In support of Lucido’s investigation, Republicans in both houses of Michigan’s legislature have introduced bills to provide funds for county prosecutors for further investigation. Specifically, Senate Bill 27, which the Senate already passed on a party line vote, appropriates $1.25 million for grants of up to $250,000 to prosecutors. House Bill 4589, which was introduced on March 25, 2021, appropriates $5 million to the “Prosecuting Attorneys Coordinating Council” for similar purposes. While it is unlikely either bill will become law, as they would require Governor Whitmer’s approval, Lucido’s efforts could have significant ramifications for the industry and, given the current political environment, are likely to spur “copy-cat” initiatives by prosecutors around the state and perhaps the nation.
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.
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.
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. Continue Reading The Ten Year Wait is Over: HRSA Releases 340B Dispute Resolution Final Rule
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. Continue Reading HHS Final Rules Modernize the Stark Law and Anti-Kickback Statute to Usher in Value-Based Care
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,” 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. Continue Reading The CDC’s New Definition of “Close Contact”: What You Need To Know
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: Continue Reading U.S. Department of Labor Issues Revised Regulations Implementing FFCRA Leaves Following New York Court’s Decision
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. Continue Reading Michigan Reinstitutes Pre-COVID Scope of Practice, Licensure, and Liability Standards
On March 27, 2020, Congress enacted the Coronavirus Aid, Relief, and Economic Security Act or “CARES Act” which includes $100 billion in relief funds for hospitals and other healthcare providers to be used to provide support for healthcare-related expenses or lost revenue attributable to COVID-19. Funding is also available to providers to assist uninsured individuals to obtain testing and treatment for COVID-19. Continue Reading DHHS Issues Terms and Conditions for Relief Funds
Nursing homes have been on the front lines throughout the COVID-19 pandemic as they care for the persons most at risk. In an effort to improve safety and curb the spread of COVID-19, federal and state authorities are relaxing certain compliance obligations. Despite this regulatory latitude, nursing facilities should remain aware that federal and state agencies continue to closely monitor nursing home compliance. Continue Reading Nursing Home Compliance Under the COVID-19 Microscope