians and other prescribing health care clinicians to either enroll in or opt out of Medicare in order for the prescriptions they write to be covered by any Medicare Part D prescription drug benefit... READ MORE

The Centers for Medicare & Medicaid Services (“CMS”) recently updated its Voluntary Self-Referral Disclosure Protocol (“SRDP”) when it posted a new form to be used as part of the SRDP process (“SRDP Form”). According to CMS, the SRDP Form is an attempt to “streamline and simplify” the SRDP process. CMS originally proposed the new SRDP... READ MORE

This is the final article in a series covering the behavioral health sections of the 21st Century Cures Act (the “Cures Act”), which was signed into law on December 13, 2016. The articles in our series are located here.  As with many of the behavioral health sections of the Cures Act, Title XIV also provides for... READ MORE

On March 13, 2017, twelve hearing impaired individuals filed suit in federal district court in Arizona against a large health system (the “System”) alleging discrimination under Section 1557 of the Affordable Care Act. In the complaint, the plaintiffs allege that the System discriminated against them by “refusing to provide effective auxiliary aids and services, despite... READ MORE

This is the sixth article in a series on the 21st Century Cures Act (the “Cures Act”), which was signed into law on December 13, 2016. We will continue publishing a series of articles summarizing various components under the Cures Act. The articles in our series are located here.  This article highlights the provisions... READ MORE

On March 27, 2017, the Michigan State Legislature revised the telehealth services regulations that were enacted on December 21, 2016. This revision to MCL 333.16285 goes into effect on March 29, 2017 and will allow health care professionals providing telehealth services to prescribe controlled substances. The original regulations prohibited prescription of controlled substances; however,... READ MORE

On March 15, 2017, the U.S. District Court for the Western District of Pennsylvania provided the first federal court interpretation of the writing requirements affecting several regulatory exceptions in the federal physician self-referral statute (“Stark Law”) and its implementing regulations since the Centers for Medicare & Medicaid Services (“CMS”) provided sweeping revisions and clarifications... READ MORE

On March 27, 2017, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a resource guide to assist health care organizations in assessing the effectiveness of their compliance programs (“Resource Guide”). OIG developed the Resource Guide in collaboration with 30 health care compliance professionals through a collaborative... READ MORE

This is the fifth article in a series on the 21st Century Cures Act (the “Cures Act”), which was signed into law on December 13, 2016. We will continue publishing a series of articles summarizing various components under the Cures Act. The articles in our series are located here. This article highlights the opportunities... READ MORE

On March 20, 2017, the Food and Drug Administration (“FDA”) published a notice in the Federal Register delaying the implementation of the final rule (“Final Rule”) regulating off-label drug promotion until March 19, 2018. The Final Rule was published in the Federal Register of January 9, 2017. The effective date was originally delayed until... READ MORE