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Homeostasis: Health Care Law Blog

Homeostasis: Health Care Law Blog

Contributors

New COVID-19 Vaccine Requirements for Nursing Homes

On May 13, 2021, the Centers for Medicare and Medicaid Services (“CMS”) published an interim final rule with comment period addressing COVID vaccine education, administration, and reporting requirements for nursing homes. Designed to reduce the spread of COVID-19, the rule updates the existing infection control requirements that nursing homes must meet to participate in the Medicare program, found at 42 C.F.R § 483.80. The effective date for the new rule is May 21, 2021, and Michigan’s state survey and certification staff have advised that they will begin enforcement of the new rule on June 14, 2021. Read More ›

Senate Antitrust Subcommittee Turns the Spotlight on Hospital Consolidation

While much of the antitrust world is focused on the actions brought by federal and state antitrust regulators against “big tech,” the Senate Judiciary Subcommittee on Competition Policy, Antitrust and Consumer Rights recently held a hearing to consider the impact of hospital consolidation on the healthcare industry and consumers.  Led by Subcommittee Chairwoman Senator Amy Klobuchar, the Committee heard divergent views on the causes of hospital consolidation and its potential impacts on consumers. Read More ›

Long Term Care Facilities Should Prepare for County Investigations Into COVID Deaths

Earlier this month, Peter Lucido, the Macomb County Prosecutor, who was also a former Republican State Senator and State Senate Majority Whip, announced a plan to investigate COVID-19 deaths in Macomb County nursing homes to determine whether Executive Order 2020-50, which was issued in April 2020 by Governor Gretchen Whitmer, and is no longer in effect, was responsible for those deaths. Prosecutor Lucido made a form available to families of former nursing home residents to collect information from the facility and then share with Macomb County law enforcement officials.  Read More ›

OIG Puts Telehealth in its Crosshairs

The COVID-19 pandemic has dramatically altered the way health care providers render services, including the proliferation of telehealth options available. Most have viewed telehealth expansion positively with its ability to increase access to services while reducing burdens for both patients and providers. Dramatic growth in a health care service, however, also brings with it the opportunity for bad actors, especially in light of the inherent challenges associated with regulating a virtual service platform.    Read More ›

Healthcare Providers Must Remain Vigilant with ADA Service Animal Requirements

Health facilities and individual healthcare providers who open their offices to the public should remain aware they are subject to the Americans with Disabilities Act (“ADA”) requirements regarding service animals. Failing to adhere to the stringent ADA standards can quickly lead to patient complaints escalating to U.S. Department of Justice intervention, costly settlements, and steep civil penalties. Read More ›

The Ten Year Wait is Over: HRSA Releases 340B Dispute Resolution Final Rule

The 340B Program, named after its section within the 1992 Public Health Service Act, allows covered entities to stretch their scarce federal resources as far as possible, by setting  a ceiling price on the sale of covered outpatient drugs from participating pharmaceutical manufactures to covered entities. With the passage of the Patient Protection and Affordable Care Act in 2010, 340B’s oversight agency, the Health Resources and Services Administration (“HRSA”) within the Department of Health and Human Services (“HHS”), was directed to establish an administrative dispute resolution (“ADR”) process. Covered entities and pharmaceutical manufactures would then use the ADR process to settle claims such as drug overcharging, diversion, or duplicate discounts. It took ten years, but HHS has finally taken action. Read More ›

HHS Final Rules Modernize the Stark Law and Anti-Kickback Statute to Usher in Value-Based Care

On November 20, 2020, the U.S. Department of Health and Human Services (“HHS”) released final rules seeking to modernize the Physician Self-Referral Law (“Stark Law”) and the federal Anti-Kickback Statute (“AKS”).

The final rules, released by HHS’ Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”), are part of The Regulatory Sprint to Coordinated Care—an effort launched by HHS in 2018 aimed at removing barriers to value-based care. Among other changes, the final rules add new value-based exceptions to the Stark Law and additional safe harbors under the AKS. The important changes to the Stark Law and AKS are highlighted below. Read More ›

The CDC’s New Definition of “Close Contact”: What You Need To Know

The Centers for Disease Control and Prevention has expanded the definition of close contact to now evaluate exposure cumulatively over a 24-hour period such that “15 cumulative minutes of exposure at a distance of 6 feet or less can be used as an operational definition for contact investigation,”[1] Because the newly expanded definition is not limited, it impacts many different industries (including transportation and logistics, health care, automotive, manufacturing, and educational industries) and different persons (e.g., first responders, health care professionals, customer-facing employees, and others). As winter is coming and the holiday season is upon us, the CDC’s new “close contact” definition greatly impacts all workers, employers, and workplaces, as everyone now needs to evaluate physical distancing in smaller, repetitive increments of time. Read More ›

U.S. Department of Labor Issues Revised Regulations Implementing FFCRA Leaves Following New York Court’s Decision

We reported last month on a decision by a New York federal court that rejected portions of the Department of Labor regulations implementing the Families First Coronavirus Response Act (“FFCRA”) leaves signed into law earlier this year. The FFCRA created rights for employees of employers with fewer than 500 employees, and all public employers, to take up to 10 days of paid sick leave under the Emergency Paid Sick Leave Act (“EPSLA”) for various COVID-19 related reasons, and another 10 weeks of paid leave under the Emergency Family and Medical Leave Expansion Act (“EFMLEA”) for leaves necessitated by COVID-19 related school and day care closures. The court held that the following FFCRA rules were improper: Read More ›

Michigan Reinstitutes Pre-COVID Scope of Practice, Licensure, and Liability Standards

On July 13, 2020, Michigan Governor Gretchen Whitmer issued Executive Order 2020-150 to rescind a previous order (Executive Order 2020-61) that had permitted certain health care professionals to temporarily practice beyond the scope of their license. Governor Whitmer cited Michigan’s progress in slowing the spread of COVID-19 and the reduced pressure on hospitals as reasons for rescinding the prior expansion of scope.    Read More ›