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Homeostasis: Health Care Law Blog

Homeostasis: Health Care Law Blog

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California Attorney General Settlement of Hospital Merger Challenge Potentially Raises the Stakes for Hospital Mergers Nationwide

A California Superior Court recently approved the settlement of a hospital merger challenge brought by the California Attorney General’s Office against Cedars-Sinai Health System and Huntington Hospital. The action – and subsequent settlement – is noteworthy for at least two reasons. First, unlike in most other health system merger challenges, the two merging systems in this matter were not direct competitors. Second, the merging parties agreed to a number of limitations on their conduct going forward - including price controls and the appointment of a “monitor” to oversee their compliance going forward – that are quite uncommon and restrictive. Read More ›

Winning with FDA: How to Manage a Successful 510(k) Device Submission

In order to secure approval of a medical device, a sponsor must use one of several pathways prescribed by the FDA. The primary avenues are the 510(k) clearance, the Pre-Market Approval (PMA) and the de novo submission. This post will focus on the most common pathway, the 510(k). Virtually all Class II medical devices are cleared via the 510(k) submission process. While the 510(k) process is the least complicated, sponsors sometimes find it obscure and difficult to navigate. We will explore the most effective strategies for securing a 510(k) clearance, with a focus on the needs of smaller companies that have less experience with this pathway. Read More ›

Biden Executive Order Calls out the Healthcare Industry for More Vigorous Antitrust Scrutiny

Claiming that “federal inaction” has caused a weakening of competition in many U.S. industries, on July 9 President Biden issued an Executive Order directing the Attorney General and the Chair of the Federal Trade Commission to “vigorously” enforce the antitrust laws.  While the Order seeks to increase antitrust enforcement across a wide range of industries, President Biden singles out the healthcare industry for special attention and heightened enforcement. See Executive Order Fact SheetRead More ›

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 ›