Look Before You Leap – Early Determination Of Product Classification And Regulatory Pathway For FDA-Regulated Products

Originally published in Healthcare Michigan, Volume 41,  No. 4 The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary products, and cosmetics. Although these various product categories may appear to be clearly cut, the fact of the matter is that a product can very easily cross …

Providers Face Government Scrutiny Over COVID Coverage For Uninsured

Originally published in Healthcare Michigan, Volume 41,  No. 3 The Families First Coronavirus Response Act (FFCRA) was enacted in March 2020 as part of the government’s response to the COVID-19 pandemic. The FFCRA, among other things, provided funds for diagnostic testing and services for people without insurance for COVID-19. These funds were distributed through the …

NY Doctor Indicted for Medicare Fraud Related to Genetic Testing and Equipment

The government is continuing to take a close look at laboratory testing in the wake of the COVID-19 pandemic. On February 21, 2024, a federal grand jury in New Jersey issued a superseding indictment against a New York physician. The indictment claims the physician committed healthcare fraud and conspired to defraud the United States by …

How Did They Get My Protected Health Information?

It is no secret that protected health information (or “PHI”) is more and more at risk for cybersecurity attacks. In 2022 (the most recent year this statistic is available), the Department for Health and Human Services Office for Civil Rights (“OCR”) received over 30,000 new complaints alleging violations of HIPAA and, in addition to other …

Telehealth Update: Controlled Substances & E/M Claims

Prior to the COVID-19 public health emergency (“PHE”), the federal Ryan Haight Act allowed a provider to prescribe controlled substance medications to a patient only after conducting an in-person evaluation of that patient (with limited exceptions). At the beginning of the PHE, the Drug Enforcement Agency (“DEA”) granted temporary exceptions to the in-person requirement and …

6 Key Steps to Respond to a Health Care Investigation (and Related Issues)

Originally published in Healthcare Michigan, Volume 41,  No. 2 The United States Department of Justice (“DOJ”) and state law enforcement agencies have robust teams investigating and prosecuting health care fraud. Law enforcement often uses advanced data analytics and algorithmic methods to identify newly emerging health care fraud schemes. DOJ also employs nine regional strike forces located …

A State-Based Cure – Interested Government Agency J-1 Waivers for Physicians

Originally published in Healthcare Michigan, Volume 41,  No. 1 Recently, the president of the American Medical Association, Jesse M. Ehrenfeld, MD, stated in a national address that the physician shortage long-feared is here and that “It’s an urgent crisis…hitting every corner of this country—urban and rural—with the most direct impacting hitting families with high needs and limited …

Top Issues in Negotiating Physician Employment Agreements

Originally published in Healthcare Michigan, Volume 40,  No. 12 Successful negotiation of physician employment agreements requires a careful balance of the objectives of the prospective employer with those of the prospective employee while ensuring that the negotiated agreement complies with the federal and state laws that apply to agreements of this type.  The prospective employer wants …

Major Nursing Shortages? Foreign National Nursing Intervention as a Plan of Care.

Originally published in Healthcare Michigan, Volume 40,  No. 11 The nursing profession’s vital signs are unstable and require an intervention. The single largest occupation of health care workers is Registered Nurses (RN). It is also the fifth largest profession nationally.[1] Yet the nursing profession is facing extreme shortages as the need for health care workers grows. Specifically, …

Value-Based Care Ushers in a New Era for Primary Care Providers

Originally published in Healthcare Michigan, Volume 40,  No. 10 In an age of highly polarized opinions, there is a common consensus to address the rapidly rising health care costs in the United States. Research shows that the US average gross national product for health care costs is 17.1% while the rest of the world average is …